Syphilis Rapid Test Cassette(WB/S/P)
¡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. 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. 3 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 Cassette (Whole Blood/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 whole blood, serum or plasma.
¡¾DIRECTIONS FOR USE¡¿
Allow the test, specimen, buffer 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 cassette from the sealed pouch and use it as soon as possible.
2. Place the cassette on a clean and level surface.
For Serum or Plasma specimen: Hold the dropper vertically and transfer 1 drop of serum or plasma (approximately 40 ul) to the specimen area, then add 1 drop of buffer (approximately 40 ul),and start the timer, see illustration below.
For Venipuncture Whole Blood specimen: Hold the dropper vertically and transfer 2 drops of whole blood (approximately 80 ul) to the specimen area, then add 1 drop of buffer (approximately 40 ul), and start the timer. See illustration below.
For Fingerstick Whole Blood specimen:
· To use a capillary tube: Fill the capillary tube and transfer approximately 80 m mL of fingerstick whole blood specimen to the specimen area of test cassette, then add 1 drop of buffer (approximately 40 ul) and start the timer. See illustration below.
·To use hanging drops: Allow 2 hanging drops of fingerstick whole blood specimen (approximately 80 ul) to fall into the specimen area of test cassette, then add 1 drop of buffer (approximately 40 ul) and start the timer. See illustration below.
3. Wait for the colored line(s) to appear. Read results at 5 minutes. Do not interpret the result after 20 minutes.
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. 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. 3 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 Cassette (Whole Blood/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 whole blood, serum or plasma.
¡¾DIRECTIONS FOR USE¡¿
Allow the test, specimen, buffer 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 cassette from the sealed pouch and use it as soon as possible.
2. Place the cassette on a clean and level surface.
For Serum or Plasma specimen: Hold the dropper vertically and transfer 1 drop of serum or plasma (approximately 40 ul) to the specimen area, then add 1 drop of buffer (approximately 40 ul),and start the timer, see illustration below.
For Venipuncture Whole Blood specimen: Hold the dropper vertically and transfer 2 drops of whole blood (approximately 80 ul) to the specimen area, then add 1 drop of buffer (approximately 40 ul), and start the timer. See illustration below.
For Fingerstick Whole Blood specimen:
· To use a capillary tube: Fill the capillary tube and transfer approximately 80 m mL of fingerstick whole blood specimen to the specimen area of test cassette, then add 1 drop of buffer (approximately 40 ul) and start the timer. See illustration below.
·To use hanging drops: Allow 2 hanging drops of fingerstick whole blood specimen (approximately 80 ul) to fall into the specimen area of test cassette, then add 1 drop of buffer (approximately 40 ul) and start the timer. See illustration below.
3. 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-402 | Syphilis Rapid Test Cassette | WB/S/P | Cassette | 40 T | See Insert | CE |
