Syphilis Test is a qualitative membrane device based immunoassay for the detection of TP antibodies (IgG and IgM) in whole blood, serum or plasma. In this test procedure, recombinant Syphilis antigen is immobilized in the test line region of the device. After a specimen is added to the specimen well of the device, it reacts with Syphilis antigen coated particles in the test. This mixture migrates chromatographically along the length of the test strip and interacts with the immobilized Syphilis antigen. The double antigen test format can detect both IgG and IgM in specimens. If the specimen contains TP antibodies, a coloured line will appear in the test line region, indicating a positive result. If the specimen does not contain TP antibodies, a coloured line will not appear in this region, indicating a negative result.
Used for: Syphilis
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Package1mg × 1 devices
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Price$ 2.00
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Per device$ 2.00
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Syphilis Test is a qualitative membrane device based immunoassay for the detection of TP antibodies (IgG and IgM) in whole blood, serum or plasma. In this test procedure, recombinant Syphilis antigen is immobilized in the test line region of the device. After a specimen is added to the specimen well of the device, it reacts with Syphilis antigen coated particles in the test. This mixture migrates chromatographically along the length of the test strip and interacts with the immobilized Syphilis antigen. The double antigen test format can detect both IgG and IgM in specimens. If the specimen contains TP antibodies, a coloured line will appear in the test line region, indicating a positive result. If the specimen does not contain TP antibodies, a coloured line will not appear in this region, indicating a negative result. To serve as a procedural control, a coloured line will always appear in the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
The test device contains Syphilis antigen coated particles and Syphilis antigen coated on the membrane.
Store as packed in the sealed pouch either at room temperature or refrigerated (2-30°C). The test device is stable through the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use. DO NOT FREEZE. Do not use after the expiration date.
SPECIMEN COLLECTION AND PREPARATION
The Syphilis Rapid Test Device (Whole Blood/Serum/Plasma) can be performed using whole blood (from venipuncture or fingerstick), serum or plasma.
To collect fingerstick whole blood specimens:
Testing should be performed immediately after the specimens have been collected. Do not leave the specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to 3 days. For long term storage, specimens should be kept below 20°C. Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 2 days of collection. Do not freeze whole blood specimens. Whole blood collected by fingerstick should be tested immediately.
For testing:
Venipuncture Whole Blood
Fingerstick Whole Blood
To use hanging drops
POSITIVE: Two distinct coloured lines appear. One coloured line should be in the control line region and another apparent coloured line should be in the test line region.
*NOTE: The intensity of the colour in the test line region will vary depending on the concentration of TP antibodies present in the specimen. Therefore, any shade of colour in the test line region should be considered positive.
NEGATIVE: One coloured line appears in the control line region. No line appears in the test line region.
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
A procedural control is included in the test. A coloured line appearing in the control line region is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique. Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.
The Syphilis Rapid Test Device (Whole Blood/Serum/Plasma) has been compared with a leading commercial TPHA Syphilis test, demonstrating an overall accuracy greater than or equal to 99.7%.
The Syphilis Rapid Test Device (Whole Blood/Serum/Plasma) has correctly identified specimens of a seroconversion panel and has been compared to a leading commercial TPHA Syphilis test using clinical specimens. The results show that the relative sensitivity of the Syphilis Rapid Test Device (Whole Blood/Serum/Plasma) is 99.7%, and the relative specificity is 99.6%. The Confidence Interval is 95%.