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Diagnostic Accuracy of the PURE-LAMP Test for Pulmonary Tuberculosis at the County-Level Laboratory in China

BACKGROUND: Early and effective detection of Mycobacterium tuberculosis (MTB), particularly in smear-negative tuberculosis (TB), is a priority for global TB control. Loop-mediated isothermal amplification with a procedure for ultra rapid DNA extraction (PURE-LAMP) can detect TB in sputum samples rap...

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Autores principales: Ou, Xichao, Li, Qiang, Xia, Hui, Pang, Yu, Wang, Shengfen, Zhao, Bing, Song, Yuanyuan, Zhou, Yang, Zheng, Yang, Zhang, Zhijian, Zhang, Zhiying, Li, Junchen, Dong, Haiyan, Zhang, Jack, Kam, Kai Man, Chi, Junying, Huan, Shitong, Chin, Daniel P., Zhao, Yanlin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4006777/
https://www.ncbi.nlm.nih.gov/pubmed/24788724
http://dx.doi.org/10.1371/journal.pone.0094544
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author Ou, Xichao
Li, Qiang
Xia, Hui
Pang, Yu
Wang, Shengfen
Zhao, Bing
Song, Yuanyuan
Zhou, Yang
Zheng, Yang
Zhang, Zhijian
Zhang, Zhiying
Li, Junchen
Dong, Haiyan
Zhang, Jack
Kam, Kai Man
Chi, Junying
Huan, Shitong
Chin, Daniel P.
Zhao, Yanlin
author_facet Ou, Xichao
Li, Qiang
Xia, Hui
Pang, Yu
Wang, Shengfen
Zhao, Bing
Song, Yuanyuan
Zhou, Yang
Zheng, Yang
Zhang, Zhijian
Zhang, Zhiying
Li, Junchen
Dong, Haiyan
Zhang, Jack
Kam, Kai Man
Chi, Junying
Huan, Shitong
Chin, Daniel P.
Zhao, Yanlin
author_sort Ou, Xichao
collection PubMed
description BACKGROUND: Early and effective detection of Mycobacterium tuberculosis (MTB), particularly in smear-negative tuberculosis (TB), is a priority for global TB control. Loop-mediated isothermal amplification with a procedure for ultra rapid DNA extraction (PURE-LAMP) can detect TB in sputum samples rapidly and with high sensitivity and specificity. However, the PURE-LAMP test has not been effectively evaluated, especially in resource-limited laboratories. In this study, we evaluated the performance of the PURE-LAMP test for TB detection in TB suspects from two county-level TB dispensaries in China. METHODOLOGY/PRINCIPAL FINDINGS: From April 2011 to February 2012, patients with suspected TB were continuously enrolled from two county-level TB laboratories in China. Three sputum samples (spot, night, and morning sputum) were collected from each recruited patient. Detection of MTB by PURE-LAMP was compared to a reference standard L-J culture. The results showed that the sensitivity of the PURE-LAMP test based on spot sputum for MTB detection was 70.67%, while the sensitivity of the PURE-LAMP test based on spot sputum for MTB detection in smear positive and culture positive patients and smear negative and culture positive patients was 92.12% and 53.81%, respectively. The specificity of PURE-LAMP based on spot sputum for MTB detection was 98.32%. The sensitivity and specificity of the PURE-LAMP test based on three sputa combination for MTB detection was 88.80% and 96.86%, respectively. The results also showed that the PURE-LAMP test had a significantly lower contamination rate than did solid culture. CONCLUSIONS/SIGNIFICANCE: The study suggested that, in peripheral-level TB laboratories in China, the PURE-LAMP test showed high sensitivity and specificity for TB detection in TB suspects, making it a more effective, rapid, and safe method worthy of broader use in the future.
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spelling pubmed-40067772014-05-09 Diagnostic Accuracy of the PURE-LAMP Test for Pulmonary Tuberculosis at the County-Level Laboratory in China Ou, Xichao Li, Qiang Xia, Hui Pang, Yu Wang, Shengfen Zhao, Bing Song, Yuanyuan Zhou, Yang Zheng, Yang Zhang, Zhijian Zhang, Zhiying Li, Junchen Dong, Haiyan Zhang, Jack Kam, Kai Man Chi, Junying Huan, Shitong Chin, Daniel P. Zhao, Yanlin PLoS One Research Article BACKGROUND: Early and effective detection of Mycobacterium tuberculosis (MTB), particularly in smear-negative tuberculosis (TB), is a priority for global TB control. Loop-mediated isothermal amplification with a procedure for ultra rapid DNA extraction (PURE-LAMP) can detect TB in sputum samples rapidly and with high sensitivity and specificity. However, the PURE-LAMP test has not been effectively evaluated, especially in resource-limited laboratories. In this study, we evaluated the performance of the PURE-LAMP test for TB detection in TB suspects from two county-level TB dispensaries in China. METHODOLOGY/PRINCIPAL FINDINGS: From April 2011 to February 2012, patients with suspected TB were continuously enrolled from two county-level TB laboratories in China. Three sputum samples (spot, night, and morning sputum) were collected from each recruited patient. Detection of MTB by PURE-LAMP was compared to a reference standard L-J culture. The results showed that the sensitivity of the PURE-LAMP test based on spot sputum for MTB detection was 70.67%, while the sensitivity of the PURE-LAMP test based on spot sputum for MTB detection in smear positive and culture positive patients and smear negative and culture positive patients was 92.12% and 53.81%, respectively. The specificity of PURE-LAMP based on spot sputum for MTB detection was 98.32%. The sensitivity and specificity of the PURE-LAMP test based on three sputa combination for MTB detection was 88.80% and 96.86%, respectively. The results also showed that the PURE-LAMP test had a significantly lower contamination rate than did solid culture. CONCLUSIONS/SIGNIFICANCE: The study suggested that, in peripheral-level TB laboratories in China, the PURE-LAMP test showed high sensitivity and specificity for TB detection in TB suspects, making it a more effective, rapid, and safe method worthy of broader use in the future. Public Library of Science 2014-05-01 /pmc/articles/PMC4006777/ /pubmed/24788724 http://dx.doi.org/10.1371/journal.pone.0094544 Text en © 2014 Ou et al http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited.
spellingShingle Research Article
Ou, Xichao
Li, Qiang
Xia, Hui
Pang, Yu
Wang, Shengfen
Zhao, Bing
Song, Yuanyuan
Zhou, Yang
Zheng, Yang
Zhang, Zhijian
Zhang, Zhiying
Li, Junchen
Dong, Haiyan
Zhang, Jack
Kam, Kai Man
Chi, Junying
Huan, Shitong
Chin, Daniel P.
Zhao, Yanlin
Diagnostic Accuracy of the PURE-LAMP Test for Pulmonary Tuberculosis at the County-Level Laboratory in China
title Diagnostic Accuracy of the PURE-LAMP Test for Pulmonary Tuberculosis at the County-Level Laboratory in China
title_full Diagnostic Accuracy of the PURE-LAMP Test for Pulmonary Tuberculosis at the County-Level Laboratory in China
title_fullStr Diagnostic Accuracy of the PURE-LAMP Test for Pulmonary Tuberculosis at the County-Level Laboratory in China
title_full_unstemmed Diagnostic Accuracy of the PURE-LAMP Test for Pulmonary Tuberculosis at the County-Level Laboratory in China
title_short Diagnostic Accuracy of the PURE-LAMP Test for Pulmonary Tuberculosis at the County-Level Laboratory in China
title_sort diagnostic accuracy of the pure-lamp test for pulmonary tuberculosis at the county-level laboratory in china
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4006777/
https://www.ncbi.nlm.nih.gov/pubmed/24788724
http://dx.doi.org/10.1371/journal.pone.0094544
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