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Feasibility of Decentralised Deployment of Xpert MTB/RIF Test at Lower Level of Health System in India
BACKGROUND: Xpert MTB/RIF is an automated cartridge-based nucleic acid amplification test that has demonstrated its potential to detect tuberculosis and rifampicin resistance with high accuracy. To assist scale-up decisions in India, a feasibility assessment of Xpert MTB/RIF implementation was condu...
Autores principales: | , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Public Library of Science
2014
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3935858/ https://www.ncbi.nlm.nih.gov/pubmed/24586675 http://dx.doi.org/10.1371/journal.pone.0089301 |
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author | Raizada, Neeraj Sachdeva, K. S. Sreenivas, Achuthan Vadera, Bhavin Gupta, R. S. Parmar, Malik Kulsange, Shubhangi Babre, Ameet Thakur, Rahul Gray, Christen Ramachandran, Ranjani Alavadi, Umesh Ghedia, Mayank Vollepore, Balasangameshwara Dewan, Puneet Boehme, Catharina Paramsivan, C. N. |
author_facet | Raizada, Neeraj Sachdeva, K. S. Sreenivas, Achuthan Vadera, Bhavin Gupta, R. S. Parmar, Malik Kulsange, Shubhangi Babre, Ameet Thakur, Rahul Gray, Christen Ramachandran, Ranjani Alavadi, Umesh Ghedia, Mayank Vollepore, Balasangameshwara Dewan, Puneet Boehme, Catharina Paramsivan, C. N. |
author_sort | Raizada, Neeraj |
collection | PubMed |
description | BACKGROUND: Xpert MTB/RIF is an automated cartridge-based nucleic acid amplification test that has demonstrated its potential to detect tuberculosis and rifampicin resistance with high accuracy. To assist scale-up decisions in India, a feasibility assessment of Xpert MTB/RIF implementation was conducted within microscopy centres of 18 RNTCP TB units. METHODS: As part of programme-based demonstration of Xpert MTB/RIF implementation, we recorded and analysed association between key implementation factors and the ability of test to produce valid results. Factors contributing to test failures were analysed from GeneXpert software data which provides ‘failure codes’ and causes for test failures. RESULTS: From March’12 to January’13, total 40,035 suspects were tested by Xpert MTB/RIF, and 39,680 (99.1%) received valid results (Cumulative: 37157 (92.8%) on first attempt, 39410 (98.4%) on second attempt, 39637 (99.0%) on third attempt and 39680 (99.1%) on more attempts). Overall initial test failure was 2,878 (7.2% (4%–17%)); of these, 2,594 (90.1%) were re-tested and produced valid results. Most frequent reason of test failure was inadequate sample processing or equipment malfunction (3.9%). Other reasons included power failure (1.1%), cartridge integrity/component failure (0.8%), device-computer communication error (0.5%), and temperature-related errors (0.08%). Significant variation was observed in failure rates both across instruments and over time; furthermore, substantial variation was observed in failure rate in two cartridges lots. CONCLUSION: Installation required minimal infrastructure modifications and concerns about adequacy of human resources under public sector facilities and temperature extremes proved unfounded. Under routine conditions, Xpert MTB/RIF provided 99.1% valid results in TB suspects with low overall failure rates (7.2% initial failure, 0.9% final failure); devices provided valuable real-time feedback on reasons for test failure, which were used for rapid corrective action. High modular replacement (32%) and inter-lot cartridge performance variation remain sources of concern, and warrant close monitoring of failure rates as a key quality indicator. |
format | Online Article Text |
id | pubmed-3935858 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | Public Library of Science |
record_format | MEDLINE/PubMed |
spelling | pubmed-39358582014-03-04 Feasibility of Decentralised Deployment of Xpert MTB/RIF Test at Lower Level of Health System in India Raizada, Neeraj Sachdeva, K. S. Sreenivas, Achuthan Vadera, Bhavin Gupta, R. S. Parmar, Malik Kulsange, Shubhangi Babre, Ameet Thakur, Rahul Gray, Christen Ramachandran, Ranjani Alavadi, Umesh Ghedia, Mayank Vollepore, Balasangameshwara Dewan, Puneet Boehme, Catharina Paramsivan, C. N. PLoS One Research Article BACKGROUND: Xpert MTB/RIF is an automated cartridge-based nucleic acid amplification test that has demonstrated its potential to detect tuberculosis and rifampicin resistance with high accuracy. To assist scale-up decisions in India, a feasibility assessment of Xpert MTB/RIF implementation was conducted within microscopy centres of 18 RNTCP TB units. METHODS: As part of programme-based demonstration of Xpert MTB/RIF implementation, we recorded and analysed association between key implementation factors and the ability of test to produce valid results. Factors contributing to test failures were analysed from GeneXpert software data which provides ‘failure codes’ and causes for test failures. RESULTS: From March’12 to January’13, total 40,035 suspects were tested by Xpert MTB/RIF, and 39,680 (99.1%) received valid results (Cumulative: 37157 (92.8%) on first attempt, 39410 (98.4%) on second attempt, 39637 (99.0%) on third attempt and 39680 (99.1%) on more attempts). Overall initial test failure was 2,878 (7.2% (4%–17%)); of these, 2,594 (90.1%) were re-tested and produced valid results. Most frequent reason of test failure was inadequate sample processing or equipment malfunction (3.9%). Other reasons included power failure (1.1%), cartridge integrity/component failure (0.8%), device-computer communication error (0.5%), and temperature-related errors (0.08%). Significant variation was observed in failure rates both across instruments and over time; furthermore, substantial variation was observed in failure rate in two cartridges lots. CONCLUSION: Installation required minimal infrastructure modifications and concerns about adequacy of human resources under public sector facilities and temperature extremes proved unfounded. Under routine conditions, Xpert MTB/RIF provided 99.1% valid results in TB suspects with low overall failure rates (7.2% initial failure, 0.9% final failure); devices provided valuable real-time feedback on reasons for test failure, which were used for rapid corrective action. High modular replacement (32%) and inter-lot cartridge performance variation remain sources of concern, and warrant close monitoring of failure rates as a key quality indicator. Public Library of Science 2014-02-26 /pmc/articles/PMC3935858/ /pubmed/24586675 http://dx.doi.org/10.1371/journal.pone.0089301 Text en © 2014 Raizada et al http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited. |
spellingShingle | Research Article Raizada, Neeraj Sachdeva, K. S. Sreenivas, Achuthan Vadera, Bhavin Gupta, R. S. Parmar, Malik Kulsange, Shubhangi Babre, Ameet Thakur, Rahul Gray, Christen Ramachandran, Ranjani Alavadi, Umesh Ghedia, Mayank Vollepore, Balasangameshwara Dewan, Puneet Boehme, Catharina Paramsivan, C. N. Feasibility of Decentralised Deployment of Xpert MTB/RIF Test at Lower Level of Health System in India |
title | Feasibility of Decentralised Deployment of Xpert MTB/RIF Test at Lower Level of Health System in India |
title_full | Feasibility of Decentralised Deployment of Xpert MTB/RIF Test at Lower Level of Health System in India |
title_fullStr | Feasibility of Decentralised Deployment of Xpert MTB/RIF Test at Lower Level of Health System in India |
title_full_unstemmed | Feasibility of Decentralised Deployment of Xpert MTB/RIF Test at Lower Level of Health System in India |
title_short | Feasibility of Decentralised Deployment of Xpert MTB/RIF Test at Lower Level of Health System in India |
title_sort | feasibility of decentralised deployment of xpert mtb/rif test at lower level of health system in india |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3935858/ https://www.ncbi.nlm.nih.gov/pubmed/24586675 http://dx.doi.org/10.1371/journal.pone.0089301 |
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