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

James H Kimotho,Samson M Nzou,Alice Mumbi,Cecilia Wanjala,Missiani Ochwoto,Jacqueline Thiga,Eunice Wainaina,Jeremiah Zablon,Ronald Inyangala,Damaris Matoke-Muhia,Ann Wanjiru,Lucy Muita,Abdiaziz A Gosar,Lameck Nyabuti,Fred Siyoi,Moses Orina,Paulyne Wairimu,Samuel Omari,Joseph Mwangi

doi:10.4102/ajlm.v10i1.1317

Abstract

BackgroundTimely 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.ObjectiveThe aim of this study was to assess COVID-19 PoCTs in Kenya to support the emergency use authorisation of these tests.MethodsBetween 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.ResultsOnly 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).ConclusionSerological-based PoCTs available in Kenya can only detect COVID-19 in up to 60% of the infected population.

Highlights

The world is grappling with one of the worst disease pandemics ever experienced in over 100 years, the coronavirus disease 2019 (COVID-19)
The tests were run with real-time reverse transcription polymerase chain reaction COVID-19-positive samples
Only nine (50%) tests had sensitivities ≥ 40% and the ability of these tests to detect immunoglobin M (IgM) ranged from 0% to 50%

Summary

Introduction

The world is grappling with one of the worst disease pandemics ever experienced in over 100 years, the coronavirus disease 2019 (COVID-19). In Kenya, the number of reported cases as of 06 June 2020 was 2600 with 83 deaths.[1] Real-time reverse transcription polymerase chain reaction (rRT-PCR) is currently the gold standard for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) diagnosis as it is highly sensitive and relatively easy to develop.[2] rRT-PCR test protocols are complex, expensive, mainly suited to advanced laboratories, and typically take 4–6 h to complete These tests are manufactured by predominantly European and American companies that have adopted a ‘me first’ policy due to the high numbers of COVID-19-related deaths in their own countries, thereby successfully eliminating the chances of these test kits flowing to Africa and Kenya in quantities sufficient for use.[3,4] On the other hand, serological-based point-of-care tests (PoCTs) that take 5–15 min to complete can pick up asymptomatic or recovered cases of COVID-19, making them suitable to support disease surveillance and the determination of herd immunity.[5] these PoCTs have low overall sensitivities (34% – 80%) and specificities (70% – 100%) compared to COVID-19 rRT-PCR as the gold standard.[6]. Serological point-of-care tests (PoCTs) can be useful in identifying asymptomatic and recovered cases, as well as herd immunity

Methods

Results

Conclusion