Mycobacterium Tuberculosis TB-SA Antibody Detection Kit (Colloidal Gold Method) For TB Diagnostic Value Assessment

OBJECTIVE: Research and evaluation the sensitivity and specificityof the CYPCO-Mycobacterium tuberculosis TB-SA antibody detection kit(colloidal gold method) in the diagnosis of tuberculosis, which canprovide the basis for clinical application of the kit.METHODS: A total of250cases were selected, involved patientswith tuberculous and other non-tuberculous lung disease patients andhealthy volunteers, then divided into five groups,which were namedsputum positive pulmonary tuberculosis group, culture negativetuberculosis group, extrapulmonary tuberculosis group, other disease groupand healthy control group respectively.Every case of each group wasaccepted both serum and whole blood detection with the Mycobacteriumtuberculosis TB-SA antibody detection kit and similar reference reagents tobe selected for parallel detection.RESULTS: The overall sensitivity of Mycobacterium tuberculosisTB-SA antibody test for diagnosis of tuberculosis in serum samples was76%, specificity of64%; the overall sensitivity of36%and specificity of88%in whole blood. CONCLUSION: The sensitivity of CYPCO Mycobacteriumtuberculosis TB-SA antibody detection kit for detection serum samples wassuperior to whole blood samples. Comprehensive of its sensitivity andspecificity, CYPCO has good prospects for clinical application, worthy of awider range of validation and promotion, compared with the referencereagent.