Syphilis Antibody Rapid Test
The Syphilis Antibody Rapid Test is a qualitative membrane based immunoassay for thedetection of TP total lgG in whole blood, serum or plasma. In this test procedure, recombinantSyphilis antigen is immobilized in the test line region of the test. After a specimen is added tothe specimen pad it reacts with Syphilis antigen coated particles that have been applied to thespecimen pad.This mixture migrates chromatographically along the length of the test andinteracts with the immobilized Syphilis antigen. The double antigen test format can detect totallgG in specimens. lf the specimen contains TP antibodies, a colored line will appear in the testline region, indicating a positive result. lf the specimen does not contain TP antibodies, a coloredline will not appear in this region, indicating a negative result. To serve as a procedural control,a colored line will always appear in the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
The Syphilis Antibody Rapid Test has correctly identified specimens of a seroconversion panel
and has been compared to a leading commercial TPPA Syphilis test using clinical specimens.
| Syphilis Antibody Rapid Test | |||
| Syphilis Test Strip | Positive | Negative | Total |
| Positive | 84 | 7 | 91 |
| Negative | 1 | 445 | 446 |
| Total | 85 | 452 | 537 |
| Relative Sensitivity | 98.82% | ||
| Relative Specificity | 98.45% | ||
When ready to test, open the pouchat the notch and remove device. Placethe test device on a clean, flat surface.
Fingerstick Whole Blood specimens
Serum - Plasma / Venipuncture Whole Bloodspecimens
Fingerstick Whole Blood specimens
Read results at 10 minutes.
Do notinterpret the result after 20 minutes.
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