In vitro assessment and comparison of quality of alcohol-based hand rubs, pre- and peri-COVID-19 pandemic outbreak in Kenya.

Background: In the wake of the coronavirus disease 2019 (COVID-19) pandemic, the World Health Organization recommended the use of alcohol-based hand rubs (ABHRs) to curb transmission, leading to increased production and use. This has posed a danger of production and use of poor-quality ABHRs. Methods: This study assessed and compared the quality of ABHRs in the Kenyan market that were produced before and after the outbreak of the COVID-19 pandemic in March 2020. Quality testing was carried out against European EN 1500:2013 and Kenyan EAS 789:2013 Standards and 20 samples analyzed for alcohol content by GC-FID. Results: The study found that 27.8% of the peri-COVID-19 pandemic sanitizers had less than 90% bactericidal reduction activity as compared to 12.5% manufactured pre-COVID-19 pandemic. Only 25% peri-COVID-19 pandemic ABHRs met the EAS 789:2013 acceptable limit of over 60% alcohol content. Product adulteration with methanol was found in 20 % of the samples with only 5% complying with FDA approval limit of <0.063% v/v methanol. Study found no correlation between the total alcohol content and the efficacy of ABHRs. Conclusions: The study found that more substandard products were produced during the pandemic. This raises a concern about possible emergence of alcohol resistant strains of microorganisms. The study therefore recommends an adequate quality monitoring system to curb against substandard products.

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

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.

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

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.