Original Research

Pre-evaluation assessment of serological-based COVID-19 point-of-care lateral flow assays in Kenya

James K. Kimotho, Abdiaziz A. Gosar, Ronald Inyangala, Paulyne Wairimu, Fred Siyoi, Damaris Matoke-Muhia, Cecilia Wanjala, Jeremiah Zablon, Moses Orina, Lucy Muita, Jacqueline Thiga, Lameck Nyabuti, Eunice Wainaina, Joseph Mwangi, Alice Mumbi, Samuel Omari, Ann Wanjiru, Samson M. Nzou, Missiani Ochwoto
African Journal of Laboratory Medicine | Vol 10, No 1 | a1317 | DOI: https://doi.org/10.4102/ajlm.v10i1.1317 | © 2021 paulyne Wairimu | This work is licensed under CC Attribution 4.0
Submitted: 25 June 2020 | Published: 17 September 2021

About the author(s)

James K. Kimotho, Innovation Technology Transfer Division, Kenya Medical Research Institute, Nairobi, Kenya
Abdiaziz A. Gosar, Innovation Technology Transfer Division, Kenya Medical Research Institute, Nairobi, Kenya
Ronald Inyangala, Pharmacy and Poisons Board of Kenya, Nairobi, Kenya
Paulyne Wairimu, Pharmacy and Poisons Board of Kenya, Nairobi, Kenya
Fred Siyoi, Pharmacy and Poisons Board of Kenya, Nairobi, Kenya
Damaris Matoke-Muhia, Centre of Biotechnology Research Development, Kenya Medical Research Institute, Nairobi, Kenya
Cecilia Wanjala, Innovation Technology Transfer Division, Kenya Medical Research Institute, Nairobi, Kenya
Jeremiah Zablon, Kenyatta National Hospital, Nairobi, Kenya
Moses Orina, Innovation Technology Transfer Division, Kenya Medical Research Institute, Nairobi, Kenya
Lucy Muita, Innovation Technology Transfer Division, Kenya Medical Research Institute, Nairobi, Kenya
Jacqueline Thiga, Innovation Technology Transfer Division, Kenya Medical Research Institute, Nairobi, Kenya
Lameck Nyabuti, Innovation Technology Transfer Division, Kenya Medical Research Institute, Nairobi, Kenya
Eunice Wainaina, Innovation Technology Transfer Division, Kenya Medical Research Institute, Nairobi, Kenya
Joseph Mwangi, Centre for Virus Research, Kenya Medical Research Institute, Nairobi, Kenya
Alice Mumbi, Innovation Technology Transfer Division, Kenya Medical Research Institute, Nairobi, Kenya
Samuel Omari, Innovation Technology Transfer Division, Kenya Medical Research Institute, Nairobi, Kenya
Ann Wanjiru, Innovation Technology Transfer Division, Kenya Medical Research Institute, Nairobi, Kenya
Samson M. Nzou, Innovation Technology Transfer Division, Kenya Medical Research Institute, Nairobi, Kenya
Missiani Ochwoto, Innovation Technology Transfer Division, Kenya Medical Research Institute, Nairobi, Kenya

Abstract

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.


Keywords

COVID-19; point-of-care; IgM; IgG; sensitivity; specificity; SARS-CoV-2

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