The development and implementation of a proficiency testing program for SARS-CoV-2 using dried tube specimens in resource-limited countries

Autor: Pius Lutaaya, Ocung Guido, Hasifah Nakato Ssentamu, George William Kasule, Mary Akumu, Jupiter Marina Kabahita, Bernard Bagaya, Kenneth Musisi, Denis Oola, Anitah Katuramu, Andrew Nsawotebba, Edgar Kigozi, Faith Nakazzi, Joel Kabugo Solomon, Isa Adam, Orena Beatrice, Joanita Namutebi, Brenda Ayebare, Abdunoor Nyombi, Charles Manyonge, Ademun Julius Patrick, Kangave Fredrick, Moses L Joloba
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: BMC Infectious Diseases, Vol 24, Iss 1, Pp 1-8 (2024)
Druh dokumentu: article
ISSN: 1471-2334
DOI: 10.1186/s12879-024-09555-y
Popis: Abstract Introduction When COVID-19 hit the world in 2019, an enhanced focus on diagnostic testing for SARS-CoV-2 was essential for a successful pandemic response. Testing laboratories stretched their capabilities for the new coronavirus by adopting different test methods. The necessity of having external quality assurance (EQA) mechanisms was even more critical due to this rapid expansion. However, there was a lack of experience in providing the necessary SARS-CoV-2 EQA materials, especially in locations with constrained resources. Objective We aimed to create a PT (Proficiency testing) programme based on the Dried Tube Specimens (DTS) method that would be a practical option for molecular based SARS-CoV-2 EQA in Low- and Middle-Income Countries. Methods Based on previous ISO/IEC 17043:2010 accreditation experiences and with assistance from the US Centers for Disease Control and Prevention, The Supranational Reference Laboratory of Uganda (adapted the DTS sample preparation method and completed a pilot EQA program between 2020 and 2021. Stability and panel validation testing was conducted on the designed materials before shipping to pilot participants in six African countries. Participants received a panel containing five SARS-CoV-2 DTS samples, transported at ambient conditions. Results submitted by participants were compared to validation results. Participants were graded as satisfactory (≥ 80%) or unsatisfactory (
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