40 individually packed test strips for the qualitative, presumptive detection of IgM and IgG antibodies to Treponema pallidum (T. pallidum) in human whole blood, serum or plasma specimens.
Package contents:
40 test strips
40 disposable pipettes
2 vials of buffer (3.0 mL)
1 package insert
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The NADAL® Syphilis Test (whole blood/serum/plasma) is a rapid visual immunoassay for the qualitative, presumptive detection of IgM and IgG antibodies to Treponema pallidum (T. pallidum) in human whole blood, serum or plasma specimens. The NADAL® Syphilis Test is intended for use as an aid in the diagnosis of syphilis.
Treponema pallidum (T. pallidum), a spirochete bacterium with an outer cell membrane and a cytoplasmic membrane, is the causative agent of the venereal disease syphilis. Although syphilis rates are declining in the United States after an epidemic between 1986 and 1990, the incidence of syphilis in Europe has increased 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 been rising recently. The serological detection of specific antibodies to T. pallidum has been long recognized in the diagnosis of syphilis, since the natural course of the infection is characterized 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 early detection and diagnosis of 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.
