Ministry orders audit of labs testing coronavirus
Health workers with coronavirus samples for testing from hotel workers in Nyeri. Some labs have been giving conflicting results. PHOTO | JOSEPH KANYI | NATION MEDIA GROUP
What you need to know:
- KMPDC added that testing for Covid-19 by PLK is PCR, which is as recommended by the Ministry of Health, the Centres for Disease Control and the World Health Organization.
- Dr Ahmed Kalebi, who has found himself at the centre of some of the contradictory results, said the Seegen Allplex assay used by Lancet has high sensitivity “and this makes it more accurate in detecting Covid-19”.
The Ministry of Health has ordered an audit of private and public laboratories conducting Covid-19 tests.
In a letter to the Kenya Medical Laboratory Technicians and Technologists Board (KMLTTB), Health Ministry Acting Director-General Patrick Amoth said 30 laboratories have to be audited following conflicting coronavirus test results.
KMLTTB is mandated to license technicians and regulate the conduct of laboratory functions. It is against the law for unlicensed personnel to test clinical samples.
Dr Amoth said the board ought to assess the compliance of laboratories with standards for Covid-19, and determine how their kits got into the market, among other parameters. He said a report on the audit should be released no later than July 28.
PRIVATE LAB
The issue has taken centre stage after some laboratories issued same patients with contradictory Covid-19 results.
Despite the many discrepancies, the ministry ordered an investigation on just one laboratory.
Pathologists Lancet Kenya (PLK), the only private lab among those in government and top private hospitals conducting the Covid-19 tests, was however allowed to continue with sample testing after a recent investigation by the Kenya Medical Practitioners and Dentists Council (KMPDC).
“Testing...by Lancet Laboratories meets quality requirements expected, including having qualified and duly licensed personnel, validated and approved kits and the handling and carrying out of external quality assurance,” the council said in its report.
COVID TESTING
KMPDC added that testing for Covid-19 by PLK is PCR, which is as recommended by the Ministry of Health, the Centres for Disease Control (CDC) and the World Health Organization (WHO).
“Lancet tests for three SARS-CoV-2 (the coronavirus that causes Covid-19) genes whereas other labs could be testing for two genes, thereby creating possible discordant results,” the council said.
Dr Ahmed Kalebi, who has found himself at the centre of some of the contradictory results, said the Seegen Allplex assay used by Lancet has high sensitivity “and this makes it more accurate in detecting Covid-19”.
“An evaluation by WHO confirms that Seegen Allplex has superior sensitivity and documented instances of Covid-19 positive cases on the assay which other kits fail to detect,” he said.
