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Meta-Analysis
. 2016 Dec 13:6:39090.
doi: 10.1038/srep39090.

Diagnostic test accuracy of loop-mediated isothermal amplification assay for Mycobacterium tuberculosis: systematic review and meta-analysis

Kenjiro Nagai  1 , Nobuyuki Horita  1 , Masaki Yamamoto  1 , Toshinori Tsukahara  1 , Hideyuki Nagakura  1 , Ken Tashiro  1 , Yuji Shibata  1 , Hiroki Watanabe  1 , Kentaro Nakashima  1 , Ryota Ushio  1 , Misako Ikeda  1 , Atsuya Narita  1 , Akinori Kanai  1 , Takashi Sato  1 , Takeshi Kaneko  1
Affiliations
Meta-Analysis

Diagnostic test accuracy of loop-mediated isothermal amplification assay for Mycobacterium tuberculosis: systematic review and meta-analysis

Kenjiro Nagai et al. Sci Rep. .

Abstract

Diagnostic test accuracy of the loop-mediated isothermal amplification (LAMP) assay for culture proven tuberculosis is unclear. We searched electronic databases for both cohort and case-control studies that provided data to calculate sensitivity and specificity. The index test was any LAMP assay including both commercialized kits and in-house assays. Culture-proven M. tuberculosis was considered a positive reference test. We included 26 studies on 9330 sputum samples and one study on 315 extra-pulmonary specimens. For sputum samples, 26 studies yielded the summary estimates of sensitivity of 89.6% (95% CI 85.6-92.6%), specificity of 94.0% (95% CI 91.0-96.1%), and a diagnostic odds ratio of 145 (95% CI 93-226). Nine studies focusing on Loopamp MTBC yielded the summary estimates of sensitivity of 80.9% (95% CI 76.0-85.1%) and specificity of 96.5% (95% CI 94.7-97.7%). Loopamp MTBC had higher sensitivity and lower specificity for smear-positive sputa compared to smear-negative sputa. In-house assays showed higher sensitivity and lower specificity compared to Loopamp MTBC. LAMP promises to be a useful test for the diagnosis of TB, however there is still need to improve the assay to make it simpler, cheaper and more efficient to make it competitive against other PCR methods already available.

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Figures

Figure 1
Figure 1. The study search flow chart.
We found 70, 72, 133, and 10 articles from Pubmed, Web of Science, EMBASE, and Cochrane database, respectively.
Figure 2
Figure 2. The paired forest plots.
Figure 3
Figure 3. Hierarchical summary receiver operating characteristics curves for studies evaluating sputum samples.
Size of circles indicates weight of each study.
Figure 4
Figure 4. Predictive values of the Loopamp MTBC assay depending on sputum smear status and pre-test probability.
PPV: positive predictive value. NPV: negative predictive value. PoTP: post-test predictive value. The figure was drawn based on the sensitivity of 0.966 and specificity of 0.713 for smear-positive sputum samples and the sensitivity of 0.543 and specificity of 0.986 for smear-negative sputum samples. Pre-test probability has similar meaning to prevalence. Readers can simply input the prevalence in the country or area into pre-test probability. For example, in the area of prevalence of 5%, the pre-test probability may be 5% for screening setting. However, if clinical information is available, patient specific pre-test probability is preferred. For example, the pre-test probability may be 50% for a patients with chronic fever, history of TB contact, and a cavitation on X-ray even in an area with prevalence of 5%.
See this image and copyright information in PMC

References

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