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Feasibility, accuracy, and clinical effect of point-of-care Xpert MTB/RIF testing for tuberculosis in primary-care settings in Africa: a multicentre, randomised, controlled trial

Theron, Grant, PhD ; Zijenah, Lynn, Prof ; Chanda, Duncan, MD ; Clowes, Petra, MD ; Rachow, Andrea, MD ; Lesosky, Maia, PhD ; Bara, Wilbert, MD ; Mungofa, Stanley, MD ; Pai, Madhukar, MD ; Hoelscher, Michael, Prof ; Dowdy, David, PhD ; Pym, Alex, PhD ; Mwaba, Peter, Prof ; Mason, Peter, Prof ; Peter, Jonny, MBChB ; Dheda, Keertan, Prof

The Lancet (British edition), 2014-02, Vol.383 (9915), p.424-435 [Periódico revisado por pares]

Kidlington: Elsevier Ltd

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Título:
Feasibility, accuracy, and clinical effect of point-of-care Xpert MTB/RIF testing for tuberculosis in primary-care settings in Africa: a multicentre, randomised, controlled trial
Autor: Theron, Grant, PhD ; Zijenah, Lynn, Prof ; Chanda, Duncan, MD ; Clowes, Petra, MD ; Rachow, Andrea, MD ; Lesosky, Maia, PhD ; Bara, Wilbert, MD ; Mungofa, Stanley, MD ; Pai, Madhukar, MD ; Hoelscher, Michael, Prof ; Dowdy, David, PhD ; Pym, Alex, PhD ; Mwaba, Peter, Prof ; Mason, Peter, Prof ; Peter, Jonny, MBChB ; Dheda, Keertan, Prof
Assuntos: Accuracy ; Adult ; Africa ; Bacterial diseases ; Bacteriological Techniques - standards ; Biological and medical sciences ; Clinics ; Feasibility Studies ; Female ; General aspects ; Human bacterial diseases ; Humans ; Infectious diseases ; Internal Medicine ; Laboratories ; Male ; Medical sciences ; Microscopy ; Middle Aged ; Morbidity ; Mortality ; Mycobacterium ; Patients ; Point-of-Care Systems - standards ; Pragmatism ; Prevention and actions ; Primary Health Care ; Public health. Hygiene ; Public health. Hygiene-occupational medicine ; Sputum - microbiology ; Tuberculosis ; Tuberculosis and atypical mycobacterial infections ; Tuberculosis, Multidrug-Resistant - diagnosis ; Tuberculosis, Multidrug-Resistant - nursing ; Tuberculosis, Pulmonary - diagnosis ; Tuberculosis, Pulmonary - nursing
É parte de: The Lancet (British edition), 2014-02, Vol.383 (9915), p.424-435
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ObjectType-News-3
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ObjectType-Undefined-2
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ObjectType-Evidence Based Healthcare-3
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Descrição: Summary Background The Xpert MTB/RIF test for tuberculosis is being rolled out in many countries, but evidence is lacking regarding its implementation outside laboratories, ability to inform same-day treatment decisions at the point of care, and clinical effect on tuberculosis-related morbidity. We aimed to assess the feasibility, accuracy, and clinical effect of point-of-care Xpert MTB/RIF testing at primary-care health-care facilities in southern Africa. Methods In this pragmatic, randomised, parallel-group, multicentre trial, we recruited adults with symptoms suggestive of active tuberculosis from five primary-care health-care facilities in South Africa, Zimbabwe, Zambia, and Tanzania. Eligible patients were randomly assigned using pregenerated tables to nurse-performed Xpert MTB/RIF at the clinic or sputum smear microscopy. Participants with a negative test result were empirically managed according to local WHO-compliant guidelines. Our primary outcome was tuberculosis-related morbidity (measured with the TBscore and Karnofsky performance score [KPS]) in culture-positive patients who had begun anti-tuberculosis treatment, measured at 2 months and 6 months after randomisation, analysed by intention to treat. This trial is registered with Clinicaltrials.gov , number NCT01554384. Findings Between April 12, 2011, and March 30, 2012, we randomly assigned 758 patients to smear microscopy (182 culture positive) and 744 to Xpert MTB/RIF (185 culture positive). Median TBscore in culture-positive patients did not differ between groups at 2 months (2 [IQR 0–3] in the smear microscopy group vs 2 [0·25–3] in the MTB/RIF group; p=0·85) or 6 months (1 [0–3] vs 1 [0–3]; p=0·35), nor did median KPS at 2 months (80 [70–90] vs 90 [80–90]; p=0·23) or 6 months (100 [90–100] vs 100 [90–100]; p=0·85). Point-of-care MTB/RIF had higher sensitivity than microscopy (154 [83%] of 185 vs 91 [50%] of 182; p=0·0001) but similar specificity (517 [95%] 544 vs 540 [96%] of 560; p=0·25), and had similar sensitivity to laboratory-based MTB/RIF (292 [83%] of 351; p=0·99) but higher specificity (952 [92%] of 1037; p=0·0173). 34 (5%) of 744 tests with point-of-care MTB/RIF and 82 (6%) of 1411 with laboratory-based MTB/RIF failed (p=0·22). Compared with the microscopy group, more patients in the MTB/RIF group had a same-day diagnosis (178 [24%] of 744 vs 99 [13%] of 758; p<0·0001) and same-day treatment initiation (168 [23%] of 744 vs 115 [15%] of 758; p=0·0002). Although, by end of the study, more culture-positive patients in the MTB/RIF group were on treatment due to reduced dropout (15 [8%] of 185 in the MTB/RIF group did not receive treatment vs 28 [15%] of 182 in the microscopy group; p=0·0302), the proportions of all patients on treatment in each group by day 56 were similar (320 [43%] of 744 in the MTB/RIF group vs 317 [42%] of 758 in the microscopy group; p=0·6408). Interpretation Xpert MTB/RIF can be accurately administered by a nurse in primary-care clinics, resulting in more patients starting same-day treatment, more culture-positive patients starting therapy, and a shorter time to treatment. However, the benefits did not translate into lower tuberculosis-related morbidity, partly because of high levels of empirical-evidence-based treatment in smear-negative patients. Funding European and Developing Countries Clinical Trials Partnership, National Research Foundation, and Claude Leon Foundation.
Editor: Kidlington: Elsevier Ltd
Idioma: Inglês

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Feasibility, accuracy, and clinical effect of point-of-care Xpert MTB/RIF testing for tuberculosis in primary-care settings in Africa: a multicentre, randomised, controlled trial

Kidlington: Elsevier Ltd

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