External quality control of phenotypic drug susceptibility testing for Mycobacterium tuberculosis in China.

Abstract

The aim of our study was to evaluate the performance of conventional drug susceptibility testing (DST) among the tuberculosis (TB)-specialized hospitals in China. A total of 40 hospitals participated in the external quality assurance program for assessment of DST results from each hospital. The sensitivity, specificity, and accuracy of DST were analyzed. The mean accuracy was 96.5% for isoniazid (INH), 95.8% for rifampin (RIF), 97.0% for ethambutol (EMB), 96.8% for ofloxacin (OFX), 97.1% for kanamycin (KAN), 96.1% for amikacin (AMK), and 93.6% for capreomycin (CAP), respectively. Of the 40 participating laboratories, 4 (10.0%) and 6 (15%) failed to achieve 90% accuracy for INH and RIF, respectively. In addition, six hospitals (15%) were confirmed as certified to provide reliable DST results for both first-line and second-line drugs. The certified proportion for DST dropped from 73.9% in the non-western region to 59.2% in the western region. The significant difference was observed in the certified proportion for first-line drugs between the western and non-western region (P = 0.013). Our results demonstrate that the quality of phenotypical DST is frequently unsatisfactory, with approximately one-third of participated laboratories failing to produce certified phenotypical DST results. In addition, the uncertified laboratories majorly come from the western region in China.

• Authors: Wei Shu, Jian Du, Yuhong Liu, Yufeng Wang, Fengmin Huo, Guanglu Jiang, Liang Li, Yu Pang
• Journal: European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology (Eur J Clin Microbiol Infect Dis) Vol. 39 Issue 5 Pg. 871-875 (May 2020) ISSN: 1435-4373 [Electronic] Germany
• PMID: 31898799 (Publication Type: Journal Article)

Chemical References

• Antitubercular Agents

Topics

• Antitubercular Agents (pharmacology)
• China (epidemiology)
• Clinical Laboratory Techniques (standards)
• Hospitals
• Humans
• Microbial Sensitivity Tests (standards)
• Mycobacterium tuberculosis (drug effects)
• Phenotype
• Quality Control
• Reproducibility of Results
• Sensitivity and Specificity
• Tuberculosis, Multidrug-Resistant (epidemiology, microbiology)