INTRODUCTION
Treponema Pallidum (TP), a spirochete bacterium with an outer envelope and a cytoplasmic membrane, is the causative agent of the venereal disease syphilis.The positive rate of serological test results for syphilis in HIV-infected individuals has been rising recently.
The serological detection of specific antibodies to TP has been long recognized in the diagnosis of syphilis since the natural course of the infection is characterized by periods without clinical manifestations. The antibody response to TP can be detected within 4 to 7 days after the syphilis chancre appears, allowing early detection and diagnosis of syphilis infection.
A variety of antigens have been used in syphilis serological tests, such as Rapid Plasma Cardiolipin (RPR) or VDRL antigen, TP extracts derived from in vitro culture or inoculated rabbit testes. However, RPR and VDRL antigens are not treponemal specific, and whole TP extracts are not reproducible and contain a certain amount of contaminating materials such as flagella, which may lead to a nonspecific reaction in assays of test serum.
INTENDED USE
The Syphilis Rapid Test is a rapid visual immunoassay for the qualitative, presumptive detection of IgM and IgG antibodies to Treponema Pallidum (TP) in human serum or plasma specimens. This kit is intended for use as an aid in the diagnosis of syphilis.
| Detection |
IgG & IgM Antibodies |
| Main Contents |
Rapid test cassette+Disposable pipettes |
| Usage |
For professional use only |
| Storage |
2~30ºC |
SAMPLE COLLECTION
• The Syphilis Rapid Test is intended for use with human serum or plasma specimens only.
• Only clear, non-hemolyzed specimens are recommended for use with this test. Serum or plasma should be separated as soon as possible to avoid hemolysis.
• Perform testing immediately after specimen collection. Do not leave 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.
• Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing of specimens.
• If specimens are to be shipped, pack them in compliance with all applicable regulations for transportation of etiological agents.
• Icteric, lipemic, hemolysed, heat treated and contaminated specimens may cause erroneous results.
OPERATING INSTRUCTION
Bring tests, specimens, buffer and/or controls to room temperature (15- 30°C) before use.
1.Remove the test from its sealed pouch, and place it on a clean, level surface. Label the test with patient or control identification. For best results, the assay should be performed within one hour.
2.Using the provided disposable pipette, transfer 2 drops of serum/Plasma to the specimen well (S) of the cassette with the provided disposable pipette, then start the timer. Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area. As the test begins to work, color will migrate across the membrane.
3. Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.
INTERPRETATION OF RESULTS
POSITIVE: The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.
NEGATIVE: The presence of only control line (C) within the result window indicates a negative result.
INVALID: If the control line (C) is not visible within the result window after performing the test, the result is considered invalid.
COMPANY PROFILE
Audited Supplier 
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