April 2020
EDITORS
Katherine A. Angelo-Dela Cruz, MD
Jhorose R. Gementiza, MD
Florida F. Taladtad, MD
Cheryl T. Tiuseco, MD
BACKGROUND ON COVID-19
Sybil Lizanne R. Bravo, 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.
Erwin R. De Mesa, MD
President
Maria Lu D. Andal, MD
External Vice President
Analyn F. Fallarme, MD
Secretary
Louella P. Aquino, MD
Assistant Secretary
Valiant L. See, MD
Assistant Treasurer
Christine D. Dizon, MD
Auditor
I. Background on COVID-19
1
Sybil Lizanne R. Bravo, 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?
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.
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
PIDSOG Handbook: A Guidance for Clinicians on the Obstetric Management of Patients with Coronavirus Disease 2019
Version 2.0 -- Released May 16, 2020
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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.
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
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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
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.
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Version 2.0 -- Released May 16, 2020
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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
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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.
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
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
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Version 2.0 -- Released May 16, 2020
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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
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
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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
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Version 2.0 -- Released May 16, 2020
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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
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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.
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
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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
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
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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.
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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Version 2.0 -- Released May 16, 2020
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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.
PIDSOG Handbook: A Guidance for Clinicians on the Obstetric Management of Patients with Coronavirus Disease 2019
Version 2.0 -- Released May 16, 2020
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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.
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.
PIDSOG Handbook: A Guidance for Clinicians on the Obstetric Management of Patients with Coronavirus Disease 2019
Version 2.0 -- Released May 16, 2020
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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.
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
Version 2.0 -- Released May 16, 2020
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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
PIDSOG Handbook: A Guidance for Clinicians on the Obstetric Management of Patients with Coronavirus Disease 2019
Version 2.0 -- Released May 16, 2020
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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
PIDSOG Handbook: A Guidance for Clinicians on the Obstetric Management of Patients with Coronavirus Disease 2019
Version 2.0 -- Released May 16, 2020
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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.
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Version 2.0 -- Released May 16, 2020
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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.
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Version 2.0 -- Released May 16, 2020
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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.
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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:
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 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 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.
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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.
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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.
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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.
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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
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
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
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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
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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.
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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)
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CLINICAL SCENARIO /
LEVEL RECOMMENDED PPE
INFECTIOUS AGENT
* Adapted from Public Health England & NHS Sheffield (Feb 2019)1
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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
* 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
HEALTH RECOMMENDED
TASK PPE
PERSONNEL LEVEL OF PPE
Consider fluid-resistant
disposable gown if apron is
inadequate to provide
protection for the
procedure/task being
performed
HEALTH RECOMMENDED
TASK PPE
PERSONNEL LEVEL OF PPE
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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
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AREA 3: PATIENT IN TREATMENT ZONE
HEALTH RECOMMENDED
TASK PPE
PERSONNEL LEVEL OF PPE
WARD
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AREA 3: PATIENT IN TREATMENT ZONE
HEALTH RECOMMENDED
TASK PPE
PERSONNEL LEVEL OF PPE
HEALTH RECOMMENDED
TASK PPE
PERSONNEL LEVEL OF PPE
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AREA 4: NON-TREATMENT HOSPITAL ZONES / AREAS
HEALTH RECOMMENDED
TASK PPE
PERSONNEL LEVEL OF PPE
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.
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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
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.
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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.
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
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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
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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
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
Inner layer:
polypropylene
fiber
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
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,
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.
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.
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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
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
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APPENDIX B-1: Different Kinds of Face Mask
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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
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APPENDIX D-2: Level 3 PPE for OB-Gyn Procedures
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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
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APPENDIX E-2 Components of Level 4 PPE for OB-Gyn Procedures
Face shield
Goggles
N95 mask
Shoe cover
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APPENDIX E-3 Components of Level 4 PPE for OB-Gyn Procedures
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.
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