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Peripheral clinic versus centralized laboratory-based Xpert MTB/RIF performance: Experience gained from a pragmatic, stepped-wedge trial in Botswana
BACKGROUND: In 2011, the Botswana National Tuberculosis Program adopted World Health Organization guidelines and introduced Xpert MTB/RIF (Xpert) assay to support intensified case finding among people living with HIV enrolling in care. An evaluation was designed to assess performance under operation...
Autores principales: | , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Public Library of Science
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5560557/ https://www.ncbi.nlm.nih.gov/pubmed/28817643 http://dx.doi.org/10.1371/journal.pone.0183237 |
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author | Agizew, Tefera Boyd, Rosanna Ndwapi, Ndwapi Auld, Andrew Basotli, Joyce Nyirenda, Sambayawo Tedla, Zegabriel Mathoma, Anikie Mathebula, Unami Lesedi, Chawangwa Pals, Sherri Date, Anand Alexander, Heather Kuebrich, Thomas Finlay, Alyssa |
author_facet | Agizew, Tefera Boyd, Rosanna Ndwapi, Ndwapi Auld, Andrew Basotli, Joyce Nyirenda, Sambayawo Tedla, Zegabriel Mathoma, Anikie Mathebula, Unami Lesedi, Chawangwa Pals, Sherri Date, Anand Alexander, Heather Kuebrich, Thomas Finlay, Alyssa |
author_sort | Agizew, Tefera |
collection | PubMed |
description | BACKGROUND: In 2011, the Botswana National Tuberculosis Program adopted World Health Organization guidelines and introduced Xpert MTB/RIF (Xpert) assay to support intensified case finding among people living with HIV enrolling in care. An evaluation was designed to assess performance under operational conditions to inform the national Xpert scale-up. METHODS: Xpert was implemented from August 2012 through November 2014 with 13 GeneXpert instruments (GeneXpert) deployed in a phased approach over nine months: nine centralized laboratory and four point-of-care (POC) peripheral clinics. Clinicians and laboratorians were trained on the four-symptom tuberculosis screening algorithm and Xpert testing. We documented our experience with staff training and GeneXpert performance. Test results were extracted from GeneXpert software; unsuccessful tests were analysed in relation to testing sites and trends over time. RESULTS: During 276 instrument-months of operation a total of 3,630 tests were performed, of which 3,102 (85%) were successful with interpretable results. Mycobacterium tuberculosis complex was detected for 447 (14%); of these, 36 (8%) were rifampicin resistant. Of all 3,630 Xpert tests, 528 (15%) were unsuccessful; of these 361 (68%) were classified as “error”, 119 (23%) as “invalid” and 48 (9%) as “no result”. The total number of recorded error codes was 385 and the most common reasons were related to sample processing (211; 55%) followed by power supply (77; 20%) and cartridge/module related (54; 14%). Cumulative incidence of unsuccessful test was similar between POC (17%, 95% CI: 11–25%) and centralized laboratory-based GeneXpert instruments (14%, 95% CI: 11–17%; p = 0.140). CONCLUSIONS: Xpert introduction was successful in the Botswana setting. The incidence of unsuccessful test was similar by GeneXpert location (POC vs. centralized laboratory). However, unsuccessful test incidence (15%) in our settings was higher than previously reported and was mostly related to improper sample processing. Ensuring adequate training among Xpert testing staff is essential to minimize errors. |
format | Online Article Text |
id | pubmed-5560557 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | Public Library of Science |
record_format | MEDLINE/PubMed |
spelling | pubmed-55605572017-08-25 Peripheral clinic versus centralized laboratory-based Xpert MTB/RIF performance: Experience gained from a pragmatic, stepped-wedge trial in Botswana Agizew, Tefera Boyd, Rosanna Ndwapi, Ndwapi Auld, Andrew Basotli, Joyce Nyirenda, Sambayawo Tedla, Zegabriel Mathoma, Anikie Mathebula, Unami Lesedi, Chawangwa Pals, Sherri Date, Anand Alexander, Heather Kuebrich, Thomas Finlay, Alyssa PLoS One Research Article BACKGROUND: In 2011, the Botswana National Tuberculosis Program adopted World Health Organization guidelines and introduced Xpert MTB/RIF (Xpert) assay to support intensified case finding among people living with HIV enrolling in care. An evaluation was designed to assess performance under operational conditions to inform the national Xpert scale-up. METHODS: Xpert was implemented from August 2012 through November 2014 with 13 GeneXpert instruments (GeneXpert) deployed in a phased approach over nine months: nine centralized laboratory and four point-of-care (POC) peripheral clinics. Clinicians and laboratorians were trained on the four-symptom tuberculosis screening algorithm and Xpert testing. We documented our experience with staff training and GeneXpert performance. Test results were extracted from GeneXpert software; unsuccessful tests were analysed in relation to testing sites and trends over time. RESULTS: During 276 instrument-months of operation a total of 3,630 tests were performed, of which 3,102 (85%) were successful with interpretable results. Mycobacterium tuberculosis complex was detected for 447 (14%); of these, 36 (8%) were rifampicin resistant. Of all 3,630 Xpert tests, 528 (15%) were unsuccessful; of these 361 (68%) were classified as “error”, 119 (23%) as “invalid” and 48 (9%) as “no result”. The total number of recorded error codes was 385 and the most common reasons were related to sample processing (211; 55%) followed by power supply (77; 20%) and cartridge/module related (54; 14%). Cumulative incidence of unsuccessful test was similar between POC (17%, 95% CI: 11–25%) and centralized laboratory-based GeneXpert instruments (14%, 95% CI: 11–17%; p = 0.140). CONCLUSIONS: Xpert introduction was successful in the Botswana setting. The incidence of unsuccessful test was similar by GeneXpert location (POC vs. centralized laboratory). However, unsuccessful test incidence (15%) in our settings was higher than previously reported and was mostly related to improper sample processing. Ensuring adequate training among Xpert testing staff is essential to minimize errors. Public Library of Science 2017-08-17 /pmc/articles/PMC5560557/ /pubmed/28817643 http://dx.doi.org/10.1371/journal.pone.0183237 Text en https://creativecommons.org/publicdomain/zero/1.0/ This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 (https://creativecommons.org/publicdomain/zero/1.0/) public domain dedication. |
spellingShingle | Research Article Agizew, Tefera Boyd, Rosanna Ndwapi, Ndwapi Auld, Andrew Basotli, Joyce Nyirenda, Sambayawo Tedla, Zegabriel Mathoma, Anikie Mathebula, Unami Lesedi, Chawangwa Pals, Sherri Date, Anand Alexander, Heather Kuebrich, Thomas Finlay, Alyssa Peripheral clinic versus centralized laboratory-based Xpert MTB/RIF performance: Experience gained from a pragmatic, stepped-wedge trial in Botswana |
title | Peripheral clinic versus centralized laboratory-based Xpert MTB/RIF performance: Experience gained from a pragmatic, stepped-wedge trial in Botswana |
title_full | Peripheral clinic versus centralized laboratory-based Xpert MTB/RIF performance: Experience gained from a pragmatic, stepped-wedge trial in Botswana |
title_fullStr | Peripheral clinic versus centralized laboratory-based Xpert MTB/RIF performance: Experience gained from a pragmatic, stepped-wedge trial in Botswana |
title_full_unstemmed | Peripheral clinic versus centralized laboratory-based Xpert MTB/RIF performance: Experience gained from a pragmatic, stepped-wedge trial in Botswana |
title_short | Peripheral clinic versus centralized laboratory-based Xpert MTB/RIF performance: Experience gained from a pragmatic, stepped-wedge trial in Botswana |
title_sort | peripheral clinic versus centralized laboratory-based xpert mtb/rif performance: experience gained from a pragmatic, stepped-wedge trial in botswana |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5560557/ https://www.ncbi.nlm.nih.gov/pubmed/28817643 http://dx.doi.org/10.1371/journal.pone.0183237 |
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