Comparative analysis of TB-Biochip, Xpert MTB/RIF, and GenoType MTBDRplus test systems for rapid determination of mutations responsible for drug resistance of M. tuberculosis complex (in sputum from patients in Moscow region)

Nosova, Elena; Krasnova, M. A.; Galkina, Ksenia; Makarova, Marina; Litvinov, V. I.; Мороз, А. М.

doi:10.1134/s002689331301010x

Cited by 6 publications

(9 citation statements)

References 13 publications

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“…In the Index Test domain, we considered all studies to have low risk of bias. With respect to applicability, we considered most studies to have low concern and eight studies to have unclear concern because the ratio of sample reagent to specimen volume differed from that recommended by the manufacturer or we could not tell ( Balcells 2012 ; Friedrich 2011 ; Mok 2016 ; Moure 2011 ; Mutingwende 2015 ; Nosova 2013a ; Reechaipichitkul 2017 ; Scott 2011 ).…”

Section: Resultsmentioning

confidence: 99%

“…Twenty‐eight studies evaluating Xpert MTB/RIF and involving 8901 participants provided data on a variety of NTMs that grew from the specimens tested, to look for evidence of cross‐reactivity: one NTM ( Al‐Darraji 2013 ); four NTMs ( Balcells 2012 ); two NTMs ( Barnard 2015 ); 50 NTMs ( Bjerrum 2016 ); one NTM ( Chaisson 2014 ); 16 NTMs ( Cowan 2017 ); three NTMs ( Davis 2014 ); 12 NTMs ( Kim CH 2015 ); one NTM ( Kurbatova 2013 ); nine NTMs ( Le Palud 2014 ); 16 NTMs ( Lee 2013 ); 40 NTMs ( Lippincott 2014 ); 14 NTMs ( Lorent 2015 ); 95 NTMs ( Luetkemeyer 2016 ); 20 NTMs ( Moure 2011 ); four NTMs ( Nosova 2013a ); 10 NTMs ( Pinyopornpanish 2015 ); 45 NTMs ( Rachow 2011 ); 122 NTMs ( Rice 2017 ); seven NTMs ( Safianowska 2012 ); five NTMs ( Scott 2011 ); three NTMs ( Sohn 2014 ); 19 NTMs ( Ssengooba 2014 ); two NTMs ( Tang 2017 ); eight NTMs ( Theron 2011 ); three NTMs ( Van Rie 2013 ); 22 NTMs ( Williamson 2012 ); and two NTMs ( Zmak 2013 ). Among these 28 studies comprising 536 NTMs, Xpert MTB/RIF was positive in 16 specimens that grew NTMs, pooled proportion 2.0% (0.4% to 4.4%).…”

Section: Resultsmentioning

confidence: 99%

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Xpert MTB/RIF and Xpert MTB/RIF Ultra for pulmonary tuberculosis and rifampicin resistance in adults

Horne

Kohli

Zifodya

et al. 2019

Cochrane Database of Systematic Reviews

182

157

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Background Xpert MTB/RIF (Xpert MTB/RIF) and Xpert MTB/RIF Ultra (Xpert Ultra), the newest version, are the only World Health Organization (WHO)‐recommended rapid tests that simultaneously detect tuberculosis and rifampicin resistance in persons with signs and symptoms of tuberculosis, at lower health system levels. A previous Cochrane Review found Xpert MTB/RIF sensitive and specific for tuberculosis ( ). Since the previous review, new studies have been published. We performed a review update for an upcoming WHO policy review. Objectives To determine diagnostic accuracy of Xpert MTB/RIF and Xpert Ultra for tuberculosis in adults with presumptive pulmonary tuberculosis (PTB) and for rifampicin resistance in adults with presumptive rifampicin‐resistant tuberculosis. Search methods We searched the Cochrane Infectious Diseases Group Specialized Register, MEDLINE, Embase, Science Citation Index, Web of Science, Latin American Caribbean Health Sciences Literature, Scopus, the WHO International Clinical Trials Registry Platform, the International Standard Randomized Controlled Trial Number Registry, and ProQuest, to 11 October 2018, without language restriction. Selection criteria Randomized trials, cross‐sectional, and cohort studies using respiratory specimens that evaluated Xpert MTB/RIF, Xpert Ultra, or both against the reference standard, culture for tuberculosis and culture‐based drug susceptibility testing or MTBDR plus for rifampicin resistance. Data collection and analysis Four review authors independently extracted data using a standardized form. When possible, we also extracted data by smear and HIV status. We assessed study quality using QUADAS‐2 and performed meta‐analyses to estimate pooled sensitivity and specificity separately for tuberculosis and rifampicin resistance. We investigated potential sources of heterogeneity. Most analyses used a bivariate random‐effects model. For tuberculosis detection, we first estimated accuracy using all included studies and then only the subset of studies where participants were unselected, i.e. not selected based on prior microscopy testing. Main results We identified in total 95 studies (77 new studies since the previous review): 86 studies (42,091 participants) evaluated Xpert MTB/RIF for tuberculosis and 57 studies (8287 participants) for rifampicin resistance. One study compared Xpert MTB/RIF and Xpert Ultra on the same participant specimen. Tuberculosis detection Of the total 86 studies, 45 took place in high tuberculosis burden and 50 in high TB/HIV burden countries. Most studies had low risk of bias. Xpert MTB/RIF pooled sensitivity and specificity (95% credible Interval (CrI)) were 85% (82% to 88%) and 98% (97% to 98%), (70 studies, 37,237 unselected participants; high‐certainty evidence). We found similar accuracy when ...

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Xpert MTB/RIF and Xpert MTB/RIF Ultra for pulmonary tuberculosis and rifampicin resistance in adults

Horne

Kohli

Zifodya

et al. 2019

Cochrane Database of Systematic Reviews

182

157

View full text Add to dashboard Cite

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“…NIHR Journals Library www.journalslibrary.nihr.ac.uk studies (n = 18), 34,[62][63][64][65][66][67][68][69][70][71][72][73][74][75][98][99][100] MTBDRsl studies (n = 6) 37,76-80 and other rapid diagnostic studies (n = 17); [81][82][83][84][85][86][87][88][89][90][91][92][93][94][95][96][97] the last category comprised any report with insufficient information about the type and manufacture of the assay tested, or assays that had been designed in-house.…”

Section: Systematic Reviewmentioning

confidence: 99%

“…In addition to the studies that reported diagnostic data from the widely used commercial tests, 17 studies [81][82][83][84][85][86][87][88][89][90][91][92][93][94][95][96][97] reporting data on other genetic rapid diagnostic tests were identified using the inclusion criteria. These tests were broadly broken into those studies that utilised a variety of TB biochip assays (n = 7, 41.2%) and those that used in-house PCR assays (n = 10, 59.8%).…”

Section: Other Studiesmentioning

confidence: 99%

Systematic review, meta-analysis and economic modelling of molecular diagnostic tests for antibiotic resistance in tuberculosis

Drobniewski

Cooke

Jordan

et al. 2015

Health Technology Assessment

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BackgroundDrug-resistant tuberculosis (TB), especially multidrug-resistant (MDR, resistance to rifampicin and isoniazid) disease, is associated with a worse patient outcome. Drug resistance diagnosed using microbiological culture takes days to weeks, as TB bacteria grow slowly. Rapid molecular tests for drug resistance detection (1 day) are commercially available and may promote faster initiation of appropriate treatment.ObjectivesTo (1) conduct a systematic review of evidence regarding diagnostic accuracy of molecular genetic tests for drug resistance, (2) conduct a health-economic evaluation of screening and diagnostic strategies, including comparison of alternative models of service provision and assessment of the value of targeting rapid testing at high-risk subgroups, and (3) construct a transmission-dynamic mathematical model that translates the estimates of diagnostic accuracy into estimates of clinical impact.Review methods and data sourcesA standardised search strategy identified relevant studies from EMBASE, PubMed, MEDLINE, Bioscience Information Service (BIOSIS), System for Information on Grey Literature in Europe Social Policy & Practice (SIGLE) and Web of Science, published between 1 January 2000 and 15 August 2013. Additional ‘grey’ sources were included. Quality was assessed using quality assessment of diagnostic accuracy studies version 2 (QUADAS-2). For each diagnostic strategy and population subgroup, a care pathway was constructed to specify which medical treatments and health services that individuals would receive from presentation to the point where they either did or did not complete TB treatment successfully. A total cost was estimated from a health service perspective for each care pathway, and the health impact was estimated in terms of the mean discounted quality-adjusted life-years (QALYs) lost as a result of disease and treatment. Costs and QALYs were both discounted at 3.5% per year. An integrated transmission-dynamic and economic model was used to evaluate the cost-effectiveness of introducing rapid molecular testing (in addition to culture and drug sensitivity testing). Probabilistic sensitivity analysis was performed to evaluate the impact on cost-effectiveness of diagnostic and treatment time delays, diagnosis and treatment costs, and associated QALYs.ResultsA total of 8922 titles and abstracts were identified, with 557 papers being potentially eligible. Of these, 56 studies contained sufficient test information for analysis. All three commercial tests performed well when detecting drug resistance in clinical samples, although with evidence of heterogeneity between studies. Pooled sensitivity for GenoType®MTBDRplus (Hain Lifescience, Nehren, Germany) (isoniazid and rifampicin resistance), INNO-LiPA Rif.TB®(Fujirebio Europe, Ghent, Belgium) (rifampicin resistance) and Xpert®MTB/RIF (Cepheid Inc., Sunnyvale, CA, USA) (rifampicin resistance) was 83.4%, 94.6%, 95.4% and 96.8%, respectively; equivalent pooled specificity was 99.6%, 98.2%, 99.7% and 98.4%, respectively. Results of the transmission model suggest that all of the rapid assays considered here, if added to the current diagnostic pathway, would be cost-saving and achieve a reduction in expected QALY loss compared with current practice. GenoType MTBDRplus appeared to be the most cost-effective of the rapid tests in the South Asian population, although results were similar for GeneXpert. In all other scenarios GeneXpert appeared to be the most cost-effective strategy.ConclusionsRapid molecular tests for rifampicin and isoniazid resistance were sensitive and specific. They may also be cost-effective when added to culture drug susceptibility testing in the UK. There is global interest in point-of-care testing and further work is needed to review the performance of emerging tests and the wider health-economic impact of decentralised testing in clinics and primary care, as well as non-health-care settings, such as shelters and prisons.Study registrationThis study is registered as PROSPERO CRD42011001537.FundingThe National Institute for Health Research Health Technology Assessment programme.

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“…Multidrug-resistant strains of Mycobacterium [50], which has been successfully validated in several studies [106,107]. In 2013, the same group published a new DNA microarray test for XDR-TB diagnosis [61].…”

Section: Mycobacteriamentioning

confidence: 99%

DNA Microarrays for Pathogen Detection

Schulze

Rubtsova

Bachmann

2015

Modern Techniques for Pathogen Detection

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Comparative analysis of TB-Biochip, Xpert MTB/RIF, and GenoType MTBDRplus test systems for rapid determination of mutations responsible for drug resistance of M. tuberculosis complex (in sputum from patients in Moscow region)

Cited by 6 publications

References 13 publications

Xpert MTB/RIF and Xpert MTB/RIF Ultra for pulmonary tuberculosis and rifampicin resistance in adults

Xpert MTB/RIF and Xpert MTB/RIF Ultra for pulmonary tuberculosis and rifampicin resistance in adults

Systematic review, meta-analysis and economic modelling of molecular diagnostic tests for antibiotic resistance in tuberculosis

DNA Microarrays for Pathogen Detection

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