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This document provides guidance for clinicians on the obstetric management of patients with COVID-19. It was created by the Philippine Infectious Diseases Society for Obstetrics and Gynecology (PIDSOG) to address the lack of evidence-based guidelines for treating pregnant women with COVID-19. The document includes sections on diagnosing and managing COVID-19 in pregnancy, investigational drugs being used to treat COVID-19, and recommended personal protective equipment for healthcare workers treating pregnant COVID-19 patients. It was created through an extensive review of the limited available literature on COVID-19 and pregnancy and provides the best interim strategies until more data is available.
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0% found this document useful (0 votes)
215 views70 pages

PDF

This document provides guidance for clinicians on the obstetric management of patients with COVID-19. It was created by the Philippine Infectious Diseases Society for Obstetrics and Gynecology (PIDSOG) to address the lack of evidence-based guidelines for treating pregnant women with COVID-19. The document includes sections on diagnosing and managing COVID-19 in pregnancy, investigational drugs being used to treat COVID-19, and recommended personal protective equipment for healthcare workers treating pregnant COVID-19 patients. It was created through an extensive review of the limited available literature on COVID-19 and pregnancy and provides the best interim strategies until more data is available.
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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PIDSOG HANDBOOK:

A GUIDANCE FOR CLINICIANS ON


THE OBSTETRIC MANAGEMENT OF
PATIENTS WITH CORONAVIRUS
DISEASE 2019 (COVID-19)

Philippine Obstetrical and Gynecological Society (Foundation), Inc.

Philippine Infectious Diseases Society for


Obstetrics and Gynecology, Inc.

April 2020
EDITORS
Katherine A. Angelo-Dela Cruz, MD
Jhorose R. Gementiza, MD
Florida F. Taladtad, MD
Cheryl T. Tiuseco, MD

TECHNICAL WORKING GROUP


PIDSOG Handbook: Guidance for Clinicians on the Obstetric
Management of Patients with COVID-19
Martha M. Aquino, MD
Analyn F. Fallarme, MD
Maria Lorena L. Santos, MD
Valiant L. See, MD
CONTRIBUTORS

BACKGROUND ON COVID-19
Sybil Lizanne R. Bravo, MD

DIAGNOSIS OF COVID-19 IN PREGNANCY


Head: Maria Lorena L. Santos, MD
Members:
Maria Meden P. Cortero, MD
Josefa Dawn V. Martin, MD
Sharon Faith B. Pagunsan, MD

MANAGEMENT OF COVID-19 IN PREGNANCY


Head: Martha M. Aquino, MD
Members:
Louella P. Aquino, MD Analyn F. Fallarme, MD
May G. Asis, MD Patricia M. Kho, MD
Ma. Angela R. Bandola, MD Henrietta S. Lucasan, MD
Sigrid A. Barinaga, MD Judith R. Peralta, MD
Erwin R. De Mesa, MD Guadalupe N. Villanueva, MD

INVESTIGATIONAL DRUGS USED IN COVID-19


Head: Analyn F. Fallarme, MD
Members:
Katherine A. Angelo-Dela Cruz, MD Josefa Dawn V. Martin, MD
Sybil Lizanne R. Bravo, MD Marilez H. Nazal, MD
Mary Judith Q. Clemente, MD Rojannah T. Sahagun, MD
Lorina Q. Esteban, MD Florida F. Taladtad, MD
Jhorose R. Gementiza, MD Cheryl T. Tiuseco, MD
Helen V. Madamba, MD

RECOMMENDED PPE USE FOR HEALTHCARE WORKERS CARING FOR


SUSPECTED AND CONFIRMED COVID-19 PREGNANT WOMEN
Head: Valiant L. See, MD
Members:
Sybil Lizanne R. Bravo, MD Christine D. Dizon, MD
Jennifer T. Co, MD Shareza B. Nadal, MD
Catherine Jane R. Costa, MD Mary Jane B. Noble, MD

COVER DESIGN
Ariel B. Vinarao, MD
FOREWORD

The Philippine Infectious Diseases Society for Obstetrics and Gynecology, Inc.
(PIDSOG) 2019-2020 Board of Directors and its members, were tasked to come up
with the appropriate algorithm for managing pregnant patients during this COVID-19
pandemic. This handbook will provide the best available strategy in the diagnosis,
management, treatment and prevention of COVID-19 among pregnant women.

The immediate development of this handbook was done with extensive search of
available literature and quality evidence of data gathered in a short period of time. The
COVID-19 disease is still in its early phase – constantly progressing and data on the
disease is dynamic. Real knowledge on its causative agent, SARS-CoV-2, is still
insufficient. As updates are ongoing, expect constant changes on recommendations
in the near future as we learn more about this evolving disease.

The PIDSOG 2019-2020 Board of Directors would like to commend all the members
of the technical working group for their efforts and dedication in the completion of this
handbook amidst these unprecedented times. We are in deep gratitude to the different
stakeholders who have contributed and supported the cause for which this handbook
was formulated.

Lastly, we hope that this handbook will be of great help to our fellow colleagues –
obstetricians, residents and fellows-in-training and allied medical practitioners – as we
fight our elusive opponent. Always remember that there is NO EMERGENCY in a
pandemic. Keep safe and God bless the Philippines!
Philippine Infectious Diseases Society for Obstetrics and
Gynecology (PIDSOG), Inc.

2019 – 2020 BOARD OF DIRECTORS

Erwin R. De Mesa, MD
President

Sybil Lizanne R. Bravo, MD


Internal Vice President

Maria Lu D. Andal, MD
External Vice President

Analyn F. Fallarme, MD
Secretary

Louella P. Aquino, MD
Assistant Secretary

Catherine Jane R. Costa, MD


Treasurer

Valiant L. See, MD
Assistant Treasurer

Christine D. Dizon, MD
Auditor

Maria Lorena L. Santos, MD


P.R.O

Maria Angela R. Bandola, MD


Immediate Past President
TABLE OF CONTENTS

I. Background on COVID-19
1
Sybil Lizanne R. Bravo, MD

II. Diagnosis of COVID-19 in Pregnancy – updated as of May 16, 2020

Maria Lorena L. Santos, MD / Maria Meden P. Cortero, MD / 3


Josefa Dawn V. Martin, MD / Sharon Faith B. Pagunsan, MD

III. Management of COVID-19 in Pregnancy

Martha M. Aquino, MD / Louella P. Aquino, MD / May G. Asis, MD / Maria


Angela R. Bandola, MD / Sigrid A. Barinaga, MD /
Erwin R. De Mesa, MD / Analyn F. Fallarme, MD /
Patricia M. Kho, MD / Henrietta S. Lucasan, MD /
Judith R. Peralta, MD / Guadalupe N. Villanueva, MD

IV. Investigational Drugs Used in COVID-19

Analyn F. Fallarme, MD / Katherine A. Angelo-Dela Cruz, MD /


Sybil Lizanne R. Bravo, MD / Mary Judith C. Clemente, MD /
Lorina Q. Esteban, MD / Jhorose R. Gementiza, MD /
Helen V. Madamba MD / Josefa Dawn V. Martin MD /
Mariles H. Nazal, MD / Rojannah T. Sahagun, MD /
Florida F. Taladtad, MD / Cheryl T. Tiuseco, MD

V. Recommended PPE Use for Healthcare Workers Caring for Suspected


and Confirmed COVID-19 Pregnant Women

Valiant L. See, MD / Sybil Lizanne R. Bravo, MD / Jennifer T. Co, MD / 32


Catherine Jane R. Costa, MD / Christine D. Dizon, MD /
Shareza B. Nadal, MD / Mary Jane B. Noble, MD

VI. Appendices

APPENDIX A: 55
Algorithm on Screening Pregnant Patients for SARS-CoV-2
APPENDIX B1: 56
Different Kinds of Face Mask
APPENDIX B2: 57
Different Kinds of N95 Face Mask
APPENDIX C: 58
PGH-HICU Risk-Based Personal Protective Equipment (PPE) Levels Infographic
APPENDICES D1-D2: 59
Components of Level 3 PPE for Ob-Gyn Procedures
APPENDICES E1-E3: 61
Components of Level 4 PPE for Ob-Gyn Procedures
BACKGROUND ON COVID-19
Sybil Lizanne R. Bravo, RPh, MD, MSc

WHAT IS A PANDEMIC?

Pandemic is defined as “an outbreak of a disease that occurs over a wide


geographical area and affects an exceptionally high proportion of the population,1”
or as defined by the World Health Organization (WHO), “is the worldwide spread of
a new disease.2”

The world has suffered a number of pandemics. There was the 1918 Spanish flu
wherein millions died. About eighteen years ago, we had the 2002-2004 severe
acute respiratory syndrome (SARS), which was also caused by a coronavirus. And
of course, there is the Ebola contagion which has originated in the African region
but made its way to some countries and which has baffled scientists all over.

Who would have thought that, indeed, in our lifetime, we would experience a
pandemic? This current COVID-19 pandemic has indeed been a conundrum for
men of science.

COVID-19 AND SARS-CoV-2

As detailed by the World Health Organization (WHO), there are two official names
for this pathogen – COVID-19 refers to the coronavirus disease, while severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) is used when referring to the
virus itself.3

Last February 11, 2020, the International Committee on Taxonomy of Viruses


(ICTV) announced the term SARS-CoV-2, because this current virus is genetically
related to the coronavirus that caused the SARS outbreak in year 2003.

CLINICAL PRESENTATION OF COVID-19?

As of current knowledge and with global experience, a substantial proportion of


severely ill patients may require intensive care. The main reason for admission into
an intensive care unit is mainly due to viral pneumonitis that evolves into acute
respiratory distress syndrome (ARDS). The usual symptoms are fever, cough, sore
throat, and malaise. The onset of difficulty of breathing is on day 5 to day 7, though
progression into ARDS may be fast thereafter, about 2-3 days from difficulty of
breathing. Almost half to all who are critically ill would eventually require mechanical

PIDSOG Handbook: A Guidance for Clinicians on the Obstetric Management of Patients with Coronavirus Disease 2019
Version 2.0 -- Released May 16, 2020
1
ventilation. Complications include acute renal failure, liver enzyme elevation,
cardiac pathologies such as cardiomyopathy, arrhythmia and sudden cardiac
death, septic shock, secondary bacterial pneumonia, altered lung compliance, and
encephalopathy. In lieu of these complications, it is imperative that healthcare
providers offer what they think and believe are best supportive forms of
management including the use of some investigational pharmacological therapies.

In these past few months, risk factors have been identified and most healthcare
providers agreed that there are at-risk or vulnerable populations, such as the
elderly, the young, and those with immunocompromising conditions. Pregnant
women, in any disease state, are considered a vulnerable population.

As such, this handbook will function as guidance for obstetrician-gynecologists and


other healthcare providers who tirelessly devote much of their time and effort in
making sure our Filipino gravidas and their unborn children will be given, if not the
definitive, but as of current situation, the most ideal and applicable management.

While it is true that knowledge of the pathophysiology, the virulence of this


contagion, and the therapy of this infection are very much in evolution, the authors
of this guidance hope that this will be of assistance to everyone involved in the care
of our pregnant women as the following are discussed: diagnosis, management,
treatment and prevention including proper use of personal protective equipment.

REFERENCES:
1. https://www.merriam-webster.com/dictionary/pandemic
2. https://www.who.int/csr/disease/swineflu/frequently_asked_questions/pandemic/en/
3. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/naming-the-coronavirus-
disease-(covid-2019)-and-the-virus-that-causes-it

PIDSOG Handbook: A Guidance for Clinicians on the Obstetric Management of Patients with Coronavirus Disease 2019
Version 2.0 -- Released May 16, 2020
2
DIAGNOSIS OF COVID-19 IN PREGNANCY
Maria Lorena L. Santos, MD
Maria Meden P. Cortero, MD / Josefa Dawn V. Martin, MD /
Sharon Faith B. Pagunsan, MD, MMPM

WHAT ARE THE CASE DEFINITIONS FOR COVID-19 IN PREGNANT WOMEN?


STATEMENT:
The case definitions for COVID-19 in pregnant women are no different from that
of the general population. The terms SUSPECTED case, PROBABLE case and
CONFIRMED case are used.
SUPPORTING STATEMENTS:
Suspected case
A patient with acute respiratory tract infection (i.e. sudden onset of at least one of the
following: fever, cough, shortness of breath) AND with no other etiology that fully
explains the clinical presentation AND with a history of travel or residence in a
country/area reporting local or community transmission during the 14 days prior to
symptom onset;
OR
A patient with any acute respiratory illness AND having been in close contact with a
confirmed or probable COVID-19 case in the last 14 days prior to onset of symptoms;
OR
A patient with severe acute respiratory illness (fever and at least one sign/symptom
of respiratory disease, e.g., cough, shortness of breath; AND requiring
hospitalization) AND in the absence of an alternative diagnosis that fully explains the
clinical presentation.

Probable Case
A suspected case for whom testing for virus causing COVID-19 is inconclusive
(according to the test results reported by the laboratory) or for whom testing was
positive on a pan-coronavirus assay.
Confirmed Case
A person with laboratory confirmation of virus causing COVID-19 infection,
irrespective of clinical signs and symptoms.

PIDSOG Handbook: A Guidance for Clinicians on the Obstetric Management of Patients with Coronavirus Disease 2019
Version 2.0 -- Released May 16, 2020
3
Close Contact
A close contact of a probable or confirmed case is defined as:
• A person living in the same household as a COVID-19 case;
• A person having had direct physical contact with a COVID-19 case (e.g. shaking
hands);
• A person having unprotected direct contact with infectious secretions of a COVID-
19
case (e.g. being coughed on, touching used paper tissues with a bare hand);
• A person having had face-to-face contact with a COVID-19 case within 2 meters
and > 15 minutes;
• A person who was in a closed environment (e.g. classroom, meeting room, hospital
waiting room, etc.) with a COVID-19 case for 15 minutes or more and at a distance
of less than 2 meters;
• A healthcare worker (HCW) or other person providing direct care for a COVID-19
case, or laboratory workers handling specimens from a COVID-19 case without
recommended personal protective equipment (PPE) or with a possible breach of
PPE;
• A contact in an aircraft sitting within two seats (in any direction) of the COVID-19
case, travel companions or persons providing care, and crew members serving in
the section of the aircraft where the index case was seated (if severity of symptoms
or movement of the case indicate more extensive exposure, passengers seated in
the entire section or all passengers on the aircraft may be considered close
contacts).
REFERENCES:
1. https://www.who.int/docs/default-source/coronaviruse/who-china-joint-missionon-covid-19-final-report.pdf
2. https://www.ecdc.europa.eu/en/case-definition-and-europe an-surveillance-human-infection-novel-coronavirus-2019-ncov

PIDSOG Handbook: A Guidance for Clinicians on the Obstetric Management of Patients with Coronavirus Disease 2019
Version 2.0 -- Released May 16, 2020
4
WHEN DO YOU SUSPECT THAT A PREGNANT PATIENT HAS COVID-19?
STATEMENT:
The possibility of COVID-19 infection is suspected in a pregnant woman with
new-onset fever and/or respiratory symptoms. It should also be considered in
a pregnant woman with severe lower respiratory tract illness without any clear
cause.
SUPPORTING STATEMENTS:
Clinical findings
The clinical characteristics reported among pregnant women with confirmed COVID-
19 infection are similar to those reported in non-pregnant adults in the general
population. There are no specific clinical features that can reliably distinguish COVID-
19 infection from other viral respiratory infections.

Pneumonia appears to be the most frequent serious manifestation of the infection,


characterized by fever, cough, dyspnea, and bilateral infiltrates on chest imaging.1-4
In a study describing 138 patients with COVID-19 pneumonia in Wuhan, the most
common clinical features at the onset of illness were fever, cough, and dyspnea.4

Similarly, other cohort studies of patients from Wuhan with confirmed COVID-19
infection have reported a similar range of clinical findings.2,3
Table 2.1 COVID-19 Common Clinical Features

Nonetheless, the symptoms expressed by COVID-19 patients are nonspecific and


cannot be used for an accurate diagnosis.

Other less common symptoms include headache, sore throat, and rhinorrhea. In
addition to respiratory symptoms, gastrointestinal symptoms (e.g. nausea and
diarrhea) have also been reported; and in some patients, these may be the
presenting complaint.2,4

PIDSOG Handbook: A Guidance for Clinicians on the Obstetric Management of Patients with Coronavirus Disease 2019
Version 2.0 -- Released May 16, 2020
5
Reports of cohorts in locations outside of Wuhan have described similar clinical
findings, although some have suggested that milder illness may be more common.5-
7
As an example, in a study of 62 patients with COVID-19 infection in the Zhejiang
province of China, all but one had pneumonia, but only two developed dyspnea, and
only one warranted mechanical ventilation.6

Anosmia has been anecdotally reported as a distinguishing symptom in patients who


were ultimately diagnosed with COVID-19.8 However, published cohort studies have
not highlighted this symptom, and its frequency and utility in suspecting COVID-19
infection is uncertain.

Laboratory findings
In patients with COVID-19 infection, the white blood cell count can vary. Leukopenia,
leukocytosis, and lymphopenia have been reported, although lymphopenia appears
most common.9 Elevated lactate dehydrogenase and ferritin levels are common, and
elevated aminotransferase levels have also been described. On admission, many
patients with pneumonia have normal serum procalcitonin levels. However, in those
requiring ICU care, they are more likely to be elevated.2-4 High D-dimer levels and
more severe lymphopenia have been associated with mortality.3

Inflammatory Markers
Serum Procalcitonin
Serum procalcitonin is often normal on admission, however, it increases in patients
who require ICU care.
C-reactive protein (CRP)
COVID-19 infection increases CRP. This seems to track with disease severity and
prognosis. In patients suffering from with severe respiratory failure with a normal CRP
level an alternative diagnosis should always be sought.10

REFERENCES:
1. Guan WJ, Ni ZY, Hu Y, et al. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med 2020.
2. Huang C, Wang Y, Li X, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet
2020; 395:497.
3. Chen N, Zhou M, Dong X, et al. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus
pneumonia in Wuhan, China: a descriptive study. Lancet 2020; 395:507.
4. Wang D, Hu B, Hu C, et al. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected
Pneumonia in Wuhan, China. JAMA 2020.
5. Chang, Lin M, Wei L, et al. Epidemiologic and Clinical Characteristics of Novel Coronavirus Infections Involving 13 Patients
Outside Wuhan, China. JAMA 2020.
6. Xu XW, Wu XX, Jiang XG, et al. Clinical findings in a group of patients infected with the 2019 novel coronavirus (SARS-
Cov-2) outside of Wuhan, China: retrospective case series. BMJ 2020; 368:m606.
7. Wu J, Liu J, Zhao X, et al. Clinical Characteristics of Imported Cases of COVID-19 in Jiangsu Province: A Multicenter
Descriptive Study. Clin Infect Dis 2020.
8. https://www.entnet.org/content/coronavirus-disease-2019-resources (Accessed on March 28, 2020).
9. Centers for Disease Control and Prevention. Interim Clinical Guidance for Management of Patients with Confirmed 2019
Novel Coronavirus (2019-nCoV) Infection
10. Guan W, Ni Z, Yu Hu W, Liang, C. Ou, J He, Liu L, Shan H, Lei C, Hui D.S.C., Du B, Li L, Zeng G, Yuen K.Y., Chen R.
Clinical Characteristics of Coronavirus Disease 2019 in China.

PIDSOG Handbook: A Guidance for Clinicians on the Obstetric Management of Patients with Coronavirus Disease 2019
Version 2.0 -- Released May 16, 2020
6
WHO SHOULD BE TESTED FOR COVID-19?
STATEMENT:
All pregnant women with symptoms associated to COVID-19 infection should
be tested. Testing should also be considered in pregnant women with
increased of exposure to the diseases, such as those who reside in or has a
history of travel within the prior 14 days to a location with community
transmission or those who had close contact with a confirmed or suspected
case of COVID-19.
SUPPORTING STATEMENTS:
Testing is done based on approved
local protocols. Current guidelines do
not recommend testing for
asymptomatic individuals with no
comorbidities.1

Although the DOH has recognized the


pregnant population as a “vulnerable”
group, the evidence, so far, have shown
that pregnant women are still no more
likely to contract the infection than the
general population. In fact, the
Infectious Disease Society of America
(IDSA) classified pregnant women
under “Tier 3” for COVID-19
2
Prioritization Testing. However,
pregnancy in a small proportion of
Figure 2.1 Case Definition Classification
women, may alter the response of the
body to severe viral infections, and as such, some pregnant women may be at a
greater risk for severe illness, morbidity or mortality compared with the general
population.

Hence, pregnancy alone in the setting of new-flu like symptoms is sufficient to


warrant COVID-19 testing, especially if additional risk factors (e.g. close contact with
a known COVID-19 case, immunocompromised, with comorbidities such as
hypertension, diabetes, etc.) are identified in the patient.
The possibility of COVID-19 should be considered primarily in patients with new
onset fever and/or respiratory tract symptoms. It should also be considered in
patients with severe lower respiratory tract illness without any clear cause.

PIDSOG Handbook: A Guidance for Clinicians on the Obstetric Management of Patients with Coronavirus Disease 2019
Version 2.0 -- Released May 16, 2020
7
Although these syndromes can occur with other viral respiratory illnesses, the
likelihood of COVID-19 is increased if the patient:

• Resides in or has traveled within the prior 14 days to a location where there is
community transmission of COVID-19 (i.e. large numbers of cases that cannot
be linked to specific transmission chains) OR
• Has had close contact with a confirmed or suspected case of COVID-19 in the
prior 14 days, including those who work in health care settings.

Close contact includes being within approximately six feet (about two meters) of a
patient for a prolonged period of time while not wearing personal protective
equipment or having direct contact with infectious secretions while not wearing
personal protective equipment.
REFERENCES:
1. Philippine Society for Microbiology and Infectious Diseases Interim Guidelines On The Clinical Management Of Adult
Patients With Suspected Or Confirmed Covid-19 Infection Version 2.0, as of 26 March 2020
2. Infectious Diseases Society of America. COVID-19 Prioritization of Diagnostic Testing.
https://www.idsociety.org/globalassets/idsa/public-health/covid-19-prioritization-of-dx-testing.pdf

PIDSOG Handbook: A Guidance for Clinicians on the Obstetric Management of Patients with Coronavirus Disease 2019
Version 2.0 -- Released May 16, 2020
8
SHOULD ASYMPTOMATIC PREGNANT WOMEN BE SCREENED FOR SARS-
CoV-2 PRIOR TO DELIVERY?

STATEMENT:
Asymptomatic individuals play a role in the transmission of COVID-19. Hence,
screening for SARS-CoV-2 should be considered among pregnant women at
37 – 38 weeks to give time for the release of the results prior to delivery.

SUPPORTING STATEMENTS:
Experience with COVID-19 in pregnancy is limited. To date, data is based on case-
series that are not controlled. The background comorbidities in the population, local
testing policies, and obstetric care practices may limit generalizability to our
population.

Identifying pregnant women with COVID-19 infection has several goals:


1. To tailor frequency and location of prenatal care for identified COVID-19
confirmed women and COVID suspects and probable cases.
2. To decrease risk of transmission to other patients, healthcare personnel, and
family living in the same space
3. To plan for labor and delivery care
4. To plan for mother-infant separation strategies, if necessary

Rate of Asymptomatic Women with Positive


SARS-CoV-2 Results
Pregnancy alone in the setting of new flu-like
symptoms is sufficient to warrant COVID-19
testing especially if with additional risk factors
(e.g. close contact with known COVID-19 case,
immunocompromised, with co-morbidities e.g.,
hypertension, diabetes). However, patients
may present early in their infectious course
prior to symptoms or may have asymptomatic
viral carriage.
Figure 2.2 Symptom status and SARS-CoV-2 test
results among 215 obstetrical patients presenting for
delivery. (SOURCE: Adapted from Sutton NEJM)

In a series of 43 COVID-19 infected pregnant women in New York, 32.6% of them


presented WITHOUT symptoms. Of these, 46.2% developed symptoms within 7
days after the positive test.1

A recent series (by Sutton et al.) of 215 pregnant patients from New York
demonstrated a 13.7% rate of positive testing for SARS-CoV-2 amongst

PIDSOG Handbook: A Guidance for Clinicians on the Obstetric Management of Patients with Coronavirus Disease 2019
Version 2.0 -- Released May 16, 2020
9
asymptomatic women (4/215 had fever, while 211/215 were asymptomatic).
Nasopharyngeal swabs were obtained from 210 of the 211 women (99.5%) who did
not have symptoms of COVID-19. Of these women, 29 (13.7%) were positive for
SARS-CoV-2. Thus, 4 out of 33 patients who were positive for SARS-CoV-2 on
admission were symptomatic (12.1%), while 29 of the 33 patients who were positive
for SARS-CoV-2 at admission (87.9%) had no symptoms of COVID-19 at
presentation.2

Sutton et al. said that “use of universal SARS-CoV-2 testing in all pregnant patients
presenting for delivery revealed that at this point in the pandemic in New York City,
most of the patients who were positive for SARS-CoV-2 at delivery were
asymptomatic”. This highlights the risk of COVID-19 infection in asymptomatic
pregnant women. Hence, they concluded that the potential benefits of a universal
testing approach include the ability to use COVID-19 status to determine hospital
isolation practices and bed assignments, inform neonatal care, and guide the use of
personal protective equipment.2 This report in a high prevalence area demonstrated
1 out of 8 asymptomatic pregnant patients presenting for delivery were SARS-CoV-
2 positive, illustrating a need for universal screening.

Another New York study was done by Vintzileos et al. with the primary objective of
determining the accuracy of maternal symptomatology in predicting the COVID-19
infection as confirmed by rapid laboratory testing using GeneXpert SARS-CoV-2
Nasopharyngeal Sample Collection Kit.3 A total of 161 patients underwent routine
COVID-19 testing on admission to labor and delivery room. Of the 161 patients
tested, 32 (19.9%) were COVID-19 positive and of these, 11 (34%) were
symptomatic and 21 (66%) were asymptomatic.3

Table 2.2 Accuracy of maternal symptomatology in predicting the COVID-19 infection.3


Positive COVID- Negative COVID-19 Total
19
Symptomatic 11 5 16
Asymptomatic 21 124 145
Total 32 129 161
Note. Sensitivity = 11/32 (34.4%); specificity = 124/129 (96.1%); positive predictive value = 11/16 (68.7%); negative predictive
value = 124/145 (85.5%); positive likelihood ratio = 8.8; negative likelihood ratio = 0.68.

Can these numbers be generalizable to areas with lower infection rates like the
Philippines? It would be good to know how transmission rates differ between
symptomatic carriers and those who are asymptomatic. As this pandemic evolves,
we are learning more and more, and it is important to expand our understanding of
asymptomatic transmission and the risk this may pose.

Key benefits to screening are the capability for labor and delivery units to implement
best hospital practices in their care of mothers and babies, such as admitting

PIDSOG Handbook: A Guidance for Clinicians on the Obstetric Management of Patients with Coronavirus Disease 2019
Version 2.0 -- Released May 16, 2020
10
confirmed patients to cohort units. Such units would allow for closer monitoring of
mothers and babies, as well as ensuring proper use of personal protective equipment
by health care teams and also would help preserve supplies of personal protective
equipment.

Hospital testing capacity is an obvious barrier to screening of pregnant


women, as well as factors like the need for additional protective equipment to
be used during swab collection. Also, if you get a negative result and there is
a strong suspicion for COVID-19 infection, when do you retest? These are key
questions or areas of assessment that should be considered before embarking
on screening for pregnant women. In addition, some patients may refuse
testing out of fear of stigma or separation from their newborn.

Implementing an ‘opt out’ approach to screening may be encouraged, whereby a


patient is informed that a test will be included in standard preventive screening, and
they may decline the test. Routine, opt-out screening approaches have proven to be
highly effective as it removes the stigma associated with testing, fosters earlier
diagnosis and treatment, reduces risk of transmission, and has proven to be cost
effective. Pregnant women should be reassured that screening is beneficial for their
care and the care of their newborn baby.

Traditional infection control and public health strategies rely heavily on early
detection of disease to contain spread. When COVID-19 burst onto the global scene,
public health officials initially deployed interventions that were used to control severe
acute respiratory syndrome (SARS) in 2003, including symptom-based case
detection and subsequent testing to guide isolation and quarantine.

This initial approach was justified by the many similarities between SARS-CoV-1 and
SARS-CoV-2, including high genetic relatedness, transmission primarily through
respiratory droplets, and the frequency of lower respiratory symptoms with both
infections developing a median of 5 days after exposure. However, despite the
deployment of similar control interventions, the trajectories of the two epidemics have
veered in dramatically different directions.

What explains these differences in transmission and spread? A key factor in the
transmissibility of Covid-19 is the high level of SARS-CoV-2 shedding in the upper
respiratory tract, even among pre-symptomatic patients, which distinguishes it from
SARS-CoV-1, where replication occurs mainly in the lower respiratory tract.4,5 Viral
loads with SARS-CoV-1, which are associated with symptom onset, peak a median
of 5 days later than viral loads with SARS-CoV-2, which makes symptom-based
detection of infection more effective in the case of SARS CoV-1.6

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Ultimately, the rapid spread of COVID-19 across the globe, the clear evidence of
SARS-CoV-2 transmission from asymptomatic persons, and the eventual need to
relax current social distancing practices argue for broadened SARS-CoV-2 testing to
include asymptomatic persons even in low epidemics.

Depending on the availability of testing capacity and resources, institutions


should consider implementing screening on labor and delivery as several
geographic areas are predicted to reach their peak time of COVID-19
transmission, and it is clear that asymptomatic individuals continue to play a
role in its transmission. It may be more prudent to conduct the testing at 37-38
weeks, giving a lead time for the release of results prior to delivery. If labor
ensues >14 days from the last testing, repeat testing may be done, if resources
would allow (Appendix A).
REFERENCES:
1. Breslin N, Baptiste C, Gyamfi-Bannerman C, Miller R, Martinez R, Bernstein K, Ring L, Landau R, Purisch S, Friedman AM,
Fuchs K, Sutton D, Andrikopoulou M, Rupley D, Sheen JJ, Aubey J, Zork N, Moroz L, Mourad M, Wapner R, Simpson LL,
D’Alton ME, Goffman D. COVID-19 infection among asymptomatic and symptomatic pregnant women: Two weeks of
confirmed presentations to an affiliated pair of New York City hospitals
2. Sutton D, Fuchs K, D’Alton M, Goffman D. Correspondence: Universal Screening for SARS-CoV-2 in Women Admitted for
Delivery. N Engl J Med. 2020 Apr 13. doi: 10.1056/NEJMc2009316.
3. Vintzileos W, Muscat J, Hoffman E, Vo D, John N, Vertichio R, Vintzileos A. Screening all pregnant women admitted to labor
and delivery for the virus responsible for COVID-19. American Journal of Obstetrics and Gynecology. www.ajog.org
4. Wölfel R, Corman VM, Guggemos W, et al. Virological assessment of hospitalized patients with COVID-2019. Nature 2020
April 1.
5. Cheng PK, Wong DA, Tong LK, et al. Viral shedding patterns of coronavirus in patients with probable severe acute respiratory
syndrome. Lancet 2004; 363: 1699-700.
6. To KK-W, Tsang OT-Y, Leung W-S, et al. Temporal profiles of viral load in posterior oropharyngeal saliva samples and
serum antibody responses during infection by SARS-CoV-2: an observational cohort study. Lancet Infect Dis 2020 March
23

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WHAT IS THE GOLD STANDARD IN THE DIAGNOSIS OF COVID-19
INFECTION?

STATEMENT:
Reverse Transcription-Polymerase Chain Reaction (RT-PCR) test is the gold
standard to identify COVID-19 infection.

SUPPORTING STATEMENTS:
Thus far, the most commonly used and reliable test for diagnosis of COVID-19 has
been the RT-PCR test performed using nasopharyngeal swabs or other upper
respiratory tract specimens, including throat swab or, more recently, saliva. Test
results are generally available within a few hours to 2 days.

Table 2.3 Detection Rate from Different Biological Sources


Furthermore, the accuracy
and reliability of RT-PCR for
diagnosing SARS-CoV-2
infection depends on many
biological and technical
15
variables. Beside the
influence of procedures used
for collecting, transporting
and storing the specimens, as
well as from concomitant
antiviral therapy,16 virus
detection is largely influenced
by the biological source. Wang et al, for example, recently showed that the rate of
RT-PCR detection of SARS-CoV-2 in patients diagnosed with COVID-19 is as high
as 93% in bronchoalveolar lavage (BAL) fluid, but then decreases to 72% in sputum
and 63% in nasal swabs, respectively, whilst it is only 32% in pharyngeal swabs and
29% in stool. To et al also reported that the positive rate of RT-PCR for SARS-CoV-
2 is 15-30% in blood and 14-38% in rectal swabs, respectively.

False-negative result, on the other hand, ranges of 17-63% for nasopharyngeal


SARS-CoV2 RT-PCR have been reported in non-pregnant patients; however,
without clear gold standard tests available, diagnostic test characteristics including
sensitivity, specificity, positive and negative predictive values of SARS-CoV2 RT-
PCR assays are difficult to determine.19-21 Sensitivity of BAL samples appear to
be higher than nasopharyngeal or oropharyngeal swabs, but requires invasive and
high-risk aerosolizing bronchoscopy to obtain a sample.20,21

Given these, the most prudent strategy may be to presume that all patients are
infected and use the best available infection prevention possible during the duration
of this pandemic.

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Then again, there are issues that have arisen with RT-PCR. First, the availability
of RT-PCR reagent kits has not kept up with demand. Second, community or
provincial hospitals outside of urban cities (NCR or laboratories other than
those identified as subnational laboratories) lack the PCR infrastructure to
accommodate high sample output. Lastly, RT-PCR relies on the presence of
detectable SARS-CoV-2 in the sample collected. If an asymptomatic patient
was infected with SARS-CoV-2 but has since recovered, RT-PCR would not
identify this prior infection, and control measures would not be enforced.
Despite these issues, given the lack of effective vaccines or treatments as of
writing, the only currently available lever to reduce SARS-CoV-2 transmission
is to identify and isolate persons who are contagious.

Reverse Transcription Polymerase Chain Reaction (RT-PCR)

RT-PCR assays have been designed to detect SARS-CoV-2 genetically. RT-PCR


involves the reverse transcription of SARS-CoV-2 RNA into complementary DNA
(cDNA) strands, followed by amplification of specific regions of the cDNA.1,2

RT-PCR is the most predominantly used method for diagnosing COVID-19 using
respiratory sample.8 Upper respiratory samples are broadly recommended, although
lower respiratory samples are recommended for patients exhibiting productive
cough.9 Upper respiratory tract samples include nasopharyngeal swabs,
oropharyngeal swabs, nasopharyngeal washes, and nasal aspirates. Lower
respiratory tract samples include sputum, bronchoalveolar lavage (BAL) fluid, and
tracheal aspirates. Both BAL and tracheal aspirates can be high risk for aerosol
generation.

The detectable viral load depends on the days after illness onset. In the first 14 days
after onset, SARS-CoV-2 could most reliably be detected in sputum followed by nasal
swabs, whereas throat swabs were unreliable 8 days after symptom onset.10 Given
the variability in the viral loads, a negative test result from respiratory samples does
not rule out the disease. These negatives could result from improper sampling
techniques, low viral load in the area sampled, or mutations in the viral genome.11
Moreover, a “positive” PCR result reflects only the detection of viral RNA and does
not necessarily indicate presence of viable virus.12

PIDSOG Handbook: A Guidance for Clinicians on the Obstetric Management of Patients with Coronavirus Disease 2019
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In some cases, viral RNA
has been detected by RT-
PCR even beyond week 6
following the first positive
test.14 A few cases have
also been reported positive
after 2 consecutive
negative PCR tests
performed 24 hours apart.
It is unclear if this is a
testing error, reinfection, or
reactivation. In a study of 9
Figure 2.3 Estimated Variation Over Time in Diagnostic Tests for Detection patients, attempts to isolate
of SARS-CoV-2 Infection Relative to Symptom Onset (Source: Sethuraman, et al.)
the virus in culture were not
successful beyond day 8 of illness onset, which correlates with the decline of
infectivity beyond the first week. 12 That is in part why the “symptom-based strategy”
of the Centers for Disease Control and Prevention (CDC) indicates that health care
workers can return to work, if “at least 3 days (72 hours) have passed since recovery
defined as resolution of fever without the use of fever-reducing medications and
improvement in respiratory symptoms (e.g., cough, shortness of breath); and, at least
10 days have passed since symptoms first appeared.”13

Bronchoscopy

Bronchoscopy helps in obtaining BAL samples in patients who are unable to


expectorate sputum for bacterial culture studies, AFB smear, or GeneXpert.1 It can
also be used to clear out mucus plugs in ventilated patients. However, it may cause
some deterioration in clinical condition, especially in patients who are on high oxygen
support. Likewise, there is high risk of infection transmission to providers resulting
from high aerosol production during the procedure. Moreover, there will be significant
utilization of valuable resources during bronchoscopy, which will be limited in supply
during a pandemic. Hence, bronchoscopy should not be done only for the purpose
of ruling COVID-19.4,5

If bronchoscopy is warranted, consider the use of a disposable bronchoscope if


available. Consider performing bronchoscopy in the patient’s place of care to
minimize the exposure and contamination. Minimize staff inside the room during
procedure; use a negative pressure room if available. Complete personal protective
equipment should be used. Standard disinfection protocols should be followed for
cleaning your flexible bronchoscopes and video monitors.

PIDSOG Handbook: A Guidance for Clinicians on the Obstetric Management of Patients with Coronavirus Disease 2019
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REFERENCES:
1. Freeman, W.M.; Walker, S.J.; Vrana, K.E. Quantitative RTPCR: Pitfalls and Poternial. BioTechniques 1999, 26 (1), 124-
125.
2. Kageyama, t.; Kojima,S.; Shinohara.; Uchida, K.; Fukushi, s.; Hoshino, F.B.; Takeda, n.; Katayama, K.; Broadly Reactive
ang Highly Sensitive Assay for Norwalk-like Viruses Based on Real-Time Qunatitative Reverse Transcription-PCR. J. Clin.
Microbiol. 2003, 41(4), 1548-1557.
3. Bouadma L, Lescure FX, Lucet JC, Yazdanpanah Y and Timsit JF. Severe SARS-CoV-2 infections: practical
considerations and management strategy for intensivists. https://link.springer.com/content/pdf/10.1007/s00134-020-
05967-x.pdf.
4. Momen M. Wahidi MM, Lamb C, Murgu S, MD. American Association for Bronchology and Interventional Pulmonology
(AABIP) Statement on the Use of Bronchoscopy and Respiratory Specimen Collection in Patients with Suspected or
Confirmed COVID-19 Infection.
5. Buonsenso D, Piano A, Raffaelli F, Bonadia N. Point-of-Care Lung Ultrasound findings in novel coronavirus disease-19
pnemoniae: a case report and potential applications during COVID-19 outbreak. Eur Rev Med Pharmacol Sci. 2020;
24:2776–80.
6. Rothe C, Schunk M, Sothmann P, et al. Transmission of 2019-nCoV Infection from an Asymptomatic Contact in Germany.
N Engl J Med 2020; 382:970.17.
7. Kupferschmidt K. Study claiming new coronavirus can be transmitted by people without symptoms was flawed. Science.
February 3, 2020. https://www.science mag.org/news/2020/02/paper-non-symptomatic-patient-transmitting-coronavirus-
wrong
8. Laboratory Testing for Coronavirus Disease 2019 (COVID-19) in Suspected Human Cases; World Health Organization:
Geneva, 2020.
9. Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons Under Investigation (PUIs) for
Coronavirus Disease 2019 (COVID-19); Centers for Disease Control and Prevention.
10. Yang, Y.; Yang, M.; Shen, C.; Wang, F.; Yuan, J.; Li, J.; Zhang, M.; Wang, Z.; Xing, L.; Wei, J.; et al. Laboratory Diagnosis
and Monitoring the Viral Shedding of 2019-nCoV Infections. medRxiv, February 17, 2020.
11. Winichakoon, P.; Chaiwarith, R.; Liwsrisakun, C.; Salee, P.; Goonna, A.; Limsukon, A.; Kaewpoowat, Q. Negative
Nasopharyngeal and Oropharyngeal Swab Does Not Rule Out COVID-19. J. Clin. Microbiol. 2020
12. Wölfel R, Corman VM, GuggemosW, et al. Virological assessment of hospitalized patients with COVID-2019. Nature.
2020. Published online April 1, 2020.
13. CDC. Return-to-work criteria for healthcare workers. Updated April 30, 2020. Accessed May 3, 2020.
14. Sethuraman N, Jeremiah SS, Ryo A. Interpreting Diagnostic Tests for SARS-CoV-2. JAMA, Published Online:May 6,
2020. doi:10.1001/jama.2020.8259
15. Galli C, Plebani M. Clinical laboratory and SARS-CoV-2 infection: where do we stand? Clin Chem Lab Med. 2020 Apr 2.
16. Lippi G, Simundic AM, Plebani M. Potential preanalytical and analytical vulnerabilities in the laboratory diagnosis of
coronavirus disease 2019 (COVID-19). Clin Chem Lab Med. 2020 Mar 16.
17. Wang W, Xu Y, Gao R, et al. Detection of SARS-CoV-2 in Different Types of Clinical Specimens. JAMA. 2020 Mar 11.
doi: 10.1001/jama.2020.3786.
18. To KK, Tsang OT, Leung WS, et al. Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum
antibody responses during infection by SARS-CoV-2: an observational cohort study. Lancet Infect Dis. 2020 Mar 23.
19. Xiao AT, Tong YX, Zhang S. False-negative of RT-PCR and prolonged nucleic acid conversion in COVID-19: Rather than
recurrence. Journal of Medical Virology. doi:10.1002/jmv.25855
20. Ai T, Yang Z, Hou H, et al. Correlation of Chest CT and RT-PCR Testing in Coronavirus Disease 2019 (COVID-19) in
China: A Report of 1014 Cases. Radiology. February 2020:200642. doi:10.1148/radiol.2020200642
21. Long C, Xu H, Shen Q, et al. Diagnosis of the Coronavirus disease (COVID-19): rRT-PCR or CT? Eur J Radiol.
2020;126:108961. doi:10.1016/j.ejrad.2020.108961

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WHAT IS THE ROLE OF ANTIBODY TESTING IN THE DIAGNOSIS AND
MANAGEMENT OF COVID-19 INFECTION?

STATEMENT:
The rapid antibody-based (IgM/IgG) tests may be used as an adjunct to RT-PCR
and must not be used as a stand-alone test.

SUPPORTING STATEMENTS:
Serology, or antibody testing, is the latest entry in the COVID-19 testing landscape.
Serological diagnosis is especially important for patients with mild to moderate illness
who may present late, beyond the first 2 weeks of illness onset. Serological diagnosis
also is becoming an important tool to understand the extent of COVID-19 in the
community and to identify individuals who are immune and potentially “protected”
from becoming infected.

Serology testing is used to detect antibodies against SARS-COV-2 in the blood and
provides evidence that the patient has been exposed to the virus. Serology testing
alone is not recommended for COVID-19 diagnosis due to the kinetics of infection.
In the majority of individuals infected with SARS-CoV-2, we would expect to see a
peak in viral replication that coincides with the development of symptoms. This is
followed by the development of antibodies several days later (known as
seroconversion). Testing a patient too early in the course of infection may yield a
false-negative result because the patient has not yet seroconverted. Moreover, even
when patients have seroconverted, they still may be infectious and continue to shed
virus.

But, any antibody test, whether performed in the laboratory (e.g., laboratory-based
enzyme immunoassays on high throughput automated platforms) or at the rapid
point-of-care, as is the case with finger stick antibody testing at primary health
facilities, must be validated to ensure accuracy, consistency, reliability, and
reproducibility.

COVID-19 Rapid Diagnostic Test qualitatively detects the


presence of IgG and IgM antibodies to SARS-CoV-2 in human
whole blood, serum, plasma samples of people believed to have
been infected with COVID-19.6,7

This test applies lateral flow immuno-chromatography and is a tool


to assist in the diagnosis of SARS-CoV-2 infections. The IgM-IgG
combined assay has better utility and sensitivity compared with a
single IgM or IgG test. It can be used for the rapid screening of
SARS-CoV-2 carriers, symptomatic or asymptomatic, in hospitals,
clinics, and test laboratories.1

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These point-of-care tests are used to diagnose patients without sending samples to
centralized facilities, thereby enabling communities without laboratory infrastructure
to detect infected patients. Despite the promise, there is no definitive evidence
regarding the utility of rapid kits for testing COVID 19 suspected patients
respiratory/serum samples.

Studies suggest that the majority of patients develop antibody response only in the
second week after onset of symptoms.6 This means that a diagnosis of COVID-19
infection based on antibody response will often only be possible in the recovery
phase, when many of the opportunities for clinical intervention or interruption of
disease transmission have already passed.

Moreover, antibody detection tests targeting COVID-19 may also cross-react with
other pathogens, including other human coronaviruses and give false-positive
results.8

Lastly, there has been discussion about whether rapid diagnostic tests could predict
whether an individual was immune to reinfection with the COVID-19 virus. There is
no evidence to date to support this.

COVID-19 Expanded Testing in the Philippines

With the increasing COVID-19 cases in


the Philippines, there is also a
concomitant increase in the demand for
RT-PCR testing all over the country. In
order to maximize the limited testing
capacity, the Department of Health
(DOH) issued guidelines on risk-based
testing for COVID-19, which includes
the following groups: 1) suspect cases
or 2) individuals with relevant history of
travel and exposure (or contact),
whether asymptomatic or symptomatic,
and 3) healthcare workers with possible
exposure, whether asymptomatic or
symptomatic.

Figure 2.4 Use of rapid antibody tests as adjunct test for


testing COVID-19 among SYMPTOMATIC patients and
healthcare workers with relevant history or travel exposure

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The guidelines emphasized that based
on current available evidence, RT-PCR
testing is the confirmatory test, which
are FDA-approved and validated by the
Research Institute of Tropical Medicine
(RITM). The guidelines also made
mention of the use of rapid antibody
tests and reiterated that such shall not
be used as standalone tests to definitely
diagnose or rule out COVID-19.

The DOH guidelines further mentions


that rapid antibody-based testing may
be used for ASYMPTOMATIC non-
healthcare workers who are close
contacts of confirmed COVID-19 cases,
provided that rapid antibody-based test
kits are validated. The table to the left is
a helpful summary of recommended
actions depending on the result of the Figure 2.5 Use of rapid antibody tests among
ASYMPTOMATIC patients and healthcare workers with
rapid antibody-based test. relevant history and travel exposure

Table 2.4: Recommended Actions based on Rapid Antibody Test

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REFERENCES:
1. https://onlinelibrary.wiley.com/doi/epdf/10.1002/jmv.25727 Development and Clinical Application of A Rapid IgM/IgG
Combined Antibody Test for SARSCoV2 Infection Diagnosis
2. Bouadma L, Lescure FX, Lucet JC, Yazdanpanah Y and Timsit JF. Severe SARS-CoV-2 infections: practical
considerations and management strategy for intensivists. https://link.springer.com/content/pdf/10.1007/s00134-020-
05967-x.pdf.
3. Momen M. Wahidi MM, Lamb C, Murgu S, MD. American Association for Bronchology and Interventional Pulmonology
(AABIP) Statement on the Use of Bronchoscopy and Respiratory Specimen Collection in Patients with Suspected or
Confirmed COVID-19 Infection.
4. Buonsenso D, Piano A, Raffaelli F, Bonadia N. Point-of-Care Lung Ultrasound findings in novel coronavirus disease-19
pnemoniae: a case report and potential applications during COVID-19 outbreak. Eur Rev Med Pharmacol Sci.
2020;24:2776–80.
5. FDA Advisory No. 2020-483
6. Liu Y, Liu Y, Diao B, Ren Feifei, et al. Diagnostic indexes of a rapid IgG/IgM combined antibody test for SARS-CoV-2.
7. Pan, Y.; Zhang, D.; Yang, P.; Poon, L. L. M.; Wang, Q. Viral Load of SARS-CoV-2 in Clinical Samples. Lancet Infect. Dis.
2020, 20, 411.
8. Che X, Qiu L, Liao Z, Wang Y, et al. Antigenic cross-reactivity between severe acute respiratory syndrome-associated
coronavirus and human coronaviruses 229E and OC43. The Journal of Infectious Diseases, Volume 191, Issue 12, 15
June 2005, Pages 2033–2037.
9. DOH Department Memorandum 2020-0180, Subject: Revised Interim Guidelines on Expanded Testing for COVID-19
(April 16, 2020).

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HOW SHOULD WE INTERPRET SARS-CoV-2 IgM/IgG SEROLOGIC TEST
RESULTS?

STATEMENT:
The interpretation of serologic tests (IgM/IgG) for SARS-CoV-2 is dependent on
the phase of illness of the patient. It should not be used as a stand-alone test
and is best correlated with RT-PCR results. Only medical doctors should
interpret these serologic tests.

SUPPORTING STATEMENTS:

Table 2.5 Rapid Test Sensitivity


Antibodies are produced over days to
weeks after infection with the virus. The
strength of antibody response depends
on several factors, including age,
nutritional status, severity of disease, and
certain medications or infections like HIV
that suppress the immune system.1-3

Compared to PCR, serological testing is


advantageous with faster turn-around
time, high output and less workload.

However, the clinical value of antibodies largely depends on the understanding of


host antibody responses during infection. Given that SARS-CoV-2 is a newly
emerging virus, the antibody response in COVID-19 patients remains largely
unknown.

The present IgM/IgG serological assay is designed to complement RT-PCR in the


diagnosis of SARS-CoV-2 infections.

The table below shows the clinical interpretation of all possible scenarios that can be
encountered when testing a patient with both RT-PCR and an IgM/IgG serological
test.

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Table 2.6 Clinical Significance of an IgM/IgG Serological Test Result 5,7

The table above is based on the


current knowledge about the rise and
fall of SARS-CoV-2 RNA and antigens,
IgM antibody and IgG antibody (Figure
2) and the correlation of these level
variations with the initial time of
infection, onset of symptoms and
recovery phase. As shown in Figure 2,
serological tests are recommended to
be used on patients at least 3 days
after onset of symptoms or 7-10 days Figure 2.6 Variation of the Levels of SARS-CoV-2 RNA and
after infection with the virus.5,7 Antigen, IgM and IgG after infection (SOURCE: Lauer, et al)

The key takeaway is that the results of RT-PCR and IgM/IgG serological tests do not
necessarily need to agree. A disagreement between the two tests, if any, can often
be traced to the after-infection time points at which the tests were performed. Overall,
while RT-PCR testing may be appropriate for the detection of the SARS-CoV-2 virus
during the acute phase, IgM/IgG is an appropriate test during the chronic phase.
Since the exact time of infection is often unknown, combining RT-PCR and IgM/IgG
testing can improve the accuracy of the COVID-19 diagnosis.

The Philippine FDA, in support of all efforts to address this pandemic, has recently
approved Rapid Test Kits for COVID-19. Provided, however, that:
1. Only Food and Drug Administration (FDA) approved kits should be used.
2. A COVID-19 antibody test CANNOT be used as a standalone test to definitively
diagnose COVID-19 and CANNOT be used for mass testing.
3. The COVID-19 RDT can only be used in people who had onset of symptoms for
at least 5 days (i.e. for IgM) and 21 days (i.e. for IgG). Most kits include both IgM
and IgG, so they can be used by day 5.

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4. Anyone who tests positive for IgM should be tested with a RT-PCR to confirm the
positive test.
5. A negative IgM test DOES NOT rule out COVID-19 and the symptomatic patient
should REMAIN ISOLATED and swabbed using RT-PCR for confirmation.
6. IgG-only positive individuals without RT-PCR should be labeled as presumptive
past COVID-19 and not be officially counted as confirmed unless there is a further
validation test in the future, or if validated with a PRNT (Plaque reduction
neutralization test) or viral culture by a third party.
• If a patient is symptomatic, a RT-PCR should be done, and the patient should
be quarantined.
• If a patient is asymptomatic, there is no need to test using an RT-PCR.
7. The IgG antibody can be used as an adjunct test to clear quarantined patients
who remain asymptomatic at 14 days post discharge. The presence of antibodies
typically indicates viral clearance. If IgG is positive, the patient can be released
from self-quarantine. If IgG is negative, a repeat RT-PCR should be performed
8. ONLY medical doctors can prescribe and interpret the use of the antibody-based
test kits. These kits will not be available over the counter.
REFERENCES:
1. Zhao J, Yuan Q, Wang H, Liu W, Liao X, Su Y, et al. Antibody responses to SARS-CoV-2 in patients of novel coronavirus
disease 2019.
2. Okba N.M.A, Muller M.A., Li W, Wang C, et al. SARS-COV-2 specific antibody responses in COVID-19 patients.
3. Gorse GJ, Donovan MM, Patel GB. Antibodies to coronaviruses are higher in older compared with younger adults and
binding antibodies are more sensitive than neutralizing antibodies identifying coronavirus-associated illnesses. Journal of
medical virology.
4. FDA Advisory No. 2020-483
5. Lauer, S. et al., 2020. The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed
Cases: Estimation and Application. Annals of Internal Medicine.
6. National Health Commission of the People’s Republic of China, New Coronavirus Pneumonia Diagnosis and Treatment
Program (Trial Version 7).
7. To KK, Tsang OT, Leung WS, Tam AR, Wu TC, Lung DC et al. (2020). Temporal profiles of viral load in posterior
oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort
study. Lancet Infect Dis. 2020 Mar 23. pii: S1473-3099(20)30196-1.

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WHAT IS THE ROLE OF RADIOLOGIC IMAGING IN COVID-19?

STATEMENT:
The use to radiologic imaging (CXR, chest CT and lung ultrasound) is not
recommended as a screening tool in asymptomatic to mild cases. Radiologic
imaging in COVID-19 is indicated in moderate to severe cases of the disease
and in cases with deterioration of respiratory function.

SUPPORTING STATEMENTS:
The findings on chest imaging are not specific of the infection, and could overlap with
other entities, such as influenza. There are also recommendations about the
performance of the chest radiography, including the fact that it is better to avoid the
movement of the patient within the hospital.

The value of an imaging test relates to the generation of results that are clinically
actionable either for establishing a diagnosis or for guiding management, triage, or
therapy. That value is diminished by costs that include the risk of radiation exposure
to the patient, risk of COVID-19 transmission to uninfected healthcare workers and
other patients, consumption of PPE, and need for cleaning and downtime of radiology
rooms in resource-constrained environments.

Chest x-ray (CXR) is insensitive in mild or early COVID-19 infection.5 However, with
respect to the relative value of CXR or computed tomography (CT) for detecting the
presence of viral pneumonia, the experience is vastly different dependent upon
community norms and public health directives. When patients are encouraged to
present early in the course of their disease, as was the case in Wuhan, China, CXR
has little value. The greater sensitivity of CT for early pneumonic changes is more
relevant in the setting of a public health approach that required isolation of all infected
patients within an environment where the reliability of COVID-19 testing was limited
and turnaround times were long.12 Alternatively, in New York City where patients were
instructed to stay at home until they experienced advanced symptoms, CXR was
often abnormal at the time of presentation. While ultrasound has been suggested as
a potential triage and diagnostic tool for COVID-19 given the predilection for the
disease in subpleural regions, there is limited experience at this time,1 as well as
infection control issues.

Thoracic imaging using CXR and CT are key tools for pulmonary disease diagnosis
and management, but their role in the management of COVID-19 has not been
considered within the multivariable context of the severity of respiratory disease, pre-
test probability, risk factors for disease progression, and critical resource constraints.
To address this deficit, a multidisciplinary panel comprised principally of radiologists
and pulmonologists from 10 countries with experience managing COVID-19 patients
across a spectrum of healthcare environments evaluated the utility of imaging within

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three scenarios representing varying risk factors, community conditions, and resource
constraints.2

The Fleischner Statement 2

Written from multidisciplinary and multinational perspectives, the Fleischner


Statement is intended to provide context for the use of imaging to direct patient
management during the COVID-19 pandemic in different practice settings, different
phases of epidemic outbreak, and environments of varying critical resource
availability. The consensus statement is structured around three clinical scenarios
and three additional situations in which chest imaging is often considered in the
evaluation of patients with potential COVID-19 infection.

The scenarios apply only to patients presenting with features consistent with COVID-
19 infection. The scenarios distinguish mild respiratory disease from moderate-to-
severe respiratory disease based on the absence vs. presence of significant
pulmonary dysfunction or damage. Pre-test probability is defined by the background
prevalence of infection and can be estimated by observed transmission patterns: low
by sporadic transmission; moderate by clustered transmission; and high by
community transmission.

Scenario 1: Mild Features of COVID-19


The first scenario addresses a patient presenting for evaluation at an outpatient clinic
or via telehealth with mild respiratory features consistent with COVID-19 infection,
any pre-test probability of COVID-19 infection, and no significant critical resource
constraints.

Figure 2.7 Clinical Scenario 1

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When COVID-19 test results are unavailable, patients with moderate-to-high pre-test
probability should be initially managed as if COVID-19 testing is positive, while
patients with low pre-test probability should be initially managed as if COVID-19
testing is negative. Imaging is advised for patients with risk factors for COVID-19
progression and either positive COVID-19 testing or moderate-to-high pre-test
probability in the absence of COVID-19 testing. Imaging provides a baseline for future
comparison, may establish manifestations of important comorbidities in patients with
risk factors for disease progression, and may influence the intensity of monitoring for
clinical worsening. Imaging is not advised for patients with mild features who are
COVID-19 positive without accompanying risk factors for disease progression, or for
patients with mild features who are COVID-19 negative. The panel felt that the yield
of imaging in these settings would be very low and that it was safe for most patients
to self-monitor for clinical worsening. Regardless of COVID-19 test results and risk
factors, imaging is advised for patients with mild clinical features who subsequently
develop clinical worsening. In the absence of clinical worsening, management
involves support and isolation of patients with positive COVID-19 testing or patients
with moderate to high pre-test probability without COVID-19 test results available.
Although not specifically addressed by this scenario, in the presence of significant
resources constraints, there is no role for imaging of patients with mild features
of COVID-19.

Scenario 2: Moderate to Severe Features of COVID-19


The second scenario addresses a patient presenting with moderate-to-severe
features consistent with COVID-19 infection, any pre-test probability of COVID-19
infection, and no significant critical resource constraints.

Figure 2.8 Clinical Scenario 2

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Imaging is advised regardless of the results or availability of COVID-19 testing given
the impact of imaging in both circumstances.

For COVID-19 positive patients, imaging establishes baseline pulmonary status and
identifies underlying cardiopulmonary abnormalities that may facilitate risk
stratification for clinical worsening. In the presence of clinical worsening, imaging is
again advised to assess for COVID- 19 progression or secondary cardiopulmonary
abnormalities such as pulmonary embolism, superimposed bacterial pneumonia, or
heart failure that can potentially be secondary to COVID-19 myocardial injury.

For COVID-19 negative patients or any patient for whom testing is not performed,
imaging may reveal an alternative diagnosis to explain the patient’s clinical features,
which should direct patent care as per existing clinical guidelines or standard clinical
practice. If an alternative diagnosis is not revealed or images demonstrate features
of COVID-19 infection, then subsequent clinical evaluation would depend upon the
pre-test probability of COVID-19 infection and COVID-19 test availability. False-
negative COVID-19 testing is more prevalent in high pre-test probability
circumstances and repeat COVID-19 testing is therefore advised if available.
Depending upon the imaging findings, other clinical investigations may be pursued.

Scenario 3: Moderate-to-Severe Features of COVID-19 in a Resource Constrained Environment


The third scenario addresses a patient presenting with moderate-to-severe features
consistent with COVID-19 infection within an environment of high community disease
burden and critical resource limitations (as seen in Wuhan, China, in regions of Italy
and Spain, and in New York City, but not in the Philippines, as of yet). Because
healthcare personnel and infrastructure may be overwhelmed by a high influx of new
patients and resources are limited to provide critical care, urgent decision-making and
triage are of primary importance.

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Figure 2.9 Clinical Scenario 3

At the time of this writing, turnaround time for COVID-19 test results range from 3
days (72 hours) to over 7 days. This is an impractically long time period to consider
triage to limited hospital beds and ventilators. However, rapid point-of-care (PoC)
COVID-19 tests are expected to be released into clinical environments during the first
week of April 2020, providing routine turnaround times of less than an hour and
potentially as little as 5 minutes. While the initial availability and sample processing
capacity of PoC COVID-19 testing is expected to be limited, this should increase over
time.

The third scenario first considers the potential availability of PoC COVID-19 testing.
Imaging is advised when PoC COVID-19 testing is available and positive for the same
reasons as described for Scenario 2. Based upon imaging findings and clinical
features, patients are subsequently supported and monitored with a level of intensity
consistent with clinical features. Imaging is again indicated if patients subsequently
clinically worsen.

Imaging is advised to support more rapid triage of patients in a resource-constrained


setting when point-of-care COVID-19 testing is not available or negative. Imaging
may reveal features of COVID-19, which within this scenario may be taken as a
presumptive diagnosis of COVID-19 for medical triage and associated decisions
regarding disposition, infection control, and clinical management. In this high pre-test
probability environment, and as described for Scenario 2, the possibility of falsely
negative COVID-19 testing creates a circumstance where a COVID-19 diagnosis may
be presumed when imaging findings are strongly suggestive of COVID-19 despite
negative COVID-19 testing.

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This guidance represents a variance from other published recommendations which
advise against the use of imaging for the initial diagnosis of COVID-19 and was
supported by direct experience amongst panelists providing care within the conditions
described for this scenario. The relationship between disease severity and triage may
need to be fluid depending upon resources and case load. When imaging reveals an
alternative diagnosis to COVID-19, management is based upon established
guidelines or standard clinical practice.4

Summary of Recommendations for Imaging:


• Imaging is not routinely recommended as a screening test for COVID-19 in
asymptomatic individuals.
• Imaging is not indicated for patients with mild features of COVID-19 unless they
are at risk for disease progression (Scenario 1)
• Imaging is indicated for patients with moderate to severe features of COVID-19
regardless of COVID-19 test results (Scenarios 2 and 3)
• Imaging is indicated for patients with COVID-19 and evidence of worsening
respiratory status (Scenarios 1, 2, and 3)
• In a resource constrained environment where access to CT is limited, CXR may
be preferred for patients with COVID-19 unless features of respiratory worsening
warrant the use of CT (Scenarios 2 and 3)

Chest Radiography (CXR)

The findings on CXR are not specific, and in the initial phases of the disease the
studies could be normal. The most common features include lobar, multi-lobar, or
bilateral lung consolidation.3

Chest Computed Tomography (CT)

CT can play a vital role in the early detection and management of COVID-19.3,9
However, it is worth emphasizing that a patient with RT-PCR confirmed COVID-19
infection may have normal chest CT at admission. Bernheim et al. reported 20 (56%)
of 36 patients imaged 0–2 days after symptom onset had normal CT. Fang et al.
reported one of 51 (2%) patient imaged 3 days 6 3 after symptom onset with normal
CT. Ai et al. reported 21 of 601 (3%) RTPCR- positive patients with clinical symptoms
had normal CT scans.

In contrast, Pan et al. reported four of 21 (19%) patients with first normal CT had lung
abnormalities on the follow-up CT approximately 4 days later. Furthermore, Yang et
al. reported that among 17 of 149 (11.4%) symptomatic patients with normal chest
CT on admission, 12 remained negative 10 days later with two to three follow-up CT
examinations and the chest CT of the other five patients became positive over an

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average of 7 days. These reports confirm that a normal chest CT scan cannot
exclude the diagnosis of COVID-19, especially for patients with early onset of
symptoms.

Recent studies have reported the features on CT imaging. Pan et al. described the
tomographic changes of 21 patients with mild to moderate disease who recovered
from the disease, and they described four stages:

• Early stage (0-4 days after the onset of the symptoms), in which ground glass
opacities (GGO) are frequent, with sub-pleural distribution and involving
predominantly the lower lobes. Some patients in this stage could have a normal
CT.
• Progressive stage (5-8 days after the onset of the symptoms), the findings usually
evolved to rapidly involvement of the two lungs or multi-lobe distribution with
GGO, crazy-paving and consolidation of airspaces.
• Peak stage (9-13 days after the onset of the symptoms), the consolidation
becomes denser and it was present in almost all of the cases. Other finding was
residual parenchymal bands.
• Absorption stage (>14 days after the onset of the symptoms), no crazy paving
pattern was observed, the GGO could remain.

Shi et al. also described the CT findings in 81 patients in Wuhan, China. All of the
patients had an abnormal CT, and the features include: GGO, smooth and irregular
interlobular septal thickening, crazy paving pattern, air bronchogram and irregular
pleural thickening. Usually affecting the subpleural regions and the lower lobes.

Lung ultrasound

The lung ultrasound findings are also not specific for COVID-19 infection. Little
information is available to date on this matter. The findings include irregular pleural
lines, sub-pleural areas of consolidation, areas of white lung and thick B lines.14 It is
a tool that could be used at bed side avoiding the need for shifting infected patients
to a Radiology suite.8
REFERENCES:
1. Soldati G, Smargiassi A, Inchingolo R, Buonsenso D, Perrone T, Briganti DF, Perlini S, Torri E, Mariani A, Mossolani EE,
Tursi F, Mento F, Demi L. Is there a role for lung ultrasound during the COVID-19 pandemic? J Ultrasound Med 2020.
2. Rubin GD, Rverson CJ, Haramat LB, Sverzellati N, Kanne JP, Raoof S, Schluger NW, Volpi A, Yim JJ, Martin IBK,
Anderson DJ, Kong C, Altes T, Bush A, Desai SR, Goldin J, Jin MoGoo Jin Mo, Humbert M, Leung AN. The Role of Chest
Imaging in Patient Management during the COVID-19 Pandemic: A Multinational Consensus Statement from the Fleischner
Society. Chest, 7 April 2020.
3. Kanne JP, Little BP, Chung JH, Elicker BM, Ketai LH. Essentials for Radiologists on COVID-19: An Update-Radiology
Scientific Expert Panel. Radiology [Internet]. 2020;200527.
4. American College of Radiology: ACR Recommendations for the use of Chest Radiography and Computed Tomography
(CT) for Suspected COVID-19 Infection.
5. Wong HYF, Lam HYS, Fong AH, Leung ST, Chin TW, Lo CSY, Lui MM, Lee JCY, Chiu KW, Chung T, Lee EYP, Wan EYF,
Hung FNI, Lam TPW, Kuo M, Ng MY. Frequency and Distribution of Chest Radiographic Findings in COVID-19 Positive
Patients. Radiology 2020:201160. doi: 10.1148/radiol.2020201160

PIDSOG Handbook: A Guidance for Clinicians on the Obstetric Management of Patients with Coronavirus Disease 2019
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6. Pan, Fen; Ye, Tianhe; Sun, Peng; Gui, Shan; Liang, Bo; Li, Lingli; Zheng, Dandan; Wang, Jiazheng; Hesketh, Richard;
Yang, Lian; Zheng C. Time Course of Lung Changes On Chest CT During Recovery From 2019 Novel Coronavirus
(COVID-19) Pneumonia. Radiology. 2020;77(8):1–15.
7. Shi H, Han X, Jiang N, Cao Y, Alwalid O, Gu J, et al. Radiological findings from 81 patients with COVID-19 pneumonia in
Wuhan, China: a descriptive study. Lancet Infect Dis. 2020;3099(20):1–10.
8. Peng QY, Wang XT, Zhang LN, Critical C, Ultrasound C, Group S. Findings of lung ultrasonography of novel corona virus
pneumonia during the 2019 – 2020 epidemic. Intensive Care Med. 2020;(87):6–7.
9. Zu ZY, Jiang MD, Xu PP, et al. Coronavirus Disease 2019 (COVID-19): A Perspective from China. Radiology 2020 Feb
21:200490.
10. Bernheim A, Mei X, Huang M, et al. Chest CT Findings in Coronavirus Disease-19 (COVID-19): Relationship to Duration
of Infection. Radiology 2020 Feb 20:200463.
11. Fang Y, Zhang H, Xie J, et al. Sensitivity of Chest CT for COVID-19: Comparison to RT-PCR. Radiology 2020 Feb
19:200432.
12. Ai T, Yang Z, Hou H, et al. Correlation of Chest CT and RT-PCR Testing in Coronavirus Disease 2019 (COVID-19) in
China: A Report of 1014 Cases. Radiology 2020 Feb 26:200642.
13. Yang W, Cao Q, Qin L, et al. Clinical characteristics and imaging manifestations of the 2019 novel coronavirus disease
(COVID-19): A multi-center study in Wenzhou city, Zhejiang, China. J Infect 2020 Feb 26.
14. Buonsenso D, Piano A, Raffaelli F, Bonadia N. Point-of-Care Lung Ultrasound findings in novel coronavirus disease-19
pnemoniae: a case report and potential applications during COVID-19 outbreak. Eur Rev Med Pharmacol Sci.
2020;24:2776–80.

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Recommended PPE Use for Healthcare Workers
Caring for Suspected and Confirmed
COVID-19 Pregnant Women
Valiant L. See, MD
Sybil Lizanne R. Bravo, RPh, MD, MSc / Jennifer T. Co, MD /
Catherine Jane R. Costa, MD, MHA / Christine D. Dizon, MD /
Shareza B. Nadal, MD / Mary Jane B. Noble, MD, MBHA

WHAT IS PERSONAL PROTECTIVE EQUIPMENT?


Personal protective equipment, commonly referred to as PPE, is an equipment worn
to minimize exposure and to stop the spread of COVID-19. It is one crucial way of
keeping the frontliners safe.
WHAT CAN BE DONE TO ENSURE PROPER USE OF PERSONAL
PROTECTIVE EQUIPMENT?
All personal protective equipment should be safely designed and made in a reliable
fashion. It should fit comfortably, encouraging worker usage. If the personal
protective equipment does not fit properly, it can make the difference between being
safely covered or dangerously exposed. The things to consider when using PPEs
are:
• What kind is necessary
• How to properly put it on, adjust, wear and take it off
• The limitations of the equipment
• Proper care, maintenance, useful life, and disposal of the equipment
WHAT ARE THE COMPONENTS OF PPE?
The components of PPE used when caring for suspected or confirmed COVID-19
pregnant patients will vary according to the setting and activity. Obstetrician-
Gynecologists involved in the direct care of patients should use the following PPE:
1. Disposable cap – acts as a barrier to prevent microorganisms that may
emerge from the hair and cause infection or contamination
2. Eye goggles or Face shield – prevents contamination to the eyes from
splashing of secretions (including respiratory secretions), blood, body fluids
or excretions
3. Face mask – prevents contamination from inhalation of respiratory
secretions especially during an aerosol-generating procedure (Appendix B1
and B2)
a. Surgical mask / medical mask – filters out large particles in the air,
protect through reducing exposure to the saliva and respiratory
secretions

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b. N95 mask – a type of respirator that offers more protection and can
filter out both large and small particles. It is designed to block 95% of
very small particles
c. FFP (Filtering Face Piece) mask – a half-face mask that protects
the chin, nose and mouth; serves to protect against particulates such
as dust particles and viruses
• FFP1 – has the least filtering capacity
• FFP2 – protection from powdered chemicals; can also serve as
protection against several viruses and bacteria, similar to
the N95 mask
• FFP3 – has the most filtering capacity among the FFP masks;
can protect against very fine particles
d. Elastomeric respirators – widely used by workers for industrial,
mining, and military purposes, but they are not currently used widely
in health care
e. Powered air-purifying respirator (PAPR) – used for protection
during healthcare procedures in which there is a greater risk of
aerosolized pathogens causing acute respiratory infections, its
assigned protection factor exceed the APF of 10 for N95 FFR or
elastomeric half face piece respirators
4. Scrub suit – sanitary clothing worn by the healthcare worker in the sterile
environment
5. Isolation or Disposable gown – protects the clothes from contamination
when providing direct patient care
6. Coveralls / Disposable apron – protective body wear that is fluid resistant
to prevent the possibility of infected body fluids penetrating and
contaminating the underlying clothes or skin with possible subsequent
unrecognized transmission via the hands to the mucous membranes of the
eyes, nose or mouth
7. Disposable Gloves – worn when providing direct patient care and to
protect from exposure to blood and/or other body fluids.
8. Footwear / Shoe covers – helps maintain a sterile environment and
eliminates the risk of contamination to the wearer
REFERENCES:
1. Recommendations from WHO Article on “Interim Guidelines on Rational Use of Personal Protective Equipment for
Coronavirus Disease 2019 (COVID-19). 27 February 2020.

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WHAT ARE THE LEVELS OF PPE FOR HEALTHCARE WORKERS PROVIDING
SERVICES TO PATIENTS?
STATEMENT:
There are recommended PPEs to minimize risk of cross-transmission of
infection to self and others when providing patient care. The level of PPE that
must be used by a healthcare worker is based on the identified or suspected
infectious agent, severity of illness, route of transmission of infectious agent,
area of care and anticipated exposure to blood or body fluids in the
procedures undertaken.
SUPPORTING STATEMENTS:
Currently, an international and a local recommendation for PPE level use may be
utilized. The Health Protection Scotland PPE has based their PPE level
recommendation on the suspected or identified infectious agent being handled and
the clinical scenario of anticipated risk which depends on route of microbial
transmission, i.e. contact, droplet or airborne (Table 5-1). The local recommendation
was devised by the Philippine General Hospital-Hospital Infection Control Unit
(PGH-HICU) as part of its preparation for the establishment of PGH as a COVID
center in the National Capital Region (NCR). Its recommendation is based on
anticipated exposure risks from different areas in the hospital (Table 5-2, Appendix
C). The PGH recommendation appears to be more apt for use in our local setting.
However, clinicians should observe caution, possess good judgment and make
sound decisions on what level of PPE to utilize based on anticipated risks in their
geographic healthcare settings.

Table 5-1. Levels of Personal Protective Equipment according to Health


Protection Scotland *
CLINICAL SCENARIO /
LEVEL RECOMMENDED PPE
INFECTIOUS AGENT

LEVEL 1 STANDARD INFECTION • No suspected or known


SICPs CONTROL PRECAUTIONS infectious agent
(SICPs)
• Disposable apron • Anticipated exposure to
• Disposable gloves blood and/or other body
fluids
If with risk of spraying or splashing,
use eye and face protection (i.e.
fluid-resistant Type IIR surgical
face mask & full face visor or
goggles)

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LEVEL 2 DIRECT / INDIRECT • Suspected or confirmed
CONTACT CONTACT PRECAUTIONS infectious agent spread by
• Disposable apron; consider direct/indirect contact:
fluid-resistant disposable
gown if apron provides Examples: C. difficile, Hepatitis C,
MRSA, Salmonella
inadequate cover for the
procedure/task being • Anticipated exposure to
performed blood and/or other body
• Disposable gloves fluids
If with risk of spraying or splashing,
use eye and face protection (i.e.
fluid-resistant Type IIR surgical
face mask & full face visor or
goggles)

LEVEL 2 DROPLET (RESPIRATORY) Suspected or confirmed


DROPLET PRECAUTIONS infectious agent spread by the
• Disposable apron; consider droplet route
fluid-resistant disposable
Examples: SARS-CoV-2, whooping
gown if apron provides
cough, influenza
inadequate cover for the
procedure/task being
performed
• Disposable gloves
• Fluid-resistant Type IIR
surgical face mask &
goggles or fluid-resistant
Type IIR surgical face mask
& full face visor

LEVEL 2 AIRBORNE (RESPIRATORY) Suspected or confirmed


AIRBORNE PRECAUTIONS infectious agent spread by the
• Disposable apron; consider airborne route
fluid-resistant disposable
gown if apron provides Examples: Chickenpox, PTB,
measles, SARS-CoV-2 (in
inadequate cover for the aerosolizing procedures)
procedure/task being
performed
• Disposable gloves
• Filtering face piece 3 (FFP3)
respirator and eye protection
or a powered hood
respirator

FOR ALL AEROSOL-GENERATING PROCEDURES: FFP3 respirator (and eye


protection) or a powered hood respirator

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CLINICAL SCENARIO /
LEVEL RECOMMENDED PPE
INFECTIOUS AGENT

LEVEL 3 ENHANCED PRECAUTIONS For suspected or confirmed


ENHANCED • Reinforced fluid-resistant Infectious Diseases of High
long-sleeved surgical gown Consequence (IDHC)
• Disposable fluid-resistant
hood (if wearing a gown w/o • Spread by
an attached hood) DIRECT/INDIRECT
• Full length disposable plastic CONTACT
apron
Examples: Ebola virus, Lassa
• FFP3 respirator or powered virus
hood respirator
• Disposable full face visor • Spread by AIRBORNE
• 2 sets of long or extended ROUTE
cuff non-sterile, non-latex
disposable gloves Examples: SARS, MERS-CoV,
Avian Influenza, SARS-CoV-2
• Surgical wellington boots or (aerosolizing procedures)
closed shoes
• Disposable boot covers

* Adapted from Public Health England & NHS Sheffield (Feb 2019)1

Table 5-2. PGH-HICU Risk-Based Personal Protective Equipment Levels *


AREA
PPE LEVEL PPE COMPONENTS
(Based on PGH set-up)

LEVEL 1 • Surgical mask AT ALL Non-COVID-19


TIMES Lowest Risk Areas
• Alcohol plus hand hygiene

LEVEL 2 • Surgical mask AT ALL Non-COVID-19


TIMES Low Risk Areas
• Goggles/Face shield
• Alcohol plus hand hygiene

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• N95, KN95, FPP2 mask (fit- COVID-19
tested) Moderate Risk Areas
• Goggles/Face shield
• Surgical cap • In COVID areas where stay
• Double gloves is < 4hrs
LEVEL 3 • Surgical gown • During brief interaction with
• Scrub suits patients
• Shoe covers • To perform NPS/OPS swab
• For all safety officers in the
doffing areas

• COVID-19 Triage Area


• Areas with suspect COVID-
19 cases

LEVEL 4 • N95 mask (fit-tested) COVID-19


• Goggles/Face shield (covers High Risk Areas
front and sides of face with
no areas left uncovered) • In COVID areas where stay
• Surgical cap is > 4 hours
• Double gloves • When performing close
• Coveralls contact with patients
• Scrub suits (intubation, doing CPR,
• Dedicated shoes suctioning ET, inserting
• Shoe covers NGT, changing
linens/diaper)
• In the OR theater during
procedures or surgery
• At the ER to evaluate or
stabilize new patients with
unknown status

In case of doubt if Level 3


or 4, opt for Level 4 PPE

* Adapted from PGH HICU Risk-based PPE Levels “What to Wear” (April 24, 2020)

REFERENCES:
1. Aide Memoire for Levels of Personal Protective Equipment (PPE) – NIPCM. Appendix 16.
http://www.nipcm.hps.scot.nhs.uk/appendices/appendix-16-best-practice-aide-memoire-for-levels-of-personal-protective-
equipment-ppe-for-healthcare-workers-when-providing-patient-care/. V1.0 February 20
2. Recommendations from PGH HICU PPE LEVELS infographic on “What to Wear”. March 29,2020.
3. Recommendations from PGH HICU PPE LEVELS Infographic on “What to Wear”. April 24,2020.

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WHAT ARE THE RECOMMENDED LEVELS OF PPE AS TO HEALTHCARE
TASK AND AREAS OF EXPOSURE IN THE HOSPITAL?
STATEMENT:
The PPE is essential in protecting healthcare workers from infectious agents
transmitted through contact, droplet or by airborne route.1 To streamline this
process, the recommended level of PPE is classified according to healthcare
personnel task and area of exposure in the hospital (Table 5.3).2,3

Table 5-3. Levels of PPE According to Task and Area of Exposure


AREA 1: PATIENT IN SCREENING ZONE

HEALTH RECOMMENDED
TASK PPE
PERSONNEL LEVEL OF PPE

Doctors and Triage stable • Disposable gloves LEVEL 2


nurses suspect case of • Apron (disposable (Contact)
COVID-19 and water repellant)

Consider fluid-resistant
disposable gown if apron is
inadequate to provide
protection for the
procedure/task being
performed

Doctors and Initial evaluation • Disposable gloves LEVEL 2


nurses of unstable • Apron (disposable (Contact, Droplet)
suspect case of and water repellant)
COVID-19 at • Surgical face mask
triage area and goggles OR
surgical face mask
and full-face visor

AREA 2: PATIENT IN TRANSIT TO TREATMENT ZONE, DELIVERY ROOM OR


OPERATING ROOM COMPLEX (AMBULANCE OR STRETCHER-BORNE)

HEALTH RECOMMENDED
TASK PPE
PERSONNEL LEVEL OF PPE

Paramedics Transport and • Disposable gloves LEVEL 2


Ambulance carry suspect, • Apron, disposable (Contact, Droplet)
Driver probable or and water repellant
Utility Worker confirmed • Surgical face mask
COVID-19 and goggles OR
pregnant patients surgical face mask
and full-face visor

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AREA 2: PATIENT IN TRANSIT TO TREATMENT ZONE, DELIVERY ROOM OR
OPERATING ROOM COMPLEX (AMBULANCE OR STRETCHER-BORNE)

Utility Worker Disinfection of the • N95 Mask LEVEL 3


Janitorial ambulance • Goggles/Face
shield
• Surgical cap
• Double gloves
• Scrub suit
• Disposable gown
• Shoe covers

AREA 3: PATIENT IN TREATMENT ZONE

HEALTH RECOMMENDED
TASK PPE
PERSONNEL LEVEL OF PPE

ICU/NICU (HIGH RISK)

Doctors and Management of • 2 sets of disposable LEVEL 3


nurses suspect, probable gloves, long or (Enhanced)
or confirmed extended cuff, non-
COVID-19 sterile, non-latex
pregnant patient • Apron, full length
disposable and
water repellant
• Surgical gown, long
sleeved and fluid
resistant
• Filtering facepiece 3
(FFP3) respirator or
a powered hood
respirator
• Disposable fluid
resistant hood (if
wearing a gown
without an attached
hood)
• Disposable full
visor/face shield
• Surgical wellington
boots/closed shoes
• Disposable boot
covers

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AREA 3: PATIENT IN TREATMENT ZONE

HEALTH RECOMMENDED
TASK PPE
PERSONNEL LEVEL OF PPE

WARD

Doctors and Management of • N95 Mask LEVEL 3


nurses suspect, • Goggles/Face
probable or shield
confirmed • Surgical cap
COVID-19 • Double gloves
postpartum • Disposable gown or
patients impermeable
coveralls
• Shoe covers

Performing CPR • N95 Mask LEVEL 4


• Goggles/Face
shield
• Surgical cap
• Double gloves
• Scrub suit
• Coveralls
• Dedicated shoes
• Shoe covers

LABOR ROOM / DELIVERY ROOM / OPERATING ROOM

Doctors and Labor and • N95 Mask LEVEL 4


nurses delivery of • Goggles/Face
suspect, probable shield
or confirmed • Surgical cap
COVID-19 • Double gloves
pregnant patient • Scrub suit
• Coveralls
• Dedicated shoes
• Shoe covers

Utility Workers Labor and • N95 Mask LEVEL 3


Cleaners delivery of • Goggles/Face
suspect, probable shield
or confirmed • Surgical cap
COVID-19 • Double gloves
pregnant patient • Scrub suit
• Disposable gown
• Shoe covers

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AREA 3: PATIENT IN TREATMENT ZONE

HEALTH RECOMMENDED
TASK PPE
PERSONNEL LEVEL OF PPE

OUTPATIENT CLINIC AND ULTRASOUND UNIT

Physicians Consultation • N95 Mask LEVEL 3


Sonologist room • Goggles/Face
Nurses shield
Utility Workers Ultrasound room • Surgical cap
Cleaners • Double gloves
Performing • Disposable gown or
diagnostic tests impermeable
coveralls
• Shoe covers

AREA 4: NON-TREATMENT HOSPITAL ZONES / AREAS

HEALTH RECOMMENDED
TASK PPE
PERSONNEL LEVEL OF PPE

Accounting Receive cash or • Disposable gloves LEVEL 1


Billing paper money • Apron, disposable
Cashier payments and water repellant
• Surgical face mask
and goggles OR
surgical face mask
and full-face visor

HR / IT / Heavy handlers • Surgical facemask LEVEL 1


Medical records of papers or AT ALL TIMES
surfaces • Alcohol/Hand
hygiene

Kitchen Food handlers in • Surgical facemask LEVEL 1


Mess Hall direct contact AT ALL TIMES
with exposed • Alcohol/Hand
personnel hygiene

Pharmacy Issue medicines • Surgical facemask LEVEL 1


and supplies AT ALL TIMES
• Alcohol/Hand
hygiene

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AREA 4: NON-TREATMENT HOSPITAL ZONES / AREAS

HEALTH RECOMMENDED
TASK PPE
PERSONNEL LEVEL OF PPE

Executive Indirect contact • Surgical facemask LEVEL 1


offices with suspect, AT ALL TIMES
probable and • Alcohol/Hand
confirmed hygiene
COVID-19 patient

Hospital support Clean patient’s • N95 Mask LEVEL 3


group and bathrooms • Goggles/Face shield
Janitorial • Surgical cap
services Disinfect rooms • Double gloves
of probable, • Scrub suit
suspect or • Disposable gown
confirmed • Shoe covers
COVID-19 patient

REFERENCES:
1. Aide Memoire for Levels of Personal Protective Equipment (PPE) – NIPCM. Appendix 16.
http://www.nipcm.hps.scot.nhs.uk/appendices/appendix-16-best-practice-aide-memoire-for-levels-of-personal-protective-
equipment-ppe-for-healthcare-workers-when-providing-patient-care/. V1.0 February 20
2. Recommendations from PSMID Article on “Interim Guidelines on the Infection Prevention and Control (IPC) for COVID-19:
Suggested PPEs According to Tasks (Table 2)” V 2.0. pp 9-10. February 26, 2020.
3. Recommendations from PGH HICU PPE LEVELS infographic on “What to Wear”. March 29,2020.
4. Recommendations from PGH HICU PPE LEVELS Infographic on “What to Wear”. April 24,2020.

PIDSOG Handbook: A Guidance for Clinicians on the Obstetric Management of Patients with Coronavirus Disease 2019
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WHAT IS THE RECOMMENDED PPE LEVEL TO BE USED DURING OBSTETRIC
AND GYNECOLOGIC PROCEDURES?
STATEMENT:
For COVID-19 suspect and confirmed pregnant patients, healthcare providers
should use the level 3 personal protective equipment (PPE) for all minor
procedures and in performance of moderate-risk activities, and level 4 PPE
for major procedures.
SUPPORTING STATEMENTS:

A level 3 PPE is enhanced precaution and consists of the following: cap, goggles or
face shield, N95 mask, double gloves, scrub suits, surgical gown and shoe covers
(Appendix D-1 and D-2).

A level 4 PPE is level 3 (i.e. cap, goggles or face shield, N95 mask, double gloves,
scrub suits and shoe covers), with the addition of the following components for
added protection: surgical cap, coveralls, sterile surgical gown, sterile gloves,
apron/raincoat (optional) and dedicated shoes (Appendix E-1 to E3).

Table 5-4. Areas and activities involved where level 3 and level 4 PPEs are used
PPE Level AREAS AND ACTIVITIES INVOLVED

1. At the COVID-designated areas staying < 4 hours


2. Doing history-taking, physical examination (doing pelvic or
internal examination)
3. Performing chest x-ray, blood extraction, making daily rounds
LEVEL 3
4. Performing transvaginal / abdominal ultrasound
5. Performing nasopharyngeal and oropharyngeal specimen
collection (NPS/OPS swabbing)
6. At the Doffing area - for safety officers

1. At the COVID-designated areas staying > 4 hours


2. Transferring the patient
3. Performing change of bed linens with the patient on the bed
4. Changing diapers and doing personal hygiene on the patient
5. Suctioning procedures
6. Doing oral or endotracheal care, insertion of nasogastric tube
LEVEL 4 (NGT - use additional apron or raincoat)
7. Performing intubation and cardiopulmonary resuscitation
(CPR - use additional apron or raincoat)
8. At the operation room theatre (OR), in the performance of any
obstetrics and gynecologic surgery – don sterile surgical gown
and sterile gloves
9. Stabilizing patients at the Emergency Room (ER)

REFERENCES:
1. Recommendations from PSMID Article on “Interim Guidelines on the Infection Prevention and Control (IPC) for COVID-
19: Suggested PPEs According to Tasks (Table 2)” V 2.0. pp 9-10. February 26, 2020.2
2. Recommendations from PGH Article on “What Personnel Protective Equipment to Wear”. March 29, 2020.

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WHAT IS THE PROPER SEQUENCE OF DONNING AND DOFFING PPE IN
OBSTETRIC AND GYNECOLOGIC PROCEDURES?
STATEMENT:
The type of PPE used will vary based on the level of precautions required. The
procedure for donning and doffing of PPE should be tailored to the specific
type of PPE.
SUPPORTING STATEMENTS:
The World Health Organization (WHO) and the Centers for Disease Control and
Prevention (CDC) have guidelines on the proper donning and doffing of PPEs. More
than one donning and doffing method may be acceptable. Training and
demonstrated competency in donning and doffing PPE ensure proficiency in the use
of the equipment.

DONNING METHOD USING LEVEL 3 PPE

1. Remove all personal items (ex. jewelry, watches, cellphones, etc.).


2. Put on scrub suit.
3. Identify and gather the proper PPE to don.
- Make sure choice of gown size is correct (based on training)
- Undertake the procedure of putting on PPE under the guidance and
supervision of trained observer.
4. Perform hand hygiene.
5. Put on shoe covers.
6. Put on isolation gown.
- Tie all of the ties on the gown.
- Assistance may be needed by other healthcare personnel.
7. Put on NIOSH-approved N95 filtering facepiece respirator or higher (use
facemask if respirator is not available).
- If the respirator has a nosepiece, it should be fitted to the nose with
both hands, not bent or tented. Do not pinch the nosepiece with one
hand.
- Respirator / facemask should be extended under the chin. Both your
mouth and nose should be protected. Do not wear respirator /
facemask under your chin or store in scrubs pocket between patients.
- Respirator: Respirator straps should be placed on crown of head (top
strap) and base of neck (bottom strap). Perform a user seal check
each time you put on the respirator.
- Facemask: mask ties should be secured on crown of head (top tie)
and base of the neck (bottom tie). If mask has loops, hook them
appropriately around your ears.
8. Put on the face shield or goggles.
- Face shields provide full face coverage.

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- Goggles also provide excellent protection for the eyes, but fogging is
common.
9. Put on head cover or surgical cap.
10. Perform hand hygiene.
11. Put on pair of gloves.
- Gloves should cover the cuff (wrist) of the gown.

DONNING METHOD USING LEVEL 4 PPE

1. Remove all personal items (ex. jewelry, watches, cellphone, pens, etc.)
2. Put on scrub suit and dedicated shoes/rubber boots and put on shoe cover.
- If rubber boots are not available, make sure you have closed and
fluid resistant shoes.
3. Identify and gather the proper PPE to don.
- By visual inspection, ensure that all sizes of the PPE are correct, and
the quality is appropriate.
- Undertake the procedure of putting on the PPE under the guidance
and supervision of a trained observer.
4. Perform hand hygiene.
5. Put on first pair of gloves.
6. Put on coverall.
- Do not use adhesive tape to attach the gloves.
- If the gloves or the coverall sleeves are not long enough, make a
thumb (or middle finger) hole in the coverall sleeve to ensure that
your forearm is not exposed when making wide movements.
- Some coverall models have finger loops attached to sleeves.
7. Put on NIOSH-approved N95 filtering facepiece respirator or higher
- Use facemask if respirator is not available
- Perform a user seal check each time you put on the respirator
8. Put on face shields or goggles
9. Put on head and neck covering (surgical bonnet/cap, covering neck and
sides of the head or hood).
10. Put on disposable waterproof apron (optional)
- Apron that covers the torso and extends to mid-calf may be worn for
additional protection in case a patient has diarrhea or is vomiting
11. Put on second pair of gloves (preferably long cuff) over the cuff.
- Do not use adhesive tape to attach the gloves.
12. Put on sterile gown and sterile gloves without contamination if a sterile
obstetric or gynecologic surgery is to be performed after doing hand
hygiene.

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DOFFING METHOD USING LEVEL 3 PPE

1. Always remove PPE under the guidance and supervision of a trained


observer.
- Ensure that infectious waste containers are available in the doffing
area for safe disposal of PPE.
- Separate containers should be available for reusable items
2. Perform hand hygiene on gloved hands.
3. Remove shoe covers by one gloved hand
4. Remove pair of gloves.
- Ensure glove removal does not cause additional contamination of the
hands. Gloves can be removed using more than one technique (e.g.,
glove-in-glove or bird beak)
5. Remove gown.
- Untie all ties (or unsnap all buttons). Some gown ties can be broken
rather than untied. Do so in gentle manner, avoiding forceful
movement.
- Reach up to the shoulders and carefully pull gown down and away
from the body. Rolling the gown down is an acceptable approach.
- Dispose in trash receptacle.
- Facilities implementing the reuse or extended use of PPE will need
to adjust their donning and doffing procedures to accommodate
those practices
6. Perform hand hygiene.
7. Remove head cover or surgical cap.
8. Remove face shield or goggles.
- Carefully remove face shield or goggles by grabbing the strap and
pulling upwards and away from the head.
- Do not touch the front of face shield or goggles.
9. Remove and discard respirator (or facemask if used instead of respirator).
- Do not touch the front of the respirator or facemask.
- Facilities implementing the reuse or extended use of PPE will need
to adjust their donning and doffing procedures to accommodate
those practices.
- Respirator: Remove the bottom of the strap by touching only the
strap and bring it carefully over the head, and then pull the respirator
away from the face without touching the front of the respirator.
- Facemask: Carefully untie (or unhook from the ears) and pull away
from the face without touching the front.
10. Perform hand hygiene after removing the respirator/facemask and before
putting it on again if your workplace is practicing reuse.

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- Facilities implementing the reuse or extended use of PPE will need
to adjust their donning and doffing procedures to accommodate
those practices

DOFFING METHOD USING LEVEL 4 PPE

1. Always remove PPE under the guidance and supervision of a trained


observer (colleague).
- Ensure that infectious waste containers are available in the doffing
area for safe disposal of PPE.
- Separate containers should be available for reusable items.
2. Perform hand hygiene on gloved hands.
3. Remove apron (if worn) by leaning forward and taking care to avoid
contaminating your hands.
- When removing disposable apron, tear it off at the neck and roll it.
Down without touching the front area. Then untie the back and roll
the apron forward.
4. Remove shoe covers (if worn).
5. Perform hand hygiene on gloved hands.
6. Remove head and neck covering taking care to avoid contaminating your
face by starting from the bottom of the hood in the back and rolling from the
back to front and from the inside to outside, and then dispose of it safely.
7. Perform hand hygiene on gloved hands.
8. Remove coverall and outer pair of gloves.
- Ideally this step should be done in front of a mirror.
- Tilt head back to reach zipper, unzip completely without touching any
skin or scrubs, and start removing coverall from top to bottom. After
freeing shoulders, remove the outer gloves.
- This procedure requires properly fitted gloves. When outer gloves
are too tight or inner gloves are too loose and/or hands are sweaty,
the outer gloves may need to be removed separately, after removing
the apron while pulling the arms out of the sleeves. With inner gloves
roll the coverall, from the waist down and from the inside of the
coverall, down to the top of the boots. Use one boot and vice versa,
then step away from the coverall and dispose of it safely.
9. Perform hand hygiene on gloved hands.
10. Remove eye protection (face shield and goggles) by pulling the string from
behind the head and dispose of it safely.
11. Perform hand hygiene on gloved hands.
12. Remove the mask from behind the head by first untying the bottom string
above the head and leaving it hanging in front; and then the top string next
from behind head and dispose of it safely.
13. Perform hand hygiene on gloved hands.

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- Remove the rubber boots without touching them
- If the same boots are to be used outside of the high-risk zone, keep
them on but clean and decontaminate appropriately before leaving
the doffing area.
14. Perform hand hygiene on gloved hands.
15. Remove gloves carefully with appropriate technique and dispose of them
safely.
16. Perform hand hygiene.
REFERENCES:
1. Using Personal Protective Equipment. Accessed thru: https://www.cdc.gov
2. Steps to put on/take off personal protective equipment including coverall. Accessed thru: https://www.who.int

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WHAT ARE THE ADVANTAGES AND DISADVANTAGES OF PPE GOWNS AND
COVERALLS BASED ON TYPE OF MATERIAL USED?
STATEMENT:
Materials used for coverall and isolation gown for PPEs can be woven or non-
woven fabric. Each has its advantages and disadvantages.

Table 5-5. Types of Material Used for Coveralls and Isolation Gowns
TYPE OF GOWN MATERIAL ADVANTAGES DISADVANTAGES

Medical-grade GSM fabric • Bacterial barrier • High


coverall or gown material (non- • Water repellant susceptibility to
woven) • Washable UV degradation
• 90 days life • Poorly-resistant
span to chlorinated
solvents and
aromatics1

Improvised Taffeta cloth with • Washable • Porous


coverall or gown 70 Denier Heat • Waterproof • Non-
Sealable / Taslan • Reusable biodegradable
(woven nylon or • Lightweight • May cause
polyester) • Heat-resistant allergic reaction
to resin
component
• Cannot be used
if in direct
contact with
skin; body heat
interacts with
polyester
component that
release toxic
chemicals and
may be
absorbed by the
skin1

REFERENCES:
1. Antimicrobial Characteristics of Pulsed Laser Deposited Metal Oxides on Polypropylene Hydroentangled Nonwovens for
Medical Textiles.
https://www.researchgate.net/publication/316958768_Antimicrobial_Characteristics_of_Pulsed_Laser_Deposited_Metal_O
xides_on_Polypropylene_Hydroentangled_Nonwovens_for_Medical_Textiles

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WHAT ARE THE NON-WOVEN FABRIC MATERIALS USED IN PPEs?
STATEMENT:
Non-woven fabric materials are textiles made thru a process other than
weaving. They are extruded or blown fibers, usually polyethylene and
polypropylene, that are bound into fabric using heat, and finished to achieve
repellence, absorbance and anti-static properties. The basic method of
producing this material is by “spun-bonding”. Other methods result in a
different type of finished fabric (Table 5.5).1

Table 5-6. Non-Woven Fabric Materials Used for Standard Coverall and
Improvised PPEs
TYPE OF FIBER NO. OF
TYPE OF FABRIC DESCRIPTION
USED LAYERS

Flashspun Dense structure of fine 100% 1


Polyethylene continuous polyethylene polyethylene
(FSPE) fibers fiber

Microporous Film Microporous layer features Outer layer: 2


Laminate interlinked cavities forming polyethylene
(MPFL) “wormholes” through the film fiber

Inner layer:
polypropylene
fiber

Spun bond-Melt Spunbond layer provides 3 layers of 3


blown-Spun bond strength propylene fibers
(SMS)
Meltblown layer provides
filtration

REFERENCES:
1. Coverall Standards@safegardGP.pdi.

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IS THERE A STANDARD TESTING FOR FABRICS IN PROTECTING AGAINST
INFECTIOUS AGENTS AND BIOLOGICAL HAZARDS?
STATEMENT:
Yes. The EN 14126 is the standard protective clothing against infectious
agents and biological hazards. It defines no requirements for garment
construction, but undergoes four different tests which measure a fabric’s
ability to resist penetration by liquids that may be contaminated by bacteria
or other infectious agents.1

Table 5-7. Fabric Testing for EN 14126 Infectious Agent Protection2


COMPARISON OF FLASHSPUN POLYETHYLENE (FSPE)
AND MICROPOROUS FILM LAMINATE (MPFL)
TEST DESCRIPTION TEST # CLASSES FPSE MPFL
Resistance to ISO 1 TO 3 1 3
Penetration by Biological 22611 (3=highest)
Contaminated Aerosols
Resistance to ISO 1 TO 6 unclassified 6
Penetration by Blood- 16604 (6=highest)
borne Pathogens
Resistance to EN ISO 1 TO 6 1 6
Penetration by 22610 (6=highest)
Contaminated Liquids
Resistance to ISO 1 TO 3 1 3
Contamination by Solid 22612 (3=highest)
Particles
*SMS fabric is not tested because it is not recommended for this type of protection.2

REFERENCES:
1. Coverall Standards@safegardGP.pdi.
2. Lill, Martin. “Type 6 Disposable Safety Clothing: Which Coveralls Offer Best Liquid Protection?”. Lakeland Europe Blog.
August 30, 2019.

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HOW ARE PPEs DISINFECTED FOR REUSE?
STATEMENT:
PPEs are intended to be disposed after a single use. However, the abrupt
large-scale increase in demand during this pandemic has depleted the current
global stockpile and manufacturers are unable to keep up with the worldwide
request for supplies. For this reason, WHO released interim guidelines on the
extended use and reprocessing of PPEs. The CDC also released strategies
for effective decontamination which aim to sterilize the PPEs for reuse while
maintaining their protective functions to the user. 1,2,3,

Table 5-7. Sterilization and Disinfection Techniques for PPEs


PPE METHOD OF DISINFECTION

FFP3 / N95 masks Preserve the integrity of the mask by decontamination


through use of:
1) vaporous hydrogen peroxide,
2) 6% liquid hydrogen peroxide submersion for 30
minutes,
3) UV germicidal irradiation or
4) moist heat at 60⁰C and 85% RH (relative humidity)

Avoid using isopropyl alcohol, soap, bleach, autoclave, dry


heat and microwave for disinfection as they cause significant
filter degradation and disruption of particle penetration level.1

Limit number of reuses to no more than 5 times to ensure


adequate safety margin.2

Goggles / Face shields Clean with soap and water followed by disinfection using
and hoods either sodium hypochlorite 0.1% (1:1000) or 70% alcohol
wipes. Then rinse off with water. Contact time when using
sodium hypochlorite disinfectant must be at least 10 minutes
for optimum sterilization.3

Isolation gown / Cotton Machine-wash with warm water (60-90°C) and laundry
gowns detergent.

If machine-washing is not possible, linen can be soaked in


hot water and soap in a large drum, using a stick to stir, taking
care to avoid splashing. Then soak linen in 0.05% chlorine
for approximately 30 minutes. Rinse with clean water and let
dry fully in the sunlight.3

REFERENCES:
1. CDC website on Coronavirus 2019: “Decontamination and Reuse of Filtering Facepiece Respirators”. April 29, 2020.
2. CDC website on The National Institute for Occupational Safety and Health (NIOSH) Pandemic Planning: “Recommended
Guidance for Extended Use and Limited Reuse of N95 Filtering Facepiece Respirators in Healthcare Settings”. March
27,2020.
3. WHO Interim Guidance: “Rational use of PPE for coronavirus disease (COVID-19) and considerations during severe
shortage”. April 6, 2020.

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WHAT ARE SOME OF THE INNOVATIONS CREATED TO PROTECT
HEALTHCARE WORKERS DURING THIS COVID-19 PANDEMIC?
STATEMENT:
With the increasing incidence of healthcare workers getting infected with the
coronavirus-19 while handling their patients here in our country, a number of
novel improvised barriers were invented by colleagues in the medical field to
address this concern. The main objective of which is to protect healthcare
workers by minimizing their exposure to patients when necessary procedures
or diagnostics need to be undertaken.

Table 5-7. Improvised Barrier Protection Against SARS-CoV-2 in Different


Healthcare Settings
IMPROVISED HARM OR
USES BENEFIT
BARRIER LIMITATION

Acrylic aerosol Endotracheal Minimizes exposure Poor organ


box intubation to droplets while exposure due to
performing intubation limitation of mobility

Consultation Minimizes exposure Limited protection


barrier to droplets during
history-taking Limited access to
patient for doing
physical
examination

Plastic-covered Labor/Delivery Minimizes exposure Prolonged use can


isolation to droplets/aerosols lead to suffocation
compartment during second stage
of labor and during
delivery

Ultrasound Minimizes exposure Poor disinfection


procedures to droplet for both between patients
sonologist and may lead to
machine enhancement of
transmission

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Table 5-9. Miscellaneous Agents Used Against SARS-CoV-2 for Protection of
Healthcare Workers and/or their Environment
HARM
AGENT USES BENEFIT
OR LIMITATION

Ultraviolet Inactivates Destroys airborne Can cause eye


Germicidal microorganisms by organisms and damage (cataract
Irradiation destruction of their inactivates formation, macular
(UVGI) nucleic acid through microorganisms on degeneration) and
strand breakage and surfaces2 surface burns on
formation of photo- unshielded skin, eyes
induced byproducts Suitable for and other organs1
such as thymine viruses because of
dimer. Damaged their higher Kills microorganisms
nucleic acid cannot be susceptibility to UVGI depending on UV
used for cell than bacteria. Viruses intensity and time of
reproduction.1 are also difficult to exposure.1
filter because of their
size.1 Germicidal
effectiveness and use
is influenced by
organic matter,
temperature,
wavelength and type
of microorganism2

High Efficiency Captures a portion of Effective at removing Molds and bacteria


Particulate Air airborne virus-sized bacteria, fungus, can grow on filters.
(HEPA) Filter particles by diffusion. some viruses and Spores from molds
Trapped viruses large particulate can get released
cannot multiply on allergens like pollen, back into the air while
their own2 dander, and dust endotoxins from
mites3 degraded bacteria
Newer models provide can get dispersed
efficiency down to 0.1 into the airstream.3
micron particle size at
a removal efficiency of Filters should be
99.97%1 replaced regularly
every 6 months for
commercial use and
up to 1-2 years for
residential use.3

REFERENCES:
1. Schentagg, JJ et. al. . SARS: Clearing the Air. Washington DC: National Academics Press (USA). 2004.
2. www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-prevent-spread
3. “Pros and Cons of HEPA Filter Air Purifiers, Dissected” at https://molekule.science/pros

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APPENDIX A: Algorithm on Screening Pregnant Patients for SARS-CoV-2

DISCLAIMER: This algorithm was formulated to guide clinicians on the benefit


of SARS-CoV-2 testing in this population. This recommendation can be
adopted and modified based on geographical risk, available resources and
testing capacity of each institution or facility.

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APPENDIX B-1: Different Kinds of Face Mask

MASK TYPE STANDARDS FILTRATION EFFECTIVENESS

Image downloaded from: https://smartairfilters.com/en/blog/comparison-mask-standards-rating-effectiveness/

PIDSOG Handbook: A Guidance for Clinicians on the Obstetric Management of Patients with Coronavirus Disease 2019
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APPENDIX B-2: Different Kinds of N95 Face Mask

Source: Surgical N95 vs. Standard N95 – Which to Consider? 3M Technical Bulletin, March 2020, Revision 2
https://multimedia.3m.com/mws/media/1794572O/surgical-n95-vs-standard-n95-which-to-consider.pdf

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APPENDIX C: PGH-HICU Risk-Based Personal Protective Equipment
(PPE) Levels Infographic*

*Posted with permission from the Philippine General Hospital-Hospital Infection Control Unit

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APPENDIX D-1: Components of Level 3 PPE for OB-Gyn Procedures

Face shield

Goggles
N95 mask

Gloves

Scrub suit
worn inside
with
impermeable
gown on top

Shoe cover

Image showing the complete components of level 3 PPE

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APPENDIX D-2: Level 3 PPE for OB-Gyn Procedures

An obstetrician wearing level 3 PPE while examining a pregnant patient

An obstetrician wearing level 3 PPE while performing ultrasound

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APPENDIX E-1 Components of Level 4 PPE for OB-Gyn Procedures

Face shield

Goggles
N95 mask

Gloves
Hazmat suit
or coveralls

Plastic apron
worn over the
Hazmat suit or
coveralls

Shoe cover

Image taken shows the components of level 4 PPE prior to donning of


sterile OR gown and gloves. The physician on the left is wearing a plastic
apron over her overalls as an additional protective layer.

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APPENDIX E-2 Components of Level 4 PPE for OB-Gyn Procedures

Face shield

Goggles
N95 mask

Gloves Hazmat suit or


coveralls (white)
worn under the
sterile OR gown
(violet)

Shoe cover

Image taken shows the components of level 4 PPE, with the


addition of sterile OR gown worn over the coveralls and
additional layer of sterile gloves.

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APPENDIX E-3 Components of Level 4 PPE for OB-Gyn Procedures

Prior to donning sterile OR gown After donning sterile OR gown

Image on the left illustrates the components of level 4 PPE prior to donning the sterile OR
gown, namely: goggles, N95 mask, hair cap, coverall, scrub suit (worn underneath the
coveralls), gloves, and shoe cover.

Image on the right illustrates the components of level 4 PPE, with the addition of sterile OR
gown worn over the coveralls and another layer of sterile gloves.

PIDSOG Handbook: A Guidance for Clinicians on the Obstetric Management of Patients with Coronavirus Disease 2019
Version 2.0 -- Released May 16, 2020
63

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