Evaluation of a simplified IS6110 PCR for the rapid diagnosis of Mycobacterium tuberculosis in an area with high tuberculosis incidence

摘要: Abstract Purpose To assess the diagnostic yield of a simplified IS6110-PCR in an area with high tuberculosis incidence. Methods Pulmonary (218) and extrapulmonary (121) samples were collected from 236 patients including smearpositive leprosy patients. All processed to detect acidfast bacilli by microscopy, culture on solid media PCR. remove PCR inhibitors, three washing steps decontaminated pellet included before mycobacterial cell lysis heat treatment. No detergents, enzymes, or chelating agents used. From 339 samples, 34 selected basing their large volume tested commercial kit GenoType Mycobacteria Direct (GTMD) (VER 4, Hain Lifescience, Germany) addition tests cited above. Results The overall sensitivity specificity 93.8 98.6% for pulmonary 63.6 100% respectively. assay detected MTC 94.2% smear positive predictive value 100%. inhibition was found among seven that negative but bacteriological confirmed as containing Mycobacterium . false result occurred sensitivities GTMD 81.8 75%, Conclusion could efficiently complement conventional tools rapid diagnosis cannot replace them.