Keep the quality high: the benefits of lot testing for the quality control of malaria rapid diagnostic tests
Abstract Background The production and use of malaria rapid diagnostic tests (RDTs) has risen dramatically over the past 20 years. In view of weak or non-existing in vitro diagnostics (IVD) regulations and post-marketing surveillance (PMS) systems in malaria endemic countries, the World Health Organ...
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ftdoajarticles:oai:doaj.org/article:687b96f8420644d4b9ca2ae25042f7ef 2023-05-15T15:18:18+02:00 Keep the quality high: the benefits of lot testing for the quality control of malaria rapid diagnostic tests Sandra Incardona David Bell Ana Campillo Jane Cunningham Frederic Ariey Thierry Fandeur Jennifer Luchavez Christian Anthony Luna Didier Ménard Sina Nhem Johanna Beulah Sornillo Benoit Witkowski Zachary Katz Sabine Dittrich Xavier C. Ding 2020-07-01T00:00:00Z https://doi.org/10.1186/s12936-020-03324-3 https://doaj.org/article/687b96f8420644d4b9ca2ae25042f7ef EN eng BMC http://link.springer.com/article/10.1186/s12936-020-03324-3 https://doaj.org/toc/1475-2875 doi:10.1186/s12936-020-03324-3 1475-2875 https://doaj.org/article/687b96f8420644d4b9ca2ae25042f7ef Malaria Journal, Vol 19, Iss 1, Pp 1-7 (2020) Malaria Diagnostics Rapid diagnostic test Lot testing Quality control Post-market surveillance Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 article 2020 ftdoajarticles https://doi.org/10.1186/s12936-020-03324-3 2022-12-31T11:37:11Z Abstract Background The production and use of malaria rapid diagnostic tests (RDTs) has risen dramatically over the past 20 years. In view of weak or non-existing in vitro diagnostics (IVD) regulations and post-marketing surveillance (PMS) systems in malaria endemic countries, the World Health Organization, later joined by the Foundation for Innovative New Diagnostics, established an independent, centralized performance evaluation and Lot Testing (LT) programme to safeguard against poor quality of RDTs being distributed through the public health sector of malaria endemic countries. RDT performances and manufacturer quality management systems have evolved over the past decade raising questions about the future need for a centralized LT programme. Results Between 2007 and 2017, 6056 lots have been evaluated, representing approximately 1.6 Billion RDTs. A total of 69 lots (1.1%) failed the quality control. Of these failures, 26 were detected at receipt of the RDT lot in the LT laboratory, representing an estimated 7.9 million poor quality RDTs, and LT requesters were advised that RDTs were not of sufficient quality for use in patient management. Forty-three were detected after long-term storage in the laboratory, of which 24 (56%) were found to be due to a major issue with insufficient buffer volume in single use buffer vials, others predominantly showing loss of sensitivity. The annual cost of running the programme, based on expenses recorded in years 2014–2016, an estimated volume of 700 lots per year and including replenishment of quality control samples, was estimated at US$ 178,500 ($US 255 per lot tested). Conclusions Despite the clear benefits of the centralized LT programme and its low cost compared with the potential costs of each country establishing its own PMS system for RDTs, funding concerns have made its future beyond 2020 uncertain. In order to manage the risks of misdiagnosis due to low quality RDTs, and to ensure the continued safety and reliability of malaria case management, there is a need to ... Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic Malaria Journal 19 1 |
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Open Polar |
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Directory of Open Access Journals: DOAJ Articles |
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ftdoajarticles |
language |
English |
topic |
Malaria Diagnostics Rapid diagnostic test Lot testing Quality control Post-market surveillance Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 |
spellingShingle |
Malaria Diagnostics Rapid diagnostic test Lot testing Quality control Post-market surveillance Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 Sandra Incardona David Bell Ana Campillo Jane Cunningham Frederic Ariey Thierry Fandeur Jennifer Luchavez Christian Anthony Luna Didier Ménard Sina Nhem Johanna Beulah Sornillo Benoit Witkowski Zachary Katz Sabine Dittrich Xavier C. Ding Keep the quality high: the benefits of lot testing for the quality control of malaria rapid diagnostic tests |
topic_facet |
Malaria Diagnostics Rapid diagnostic test Lot testing Quality control Post-market surveillance Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 |
description |
Abstract Background The production and use of malaria rapid diagnostic tests (RDTs) has risen dramatically over the past 20 years. In view of weak or non-existing in vitro diagnostics (IVD) regulations and post-marketing surveillance (PMS) systems in malaria endemic countries, the World Health Organization, later joined by the Foundation for Innovative New Diagnostics, established an independent, centralized performance evaluation and Lot Testing (LT) programme to safeguard against poor quality of RDTs being distributed through the public health sector of malaria endemic countries. RDT performances and manufacturer quality management systems have evolved over the past decade raising questions about the future need for a centralized LT programme. Results Between 2007 and 2017, 6056 lots have been evaluated, representing approximately 1.6 Billion RDTs. A total of 69 lots (1.1%) failed the quality control. Of these failures, 26 were detected at receipt of the RDT lot in the LT laboratory, representing an estimated 7.9 million poor quality RDTs, and LT requesters were advised that RDTs were not of sufficient quality for use in patient management. Forty-three were detected after long-term storage in the laboratory, of which 24 (56%) were found to be due to a major issue with insufficient buffer volume in single use buffer vials, others predominantly showing loss of sensitivity. The annual cost of running the programme, based on expenses recorded in years 2014–2016, an estimated volume of 700 lots per year and including replenishment of quality control samples, was estimated at US$ 178,500 ($US 255 per lot tested). Conclusions Despite the clear benefits of the centralized LT programme and its low cost compared with the potential costs of each country establishing its own PMS system for RDTs, funding concerns have made its future beyond 2020 uncertain. In order to manage the risks of misdiagnosis due to low quality RDTs, and to ensure the continued safety and reliability of malaria case management, there is a need to ... |
format |
Article in Journal/Newspaper |
author |
Sandra Incardona David Bell Ana Campillo Jane Cunningham Frederic Ariey Thierry Fandeur Jennifer Luchavez Christian Anthony Luna Didier Ménard Sina Nhem Johanna Beulah Sornillo Benoit Witkowski Zachary Katz Sabine Dittrich Xavier C. Ding |
author_facet |
Sandra Incardona David Bell Ana Campillo Jane Cunningham Frederic Ariey Thierry Fandeur Jennifer Luchavez Christian Anthony Luna Didier Ménard Sina Nhem Johanna Beulah Sornillo Benoit Witkowski Zachary Katz Sabine Dittrich Xavier C. Ding |
author_sort |
Sandra Incardona |
title |
Keep the quality high: the benefits of lot testing for the quality control of malaria rapid diagnostic tests |
title_short |
Keep the quality high: the benefits of lot testing for the quality control of malaria rapid diagnostic tests |
title_full |
Keep the quality high: the benefits of lot testing for the quality control of malaria rapid diagnostic tests |
title_fullStr |
Keep the quality high: the benefits of lot testing for the quality control of malaria rapid diagnostic tests |
title_full_unstemmed |
Keep the quality high: the benefits of lot testing for the quality control of malaria rapid diagnostic tests |
title_sort |
keep the quality high: the benefits of lot testing for the quality control of malaria rapid diagnostic tests |
publisher |
BMC |
publishDate |
2020 |
url |
https://doi.org/10.1186/s12936-020-03324-3 https://doaj.org/article/687b96f8420644d4b9ca2ae25042f7ef |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
Malaria Journal, Vol 19, Iss 1, Pp 1-7 (2020) |
op_relation |
http://link.springer.com/article/10.1186/s12936-020-03324-3 https://doaj.org/toc/1475-2875 doi:10.1186/s12936-020-03324-3 1475-2875 https://doaj.org/article/687b96f8420644d4b9ca2ae25042f7ef |
op_doi |
https://doi.org/10.1186/s12936-020-03324-3 |
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Malaria Journal |
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19 |
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1 |
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1766348503577001984 |