Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

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

Version 1 : Received: 26 October 2023 / Approved: 30 October 2023 / Online: 30 October 2023 (12:19:14 CET)

How to cite: Ramachandra, V.; Brammacharry, U.; Muralidhar, A.; Muthukumar, A.; Mani, R.; Muthaiah, M.; Soundappan, G.; Frederick, A. Access the Diagnostic Accuracy of GeneXpert to Detect Mycobacterium tuberculosis and Rifampicin-Resistance Tuberculosis among Presumptive Tuberculosis and Presumptive Drug Resistant Tuberculosis Patients. Preprints 2023, 2023101916. https://doi.org/10.20944/preprints202310.1916.v1 Ramachandra, V.; Brammacharry, U.; Muralidhar, A.; Muthukumar, A.; Mani, R.; Muthaiah, M.; Soundappan, G.; Frederick, A. Access the Diagnostic Accuracy of GeneXpert to Detect Mycobacterium tuberculosis and Rifampicin-Resistance Tuberculosis among Presumptive Tuberculosis and Presumptive Drug Resistant Tuberculosis Patients. Preprints 2023, 2023101916. https://doi.org/10.20944/preprints202310.1916.v1

Abstract

Xpert MTB/RIF is rapid molecular diagnostic tool capable of simultaneously detecting Mycobacterium tuberculosis and rifampicin resistance. This study aimed to access the diagnostic precision of Xpert MTB/RIF assay to detect pulmonary and extra-pulmonary tuberculosis and to evaluate the performance for the detection of rifampicin resistance. Of 37695 samples, 7156(18.98%) were tuberculosis positive, 509(7.11%) were rifampicin-resistant. The sensitivity, specificity, PPV, NPV, Diseases prevalence and accuracy of Xpert MTB/RIF assay for PTB 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 EPTB, the sensitivity, specificity, PPV, NPV, Diseases prevalence and accuracy of Xpert 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, Xpert MTB/RIF had contradictory results for 20.5% of cases among patients with negative smear results and 54.9% of cases among patients with a high risk of Multidrug-resistant tuberculosis. Of 47 fluoroquinolone-resistant, 16.56% (26/157) of Multidrug-resistant tuberculosis isolates and 4.02% (20/498) isoniazid-resistant are fluoroquinolone-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.

Keywords

Mycobacterium tuberculosis; Rifampicin; drug resistant; sensitivity; specificity

Subject

Medicine and Pharmacology, Pulmonary and Respiratory Medicine

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