Covid 19 antibody tests in Kenya of low quality – regulator confirms

Covid 19 antibody tests available in Kenya are only able to detect up to 60 percent of infected persons, says local regulators.

Now government regulators want these test be limited to research work only. Elsewhere some antibody kits have been able to detect up to 90 per cent of infections.

An evaluation of 18 tests presented for evaluation, 13 of them from China, shows only nine (see chart) had effectiveness of more than 40 percent.

“The ability of these tests to detect Covid 19 antibodies ranged from zero percent to 50 percent. Most of the kits showed very weak performance,” says an evaluation report.

Some of these tests had already received emergency use authorisation and are available commercially. However the evaluation says their use should now be limited to research work only.

The evaluation is done by the Kenya Medical Research Institute (Kemri), Pharmacy and Poisons Board and Kenyatta National Hospital, all government agencies.

Despite the poor show, tests with over 50 per cent effectiveness have been approved for local use, says the report published last week (17th September 2021) in the African Journal of Laboratory Medicine.

“Serological-based PoCTs available in Kenya can only detect COVID-19 in up to 60 percent of the infected population,” concludes the evaluation led by James Kimotho of Kemri.

Currently PCR or polymerase chain reaction is the gold standard for Covid 19 diagnosis, but the team says it is expensive and time taking and not readily available due to global demand.

On the other hand serological-based point-of-care tests (PoCTs) that take 5–15 min to complete can effectively pick up asymptomatic or recovered cases of Covid 19.

This, the evaluators say make them suitable to support disease surveillance and the determination of herd immunity.

Thirteen, 72.2 per cent of the kits analysed were manufactured in China, two in Korea and one each in Canada, US and Malaysia.

One kit which failed in this evaluation was from the same Chinese manufacturer whose kits had failed in India last year.

“It is noteworthy that one kit, which failed in this study, is from the same company that made the kits that failed in India,” says the study.

The study shows 50 percent of the kits did not meet the criteria to proceed to full evaluation as they were unsatisfactory.

Of the 18 kits, one had no activity at all, two antibody detecting tests had both low sensitivity and low specificity, and three tests displayed high false-positive values.

Due to the poor show, the team recommends limited use of the evaluated kits in the country. “The kits assessed in this pre-evaluation should be limited to use in research and sero-surveillance only.”

Otherwise their use, the authors say can affect timely detection of Ccovid-19 early infection and spread of the virus.

 

By Gatonye Gathura

The report is available here: https://doi.org/10.4102/ajlm.v10i1.1317

About Gatonye Gathura 142 Articles
Science Journalist

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