Aspen Syphilis Rapid 40 Test

INTENDENT USE Treponema Pallidum (TP) is the causative agent of the venereal disease syphilis, TP is a spirochaete bacterium with an outer envelope and a cytoplasmic membrane.  One study reported a substantial epidemiological correlation between the acquisition and transmission of the HIV virus and syphilis. 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 device 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.

PRINCIPLE Syphilis test device  is a rapid  qualitative membrane Device based immunoassay for the detection of  TP antibodies (IgG and IgM) in serum or plasma. In this test procedure, recombinant syphilis antigen is immobilized in the test line region ‘T’ of  the device. After  a  specimen is  added  to  the specimen well (S) of the device, it reacts with syphilis antigen coated particles in the test. This mixture migrates chromatographically along the length of the test device 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 colored  line will appear in the test line region ‘T’ indicating a positive result. If the specimen does not contain TP antibodies a colored line 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 (C) 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.

1. For Professional in vitro diagnostic use only. Do not use after expiration date. 2. Do not eat, drink or smoke in the area where the specimen or kits are handled. 3. Do not use test if pouch is damaged. 4. 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. 5. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed. 6. Humidity and temperature can adversely affect results.

STORAGE  AND  STABILITY Store as packaged 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 kit. The test must remain in the sealed pouch until use. DO NOT FREEZE. The Syphilis test device  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.  specimens may be stored at 2-8°C for up to 3 days. For long term storage, specimens should be kept below -20°C . ! Bring specimen to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimen should not be frozen and thawed repeatedly. vdrl