Serocheck TP Devicekkkk

TM
SEROCHECK-Tp
Rapid Test for Syphilis
(Modified TPHA)
DEVICE
INTENDED USE
Serocheck-Tp™ (Device) is a rapid, qualitative, two site double antigen sandwich immunoassay for the detection of syphilis in
human serum or plasma specimens. For Professional use.
SUMMARY
Syphilis is a sexually transmitted (venereal) disease caused by the spirochete Treponema pallidum. The disease can also be
transmitted congenitally thereby attaining its importance in antenatal screening. After infection the host forms non-
Treponemal anti-lipoidal antibodies (reagins) to the lipoidal material released from the damaged host cells as well as
Treponema specific antibodies. Serological tests for non-Treponemal antibodies such as VDRL, RPR, and TRUST etc. are
useful as screening tests. Tests for Treponema specific antibodies such as TPHA, FTA-ABS, rapid Treponema antibody tests
are gaining importance as screening as well as confirmatory tests because they detect the presence of antibodies specific to
Treponema pallidum.
Serocheck-Tp™ (Device) is a modified TPHA, which qualitatively detects the presence of IgM and IgG class of Treponema
specific antibodies during syphilis in serum or plasma specimens within 15 minutes.
PRINCIPLE
Serocheck-Tp™ (Device) utilizes the principle of agglutination of antibodies / antisera with respective antigen in
immunochromatography format along with use of nano gold particles as agglutination revealing agent. The conjugate pad
contains two components, recombinant Treponema antigens conjugated to colloidal gold and rabbit globulin conjugated to
colloidal gold. As the test sample flows through the membrane assembly of the test device, the recombinant Treponema
antigen-colloidal gold conjugate forms a complex with Treponema specific antibodies in the sample and travels further on the
membrane due to capillary action along with the rabbit globulin-colloidal gold conjugate. This complex moves further on the
membrane to the test region where it is immobilized by another recombinant Treponema antigens coated on the membrane
leading to the formation of a pink to deep purple coloured band at the test region 'T'. Absence of this coloured band in test
region 'T' indicates a negative test result.
The unreacted conjugate and unbound complex, if any, along with rabbit globulin - gold conjugate moves further on the
membrane and are subsequently immobilized by the Agglutinating sera for rabbit globulin coated on the membrane at the
control region 'C', forming a pink to deep purple coloured band. This control band acts as a procedural control and serves to
validate the results.
REAGENTS AND MATERIALS SUPPLIED

Serocheck-Tp™ (Device) kit has following components:
A. Individual pouch containing:
1. DEVICE Membrane assembly pre-dispensed with recombinant Treponema pallidum antigen colloidal gold
conjugate, recombinant Treponema pallidum antigen and Agglutinating sera for rabbit globulin coated at windows 'T'
& 'C' respectively.
2. PIPETTE Disposable plastic sample applicator.
3. Desiccant Pouch.
B. BUF Sample running buffer in a dropper bottle.
C. Package insert.
REF 501100025
25 Test
OPTIONAL MATERIAL REQUIRED

Calibrated micropipette capable of delivering 25µl of sample accurately.
STORAGE AND STABILITY

The sealed pouches in the test kit may be stored at 4°C to 30°C for the duration of shelf life as indicated on the pouch/carton.
After first opening of the sample running buffer, the buffer is stable until the expiry date mentioned on the buffer label, if kept at
4°C to 30°C for the duration of its shelf life. DO NOT FREEZE.
NOTES
1. For in vitro diagnostic use only. NOT FOR MEDICINAL USE. For professional use.
2. Do not use the kit beyond expiry date and do not reuse the test device.
3. Read the instructions carefully before performing the test.
4. Handle all specimens as potentially infectious.
5. Follow standard bio-safety guidelines for handling and disposal of potentially infective material.
6. Contact with contents of desiccant pouch containing, among other substances, cobalt chloride (CAS # 7646-79-9) should
be kept to a minimum. Inhalation/swallowing may cause harm.
7. Sample running buffer contains Sodium Azide (0.1%), avoid skin contact with this reagent. Azide may react with lead and
copper in the plumbing and form highly explosive metal oxides. Flush with large volumes of water to prevent azide build-
up in the plumbing.
SAMPLE COLLECTION
No special preparation of patient is necessary prior to specimen collection by approved techniques. Though fresh serum/
plasma is preferable, serum/ plasma specimens may be stored at 2°C to 8°C for up to 72 hours, in case of delay in testing. Do
not use haemolysed or contaminated specimens. Turbid specimens should be centrifuged or allowed to settle and only the
clear supernatant should be used for testing.
TESTING PROCEDURE AND INTERPRETATION OF RESULTS

Bring kit components, specimen to room temperature prior to testing.
1. Bring the sealed pouch to room temperature, if the pouch of the device is damaged, discard the device and take a new
one for the test. Open the pouch, remove the device and place it on a flat surface. Label the device with patient's identity.
Once opened, the device must be used immediately. Check the colour of the desiccant. It should be blue, if it has
turned colourless or faint blue or pink, discard the device and use another device.
2. Tighten the cap of the Sample running buffer provided with the kit in the clockwise direction to pierce the dropper bottle
nozzle.
3. With the help of applicator provided in the pouch dispense one drop (approx. 25 µl) of serum / plasma to the sample port
“S”. Alternatively, 25 µl of serum / plasma may be delivered in the sample port “S” using a micropipette.
4. Immediately add one drop of Sample running buffer from the buffer bottle to the sample port “S”.
5. Read the results at the end of 15 minutes as follows:
Negative:
C T S Appearance of only one pink to deep purple coloured band on the device.
Positive:
C T S Appearance of two distinct pink to deep purple coloured bands on the device.
Invalid:
C T S The test should be considered invalid if no bands appear on the device. The test should also be
considered invalid if only test band appears and no control band appears. Repeat the test with
C T S
a new device ensuring that the test procedure has been followed accurately.
6. Although, depending on the concentration of Treponemal antibodies in the specimen, positive results may appear as
early as 2 to 3 minutes, negative results should be confirmed only at the end of 15 minutes.
PERFORMANCE CHARACTERISTICS
1. In an in-house evaluation, 50 known Positive and 220 known Negative samples were tested with Serocheck-Tp™
(Device) and compared with commercial Rapid and ELISA kits. The results obtained were as follows:
Samples Total No. of Commercial Commercial Serocheck-Tp™ Sensitivity

PPV
samples tested ELISA Rapid Test (Device) (95% CI)
Syphilis Positive 50 nos 49 nos 49 nos 49 nos 98.00%
(99.63% to 100.00%) 100%
* PPV: Positive Predictive Value
Samples Total No. of Commercial Serocheck-Tp™ Sensitivity

NPV
samples tested ELISA (Device) (95% CI)
Syphilis Negative 220 nos 220 nos 220 nos 100.00%
(98.34% to 100.00%) 100%
* NPV: Negative Predictive Value
Based on the above study,

Specificity of Serocheck-Tp™ (Device) is 100%.
Sensitivity of Serocheck-Tp™ (Device) is 98%.
2. Serocheck-Tp™ (Device) was evaluated with SYPHILIS PERFORMANCE PANEL
(NIB-SYPHILIS-01/2017) obtained from NATIONAL INSTITUTE OF BIOLOGICALS (NIB) consisting of 25 nos. reactive
and 25 nos. non-reactive plasma samples. The results obtained were as follows:
ID of Syphilis Serocheck-Tp™ ID of Syphilis Serocheck-Tp™

reactive samples (Device) non-reactive samples (Device)
V1 POSITIVE N1 NEGATIVE
Note: From the above evaluation, it can be noted that Serocheck-Tp™ (Device) shows results which are co-relating with
results provided by NATIONAL INSTITUTE OF BIOLOGICALS (NIB).
LIMITATIONS OF THE TEST

1. Serocheck-Tp™ (Device) detects the presence of Treponemal antibodies; thus a positive result indicates a past or
present infection. Positive results should be evaluated in co-relation with the clinical condition before arriving at a final
diagnosis.
2. Low levels of antibodies to Treponema pallidum such as those present at a very early primary stage of infection can give a
negative result. But a negative result does not exclude the possibility of exposure to or infection with Treponema pallidum.
Retesting is indicated after two weeks if clinically syphilis is still suspected.
3. In order to assess the clinical response to treatment it is advisable to use a reagin test such as VDRL, RPR.
4. Serocheck-Tp™ (Device) detects Treponemal antibodies in serum/ plasma; other body fluids may not give accurate
results.
5. In immunocompromised patients the test results must be interpreted with caution.
6. As with all diagnostic tests, results must be co-related with clinical findings.
WARRANTY
This product is designed to perform as described on the label and package insert. The manufacturer disclaims any implied
warranty of use and sale for any other purpose.
BIBLIOGRAPHY
1. Syphilis: New Diagnostic Directions, H. Young, International Journal of STD and AIDS, 1992, 3: 391-413.
2. Clinical Laboratory Diagnostics: Use and Assessment of Clinical Laboratory Results, Lothar Thomas, 1st Edition, 1998,
TH-Books.
3. AABB Technical Manual, 13th Edition, 1999.
4. Clinical Diagnosis and Management by Laboratory Methods, John Bernard Henry, 17th Edition, 1979, W.B.Saunders
Company.
5. Data on File: Zephyr Biomedicals.
SYMBOL KEYS
Consult
Temperature
Limitation
Instructions
for use
Date of
Manufacture 2 Do not reuse
In vitro Diagnostic Sample

Manufacturer IVD Medical Device
This side up BUF Running Buffer
Catalogue
Use by REF Number DEVICE Device
EC REP
Disposable Authorised Representative
Contains sufficient Batch Number /
for <n> tests LOT Lot Number PIPETTE Plastic Sample
Applicator
in the European Community
Manufactured by:
Zephyr Biomedicals
A Division of Tulip Diagnostics (P) Ltd.
M 46-47, Phase lIl B, Verna Industrial Estate, Verna, Goa - 403 722, INDIA.
Regd. Office: Gitanjali, Tulip Block, Dr. Antonio Do Rego Bagh, Alto Santacruz,
1118/VER-01
Bambolim Complex P.O., Goa - 403 202, INDIA.
EC REP
CMC Medical Devices & Drugs S.L., Spain.

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REAGENTS AND MATERIALS SUPPLIED

OPTIONAL MATERIAL REQUIRED

STORAGE AND STABILITY

TESTING PROCEDURE AND INTERPRETATION OF RESULTS

Samples Total No. of Commercial Commercial Serocheck-Tp™ Sensitivity

* PPV: Positive Predictive Value

Samples Total No. of Commercial Serocheck-Tp™ Sensitivity

* NPV: Negative Predictive Value

Based on the above study,

ID of Syphilis Serocheck-Tp™ ID of Syphilis Serocheck-Tp™

LIMITATIONS OF THE TEST

In vitro Diagnostic Sample

Bambolim Complex P.O., Goa - 403 202, INDIA.

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