Abstract
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.
Highlights
In 2013, the World Health Organization (WHO) estimated that mycobacterium tuberculosis (MTB) caused 9 million new active infections and 1.5 million deaths worldwide[1]
Previous evaluations were mainly carried out on M. tuberculosis cultures, few studies have evaluated the performance of the Biochip system with unprocessed sputum samples collected in multiple clinical settings
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 in smear-positive unprocessed sputum samples compared against a conventional liquid culture-based referenced standard method in a clinical population
Summary
In 2013, the World Health Organization (WHO) estimated that mycobacterium tuberculosis (MTB) caused 9 million new active infections and 1.5 million deaths worldwide[1]. To respond to the urgent need for simple and rapid diagnostic tools in addressing drug resistance and MDR-TB testing, genotypic assays, such as the Cepheid Xpert MTB/RIF(Cepheid, Sunnyvale, CA, USA) and Genotype MTBDR (Hain Lifescience, Nehren, Germany) assays, have been developed[9,10] These assays usually identify mycobacterial species and mutations (i.e.,rpoB and katG gene mutations) conferring drug resistance independent of culture; the time required to obtain results has been reduced to just several hours[11,12]. 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 in smear-positive unprocessed sputum samples compared against a conventional liquid culture-based referenced standard method in a clinical population
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