The Syphilis Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Treponema Pallidum (TP) in whole blood, serum or plasma to aid in the diagnosis of Syphilis.
In this test procedure, recombinant Syphilis antigen is immobilised in the test line region of the test. After the specimen is added to the sample well of the device, it reacts with Syphilis antigen coated particles in the test. This mixture migrates chromatographically along the length of the trial and interacts with the immobilised Syphilis antigen. The second antigen test format can detect both IgG and IgM in specimens. If the sample contains TP antibodies, a coloured line will appear in the test line region, indicating a positive result. If the sample does not include TP antibodies, a coloured line will not appear in this area, 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.
ProductSyphilis rapid test kitSpecimenWhole blood, plasma, serumComponentsIndividually packed test devices, Disposable pipette, Buffer, and/orPackage insertSensitivity99.5%Accuracy99.4%Storage2-30℃Validity24 Months
The test contains Syphilis antigen coated particles and Syphilis antigen coated on the membrane.
Allow the test, specimen; Bua controls to reach room temperature (15-30°C) before testing.
1.Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible.
2.Place the device on a clean and level surface.
For Serum or Plasma specimen: Hold the dropper vertically and transfer one drop of serum or plasma (approximately 25 mL) to the specimen well (S), then add two drops of buffer (about 80 mL), and start the timer.
For Whole Blood Sample: Hold the dropper vertically and transfer two drops of whole blood (approximately 80 mL) to the specimen well (S), then add one drop of buffer (about 40 mL), and start the timer.
3.Wait for the coloured line(s) to appear. Read results at 10 minutes. Do not interpret the result after 30 minutes.
Active:* Two lines appear. One coloured line should be in the control line region (C), and another visible coloured line should be in the test line region (T).
*NOTE: The intensity of the colour in the test line region (T) will vary depending on the concentration of TP antibodies present in the specimen. Therefore, any shade of colour in the test line region (T) should be considered positive.
NEGATIVE: One coloured line appears in the control line region (C). No line appears in the test line region (T).
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. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
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.1 Relatively little is known about the organism in comparison with other bacterial pathogens. According to the Center for Disease Control (CDC), the number of cases of Syphilis infection has markedly increased since 1985.2 Some key factors that have contributed to this rise include the crack cocaine epidemic and the high incidence of prostitution among drug users.3 One study reported a substantial epidemiological correlation between the acquisition and transmission of the HIV and Syphilis.4
Multiple clinical stages and extended periods of latent, asymptomatic infection are characteristic of Syphilis. Primary Syphilis is defined by the presence of a chancre at the site of inoculation. The antibodies 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.