Infection Disease Syphilis Rapid Test with CE certificate Test Device

For professional in vitro diagnostic use only.

INTENDED USE

The Syphilis Rapid Test (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Treponema Pallidum (TP) in whole blood, serum or plasma to aid in the diagnosis of Syphilis.

Clinical Sensitivity, Specificity and Accuracy

The Syphilis Rapid Test (Whole Blood/Serum/Plasma) has correctly identified specimens of a seroconversion panel and has been compared to a leading commercial TPHA Syphilis test using clinical specimens. The results show that the relative sensitivity of The Syphilis Rapid Test Device (Whole Blood/Serum/Plasma) is 99.5% and the relative specificity is 99.3%.

Syphilis Rapid Test vs. TPHA

Relative sensitivity: 99.5% (98.2%-99.9%)*

Relative specificity: 99.3% (98.1%-99.8%)*

Accuracy: 99.4% (98.6%-99.8%)*

* 95% Confidence Intervals

SUMMARY

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 1985.² 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.⁴

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.⁵

The Syphilis Rapid Test (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.