Intended Use The Teco Diagnostics Rapid Plasma Reagin(RPR) set is a nontreponemal flocculation test that is used to detect and quantify reagin, an antibody present in serum or plasma from persons with syphilis or with other treponemal diseases. Occasionally individuals with other diseases or conditions may also be reactive in the nontreponemal tests. Principle Treponema pallidum, the etiologic agent responsible for syphilis produces at least two kinds of antibodies in human infections – trepenonemal antibodies and reagin antibodies. In the presence of the reagin antibody in the reactive sample, the RPR Antigen preparation will produce flocculation consisting of black clumps against the white background of the test card. By contrast, non-reactive samples will yield an even light-grey homogenous suspension. Test: Rapid Plasma Reagin (RPR) Set (RPR – 100) Number of Tests: 100 tests Format: Liquid Method: Agglutination Reaction Testing Procedure: Manual Storage Temperature: 2-8°C Qualitative Results: Reactive: Presence of large aggregates in the center or periphery of the test circle. Non-reactive: Smooth grey surface Limitations of Procedure: The results of this test should not be used as a single diagnostic tool to make a clinical diagnosis. Instead, the test results must be evaluated together with other clinical findings and observed symptoms to aid in the final diagnosis. False positive reactions sometimes occur in drug abuse and in such diseases as lupus erthymatosus, mononucleosis, leprosy, viral pneumonia, and after smallpox vaccinations. Plasma specimens over 48 hours old may give erroneous results. CONTACT US: TECO DIAGNOSTICS 1268 N. Lakeview Avenue Anaheim, CA 92807 Tel: 714-463-1111 Fax: 714-463-1169 QMM.152