Comparative Evaluation of the Loop-Mediated Isothermal Amplification Assay for Detecting Pulmonary Tuberculosis.
10.3343/alm.2018.38.2.119
- Author:
Chang Ki KIM
1
;
Eun A CHO
;
Dong Mi SHIN
;
Sung Won CHOI
;
So Youn SHIN
Author Information
1. Department of Laboratory Medicine, Hanyang University Guri Hospital, Guri, Korea. psoas95@gmail.com
- Publication Type:Original Article
- Keywords:
Tuberculosis;
TB-LAMP;
Real-time PCR;
Sensitivity;
Specificity
- MeSH:
Acetylcysteine;
Diagnosis;
Methods;
Microscopy;
Nontuberculous Mycobacteria;
Pathology, Molecular;
Real-Time Polymerase Chain Reaction;
Sensitivity and Specificity;
Sputum;
Tuberculosis;
Tuberculosis, Pulmonary*
- From:Annals of Laboratory Medicine
2018;38(2):119-124
- CountryRepublic of Korea
- Language:English
-
Abstract:
BACKGROUND: Early detection of tuberculosis (TB) is challenging in resource-poor settings because of limited accessibility to molecular diagnostics. The aim of this study was to evaluate the performance of the loop-mediated isothermal amplification kit (TB-LAMP) for TB diagnosis compared with conventional and molecular tests. METHODS: A total of 290 consecutive sputum samples were collected from May till September, 2015. All samples were processed using the N-Acetyl-L-cysteine (NALC) NaOH method and tested by smear microscopy, solid and liquid culture, real-time PCR, and TB-LAMP. RESULTS: The sensitivity of TB-LAMP for smear-positive and smear-negative samples with culture positivity was 92.0% and 58.8%, respectively. TB-LAMP was positive in 14.9% of TB culture-negative samples; however, all those samples were also positive by real-time PCR. In addition, none of the samples positive for nontuberculous mycobacteria by culture were positive by TB-LAMP. The overall agreement between TB-LAMP and real-time PCR was good; however, the concordance rate was significantly lower for real-time PCR positive samples with Ct values of 30–35. CONCLUSIONS: TB-LAMP could replace smear microscopy and increase TB diagnostic capacity when Xpert MTB/RIF is not feasible because of poor infrastructure.