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

Nagai, Kazuyuki; Horita, Nobuyuki; Yamamoto, Masaki; Tsukahara, Toshinori; Nagakura, Hideyuki; Tashiro, Kunio; Shibata, Yuji; Watanabe, Hiroki; Nakashima, Kentaro; Ushio, Ryota; Ikeda, Misako; Narita, Atsuya; Kanai, Akinori; Sato, Takashi; Kaneko, Takeshi

doi:10.1038/srep39090

Cited by 78 publications

(70 citation statements)

References 34 publications

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“…These results agree with pooled median sensitivity of 88.0% (95% CI 83.0-92.0%) and specificity of 98.0% (95% CI 97.0-99.0%) reported in a Cochrane Review of fifteen studies assessing the performance of GeneXpert MTB/RIF® on sputum samples [3]. Similarly, with a sensitivity of 84.6% (95% CI 78.9-89.0%) and a specificity of 98.4% (95% CI 96.2-99.4%), Loopamp MTBC Detection Kit® performance was found comparable to reports observed from the literature [2]. For both molecular assays, this agreement between locally assessed performance and reported literature data was maintained when analyzing the smear-positive and smear-negative sub-groups of isolates.…”

Section: Discussionsupporting

confidence: 70%

“…To bypass the inconvenient delays and biosecurity requirements associated with bacterial culture, GeneXpert MTB/RIF® (Cepheid; USA) polymerase chain reaction (PCR) and Loopamp MTBC Detection Kit® (Eiken Chemical Co; Japan) loop-mediated isothermal amplification (LAMP)-based molecular assays were developed, validated on direct sputum samples and endorsed by the World Health Organization (WHO) respectively in 2013 and 2016 [2,3]. Those assays can either be used as first-line testing in place of sputum smear microscopy or as a follow-on test in adults with symptoms of pulmonary TB but testing negative on smear microscopy [4,5].…”

Section: Introductionmentioning

confidence: 99%

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Performance and Impact of GeneXpert MTB/RIF® and Loopamp MTBC Detection Kit® Assays on Tuberculosis Case Detection in Madagascar

Rakotosamimanana

Lapierre

Raharimanga

et al. 2019

Preprint

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Background: Tuberculosis rapid molecular assays, including GeneXpert MTB/RIF® and Loopamp MTBC Detection Kit®, are highly sensitive and specific. Such performance does not automatically translate in improved disease control and highly depends on their use, local epidemiology and the diagnostic algorithms they're implemented within. We evaluate the performance of both assays and assess their impact on additional cases notification when implemented within WHO recommended tuberculosis diagnostic algorithms in Madagascar.Methods: Five hundred forty eight presumptive pulmonary tuberculosis patients were prospectively recruited between November 2013 and December 2014 in Antananarivo, Madagascar, a high TB incidence sub-Saharan African urban setting. Both molecular assays were evaluated as first line or add-on testing following negative smear microscopy. Based on locally defined assay performance characteristics we measure the impact of both assays and WHO-recommended diagnostic algorithms on additional tuberculosis case notifications. Results: High sensitivity and specificity was confirmed for both GeneXpert MTB/RIF® (86.6% (95% CI 81.1-90.7%) and 97.4% (95% CI 94.9-98.8%)) and Loopamp MTBC Detection Kit® (84.6% (95% CI 78.9-89.0%) and 98.4% (95% CI 96.2-99.4%)). Implementation of GeneXpert MTB/RIF® and Loopamp MTBC Detection Kit® increased tuberculosis diagnostic algorithms sensitivity from 73.6% (95% CI 67.1-79.3%) up to 88.1% (95% CI 82.8-91.9%). This increase was highest when molecular assays were used as add-on testing following negative smear microscopy. As add-on testing, GeneXpert MTB/RIF® and Loopamp MTBC Detection Kit® respectively improved case detection by 23.8 and 21.2% (p < 0.05).Conclusion: Including GeneXpert MTB/RIF® or Loopamp MTBC Detection Kit® molecular assays for TB detection on sputum samples from presumptive TB cases can significantly increase case notification in TB diagnostic centers. The TB case detection rate is further increased when those tests are use as second-line follow-on testing following negative smear microscopy results. A country wide scale-up and digital integration of molecular-based TB diagnosis assays shows promises for TB control in Madagascar.

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Section: Discussionsupporting

confidence: 70%

Section: Introductionmentioning

confidence: 99%

Performance and Impact of GeneXpert MTB/RIF® and Loopamp MTBC Detection Kit® Assays on Tuberculosis Case Detection in Madagascar

Rakotosamimanana

Lapierre

Raharimanga

et al. 2019

Preprint

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“…There are several published reports on the diagnostic potential of LAMP assays for TB diagnosis. The overall performance varied greatly across the studies (5, [14][15][16][17].…”

Section: Discussionmentioning

confidence: 99%

Comparison of Loop-Mediated Isothermal Amplification, Microscopy, Culture, and PCR for Diagnosis of Pulmonary Tuberculosis

et al. 2020

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A c c e p t e d M a n u s c r i p t SUMMARY: Diagnosis tuberculosis (TB) in endemic countries is challenging due to high caseloads and limited resources. A simple, cost-effective diagnostic test for rapid detection of Mycobacterium tuberculosis in clinical specimens is in need. In Thailand, we evaluated the performance of in-house loop-mediated isothermal amplification (LAMP) targeting M. tuberculosis 16s rRNA gene for TB diagnosis. A total of 252 sputum samples from pulmonary TB suspects were analyzed. The sensitivity of LAMP was 99.04% (103/104; 95% confidential interval [CI]: 94.76-99.98%) and 72.73% (16/22; 95% CI: 49.78-89.27) for smear-positive and smear-negative samples with TB-culture positivity, respectively. LAMP detected 20.69% (24/116) of TB-culture negative samples but those all were positive by conventional PCR. The sensitivity of LAMP was higher than that of sputum microscopy while the performance of LAMP was similar to PCR. None of the samples positive for nontuberculous mycobacteria by culture and PCR was positive by LAMP. Compared with TB culture, the positive predictive value (PPV), negative predictive value (NPV) and kappa coefficient of LAMP were 83.22%, 88.33% and 0.75 respectively. Based on the diagnostic performance, we proposed that this LAMP would be suitable as a potential diagnostic test for rapid TB diagnosis in resource-limited laboratory settings.

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“…Immunological tests are time consuming and require confirmation in longitudinal analyses and further functional studies [4]. New automatic molecular methods for the diagnosis of TB are currently available, but the cost per test is too high for resource-limited settings [5]. Therefore, new rapid, sensitive and cost-effective biomarkers or methods for TB diagnosis are urgently needed.…”

Section: Introductionmentioning

confidence: 99%

Microarray Expression Profile of Circular RNAs in Peripheral Blood Mononuclear Cells from Active Tuberculosis Patients

Huang

Yao²,

et al. 2018

Cell Physiol Biochem

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Background/Aims: Dysregulated expression of circular RNAs (circRNAs) was demonstrated to be implicated in many diseases. Here, we aimed to determine circRNA profile in peripheral blood mononuclear cells (PBMCs) from active tuberculosis (TB) patients to identify novel biomarkers for TB. Methods: Expression profile of circRNAs in PBMCs from 3 active pulmonary TB patients and 3 healthy controls were analyzed by microarray assay. Six circRNAs were selected for validation using real time-quantitative PCR (qRT-PCR) in 40 TB patients and 40 control subjects. Receiver operating characteristic (ROC) curve was constructed to evaluate their values in TB diagnosis. Hsa_circRNA_001937 was chosen for further evaluation in an independent cohort consisting of 115 TB, 40 pneumonia, 40 COPD, 40 lung cancer patients and 90 control subjects. An eight-month follow up was performed in 20 newly diagnosed TB patients to investigate the expression change of hsa_circRNA_001937 after chemotherapy. Results: We revealed and confirmed that a number of circRNAs were dysregulated in TB patients. Of the six studied physio circRNAs, the levels of hsa_circRNA_001937, hsa_circRNA_009024 and hsa_ circRNA_005086 were significantly elevated and hsa_circRNA_102101, hsa_circRNA_104964 and hsa_circRNA_104296 were significantly reduced in PBMCs from TB patients as compared to healthy controls. ROC curve analysis suggested that hsa_circRNA_001937 has the largest area under the curve (AUC = 0.873, P<0.001). Hsa_circRNA_001937 was significantly increased in patients with TB compared with patients with pneumonia, COPD and lung cancer. Hsa_ circRNA_001937 was correlated with TB severity (r = 0.4053, P = 0.010) and its expression significantly decreased after treatment. Conclusion: This study identified a set of deregulated circRNAs in active TB PBMCs, our data also suggest that hsa_circRNA_001937 can be used as a potential diagnostic biomarker of TB.

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

Cited by 78 publications

References 34 publications

Performance and Impact of GeneXpert MTB/RIF® and Loopamp MTBC Detection Kit® Assays on Tuberculosis Case Detection in Madagascar

Performance and Impact of GeneXpert MTB/RIF® and Loopamp MTBC Detection Kit® Assays on Tuberculosis Case Detection in Madagascar

Comparison of Loop-Mediated Isothermal Amplification, Microscopy, Culture, and PCR for Diagnosis of Pulmonary Tuberculosis

Microarray Expression Profile of Circular RNAs in Peripheral Blood Mononuclear Cells from Active Tuberculosis Patients

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