20/40 individually packed test cassettes/test strips for detection of anti-Treponema pallidum (T. pallidum) IgM and IgG in human whole blood, serum or plasma specimens.
Package contents:
20/40 test cassettes/test strips
20/40 disposable pipettes
1 buffer (4mL)
1 package insert
Exclusively for professional users
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The NADAL® Syphilis Test is a lateral flow chromatographic immunoassay for the qualitative detection of anti-Treponema pallidum (T. pallidum) IgM and IgG in human whole blood, serum or plasma specimens. The test is intended for use as an aid in the diagnosis of syphilis in patients suspected of having a syphilis infection (see section 12 ‘Limitations’). The test procedure is not automated and requires no special training or qualification. The NADAL® Syphilis Test is designed for professional use only.
Treponema pallidum (T. pallidum), a spirochete bacterium with an outer cell membrane and a cytoplasmic membrane, is the causative agent of the venereal disease known as syphilis. Although syphilis rates are declining in the United States after an epidemic between 1986 and 1990, the incidence of syphilis in Europe has been increasing since 1992, especially in the states of the Russian Federation, where peaks of 263 cases per 100,000 have been reported. In addition, the positive rate of serological test results for syphilis in HIV-infected individuals has recently been on the rise. The serological detection of specific antibodies to T. pallidum has been long recognised in the diagnosis of syphilis since the natural course of the infection is characterised by periods without clinical manifestations. The antibody response to T. pallidum can be detected within 4 to 7 days after the syphilis chancre appears, allowing the early detection and diagnosis of a syphilis infection. A variety of antigens, such as Cardiolipin (RPR test), VDRL antigen and T. pallidum extracts derived from in-vitro culture or inoculated rabbit testes, have been used in syphilis serological tests. However, RPR and VDRL antigens are not treponemal specific and whole T. pallidum extracts are not reproducible and contain a certain amount of contaminating materials such as flagella, which may lead to a non-specific reaction in assays of test serum.
