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Syphilis/TP Device Test
Modified rapid test for qualitative detection of Syphilis / Treponema pallidum (TP) antibody in human serum / plasma




INTENDED USE:

Syphilis Rapid Test device is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Treponema pallidum (TP) in serum or plasma to aid in the diagnosis of Syphilis. It has double antigen system which can detect both IgG and IgM antibodies of TP in the specimens.

INTRODUCTION:

Treponema pallidum (TP) is the causative agent of the venereal disease Syphilis. TP is a spirochete bacterium with an outer envelope and a cytoplasmic membrane. Multiple clinical stages and long period of latent, asymptomatic infection are characteristic of syphilis. Diagnosis of syphilis depends on the correlation of clinical data with the results of serologic (non-treponemal and treponemal) assays. Non-treponemal tests (VDRL, RPR, etc) are generally used for screening and treponemal tests (TPHA, FTA-ABS) are used as confirmatory tests. Persons in whom both assays are reactive are considered infected. One study reported a substantial epidemiological correlation between the acquisition and transmission of the HIV virus and Syphilis.

Primary Syphilis is defined by the presence of a chancre at the site of inoculation. The antibody response to the TP bacterium can be detected within 4 to 7 days after the chancre appears. The infection remains detectable until the patient receives adequate treatment.

Syphilis Rapid Test device is a very sensitive and specific test for detection of TP antibodies (IgG and IgM) qualitatively and selectively in serum or plasma. It utilizes a double antigen system where recombinant antigen of TP is conjugated with colloidal gold conjugate and immobilized on nitro cellulose membrane as test line protein. This test is a good replacement of TPHA test.

PRINCIPLE:

Syphilis Rapid Test device is based upon immuno chromatographic principle. Device contains a strip having a pad of dried gold conjugate containing recombinant antigen of TP. The nitro cellulose membrane is immobilized with recombinant antigen of TP in the test line region 'T' and another protein in the control line region 'C'. When a specimen containing antibodies to TP is added in sample well, it reacts with antigen conjugated with colloidal gold and makes an immune complex. This immune complex migrates chromatographically along the length of the test membrane and reacts with antigen immobilized at test line region 'T'. The appearance of a pink / purple line in the test line region 'T', indicating that specimen is positive for Syphilis and antibodies to TP are present. If the specimen does not contain TP antibodies, a pink / purple line will not appear in test line region 'T', indicating a negative result for Syphilis and specimen does not contains antibodies to TP.

To serve as an inbuilt procedural control, a pink / purple line will always appear in the control line region 'C', indicating that proper volume of specimen has been added and membrane components are working well.

MATERIALS PROVIDED:

Syphilis Rapid Test device kit contains the following components:

1. Test device pouches: Each pouch contains plastic device housed with a strip having sample pad, conjugate pad (recombinant antigen and anti control line protein conjugated with colloidal gold), nitro cellulose membrane immobilized with recombinant antigen & control line protein, absorbent pad and desiccant pouch.

2. Product insert

MATERIAL REQUIRED BUT NOT PROVIDED:

1. Gloves
2. Timer
3. Specimen collection tubes
4. Disinfectant etc.

STORAGE AND STABILITY:

Syphilis Rapid Test device kit should be stored at 2-30C in sealed condition. The kit has a shelf life as indicated on the pouch and box label if stored at recommended conditions. The devices should not be frozen and must be protected from exposure to humidity; once a pouch is opened, the device should be used at the earliest.

PRECAUTIONS:

1. For professional in vitro diagnostic use only.
2. Does not use after date of expiry.
3. For single use only.
4. Do not eat, drink or smoke in the area where the specimens or kits are handled.
5. Do not use test if pouch is damaged and colour of desiccant has been changed to white / pink instead of blue.
6. Handle all specimens as if they contain infectious agents. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
7. Observe established precautions against microbiological hazards throughout all procedures and follow the standard procedures for proper disposal of specimens.
8. The used test should be discarded according to local regulations.
9. Humidity and temperature can adversely affect results.
10. Clean up spills thoroughly using an appropriate disinfectant.

SPECIMEN COLLECTION AND STORAGE:

The Syphilis Rapid Test device can be performed using serum or plasma. Draw the blood by technique of vein puncture using disposable syringe and collect in a suitable blood collection tube. Allow to clot for serum and centrifuge to get clear serum or plasma. Use only clear non-hemolyzed specimens. Testing should be performed immediately after the specimens have been collected.

Do not leave the specimens at room temperature for prolonged periods. If testing is not possible immediately, specimens may be stored at 2-8C for up to 3 days. For long term storage, specimens should be kept below -20C. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly. If specimens are to be shipped, they should be packed in compliance with local regulations covering the transportation of etiologic agents.

TEST PROCEDURE:

1. Bring the test devices / specimens / controls to be tested to room temperature prior to testing.
2. Take out the test device by tearing from the notch provided at corner of pouch and place on flat surface away from high blow of air / fan.
3. Add 2 -3 drops of serum / plasma into sample well (S) using provided sample dropper.

4. Wait for 5-10 minutes for the appearance of pink / purple lines in result window. Do not interpret after 15 minutes and discard the device.

INTERPRETATION OF RESULTS:

Positive: Appearance of two pink / purple lines, one at test band region T and another at control band region C', indicates that specimen is positive for presence of antibodies to Treponema pallidum.

Negative: Appearance of only one pink / purple line at control band region C', indicates that specimen is negative for presence of antibodies to Treponema pallidum.