Evaluating the Diagnostic Accuracy of Xpert MTB/RIF Assay in Pulmonary Tuberculosis.
Pulmonary tuberculosis still remains a major communicable disease worldwide. In 2013, 9 million people developed TB and 1.5 million people died from the disease. India constitutes 24% of the total TB burden. Early detection of TB cases is the key to successful treatment and reduction of disease transmission. Xpert MTB/RIF, an automated cartridge-based molecular technique detects Mycobacterium tuberculosis and rifampicin resistance within two hours has been endorsed by WHO for rapid diagnosis of TB. Our study is the first study from India with a large sample size to evaluate the performance of Xpert MTB/RIF assay in PTB samples. The test showed an overall sensitivity and specificity of 95.7% (430/449) and 99.3% (984/990) respectively. In smear negative-culture positive cases, the test had a sensitivity of 77.7%. The sensitivity and specificity for detecting rifampicin resistance was 94.5% and 97.7% respectively with respect to culture as reference standard. However, after resolving the discrepant samples with gene sequencing, the sensitivity and specificity rose to 99.0% and 99.3% respectively. Hence, while solid culture still forms the foundation of TB diagnosis, Xpert MTB/RIF proposes to be a strong first line diagnostic tool for pulmonary TB cases.
Department of Internal Medicine, All India Institute of Medical Sciences, New Delhi, India.
Surendra K
SK
Sharma
Department of Internal Medicine, All India Institute of Medical Sciences, New Delhi, India.
Mikashmi
M
Kohli
Department of Internal Medicine, All India Institute of Medical Sciences, New Delhi, India.
Raj Narayan
RN
Yadav
Department of Internal Medicine, All India Institute of Medical Sciences, New Delhi, India.
Jigyasa
J
Chaubey
Department of Internal Medicine, All India Institute of Medical Sciences, New Delhi, India.
Dinkar
D
Bhasin
Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.
Vishnubhatla
V
Sreenivas
Department of Internal Medicine, All India Institute of Medical Sciences, New Delhi, India.
Rohini
R
Sharma
Department of Internal Medicine, All India Institute of Medical Sciences, New Delhi, India.
Binit K
BK
Singh
D000293:Adolescent; D000328:Adult; D000995:Antitubercular Agents / Q000494:pharmacology; D001426:Bacterial Proteins / Q000235:genetics*; D001681:Biological Assay / Q000592:standards*; D012321:DNA-Directed RNA Polymerases; D024881:Drug Resistance, Bacterial; D005260:Female; D006801:Humans; D008297:Male; D008853:Microscopy; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques; D009169:Mycobacterium tuberculosis / Q000235:genetics / Q000302:isolation & purification*; D012293:Rifampin / Q000494:pharmacology; D012680:Sensitivity and Specificity; D017422:Sequence Analysis, DNA; D013183:Sputum / Q000382:microbiology; D018088:Tuberculosis, Multidrug-Resistant / Q000175:diagnosis* / Q000188:drug therapy / Q000382:microbiology; D014397:Tuberculosis, Pulmonary / Q000175:diagnosis* / Q000188:drug therapy / Q000382:microbiology
D000995:Antitubercular Agents; D001426:Bacterial Proteins; C505805:rpoB protein, Mycobacterium tuberculosis; D012321:DNA-Directed RNA Polymerases; D012293:Rifampin