Multicenter Feasibility Study To Assess External Quality Assessment Panels for Xpert MTB/RIF Assay in South Africa

Scott, Lesley; Albert, Heidi; Gilpin, Chris; Alexander, Heather; DeGruy, Kyle; Stevens, Wendy

doi:10.1128/jcm.03533-13

Cited by 29 publications

(31 citation statements)

References 11 publications

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“…Since more than 90% RIF resistant strains are also resistant to INH [7][8][9][10], determining the RIF resistant strains, using the gene X-pert assay a rapid and sensitive technique, is an alternative approach to detect MDR-TB [11,9,10], and this could be explained by rate of spontaneous mutation rate; in which INH target gene has 100 times higher rate of mutation than that of RIF target gene [12]. Therefore, in high MDR-TB burden countries, diagnosis of RIF resistant TB is regarded as MDR-TB [9]. Furthermore, almost one-tenth (9%) of new MDR-TB cases, are likely to convert to extensively drug-resistant TB (XDR-TB) [1,5,6] In Sub-Saharan Africa, the estimated MDRT-TB incidence is very high (14%) [1].…”

Section: Introductionmentioning

confidence: 99%

Rifampicin resistant tuberculosis in presumptive pulmonary tuberculosis cases in Dubti Hospital, Afar, Ethiopia

Gebrehiwet

Kahsay

Welekidan

et al. 2019

J Infect Dev Ctries

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Introduction: Ethiopia stood third in drug-resistant tuberculosis (TB) in Africa, and more than 5,000 MDR-TB patients are reported each year. Greater than 90% of rifampicin (RIF) resistant strains are resistant to isoniazid (INH) and hence the objective of this study was to determine the prevalence and risk factors of RIF resistant MTB among presumptive TB cases at Dubti General Hospital, Afar, Ethiopia. Methodology: In this cross-sectional study, 384 presumptive TB cases were recruited and a structured questionnaire was used to collect socio-demographic and clinical data. Sputum samples were collected and examined using X-pertMTB/RIF assay. Bivariate, multivariate logistic regressions, and fishers' exact analysis were done to assess the associations between the prevalence of TB and MDR-TB with different socio-demographic and clinical variables. Results: In the present study, the overall prevalence of pulmonary TB was 24.5% (94/384), of this 4 (4.3%) isolates were resistant to RIF. History of anti-TB treatment (AOR = 2.4, 95% CI: 1.3-4.4 and TB contact (AOR = 3.6, 95% CI: 2.1-6.2 were significantly associated with gene X-pert MTB/RIF positive TB. Moreover, resistance to rifampicin was statistically associated with the history of TB contact with multi-drug resistant TB (P = 0.027) and khat chewer cases (P = 0.04). Conclusions: The overall prevalence of TB and its drug-resistant were relatively higher than that of in the general population in Ethiopia. History of anti-TB treatment and TB contact were significantly associated with X-pert MTB/RIF positive MDR-TB.

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Section: Introductionmentioning

confidence: 99%

Rifampicin resistant tuberculosis in presumptive pulmonary tuberculosis cases in Dubti Hospital, Afar, Ethiopia

Gebrehiwet

Kahsay

Welekidan

et al. 2019

J Infect Dev Ctries

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“…Other studies have identified continuous performance monitoring as a valuable addition to quality monitoring. External quality assessment only provides a 'snapshot' of the laboratory's routine performance, and EQA reports are evaluated retrospectively [5]. In contrast, commercially available peer review programs allow for daily monitoring in real time of instrument performance.…”

Section: Discussionmentioning

confidence: 99%

Participation in the national external quality assessment scheme as a tool to evaluate quality improvement in a South African laboratory

Schapkaitz

Moyake

2017

Int J Lab Hematology

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“…Much has been learnt from the implementation of Xpert MTB/RIF as summarised in Table 2 and includes [66, 67] cost and forecast models [68, 69], program interfacing [70], socio-economic trends [71], and quality assessment [72]. Additional innovations, being reported for the first time for possible TB control (currently, developed for GeneXpert instruments), is remote connectivity [73, 74].…”

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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Multicenter Feasibility Study To Assess External Quality Assessment Panels for Xpert MTB/RIF Assay in South Africa

Cited by 29 publications

References 11 publications

Rifampicin resistant tuberculosis in presumptive pulmonary tuberculosis cases in Dubti Hospital, Afar, Ethiopia

Rifampicin resistant tuberculosis in presumptive pulmonary tuberculosis cases in Dubti Hospital, Afar, Ethiopia

Participation in the national external quality assessment scheme as a tool to evaluate quality improvement in a South African laboratory

Diagnosis of opportunistic infections

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