Syphilis Rapid Test Dipstick
¡¾SUMMARY¡¿
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. Some key factors that have contributed to this rise include the crack cocaine epidemic and the high incidence of prostitution among drug users. 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 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.
The Syphilis Rapid Test Dipstick (Serum/Plasma) utilizes a double antigen combination of a Syphilis antigen coated particle and Syphilis antigen immobilized on membrane to detect TP antibodies (IgG and IgM) qualitatively and selectively in serum or plasma.
¡¾DIRECTIONS FOR USE¡¿
Allow the test, specimen and/or controls to reach room temperature (15-30°C) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test dipstick from the sealed pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
2. Method:
2.1 Transfer 150 μl serum or plasma to bottom of the test tube carefully. See the below illustration
2.2 With arrows pointing toward the serum or plasma specimen, immerse the test dipstick vertically into the specimen solution of the test tube and then start the timer. Do not pass the maximum line (MAX) on the test Dipstick when immersing the test dipstick. See the below illustration
2.3 Leave the Dipstick in the test tube and wait for the colored line(s) to appear. Read results at 5 minutes. Do not interpret the result after 20 minutes.
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.
The Syphilis Rapid Test Dipstick (Serum/Plasma) utilizes a double antigen combination of a Syphilis antigen coated particle and Syphilis antigen immobilized on membrane to detect TP antibodies (IgG and IgM) qualitatively and selectively in serum or plasma.
¡¾DIRECTIONS FOR USE¡¿
Allow the test, specimen and/or controls to reach room temperature (15-30°C) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test dipstick from the sealed pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
2. Method:
2.1 Transfer 150 μl serum or plasma to bottom of the test tube carefully. See the below illustration
2.2 With arrows pointing toward the serum or plasma specimen, immerse the test dipstick vertically into the specimen solution of the test tube and then start the timer. Do not pass the maximum line (MAX) on the test Dipstick when immersing the test dipstick. See the below illustration
2.3 Leave the Dipstick in the test tube and wait for the colored line(s) to appear. Read results at 5 minutes. Do not interpret the result after 20 minutes.
| Cat. No. | Product Description | Specimen | Format | Kit Size | Cut-Off | Status |
| ISY-301 | Syphilis Rapid Test Dipstick | S / P | Dipstick | 50 T | See Insert | CE |
