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전남대학교 의과대학, 전남대학교병원

Am. J. Respir. Crit. Care Med., Published Online: September 25, 2018 | https://doi.org/10.1164/rccm.201804-0654OC Xpert MTB/RIF Assay as a Substitute for Smear Microscopy in an Intermediate Burden Setting

Hyun-Seung Lee,¹ Seung-Jung Kee,^2* Ju-Hyeon Shin,² Yong-Soo Kwon,³ Sejong Chun,² Jun Hyung Lee,⁴ Eun Jeong Won,^2,5 Hyun-Jung Choi,⁴ Soo Hyun Kim,⁴ Myung-Geun Shin,⁴ JongHee Shin,² and Soon-Pal Suh^2*¹Department of Laboratory Medicine, Chonbuk National University Hospital, Jeonju, Republic of Korea; ²Department of Laboratory Medicine, Chonnam National University Medical School and Hospital, Gwangju, Republic of Korea; ³Department of Pulmonary and Critical Care Medicine, Chonnam National University Medical School and Hospital, Gwangju, Republic of Korea; ⁴Department of Laboratory Medicine, Chonnam National University Medical School and Hwasun Hospital, Hwasun, Republic of Korea; and ⁵Department of Parasitology, Chonnam National University Medical School, Gwangju, Republic of Korea

^*These authors contributed equally to this article.

Correspondence and requests for reprint should be addressed to: Seung-Jung Kee, M.D., Ph.D., Department of Laboratory Medicine, Chonnam National University Medical School and Hospital, 42 Jebong-ro, Dong-gu, Gwangju 61469, Republic of Korea. or Soon-Pal Suh, M.D., Ph.D., Department of Laboratory Medicine, Chonnam National University Medical School and Hospital, 42 Jebong-ro, Dong-gu, Gwangju 61469, Republic of Korea.

Abstract

Rationale: Use of Xpert MTB/RIF assay as a substitute for smear microscopy in routine clinical practice remains unexplored in an intermediate tuberculosis-burden setting.

Objectives: To compare the diagnostic performance of Xpert and smear microscopy, based on sampling time and location, correlation of Xpert semiquantitative category with smear grade and time-to-culture positivity, and compliance of reporting time with defined standard time.

Methods: Consecutive sputum samples collected from 2,952 suspected pulmonary tuberculosis patients over a 3-year-period were tested by Xpert, smear microscopy, and liquid culture as part of routine diagnostics in South Korea.

Measurements and Main Results: Based on the analysis of a single-sputum-specimen per patient, of 2,952 samples, 263 (8.9%) were culture-confirmed tuberculosis and 265 (9.0%) were nontuberculous mycobacteria. The overall sensitivity and specificity were 74.1% and 97.5% for Xpert versus 38.8% and 96.7% for smear microscopy, respectively (P<0.0001; P>0.05). Of 82 smear-positive nontuberculous mycobacteria, 81 (98.8%) were accurately excluded by Xpert. Sampling time and location significantly affected the performance of smear microscopy, but not that of Xpert. Xpert semiquantitative category strongly correlated with smear grade (γGoodman-Kruskal=0.982, P<0.0001) and time-to-culture positivity (γGoodman-Kruskal=-0.962, P<0.0001). Median reporting time and its compliance rate within 24h were 3.1h and 96.3% for Xpert versus 19.1h and 88.7% for smear microscopy, respectively (P<0.0001; P<0.05).

Conclusions: Xpert provides faster, more stable, and superior results compared to smear microscopy, in addition to its strong correlation with smear grade. Xpert might replace smear microscopy as the first-line diagnostic test for pulmonary tuberculosis in routine clinical practice in an intermediate-burden setting.

Keywords: Xpert MTB/RIF; tuberculosis; smear microscopy; diagnostic performance; reporting time

논문정보

형식Research article
게재일2018년 09월 (BRIC 등록일 2018-09-28)
연구진국내 연구진
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