Performance of Biochip system in detecting drug resistant and multidrug-resistant tuberculosis using sputum collected from multiple clinical settings in Zhejiang China

摘要

The objective of the present study was to conduct a multicentre, prospective evaluation of the diagnostic performance of the Biochip system for the detection of drug-resistant tuberculosis using smear-positive sputum specimens. This prospective study evaluated the diagnostic performance of this new platform for drug resistant and multidrug-resistant tuberculosis (MDR-TB) using 1491 smear-positive sputum specimens collected from multiple clinical settings. Using conventional culture-based culturing and drug-susceptibility testing as reference standards, the biochip system had a sensitivity of 86.08% and a specificity of 97.7% for rifampicin (RIF) detection, in detecting isoniazid (INH) resistance, it had a sensitivity of 79.36% and a specificity of 98.71%. With respect to MDR-TB detection, the sensitivity was 78.01% and the specificity was 98.86%. The performance only varies among different sites for RIF resistance, and there are no other statistically difference in diagnostic performance for other variables considered. The Biochip system shows favourable sensitivity and specificity for RIF and INH resistance, along with MDR-TB detection, directly using clinical smear-positive sputum samples. It is an alternative to conventional drug-susceptibility testing (DST) for detecting drug resistance or MDR-TB and is a method worth expanding to clinical settings in China.