Pre-evaluation assessment of serological-based COVID-19 point-of-care lateral flow assays in Kenya
Afr. j. lab. med. (Online)
; 10(1): 1-6, 2021. Tables, figures
Article
en En
| AIM
| ID: biblio-1291519
Biblioteca responsable:
CG1.1
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.Palabras clave
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Banco de datos:
AIM
Asunto principal:
Pruebas en el Punto de Atención
/
Prueba Serológica para COVID-19
Tipo de estudio:
Diagnostic_studies
Límite:
Humans
Idioma:
En
Revista:
Afr. j. lab. med. (Online)
Año:
2021
Tipo del documento:
Article