Ann Lab Med.  2018 Mar;38(2):119-124. 10.3343/alm.2018.38.2.119.

Comparative Evaluation of the Loop-Mediated Isothermal Amplification Assay for Detecting Pulmonary Tuberculosis

• Kim CK
• Cho EA
• Shin DM
• Choi SW
• Shin SY

• KMID: 2403356
• DOI: http://doi.org/10.3343/alm.2018.38.2.119

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.

Keyword

Tuberculosis; TB-LAMP; Real-time PCR; Sensitivity; Specificity

MeSH Terms

Acetylcysteine
Diagnosis
Methods
Microscopy
Nontuberculous Mycobacteria
Pathology, Molecular
Real-Time Polymerase Chain Reaction
Sensitivity and Specificity
Sputum
Tuberculosis
Tuberculosis, Pulmonary*
Acetylcysteine

Figure

• 

  Fig. 1 Distribution of Ct values of real-time PCR according to TB-LAMP results. Median Ct values for TB-LAMP-positive (n=79) and negative (n=24) samples were 24.5 and 31.1, respectively (P<0.0001).Abbreviations: TB-LAMP, loop-mediated isothermal amplification assay.

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