Syphilis 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. The Syphilis test strip has been compared with a leading commercial syphilis test, demonstrating an overall accuracy greater than or equal to 99.7%. Multiple clinical stages and long 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 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.
The Syphilis test strip utilizes a double antigen combination of a syphilis antigen coated particles and syphilis antigen immobilized on membrane to detect TP antibodies (IgG/IgM) qualitatively and selectively in serum or plasma.
The Syphilis test strip can be performed using serum or plasma. Testing should be performed immediately after the specimens have been collected. Do not leave the specimen at room temperature for prolonged periods. Allow the test strip, specimen, or controls to reach room temperature (15-30°C) prior to testing, if stored refrigerated. Open the sealed pouch by tearing along the notch. Remove the test strip from the pouch and with arrows pointing towards the specimen, immerse the test strip vertically in the sample, for at least 10-15 seconds. Do not immerse past the maximum line on the test strip. Place the test strip on a non-absorbent flat surface. Wait for the colored line to appear. Read result at 10 minutes. Do not read result after 30 minutes.
Do not use after expiration date. Do not eat, drink or smoke in the area where the specimen or kits are handled. Do not use test if pouch is damaged. Handle all specimen as if they contain infectious agents. Observe established precautions against microbiological hazards throughout all procedures and follow standard procedures for proper disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed. Humidity and temperature can adversely affect results.
POSITIVE: Two distinct colored lines appear. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T). Note: The intensity of the color in the test line region (T) will vary depending on the concentration of TP antibodies present in the specimen. Therefore, any shade of color in the
test line region (T) should be considered positive. NEGATIVE: One colored line appears in the control line region (C). No line appears in the test 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 strip. If the problem persists discontinue using the test kit immediately and contact your local distributor.
Store as packaged in the sealed pouch either at room temperature or refrigerated(2-30°C). The test Strip is stable through the expiration date printed on the kit. The test must remain in the sealed pouch until use. Do not freeze.
The information presented at the site has a general character. Note please this information cannot be used for self-treatment and self diagnosis. You should consult with your doctor or health care adviser regarding any specific instructions of your condition. The information is reliable, but we concede it could contain mistakes. We are not responsible for any direct, indirect, special or other damage caused by use of this information on the site and also for consequences of self-treatment.