NADAL Syphilis, rapid test for detection of Treponema pallidum in whole blood

General information about this test: NADAL SyphilisTest is a rapid chromatographic immunoassay for detection of anti- T. pallidum IgG and IgM in human serum, plasma or whole blood. NADAL SyphilisTest is designed to aid diagnosis of syphilis and is intended for professional use only. Reagents and material supplied: 20 NADAL Syphilis test cassettes (incl. disposable pipettes) 1 Buffer 1 package insert Test time : 10 min Performance characteristics: The specificity and sensitivity of NADAL SyphilisTest were determined by testing 593 samples and comparison of the results with those obtained Treponema pallidum haemagglutination test (TPHA). Sensitivity : 99.6%* Specificity: 99.1%* Overall agreement: 99.3%* *95% Confidence Interval Test principles: The NADAL Syphilis Test is a qualitative lateral flow immunoassay for the detection of anti- Treponema pallidum IgG and IgM in human blood, plasma and serum. The anti- T.pallidum antibodies are detected with the aid of specific recombinant antigens immobilized on the test line region of the membrane. After addition of sample to the sample well of the test cassette, the anti- T.pallidum IgG/IgM (if present) react with recombinant antigens conjugated to colored particles. The reaction mixture then migrates along the membrane and reacts with reagents on the membrane. If T.pallidum IgG and IgM are present in detectable levels in the tested sample, a colored line appears in the test line region of the membrane. This indicates positive results.A colored line should always appear in the control line region (C)and serves as a procedural control, indicating that the propervolume of specimen has been added and membrane wicking has occurred. Clinical significance: Treponema pallidum is a spirochete bacterium having outer cell membrane in addition to the cytoplasmic membrane. T. pallidum is the causative agent of the veneral disease syphilis. In most of the cases syphilis is transmitted sexually, there are sporadic cases in which infection is transmitted by contaminated blood infusion or usage of shared needles. The infection can also be passed vertcally from a pregnant woman to a fetus is also possible. Very rare cases of transmission by sharing eating utensils were also repoted. The incubation period of syphilis is about 26 days with a tendency for prolongation. The first clinical symptom is appearance of chancre lesions on the place of entrance of the causative agent into the patient’s organism (usually-the genitals). While in the USA there is a tendency of decrease of the number of people infected with syphilis, in Europe and especially in the Russian Federation the incidence of syphilis is increasing. In addition, increase of the positive rate of serological test results for syphilis in HIV-infected individuals has been reported. The course of syphilis infection includes latent periods without any clinical manifestation. For this reason serological tests for diagnosing syphilis are extremely suitable. The antibody response to T. pallidum can be detected 4-7 days after chancre appearance, allowing early diagnosis and detection of syphilis infection.