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

IF 1 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

African Journal of Laboratory Medicine Pub Date : 2021-09-17 eCollection Date: 2021-01-01 DOI:10.4102/ajlm.v10i1.1317

James H 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

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引用次数: 0

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.

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肯尼亚基于血清学的COVID-19护理点侧流分析的预评估

背景:及时检测是2019冠状病毒病(COVID-19)管理结果的关键决定因素。实时逆转录聚合酶链反应检测是目前COVID-19检测的主要方法。然而，血清学即时检测(PoCTs)可用于识别无症状和康复病例，以及群体免疫。目的:本研究的目的是评估肯尼亚的COVID-19 poct，以支持这些检测的紧急使用授权。方法:在2020年3月至2020年5月期间，18家公司(其中13家来自中国)向国家监管机构药房和毒物委员会提交了poct，后者将其转发给肯尼亚医学研究所进行预评估评估。检测采用实时逆转录聚合酶链反应covid -19阳性样本。2019年6月采集的covid -19前血浆样本作为阴性样本。poct的保质期从6到24个月不等。结果:只有9项(50%)检测的敏感性≥40%(范围:40% - 60%)，这些检测检测IgM的能力范围为0% - 50%。许多(7/18;38.9%的试剂盒IgM和IgG条带强度非常弱(范围:2-3)。结论:肯尼亚现有的基于血清学的poct只能在多达60%的感染人群中检测到COVID-19。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

African Journal of Laboratory Medicine MEDICINE, RESEARCH & EXPERIMENTAL-

CiteScore

1.70

自引率

9.10%

发文量

审稿时长

12 weeks

期刊介绍： The African Journal of Laboratory Medicine, the official journal of ASLM, focuses on the role of the laboratory and its professionals in the clinical and public healthcare sectors,and is specifically based on an African frame of reference. Emphasis is on all aspects that promote and contribute to the laboratory medicine practices of Africa. This includes, amongst others: laboratories, biomedical scientists and clinicians, medical community, public health officials and policy makers, laboratory systems and policies (translation of laboratory knowledge, practices and technologies in clinical care), interfaces of laboratory with medical science, laboratory-based epidemiology, laboratory investigations, evidence-based effectiveness in real world (actual) settings.