GenoType MTBDRplus Assay for Rapid Detection of Multidrug Resistance in Mycobacterium tuberculosis: A Meta-Analysis

Bai, Yuanyuan; Wang, Yueling; Shao, Chunhong; Hao, Yingying; Jin, Yan

doi:10.1371/journal.pone.0150321

Cited by 60 publications

(52 citation statements)

References 62 publications

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“…Resistance to RIF is detected by using eight rpoB wild-type probes, and resistance to INH is detected by using wild-type and mutant (315T1) katG probes as well as wild-type and mutant (Ϫ15T) inhA promoter probes. All mutations reported by the m2000rt were directly compared to the results of the GenoType MTBDRplus line probe assay, which has been previously evaluated in depth confirming its very high analytical specificity (20). The identities of the underlying rpoB mutations, which were not clearly identified by the GenoType MTBDRplus, were verified by Sanger sequencing of the RIF resistance-determining region of the rpoB gene using standard protocols and primers rpoB-F 5=-GGG AGC GGA TGA CCA CCC A-3= and rpoB-R 5=-GCG GTA CGG CGT TTC GAT GAA C-3=.…”

Section: Methodsmentioning

confidence: 94%

Evaluation of the Abbott RealTi m e MTB and RealTi m e MTB INH/RIF Assays for Direct Detection of Mycobacterium tuberculosis Complex and Resistance Markers in Respiratory and Extrapulmonary Specimens

Hofmann-Thiel

Molodtsov²,

Antonenka³

et al. 2016

J Clin Microbiol

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bThe Abbott RealTime MTB (RT MTB) assay is a new automated nucleic acid amplification test for the detection of Mycobacterium tuberculosis complex (MTBC) in clinical specimens. In combination with the RealTime MTB INH/RIF (RT MTB INH/RIF) resistance assay, which can be applied to RT MTB-positive specimens as an add-on assay, the tests also indicate the genetic markers of resistance to isoniazid (INH) and rifampin (RIF). We aimed to evaluate the diagnostic sensitivity and specificity of RT MTB using different types of respiratory and extrapulmonary specimens and to compare performance characteristics directly with those of the FluoroType MTB assay. The resistance results obtained by RT MTB INH/RIF were compared to those from the GenoType MTBDRplus and from phenotypic drug susceptibility testing. A total of 715 clinical specimens were analyzed. Compared to culture, the overall sensitivity of RT MTB was 92.1%; the sensitivity rates for smear-positive and smear-negative samples were 100% and 76.2%, respectively. The sensitivities of smear-negative specimens were almost identical for respiratory (76.3%) and extrapulmonary (76%) specimens. Specificity rates were 100% and 95.8% for culturenegative specimens and those that grew nontuberculous mycobacteria, respectively. RT MTB INH/RIF was applied to 233 RT MTB-positive samples and identified resistance markers in 7.7% of samples. Agreement with phenotypic and genotypic drug susceptibility testing was 99.5%. In conclusion, RT MTB and RT MTB INH/RIF allow for the rapid and accurate diagnosis of tuberculosis (TB) in different types of specimens and reliably indicate resistance markers. The strengths of this system are the comparably high sensitivity with paucibacillary specimens, its ability to detect INH and RIF resistance, and its high-throughput capacities. R apid and accurate diagnosis of tuberculosis (TB) and fast detection of drug resistance are essential to ensure early initiation of appropriate antituberculotic treatment, adequately manage the disease, and control further transmission. Worldwide, one-third of all TB cases and almost three-quarters of the 480,000 cases of multidrug-resistant (MDR; defined as resistance toward rifampin [RIF] and isoniazid [INH]) TB are not reported, with the vast majority of them occurring in high-burden countries (1). Molecular tests are the most promising tools to close this diagnostic gap. Consequently, nucleic acid amplification tests (NAATs), such as PCR assays that allow for the fast and accurate detection of Mycobacterium tuberculosis complex (MTBC) DNA directly in clinical specimens, have become an indispensable tool in TB diagnostics over the last several decades. Most commercial tests show excellent specificity and sensitivity rates with smear-positive specimens while sensitivity rates range from 49% to 78% with smearnegative samples (2-7).Particularly in regions with high prevalences of MDR-TB, the molecular detection of genetic markers of resistance directly in the clinical specimen is playing a pivotal role in early not...

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Section: Methodsmentioning

confidence: 94%

Evaluation of the Abbott RealTi m e MTB and RealTi m e MTB INH/RIF Assays for Direct Detection of Mycobacterium tuberculosis Complex and Resistance Markers in Respiratory and Extrapulmonary Specimens

Hofmann-Thiel

Molodtsov²,

Antonenka³

et al. 2016

J Clin Microbiol

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“…At present, LPAs have been recommended for use by the WHO for the detection of RIF and isoniazid (INH) resistance in sputum smear‐positive specimens and mycobacterial cultures . These assays represent an important opportunity of reporting RIF and INH susceptibility simultaneously . A second‐LPA used for the detection of resistance to anti‐TB drugs includes probes to detect resistance to the class of fluoroquinolones drugs , and the WHO recommended it use to detect resistance in patients diagnosed with resistance to RIF or for the diagnosis of extensively drug‐resistant .…”

Section: Challenges and Future Directions For Improving The Diagnosismentioning

confidence: 99%

Diagnosis of Tuberculosis in HIV Co‐infected Individuals: Current Status, Challenges and Opportunities for the Future

Méndez-Samperio¹

2017

Scand J Immunol

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Tuberculosis (TB) remains one of the most important causes of death among people co-infected with human immunodeficiency virus (HIV). The diagnosis of TB remains challenging in HIV co-infected individuals, due to a high frequency of smear-negative disease and high rates of extrapulmonary TB. Accurate, ease of use and rapid diagnosis of active TB are critical to the World Health Organization (WHO) End TB Strategy by 2050. Traditional laboratory techniques do not provide rapid and accurate results to effectively manage HIV co-infected patients. Over the last decade, molecular methods have provided significant steps in the fight against TB. However, many HIV co-infected patients do not have access to these molecular diagnostic tests. Given the costs closely related with confirming a TB diagnosis in HIV patients, an overtreatment for TB is used in this patient population. Nowadays, an estimated US $8 billion a year is required to provide TB treatment, which is very high compared with making an important strategy to improve the current diagnostic tests. This review focuses on current advances in diagnosing active TB with an emphasis on the diagnosis of HIV-associated TB. Also discussed are the main challenges that need to be overcome for improving an adequate initial diagnosis of active TB in HIV-positive patients.

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“…It remains the most widely studied LPA. Further data has since been published on the use of LPAs and newer versions of LPA technology have since been developed: i) Hain Genotype MTBDR plus version 2 [77–80]; and ii) the Nipro NTM+MDRTB detection kit developed by the Nipro Corporation (Japan) DR-TB [81]. These newer LPAs aim to improve sensitivity for MTBC detection and to simultaneously detect resistance to rifampicin and isoniazid.…”

Section: Who Endorsed Diagnostic Technologiesmentioning

confidence: 99%

Diagnosis of opportunistic infections

Scott

Silva

Boehme

et al. 2017

Current Opinion in HIV and AIDS

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Purpose of the review TB incidence has declined ~1.5% annually since 2000, but continued to affect 10.4 million individuals in 2015, with 1/3 remaining undiagnosed or under reported. The diagnosis of TB among those co-infected with HIV is challenging as TB remains the leading cause of death in such individuals. Accurate and rapid diagnosis of active TB will avert mortality in both adults and children, reduce transmission, and assist in timeous decisions for ART initiation. This review describes advances in diagnosing TB, especially among HIV co-infected individuals, highlights national program’s uptake, and impact on patient care. Recent Findings The TB diagnostic landscape has been transformed over the last 5 years. Molecular diagnostics such as Xpert MTB/RIF, which simultaneously detects M. tuberculosis resistance to rifampicin, has revolutionised TB control programs. WHO endorsed the use of Xpert MTB/RIF in 2010 for use in HIV/TB co-infected patients, and later in 2013 for use as the initial diagnostic test for all adults and children with signs and symptoms of pulmonary TB. Line probe assays (LPAs) are recommended for the detection of rifampicin and isoniazid resistance in sputum smear-positive specimens and mycobacterial cultures. A second-line line probe assay has been recommended for the diagnosis of extensively drug-resistant (XDR)-TB Assays such as the urine lateral flow(LF)-lipoarabinomannan(LAM), can be used at the point of care (POC) and have a niche role to supplement the diagnosis of TB in seriously ill HIV infected, hospitalized patients with low CD4<100cells/μl. Polyvalent platforms such as the m2000 (Abbott Molecular, IL, USA) and GeneXpert (Cepheid, CA, USA) offer potential for integration of HIV and TB testing services. While the Research and Development (R&D) pipeline appears to be rich at first glance, there are actually few leads for true POC tests that would allow for earlier TB diagnosis or rapid, comprehensive drug susceptibility testing, especially when considering the very high attrition rates observed between biomarker discovery and product market entry. Summary In this review, we describe diagnostic strategies specifically for HIV and TB co-infected individuals. Molecular diagnostics in particular within the past 5 years have revolutionized and “disrupted” this field. They lend themselves to integration of services with platforms capable of polyvalent testing. Impact on patient care is, however, still debatable. What has been highlighted is the need for health system strengthening and for true POC testing that can be used in active case finding.

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GenoType MTBDRplus Assay for Rapid Detection of Multidrug Resistance in Mycobacterium tuberculosis: A Meta-Analysis

Cited by 60 publications

References 62 publications

Evaluation of the Abbott RealTi m e MTB and RealTi m e MTB INH/RIF Assays for Direct Detection of Mycobacterium tuberculosis Complex and Resistance Markers in Respiratory and Extrapulmonary Specimens

Evaluation of the Abbott RealTi m e MTB and RealTi m e MTB INH/RIF Assays for Direct Detection of Mycobacterium tuberculosis Complex and Resistance Markers in Respiratory and Extrapulmonary Specimens

Diagnosis of Tuberculosis in HIV Co‐infected Individuals: Current Status, Challenges and Opportunities for the Future

Diagnosis of opportunistic infections

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