Diagnostic Performance of GeneChip for the Rapid Detection of Drug-Resistant Tuberculosis in Different Subgroups of Patients

Jinyan Shi,^1,* Bilin Tao,^2,* Zhongqi Li,² Huan Song,² Jizhou Wu,² Beibei Qiu,² Jianming Wang<sup>2

1</sup>Department of Clinical Laboratory, The Fourth People’s Hospital of Lianyungang, Lianyungang, Jiangsu, People’s Republic of China; ²Department of Epidemiology, Center for Global Health, School of Public Health, Nanjing Medical University, Nanjing, People’s Republic of China

*These authors contributed equally to this work

Correspondence: Jianming Wang
Department of Epidemiology, Center for Global Health, School of Public Health, Nanjing Medical University, 101 Longmian Ave, Nanjing, 211166, People’s Republic of China
Tel +86-25-86868438
Email jmwang@njmu.edu.cn

Objective: Drug-resistant tuberculosis (DR-TB) is a growing problem worldwide. The rapid drug susceptibility test (DST) of DR-TB enables the timely administration of a chemotherapy regimen that effectively treats DR-TB. GeneChip has been reported as a novel molecular diagnostic tool for rapid diagnosis but has limited data on the performance of subgroup patients with DR-TB. This study aims to assess the diagnostic value of GeneChip in patients with different sexes, ages, treatment histories, treatment outcomes, and places of residence.
Methods: We recruited newly registered sputum smear-positive pulmonary TB patients from January 2011 to September 2020 in Lianyungang City, Jiangsu Province, China. We applied both GeneChip and DST to measure drug resistance to rifampin (RIF) and isoniazid (INH). The kappa value, sensitivity, specificity, and agreement rate (AR) were calculated. We also applied a Classification and Regression Tree to explore factors related to the performance of GeneChip.
Results: We observed that sex, age, treatment history, treatment outcomes, and drug resistance type were significantly associated with the performance of GeneChip. For RIF resistance, there was significant accordance in young patients (kappa: 0.79) and cases with the treatment failure outcome (kappa: 0.92). For multidrug resistance (MDR), there was significant accordance in young cases (kappa: 0.77). Compared with previously treated patients, the newly treated patients had a significantly higher AR in detecting RIF resistance (0.97 vs 0.92), INH resistance (0.95 vs 0.89), and MDR (0.98 vs 0.92). The overall sensitivity, specificity, AR and kappa value for the diagnosis of MDR-TB were 0.70 (95% CI: 0.63– 0.70), 0.99 (95% CI: 0.98– 0.99), 0.98 (95% CI: 0.97– 0.98), and 0.72 (95% CI: 0.67– 0.78), respectively.
Conclusion: We observed a high concordance between GeneChip and DST among TB patients with different characteristics, indicating that GeneChip can be a potential alternative tool for rapid MDR-TB detection.

Keywords: tuberculosis, drug resistance, GeneChip, diagnosis, drug susceptibility test