Syphilis (TP) Antibody Rapid Test Uncut Sheet

Summary and Explanation

Syphilis is a systemic disease caused by Treponema pallidum. The disease has been divided into stages based on clinical findings, helping to guide treatment and follow-up. Persons who have syphilis might seek treatment for signs or symptoms of primary syphilis infection (i.e., ulcers or chancre at the infection site), secondary syphilis (i.e., manifestations that include, but are not limited to, skin rash, mucocutaneous lesions, and lymphadenopathy), or tertiary syphilis (i.e., cardiac, gummatous lesions, tabes dorsalis, and general paresis). Latent infections (i.e., those lacking clinical manifestations) are detected by serologic testing. Latent syphilis acquired within the preceding year is referred to as early latent syphilis; all other cases of latent syphilis are late latent syphilis or syphilis of unknown duration. T. pallidum can infect the central nervous system and result in neurosyphilis, which can occur at any stage of syphilis. Early neurologic clinical manifestations (i.e., cranial nerve dysfunction, meningitis, stroke, acute altered mental status, and auditory or ophthalmic abnormalities) are usually present within the first few months or years of infection. Late neurologic manifestations (i.e., tabes dorsalis and general paresis) occur 10–30 years after infection.

Syphilis (Treponema Pallidum) Antibody Test is a rapid direct binding test for the visual detection of anti-syphilis antibodies in human serum, plasma and whole blood samples as an aid in the diagnosis of syphilis infection. Test results are read visually without any instrument. It is based on the principle of double antigen sandwich immunoassay for determination of syphilis antibodies. Purified recombinant syphilis antigens are employed to identify anti-Syphilis antibodies specifically.

Test Procedure

Allow the test cassette, specimen, buffer, and/or controls to reach room temperature (15-30"C) prior to testing.

1.Bring the pouch to room temperature before opening. Remove the test cassette from the

sealed pouch and use it within one hour.

2.Place the test cassette on a clean and level surface

For Serum or Plasma Specimens

Hold the dropper vertically, draw the specimen and transfer the specimen to the sample well of the test cassette (two drops/approximately 50ul) to the sample well and start the timer. Avoid trapping air bubbles in the sample well.

For Whole Blood Specimens

Hold the dropper vertically, draw the specimen and transfer the specimen to the sample well of the test cassette (two drops/approximately 50ul), then add 1 drop of buffer(approximately 25ul)to the sample well and start the timer. Avoid trapping air bubbles in the sample well.

3. Wait for the colored line(s)to appear. The test result should be read at 10 minutes. Do not interpret the result after 20 minutes.

Result Interpretation

Negative result: if there is only a quality control line C, the detection line is colorless, indicating that Syphilis (Treponema Pallidum) antibody has not been detected and the result is negative.

Positive result: if both the quality control line C and the detection line appear, Syphilis (Treponema Pallidum) antibody has been detected and the result is positive.

Invalid result: if the quality control line C is not observed, it will be invalid regardless of whether there is detection line, and the test shall be conducted again.