Laboratory aspects of tuberculosis control in China: Diagnosis and drug resistance
Diagnosis of Tuberculosis and its susceptibility to anti-tuberculosis drugs from laboratory perspective was still the weakness for Tuberculosis control in China. The objective of this thesis was to provide scientific evidence on new diagnostic assays in intended laboratory settings and the potential effect of specific drugs for composing MDR-TB treatment regimens from a national perspective. The performance of two smear microscopy technologies for detection of acid-fast bacilli against the Ziehl-Neelson method, the domestic Genechip assay designed for rifampin and isoniazid resistance detection and commercial phenotypic MIC assay compared with reference method were assessed. The resistance prevalence of moxifloxacin and pyrazinamid were explored among national representative MDR-TB samples. Two smear microscopy assays increased 2.6% and 9% positive detection rate, respectively. The performance of Genechip for rifampin (sensitivity: 87.6%, 95% CI 83.0%-92.1%; specificity: 98.0%, 95% CI 97.3%-98.6%) and isoniazid (sensitivity: 80.3%, 95% CI 75.3%-85.4%; specificity: 95.8%, 95%CI 94.8%-96.8%) resistance detection was acceptable compared with phenotypic susceptibility testing with reduced turn-around time. The categorical agreement for the twelve drugs between MIC assay and reference method ranged 88.6%-100%. 40.7% of MDR-TB strains isolated in 2007 showed pyrazinamide resistance. 12.9% and 41.4% MDR-TB strains were resistant to moxifloxacin at 0.5μg/ml in 2007 and 2013, while the prevalence were 3.1% and 23.4% at 2.0μg/ml, respectively. The new technologies should be introduced and scaled-up in China. The high resistance prevalence of two specific drugs indicates the challenge of composing effective regimens containing these drugs.