Feasibility of Decentralised Deployment of Xpert MTB/RIF Test at Lower Level of Health System in India

التفاصيل البيبلوغرافية
العنوان: Feasibility of Decentralised Deployment of Xpert MTB/RIF Test at Lower Level of Health System in India
المؤلفون: Kuldeep Singh Sachdeva, Umesh Alavadi, Radhey Shyam Gupta, Achuthan Sreenivas, Rahul Thakur, Christen Gray, Shubhangi Kulsange, Ameet Babre, Malik Parmar, Catharina Boehme, Ranjani Ramachandran, Chinnambedu Nainarappan Paramsivan, Mayank Ghedia, Puneet Dewan, Neeraj Raizada, Bhavin Vadera, Balasangameshwara Hanumanthappa Vollepore
المصدر: PLoS ONE
PLoS ONE, Vol 9, Iss 2, p e89301 (2014)
بيانات النشر: Public Library of Science (PLoS), 2014.
سنة النشر: 2014
مصطلحات موضوعية: Bacterial Diseases, Health Screening, medicine.medical_specialty, Non-Clinical Medicine, Test failure, Science, Sample processing, India, Rifampicin resistance, Global Health, Health Services Accessibility, Key quality indicators, Diagnostic Medicine, Nucleic Acids, Tuberculosis, Multidrug-Resistant, Humans, Tuberculosis, Medicine, Health Care Quality, Multidisciplinary, GeneXpert MTB/RIF, business.industry, Drug resistant tuberculosis, Tropical Diseases (Non-Neglected), Failure rate, Mycobacterium tuberculosis, Test (assessment), Surgery, Infectious Diseases, Emergency medicine, Feasibility Studies, Public Health, Rifampin, business, Delivery of Health Care, Research Article, Test Evaluation
الوصف: BackgroundXpert 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.MethodsAs 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.ResultsFrom 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.ConclusionInstallation 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.
تدمد: 1932-6203
URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::509cb5d7159d33e04dcb8dcec9941baa
https://doi.org/10.1371/journal.pone.0089301
حقوق: OPEN
رقم الأكسشن: edsair.doi.dedup.....509cb5d7159d33e04dcb8dcec9941baa
قاعدة البيانات: OpenAIRE