Pre-evaluation assessment of serological-based COVID-19 point-of-care lateral flow assays in Kenya
African Journal of Laboratory Medicine
| Field | Value | |
| Title | Pre-evaluation assessment of serological-based COVID-19 point-of-care lateral flow assays in Kenya | |
| Creator | Kimotho, James K. Gosar, Abdiaziz A. Inyangala, Ronald Wairimu, Paulyne Siyoi, Fred Matoke-Muhia, Damaris Wanjala, Cecilia Zablon, Jeremiah Orina, Moses Muita, Lucy Thiga, Jacqueline Nyabuti, Lameck Wainaina, Eunice Mwangi, Joseph Mumbi, Alice Omari, Samuel Wanjiru, Ann Nzou, Samson M. Ochwoto, Missiani | |
| Description | Background: Timely testing is a key determinant of management outcomes of coronavirus disease 2019 (COVID-19). Real-time reverse transcription polymerase chain reaction tests are currently the mainstay for COVID-19 testing. However, serological point-of-care tests (PoCTs) can be useful in identifying asymptomatic and recovered cases, as well as herd immunity.Objective: The aim of this study was to assess COVID-19 PoCTs in Kenya to support the emergency use authorisation of these tests.Methods: Between March 2020 and May 2020, 18 firms, of which 13 were from China, submitted their PoCTs to the national regulatory authority, the Pharmacy and Poison Board, who in turn forwarded them to the Kenya Medical Research Institute for pre-evaluation assessment. The tests were run with real-time reverse transcription polymerase chain reaction COVID-19-positive samples. Pre-COVID-19 plasma samples that were collected in June 2019 were used as negative samples. The shelf lives of the PoCTs ranged from 6 to 24 months.Results: Only nine (50%) tests had sensitivities ≥ 40% (range: 40% – 60%) and the ability of these tests to detect IgM ranged from 0% to 50%. Many (7/18; 38.9%) of the kits had very weak IgM and IgG band intensities (range: 2–3).Conclusion: Serological-based PoCTs available in Kenya can only detect COVID-19 in up to 60% of the infected population. | |
| Publisher | AOSIS | |
| Date | 2021-09-17 | |
| Identifier | 10.4102/ajlm.v10i1.1317 | |
| Source | African Journal of Laboratory Medicine; Vol 10, No 1 (2021); 6 pages 2225-2010 2225-2002 | |
| Language | eng | |
| Relation |
The following web links (URLs) may trigger a file download or direct you to an alternative webpage to gain access to a publication file format of the published article:
https://ajlmonline.org/index.php/ajlm/article/view/1317/2035
https://ajlmonline.org/index.php/ajlm/article/view/1317/2036
https://ajlmonline.org/index.php/ajlm/article/view/1317/2037
https://ajlmonline.org/index.php/ajlm/article/view/1317/2038
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