طراحي كيت الايزاي غير مستقيم جهت تشخيص آنتي بادي هاي ضد هسته اي (ANA)

Designing an indirect ELISA kit for detection of Antinuclear Antibodies

The autoimmunity is one of the most important reasons of pathologic and clinical disorders. Antinuclear antibody (ANA) test is one of the best experiments to recognize the disease. The immunoflourescent (IF) method is the standard technique to detect antinuclear antibodies and then the disease. The goal of this study is to design an easy, fast and reliable method to diagnose the disease according to ELISA technology. The antigens prepared during a complete culture stage from Hep-2 cell line harvesting. Then an indirect ELISA kit was designed and optimized. The immuneflourescent lams were provided to evaluate the sensitivity and specificity of the new method. The 206 serum samples were tested with both methods. The 148 samples were recorded positive by new method in comparison to 156 samples recorded positive by IF method. The 44 samples were reported negative in comparison to 50 samples recorded negative by IF method. These results showed 94.5% sensitivity and 89% specificity of new ELISA method. The results demonstrated that the new designed kit can be replaced with the foreign kits.