Please only refer to the current product lot insert enclosed with the kits package for execution

and reporting.

MAGLUMI Syphilis (CLIA)

INTENDED USE
The kit has been designed for the qualitative determination of total
antibodies against Treponema pallidum (T. pallidum) in human
serum and plasma.
Shenzhen New Industries Lotus Medical Equipment
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The test has to be performed on MAGLUMI Fully-auto
Biomedical Engineering Co., Ltd Limited
chemiluminescence immunoassay (CLIA) analyzer (Including
No.16, Jinhui Road, 26B Cameron Court,
Maglumi 600, Maglumi 800, Maglumi 1000, Maglumi 1000 Plus,
Pingshan New District, Cork Street, Dublin 8,
Maglumi 2000, Maglumi 2000 Plus, Maglumi 4000, Maglumi 4000
Shenzhen, 518122, P.R.China Ireland
Plus) and Biolumi 8000 Integrated System.
Tel. +86-755-21536601 Tel: +353-1-6571034
Catalog Number Specification
Fax.+86-755-28292740 E-mail: peter@lotusme.org
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130219003M 100 tests

130619003M 50 tests

SUMMARY AND EXPLANATION OF THE TEST

FOR PROFESSIONAL USE ONLY
Store at 2-8°C Syphilis is a sexually transmitted disease caused by the spirochete
bacterium T. pallidum subspecies pallidum. The primary route of
transmission is through sexual contact; it may also be transmitted
CAUTION: COMPLETELY READ THE
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from mother to fetus during pregnancy or at birth. Syphilis can

INSTRUCTIONS BEFORE PROCEEDING cause significant complications and often in combination with
human immunodeficiency virus (HIV). Syphilis can present in one
of four different stages: primary, secondary, latent, and tertiary,
SYMBOLS EXPLANATIONS and may also occur congenitally. Syphilis is difficult to diagnose
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AUTHORISED REPRESENTATIVE IN clinically early in its presentation. Confirmation is either via blood
THE EUROPEAN COMMUNITY tests or direct visual inspection using microscopy. Blood tests are
more commonly used, as they are easier to perform. T. pallidum
MANUFACTURER antibody tests usually become positive two to five weeks after the
initial infection. Neurosyphilis is diagnosed by finding high
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numbers of leukocytes (predominately lymphocytes) and high

CONSULT INSTRUCTIONS FOR USE protein levels in the cerebrospinal fluid in the setting of a known
syphilis infection. Diagnostic tests are, however, unable to
distinguish between the stages of the disease.
KIT COMPONENTS Early IgM and later IgG responses are directed primarily against
the same set of antigens and although after treatment and during
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IN VITRO DIAGNOSTIC MEDICAL later stages of the disease the IgM reactivity to many antigens
DEVICE attenuates, IgG response remains and is responsible for the
serofast effect. Antitreponemal IgM antibodies are produced about
BATCH CODE 2 weeks after exposure, followed by IgG antibodies 2 weeks after
IgM production. Early responses are against TpN47 and some of
the flagellar proteins, followed by TpN15 and TpN17.
CATALOGUE NUMBER
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PRINCIPLE OF THE TEST

USE BY Sandwich chemiluminescence immunoassay:
The MAGLUMI Syphilis assay is a two-step immunoassay.
TEMPERATURE LIMITATION Use ABEI to label the T. pallidum specific recombinant antigens;
( STORE AT 2-8 °C) and use the other T. pallidum-specific recombinant antigens to
coat magnetic microbeads.
In the first incubation, sample (or calibrator/control, if applicable),
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SUFFICIENT FOR assay buffer, the magnetic microbeads and ABEI Label are mixed.
The total T. pallidum antibodies present in the sample bind to the
T. pallidum specific recombinant antigens and form a sandwich
KEEP AWAY FROM SUNLIGHT complex. After incubation, ABEI Label are added again. Following
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a wash cycle, the rest unbound materials are removed, starter

1+2 is added to initiate a flash chemiluminescent reaction. The
THIS WAY UP light signal is measured by a photomultiplier within 3 seconds as
RLU which is proportional to the concentration of total antibodies
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against T. pallidum present in samples.

KIT COMPONENTS
Material Supplies
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100 50
Component
tests tests
Magnetic Microbeads: coated with
T. pallidum specific recombinant 2.5 ml 2.0 ml
antigens, containing BSA, 0.09%NaN3.

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Please only refer to the current product lot insert enclosed with the kits package for execution and reporting.

Calibrator Low: low concentration of level with each calibration.

T. pallidum antibody, bovine serum, 3.0 ml 2.0 ml
0.09%NaN3. 3) Frequency of Recalibration
 After each exchange of lots (Reagent Integral or Starter
Calibrator High: high concentration of
T. pallidum antibody, bovine serum, 3.0 ml 2.0 ml Reagents).
 Every week and/or each time a new Integral is used
0.09%NaN3.
(recommended).
Assay Buffer: Tris buffer, containing
 After each servicing of MAGLUMI Fully-auto
7.5 ml 5.0 ml
BSA, 0.09%NaN3.
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chemiluminescence immunoassay (CLIA) analyzer.
ABEI Label: T. pallidum specific  If controls are beyond the expected range.

recombinant antigen labeled with ABEI, 22.5 ml 12.5 ml  Whenever room temperature changes exceed 5 °C
Tris buffer, containing BSA, 0.09%NaN3. (recommended).
All reagents are provided ready-to-use.
SPECIMEN COLLECTION AND PREPARATION
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Sample material: serum and plasma may be used (including

Reagent Vials in kit box
serum collected in serum separator tubes). The anticoagulants
Internal Quality Control:
sodium citrate, potassium EDTA, lithium and sodium heparin have
Negative control: bovine serum, containing BSA,
2.0 ml been tested and may be used with this assay. Other types of blood
0.09%NaN3.
collection tube has not been verified.
Positive control: T. pallidum antibody positive
Follow manufacturers’ instructions carefully when using plasma
(rabbit), bovine serum, containing BSA, 2.0 ml
collection containers and gel separator containers.
0.09%NaN3.
Separate serum or plasma by centrifugation after standing whole
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Internal quality control is only applicable with MAGLUMI system. blood at room temperature.
For instructions for use and target value refer to Quality Control Samples can be stored for 24 hours at 2 °C ~ 8 °C, and for 90 days
Information data sheet. User needs to judge results with their own or less at -20 °C. Avoid repeated freezing and thawing. Stored
standards and knowledge. samples should be thoroughly mixed prior to use (Vortex mixer).
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Please ask local representative of SNIBE for more details if you

Accessories Required But Not Provided have any doubt.
MAGLUMI Reaction Module REF: 630003
MAGLUMI Starter 1+2 REF: 130299004M Specimen Conditions
MAGLUMI Wash Concentrate REF: 130299005M  Do not use specimens with the following conditions:
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MAGLUMI Light Check REF: 130299006M (a) heat-inactivated specimens;

Please order accessories from Shenzhen New Industries (b) Cadaver specimens;
Biomedical Engineering Co., Ltd (SNIBE) or our representative. (c) Obvious microbial contamination.
 Use caution when handling patient specimens to prevent

cross contamination. Use of disposable pipettes or pipette tips

is recommended.
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Preparation of the Reagent Integral  Inspect all samples for bubbles. Remove bubbles with an

Before the sealing is removed, gentle and careful horizontal applicator stick prior to analysis. Use a new applicator stick for
shaking of the Reagent Integral is essential (avoid foam each sample to prevent cross contamination.
formation!). Remove the sealing and turn the small wheel of the  Serum specimens should be free of fibrin, red blood cells or

magnetic microbeads compartment to and fro, until the color of the other particulate matter.
suspension has changed into brown. Place the Integral into the  Ensure that complete clot formation in serum specimens has

reagent area and let it stand there for 30 min. During this time, the taken place prior to centrifugation. Some specimens,
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magnetic microbeads are automatically agitated and completely especially those from patients receiving anticoagulant or
resuspended. thrombolytic therapy, may exhibit increased clotting time. If the
Do not interchange integral components from different specimen is centrifuged before a complete clotting, the
reagents or lots! presence of fibrin may cause erroneous results.

Storage and Stability Preparation for Analysis

 Sealed: Stored at 2-8° C until the expiration date.  Patient specimens with a cloudy or turbid appearance must be
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 Opened: Stable for 4 weeks. To ensure the best kit centrifuged at 10,000 x g for 10 minutes prior to testing.
performance, it is recommended to place opened kits in the Following centrifugation, avoid the lipid layer (if present) when
refrigerator if it’s not going to be used on-board during the next pipetting the specimen into a sample cup or secondary tube.
12 hours.  Specimens must be mixed thoroughly after thawing by low
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speed vortexing or by gently inverting, and centrifuged prior to

use to remove red blood cells or particulate matter to ensure
THIS WAY UP. consistency in the results. Multiple freeze-thaw cycles of
specimens should be avoided.
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 All samples (patient specimens or controls) should be tested

KEEP AWAY FROM SUNLIGHT
within 3 hours of being placed on board the MAGLUMI
System. Refer to the SNIBE service for a more detailed
CALIBRATION AND TRACEABILITY
discussion of onboard sample storage constraints.
1) Traceability
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To perform an accurate calibration, we have provided the test

Storage
calibrators standardized against the WHO 1st International
 If testing will be delayed for more than 8 hours, remove serum
Standard 05/132.
from the serum separator, red blood cells or clot. Specimens
removed from the separator gel, cells or clot may be stored up
2) 2-Point Recalibration
to 12 hours at 2-8°C.
Via the measurement of calibrators, the predefined master curve is
 Specimens can be stored up to 30 days frozen at -20° C or
adjusted (recalibrated) to a new, instrument-specific measurement
115 Syphilis -V3.0-en-EU 2016-07 2/4

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Please only refer to the current product lot insert enclosed with the kits package for execution and reporting.

colder. +80 μl Sample, calibrator or controls

+50 μl Assay Buffer
Shipping +20 μl Magnetic microbeads
Before shipping specimens, it is recommended that specimens +50 μl ABEI label
be removed from the serum separator, red blood cells or clot. 20 min Incubation
When shipped, specimens must be packaged and labeled in 400 μl Wash cycle
compliance with applicable state, federal and international +150 μl ABEI label
regulations covering the transport of clinical specimens and 20 min Incubation
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infectious substances. Specimens must be shipped frozen (dry 400 μl Wash cycle
ice). 3s Measurement

WARNING AND PRECAUTIONS FOR USERS

DILUTION
Sample dilution by analyzer is not available in this reagent kit.
 For use in IN-VITRO diagnostic procedures only. Samples with concentrations above the measuring range can be
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 Package insert instructions must be carefully followed. diluted manually. After manual dilution, multiply the result by the
Reliability of assay results cannot be guaranteed if there are dilution factor.
any deviations from the instructions in this package insert. Please choose applicable diluents or ask SNIBE for advice before
manual dilution must be processed.
Safety Precautions
CAUTION: This product requires the handling of human QUALITY CONTROL
specimens.  Observe quality control guidelines for medical laboratories.
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 All samples, biological reagents and materials used in the  Use suitable controls for in-house quality control. Controls

assay must be considered potentially able to transmit should be run at least once every 24 hours (a run cannot
infectious agents. They should therefore be disposed of in exceed 24 hours), once per reagent kit and after every
accordance with the prevailing regulations and guidelines of calibration. The control intervals should be adapted to each
the agencies holding jurisdiction over the laboratory, and the laboratory’s individual requirements. Values obtained should
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regulations of each country. Disposable materials must be fall within the defined ranges. Each laboratory should
incinerated; liquid waste must be decontaminated with sodium establish guidelines for corrective measures to be taken if
hypochlorite at a final concentration of 5% for at least half an values fall outside the range.
hour. Any materials to be reused must be autoclaved using an
overkill approach. A minimum of one hour at 121°C is usually LIMITATIONS OF THE PROCEDURE
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considered adequate, though the users must check the 1) Limitations

effectiveness of their decontamination cycle by initially Assay results should be utilized in conjunction with other clinical
validating it and routinely using biological indicators. and laboratory data to assist the clinician in making individual
 It is recommended that all human sourced materials be patient management decisions.
considered potentially infectious and handled in accordance A skillful operation and strict adherence to the instructions are
with the 29 CFR. 1910.1030 Occupational exposure to necessary to obtain reliable results.
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bloodborne pathogens. Biosafety Level 2 or other appropriate Procedural directions must be followed exactly and careful
biosafety practices should be used for materials that contain operation must be used to obtain valid results. Any modification of
or are suspected of containing infectious agents. the procedure is likely to alter the results.
 This product contains Sodium Azide; this material and its Bacterial contamination of samples or repeated freeze-thaw cycles
container must be disposed of in a safe way. may affect the test results.
 Safety data sheets are available on request.

2) Interfering Substances
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Handling Precautions The assay is unaffected by bilirubin<60 mg/dl, hemoglobin<500

 Do not use reagent kits beyond the expiration date. mg/dl or Triglycerides <2000 mg/dl.
 Do not mix reagents from different reagent kits.

 Prior to loading the Reagent Kit on the system for the first time, 3) HAMA
the microbeads requires mixing to re-suspend microbeads Patient samples containing human anti-mouse antibodies (HAMA)
that have settled during shipment. may give falsely elevated or decreased values. Although
HAMA-neutralizing agents are added, extremely high HAMA
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 For microbeads mixing instructions, refer to the KIT

COMPONENTS, Preparation of the Reagent Integral section concentrations may occasionally influence results.
of this package insert.
 To avoid contamination, wear clean gloves when operating RESULTS
with a reagent kit and sample. 1) Calculation of Results
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 Pay attention to the residual liquids which has dried on the kit The analyzer automatically calculates the concentration of T.
surface. pallidum antibodies in each sample by means of a calibration
 For detailed handling precautions during system operation, curve which is generated by a 2-point calibration master curve
refer to the SNIBE service information. procedure. The results are expressed in mIU/ml. For further
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information please refer to the operating instructions of MAGLUMI

TEST PROCEDURE Fully-auto chemiluminescence immunoassay (CLIA) analyzer.
To ensure proper test performance, strictly adhere to the operating
instructions of MAGLUMI Fully-auto chemiluminescence 2) Interpretation of Results
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immunoassay (CLIA) analyzer. Each test parameter is identified Results obtained with the MAGLUMI Syphilis assay can be
via a RFID tag on the Reagent Integral. For further information interpreted as follows:
please refer to the operating instructions of MAGLUMI Fully-auto Non-reactive: A result less than 1.0 mIU/ml (<1.0 mIU/ml) is
chemiluminescence immunoassay (CLIA) analyzer . considered to be negative.
Reactive: A result greater than or equal to 1.0 mIU/ml (≥1.0 mIU/ml)
is considered to be positive.
Assay results should be interpreted in conjunction with the
115 Syphilis -V3.0-en-EU 2016-07 3/4

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Please only refer to the current product lot insert enclosed with the kits package for execution and reporting.

patient’s clinical presentation, history, and other laboratory results. times for each level to calculate the coefficient of variation.
All initially reactive should be redetermined in duplicate with the Sample#ID
Mean SD CV
(mIU/ml) (mIU/ml) (%)
MAGLUMI Syphilis. If the concentration values <1.0 mIU/ml are
Low Positive 2.512 0.131 5.21
found in both cases, the samples are considered negative for Moderately Positive 20.011 0.301 1.50
antibodies against T. pallidum. And repeatedly reactive samples High Positive 100.827 3.200 3.17
must be confirmed according to recommended confirmatory Negative Control 0.009 0.005 NA
algorithms. Positive Control 10.009 0.454 4.53
NA = not applicable
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PERFORMANCE CHARACTERISTICS
1) Specificity 4) Performance Panel
The MAGLUMI Syphilis assay was evaluated for potential The Syphilis Mixed Titer AccuSetTM Performance Panel Modified
cross-reactivity with other viral infections and disease state PSS202(M2) is intended for use by diagnostic manufacturers,
specimens. The results are shown in the table below: researchers, and clinical laboratories to develop, evaluate, or
Number of troubleshoot syphilis test methods. Characterized samples and
MAGLUMI
Clinical expected comprehensive data are provided for comparative analysis.
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Syphilis positive
Category negative Trinity
result Performance Panel Snibe Olympus
samples Biotech
TOXO IgG 10 0 Modified Syphilis PKTM
CAPTIATM
TOXO IgM 10 0 PSS202(M2) (mIU/ml)# TP Syphilis*
Syphilis IgG*
Rubella IgG 10 0 PSS202(M2)-01 NA 4.4 Reactive
Rubella IgM 5 0 PSS202(M2)-02 183.42 3.8 Reactive
CMV IgG 10 0 PSS202(M2)-03 277.38 3.3 Reactive
PSS202(M2)-04 NA NA NA
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CMV IgM 10 0
PSS202(M2)-05 176.26 2.2 Reactive
HSV-1/2 IgG 10 0
PSS202(M2)-06 446.51 4.5 Reactive
HSV-1/2 IgM 10 0 PSS202(M2)-07 418.06 3.6 Reactive
HTLV-1/2 6 0 PSS202(M2)-08 156.08 2.3 Reactive
EBV IgG 8 0 PSS202(M2)-09 74.352 3.8 Reactive
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EBV IgM 8 0 PSS202(M2)-10 393.42 4.4 Reactive

HAV 10 0 PSS202(M2)-11 20.309 2.5 Reactive
PSS202(M2)-12 464.27 3.9 Reactive
HBV 10 0
PSS202(M2)-13 301.19 3.2 Reactive
HCV 10 0 247.33 3.3 Reactive
PSS202(M2)-14
HIV-1/2 15 0 PSS202(M2)-15 68.516 3.5 Reactive
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Total 142 0 PSS202(M2)-16 NA NA NA

PSS202(M2)-17 277.61 2.4 Reactive
2) Sensitivity PSS202(M2)-18 278.28 2.4 Reactive
PSS202(M2)-19 224.61 2.2 Reactive
Sensitivity of the MAGLUMI Syphilis assay was evaluated by
PSS202(M2)-20 246.09 2.2 Reactive
testing sequential specimens from the SeraCare seroconversion
NA = Panel members 1, 4, and 16 are no longer available.
panels. The results from seroconversion panel PSS901 are shown
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*Data from the vendor.

in the table below (Representative performance data are shown.
The results are considered reactive and noted in bold.
Results obtained at individual laboratories may vary):
# Results obtained at individual laboratories may vary.
Trinity
Days DiaSorin
Seroconversio Snibe Biotech
Since Liaison REFERENCES
n Panel Syphilis Trep-SureTM
1st Treponema
PSS901 (mIU/ml) Syphilis 1. Burstain J M, Grimprel E, Lukehart S A, et al. Sensitive
Bleed Syphilis*
(Index)* detection of Treponema pallidum by using the polymerase
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PSS901-01 0 0.462 1.07 NEG chain reaction[J]. Journal of clinical microbiology, 1991, 29(1):
PSS901-02 5 0.760 0.475 NEG 62-69.
PSS901-03 10 0.755 0.419 NEG
2. Lynn W A, Lightman S. Syphilis and HIV: a dangerous
PSS901-04 13 1.099 0.576 NEG
PSS901-05 31 1.768 3.68 NEG
combination[J]. The Lancet infectious diseases, 2004, 4(7):
PSS901-06 45 5.253 4.07 POS 456-466.
PSS901-07 48 11.008 4.98 POS 3. Kent M E, Romanelli F. Reexamining syphilis: an update on
PSS901-08 52 31.726 4.20 POS epidemiology, clinical manifestations, and management[J].
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PSS901-09 59 74.235 11.2 POS Annals of Pharmacotherapy, 2008, 42(2): 226-236.

*Data from the vendor 4. Stamm L V. Global challenge of antibiotic-resistant Treponema
The results are considered reactive and noted in bold. pallidum[J]. Antimicrobial agents and chemotherapy, 2010,
54(2): 583-589.
3) Precision
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5. Young H. Guidelines for serological testing for syphilis[J].

Intra-assay coefficient of variation was evaluated on 3 different Sexually Transmitted Infections, 2000, 76(5): 403-405.
levels of positive samples and negative and positive control. 6. Kiss S, Damico F M, Young L H. Ocular manifestations and
Repeatedly measure 20 times in the same run to calculate the treatment of syphilis[C]//Seminars in ophthalmology. UK:
coefficient of variation.
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Informa UK Ltd, 2005, 20(3): 161-167.

Mean SD CV 7. Schmidt B L, Edjlalipour M, Luger A. Comparative Evaluation of
Sample#ID
(mIU/ml) (mIU/ml) (%)
Low Positive 2.503 0.119 4.77 Nine Different Enzyme-Linked Immunosorbent Assays for
Moderately Positive 19.965 0.295 1.48 Determination of Antibodies against Treponema pallidum in
High Positive 100.243 2.789 2.78 Patients with Primary Syphilis[J]. Journal of clinical
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Negative Control 0.008 0.003 NA microbiology, 2000, 38(3): 1279-1282.

Positive Control 9.996 0.385 3.86
NA = not applicable

Inter-assay coefficient of variation was evaluated on three batches

of kits. Repeatedly measured 3 different levels of positive samples
and negative and positive control 20 times in the same run, and 60
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