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 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.


RESULTS
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
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.
National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, P. R. China.
Xichao
X
Ou
National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, P. R. China.
Qiang
Q
Li
National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, P. R. China.
Hui
H
Xia
National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, P. R. China.
Yu
Y
Pang
National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, P. R. China.
Shengfen
S
Wang
National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, P. R. China.
Bing
B
Zhao
National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, P. R. China.
Yuanyuan
Y
Song
National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, P. R. China.
Yang
Y
Zhou
National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, P. R. China.
Yang
Y
Zheng
Respiratory Diseases Department of Nanlou, Chinese People's Liberation Army General Hospital, Beijing, P. R. China.
Zhijian
Z
Zhang
PATH, China Office, Beijing, China.
Zhiying
Z
Zhang
PATH, China Office, Beijing, China.
Junchen
J
Li
PATH, China Office, Beijing, China.
Haiyan
H
Dong
PATH, China Office, Beijing, China.
Jack
J
Zhang
Stanley Ho Centre for Emerging Infectious Diseases, Faculty of Medicine, Chinese University of Hong Kong, Hong Kong, P. R. China.
Kai Man
KM
Kam
Bill & Melinda Gates Foundation, China Office, Beijing, China.
Junying
J
Chi
Bill & Melinda Gates Foundation, China Office, Beijing, China.
Shitong
S
Huan
Bill & Melinda Gates Foundation, China Office, Beijing, China.
Daniel P
DP
Chin
National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, P. R. China.
Yanlin
Y
Zhao
D000293:Adolescent; D000328:Adult; D000368:Aged; D002681:China; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009169:Mycobacterium tuberculosis / Q000235:genetics*; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013183:Sputum / Q000382:microbiology; D014397:Tuberculosis, Pulmonary / Q000175:diagnosis*; D055815:Young Adult