Diagnostic accuracy and turnaround time of the Xpert MTB/RIF assay in routine clinical practice

• Published in: PloS one 2013-10, Vol.8 (10), p.e77456-e77456
• Main Authors: Kwak, Nakwon, Choi, Sun Mi, Lee, Jinwoo, Park, Young Sik, Lee, Chang-Hoon, Lee, Sang-Min, Yoo, Chul-Gyu, Kim, Young Whan, Han, Sung Koo, Yim, Jae-Joon
• Format: Article
• Language: English
• Subjects: Accuracy; Acids; Aged; Antitubercular Agents - therapeutic use; Assaying; Biological Assay - utilization; Clinical medicine; Critical care; Diagnosis; Diagnostic systems; Drug resistance; Drugs; Female; Hospitals; Humans; Internal medicine; Lung diseases; Male; Medical diagnosis; Medical personnel; Medical records; Medical screening; Medicine; Middle Aged; Mycobacterium tuberculosis; Mycobacterium tuberculosis - genetics; Mycobacterium tuberculosis - isolation & purification; Patients; Physicians; Reagent Kits, Diagnostic; Reproducibility of Results; Republic of Korea; Review boards; Rifampin; Rifampin - therapeutic use; Sensitivity; Sensitivity analysis; Sensitivity and Specificity; Sputum; Sputum - microbiology; Time Factors; Tuberculosis; Tuberculosis, Multidrug-Resistant - diagnosis; Tuberculosis, Multidrug-Resistant - drug therapy; Tuberculosis, Multidrug-Resistant - microbiology; Tuberculosis, Pulmonary - diagnosis; Tuberculosis, Pulmonary - drug therapy; Tuberculosis, Pulmonary - microbiology
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0077456

The Xpert MTB/RIF assay was introduced for timely and accurate detection of tuberculosis (TB). The aim of this study was to determine the diagnostic accuracy and turnaround time (TAT) of Xpert MTB/RIF assay in clinical practice in South Korea. We retrospectively reviewed the medical records of patients in whom Xpert MTB/RIF assay using sputum were requested. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for the diagnosis of pulmonary tuberculosis (PTB) and detection of rifampicin resistance were calculated. In addition, TAT of Xpert MTB/RIF assay was compared with those of other tests. Total 681 patients in whom Xpert MTB/RIF assay was requested were included in the analysis. The sensitivity, specificity, PPV and NPV of Xpert MTB/RIF assay for diagnosis of PTB were 79.5% (124/156), 100.0% (505/505), 100.0% (124/124) and 94.0% (505/537), respectively. Those for the detection of rifampicin resistance were 57.1% (8/14), 100.0% (113/113), 100.0% (8/8) and 94.9% (113/119), respectively. The median TAT of Xpert MTB/RIF assay to the report of results and results confirmed by physicians in outpatient settings were 0 (0-1) and 6 (3-7) days, respectively. Median time to treatment after initial evaluation was 7 (4-9) days in patients with Xpert MTB/RIF assay, but was 21 (7-33.5) days in patients without Xpert MTB/RIF assay. Xpert MTB/RIF assay showed acceptable sensitivity and excellent specificity for the diagnosis of PTB and detection of rifampicin resistance in areas with intermediate TB burden. Additionally, the assay decreased time to the initiation of anti-TB drugs through shorter TAT.