Development and Clinical Evaluation of
            <i>sdaA</i>
            Loop-Mediated Isothermal Amplification Assay for Detection of Mycobacterium tuberculosis with an Approach To Prevent Carryover Contamination

Nimesh, Manoj; Joon, Deepali; Varma-Basil, Mandira; Saluja, Daman

doi:10.1128/jcm.00907-14

Cited by 20 publications

(10 citation statements)

References 13 publications

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“…Although these studies have revealed generally very good diagnostic performance, there are considerable discrepancies between their results891011121314151617181920212223242526272829303132. In addition, none of the studies could describe precise diagnostic accuracy because of their limited statistical power.…”

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confidence: 99%

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

Nagai

Horita

Yamamoto

et al. 2016

Sci Rep

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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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confidence: 99%

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

Nagai

Horita

Yamamoto

et al. 2016

Sci Rep

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“…In the previous studies (Nimesh et al . 2014; Joon et al . 2015), the 190 bp region of sdaA has been considered as a diagnostic target for TB diagnosis according to PCR and LAMP.…”

Section: Discussionmentioning

confidence: 99%

“…In previous studies (Nimesh et al . 2014; Joon et al . 2015), the 190 base pair (bp) region of the L‐serine dehydratase ( sdaA ) gene has been successfully demonstrated as a specific molecular marker for TB diagnosis using PCR‐based assays; thus, the sdaA gene was a candidate target for establishing reliable diagnosis technique for target pathogen detection.…”

Section: Introductionmentioning

confidence: 99%

“…More recently, various nanoparticle-based lateral flow devices (LFD) have been developed and applied rapidly, visually and objectively indicating the MCDA results, which further simplify the MCDA analysis system (Wang et al 2018). In previous studies (Nimesh et al 2014;Joon et al 2015), the 190 base pair (bp) region of the L-serine dehydratase (sdaA) gene has been successfully demonstrated as a specific molecular marker for TB diagnosis using PCR-based assays; thus, the sdaA gene was a candidate target for establishing reliable diagnosis technique for target pathogen detection.…”

Section: Introductionmentioning

confidence: 99%

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A diagnostic test that uses isothermal amplification and lateral flow detection sdaA can detect tuberculosis in 60 min

Wang

Yin

et al. 2020

J Appl Microbiol

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Aims Tuberculosis (TB), caused by Mycobacterium tuberculosis (MTB), is now the leading cause of death from infectious disease, thus rapid diagnostic and screening techniques for TB are urgently needed. Methods and Results Here, a detection of MTB using multiple cross displacement amplification coupling with nanoparticles‐based lateral flow device (MCDA‐LFD) was developed and validated, targeting the specific sdaA gene. The whole detection procedure, including rapid genomic DNA extraction (15 min), amplification (30 min) and result reporting (2 min), was completed within 50 min. No cross‐reaction with non‐mycobacteria and non‐tuberculous mycobacteria (NTM) strains was observed. The sensitivity of sdaA‐MCDA‐LFD, Xpert MTB/RIF assay and culture results was 81·6, 48·3 and 37·9%, respectively, in TB patients. Among positive culture samples, the sensitivity of sdaA‐MCDA‐LFD and Xpert MTB/RIF assay was 93·9% (31/33) and 81·8% (27/33), respectively. Among culture‐negative samples, the sensitivity of sdaA‐MCDA‐LFD and Xpert MTB/RIF assay was 74·1% (40/54) and 27·8% (15/54), respectively. The specificity of sdaA‐MCDA‐LFD and Xpert MTB/RIF was 95·4% (62/65) and 100% (65/65) in clinical samples from non‐TB patients. Conclusion The sdaA‐MCDA‐LFD assay was a rapid, simple, specific and sensitive TB diagnostic test. Significance and Impact of the study The sdaA‐MCDA‐LFD assay holds promise for application as a useful point‐of‐care test to detect MTB, and will play an important role in controlling and preventing TB.

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“…LAMP has been successfully implemented in nucleic acid research, and in clinical application as a screening tool [ 26 ]. Several LAMP-based assays have been developed to detect M. tuberculosis infection, targeting gyrB [ 27 ], rrs [ 28 ], rimM [ 29 ], IS6110 [ 30 ], hspX [ 31 ], mpb64 [ 32 ] and sdaA gene [ 33 ].…”

Section: Introductionmentioning

confidence: 99%

Rapid molecular assays for detection of tuberculosis

Eddabra

Benhassou

2018

Pneumonia

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Tuberculosis (TB) is an infectious disease that remains an important public health problem at the global level. It is one of the main causes of morbidity and mortality, due to the emergence of antibiotic resistant Mycobacterium strains and HIV co-infection. Over the past decade, important progress has been made for better control of the disease. While microscopy and culture continue to be indispensible for laboratory diagnosis of tuberculosis, the range of several molecular diagnostic tests, including the nucleic acid amplification test (NAAT) and whole-genome sequencing (WGS), have expanded tremendously. They are becoming more accessible not only for detection and identification of Mycobacterium tuberculosis complex in clinical specimens, but now extend to diagnosing multi-drug resistant strains. Molecular diagnostic tests provide timely results useful for high-quality patient care, low contamination risk, and ease of performance and speed. This review focuses on the current diagnostic tests in use, including emerging technologies used for detection of tuberculosis in clinical specimens. The sensitivity and specificity of these tests have also been taken into consideration.

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Development and Clinical Evaluation of sdaA Loop-Mediated Isothermal Amplification Assay for Detection of Mycobacterium tuberculosis with an Approach To Prevent Carryover Contamination

Cited by 20 publications

References 13 publications

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

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

A diagnostic test that uses isothermal amplification and lateral flow detection sdaA can detect tuberculosis in 60 min

Rapid molecular assays for detection of tuberculosis

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