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Pre-evaluation assessment of serological-based COVID-19 point-of-care lateral flow assays in Kenya
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.
  • Kimotho, James K; Innovation Technology Transfer Division, Medical Research Institute. Nairobi. KE
  • Gosar, Abdiaziz A; Innovation Technology Transfer Division, Kenya Medical Research Institute. Nairobi. KE
  • Inyangala, Ronald; Pharmacy and Poisons Board of Kenya. Nairobi. KE
  • Wairimu, Paulyne; Pharmacy and Poisons Board of Kenya. Nairobi. KE
  • Siyoi, Fred; Pharmacy and Poisons Board of Kenya. Nairobi. KE
  • Matoke-Muhia, Damaris; Centre of Biotechnology Research Development, Kenya Medical Research Institute. Nairobi. KE
  • Wanjala, Cecilia; Innovation Technology Transfer Division, Kenya Medical Research Institute. Nairobi. KE
  • Zablon, Jeremiah; Kenyatta National Hospital. Nairobi. KE
  • Orina, Moses; Innovation Technology Transfer Division, Kenya Medical Research Institute. Nairobi. KE
  • Muita, Lucy; Innovation Technology Transfer Division, Kenya Medical Research Institute. Nairobi. KE
  • Thiga, Jacqueline; Innovation Technology Transfer Division, Kenya Medical Research Institute. Nairobi. KE
  • Nyabuti, Lameck; Innovation Technology Transfer Division, Kenya Medical Research Institute. Nairobi. KE
  • Wainaina, Eunice; Innovation Technology Transfer Division, Kenya Medical Research Institute. Nairobi. KE
  • Mwangi, Joseph; Centre for Virus Research, Kenya Medical Research Institute. Nairobi. KE
  • Mumbi, Alice; Innovation Technology Transfer Division, Kenya Medical Research Institute. Nairobi. KE
  • Omari, Samuel; Innovation Technology Transfer Division, Kenya Medical Research Institute. Nairobi. KE
  • Wanjiru, Ann; Innovation Technology Transfer Division, Kenya Medical Research Institute. Nairobi. KE
  • Nzou, Samson M; Innovation Technology Transfer Division, Kenya Medical Research Institute. Nairobi. KE
  • Ochwoto, Missiani; Innovation Technology Transfer Division, Kenya Medical Research Institute. Nairobi. KE
Afr. j. lab. med. (Online) ; 10(1): 1-6, 2021. Tables, figures
Article in English | AIM | ID: biblio-1291519
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 2019were 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 2­3).

Conclusion:

Serological-based PoCTs available in Kenya can only detect COVID-19 in up to 60% of the infected population.
Subject(s)

Full text: Available Index: AIM (Africa) Main subject: Point-of-Care Testing / COVID-19 Serological Testing Type of study: Diagnostic study Limits: Humans Language: English Journal: Afr. j. lab. med. (Online) Year: 2021 Type: Article Institution/Affiliation country: Centre for Virus Research, Kenya Medical Research Institute/KE / Centre of Biotechnology Research Development, Kenya Medical Research Institute/KE / Innovation Technology Transfer Division, Kenya Medical Research Institute/KE / Innovation Technology Transfer Division, Medical Research Institute/KE / Kenyatta National Hospital/KE / Pharmacy and Poisons Board of Kenya/KE

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Full text: Available Index: AIM (Africa) Main subject: Point-of-Care Testing / COVID-19 Serological Testing Type of study: Diagnostic study Limits: Humans Language: English Journal: Afr. j. lab. med. (Online) Year: 2021 Type: Article Institution/Affiliation country: Centre for Virus Research, Kenya Medical Research Institute/KE / Centre of Biotechnology Research Development, Kenya Medical Research Institute/KE / Innovation Technology Transfer Division, Kenya Medical Research Institute/KE / Innovation Technology Transfer Division, Medical Research Institute/KE / Kenyatta National Hospital/KE / Pharmacy and Poisons Board of Kenya/KE