Assess the Diagnostic Accuracy of GeneXpert to Detect Mycobacterium tuberculosis and Rifampicin-Resistant Tuberculosis among Presumptive Tuberculosis and Presumptive Drug Resistant Tuberculosis Patients

Author:

Ramachandra Venkateswari1,Brammacharry Usharani2,Muralidhar Aaina3,Muthukumar Anbazhagi4,Mani Revathi5,Muthaiah Muthuraj6,Soundappan Govindarajan6,Frederick Asha7

Affiliation:

1. Department of Medical Biochemistry, Institute of Basic Medical Sciences, University of Madras, Chennai 600113, India

2. Department of Biomedical Genetics, Institute of Basic Medical Sciences, University of Madras, Chennai 600113, India

3. Sri Venkateswaraa Medical College Hospital and Research Centre, Puducherry 605107, India

4. Department of Environmental Health Science, Central University, Kasarcode 671316, India

5. Department of Biochemistry, Queen Mary’s College, Madras 600004, India

6. State TB Training and Demonstration Centre, Intermediate Reference Laboratory, Government Hospital for Chest Diseases, Puducherry 605006, India

7. Directorate of Medical & Rural Health Services, National TB Elimination Programme, State TB Cell, Chennai 600006, India

Abstract

GeneXpert MTB/RIF is a rapid molecular diagnostic tool capable of simultaneously detecting Mycobacterium tuberculosis and rifampicin resistance. This study aimed to assess the diagnostic precision of GeneXpert MTB/RIF assay to detect pulmonary and extrapulmonary tuberculosis and evaluate the performance for detecting of rifampicin resistance. Of 37,695 samples, 7156 (18.98%) were tuberculosis-positive, and 509 (7.11%) were rifampicin-resistant. The sensitivity, specificity, positive predictive value, negative predictive value, disease prevalence, and accuracy of the GeneXpert MTB/RIF assay for pulmonary tuberculosis were 99.87% (95%CI: 99.75–99.94), 99.92% (95%CI: 99.88–99.95), 99.71% (95%CI: 99.54–99.82), 99.97% (95%CI: 99.93–99.98), 21.38% (95%CI: 20.92–21.86), and 99.91% (95%CI: 99.87–99.94), respectively. For extrapulmonary tuberculosis, the sensitivity, specificity, PPV, NPV, disease prevalence, and accuracy of GeneXpert MTB/RIF assay accounted for 99.45% (95%CI: 98.73–99.82), 99.84% (95%CI: 99.73–99.92), 98.70% (95%CI: 97.73–99.25), 99.93% (95%CI: 99.84–99.97), 10.64% (95%CI: 9.99–11.31), and 99.80% (95%CI: 99.68–99.88), respectively. Despite its high sensitivity for detecting tuberculosis and rifampicin resistance, GeneXpert MTB/RIF had contradictory results for 20.5% of cases among patients with smear-negative results and 54.9% of cases among patients with a high risk of multidrug-resistant tuberculosis. Of 46% fluoroquinolone-resistant cases, 16.56% (26/157) were multidrug-resistant tuberculosis isolates, and 4.02% (20/498) were isoniazid-resistant, a characteristic distribution leading to about 17.2% of fluoroquinolone-resistance events and relevant marker gyr-A mutations in MDR tuberculosis isolates. Further, our study indicated that increased fluoroquinolone resistance among rifampicin-resistant and isoniazid-resistant tuberculosis endangers the success of newly endorsed MDR-TB regimens.

Publisher

MDPI AG

Subject

Microbiology (medical),Molecular Biology,Microbiology

Reference47 articles.

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2. World Health Organization (2023). Global Tuberculosis Report 2023, World Health Organization. Available online: https://www.who.int/publications/m/item/global-tuberculosis-report-2023.

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4. 25 years of surveillance of drug-resistant tuberculosis: Achievements, challenges, and way forward;Dean;Lancet Infect. Dis.,2022

5. World Health Organization (2020). Global Tuberculosis Report 2020, World Health Organization. Available online: https://www.who.int/publications/i/item/9789240013131.

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