Lancet Kenya is once again on the spot over discordant Covid-19 results of 17 teaching staff of St Andrew’s School Turi, who tested positive and negative three days later.
Some 24 samples were picked from the institution and taken to Lancet for testing.
However, when the school sought a second opinion and the samples taken to the Kenya Medical Research Institute (Kemri), the 17 turned negative, according to the results the institution received yesterday.
This questions the authenticity of some tests being conducted in the country and if Kenyans should continue trusting them.
This is not the first time that the laboratory is issuing Covid-19 results that contradict other testing institutions.
The laboratory was early in the month under scrutiny following claims by a number of Kenyans that results of the Sars-CoV-2 tests it carried out were not credible.
In the past two weeks, the laboratory has been investigated and inspections carried out by several government agencies, including the National Covid-19 Command Centre.
Two women received two sets of results from different labs with one (Lancet) showing they had coronavirus while repeat tests at Nairobi Hospital indicated they were negative.
On July 7, the Kemri and Lancet Laboratory Mombasa gave contradicting Covid-19 results for the same samples.
On June 8, Khalid Nafula Mwanaidi’s sample was taken by the lab in Mombasa and the results came back as positive on June 15.
Kemri did the a test on the same Kenyan and she was declared Covid-free.
So which results should be trusted?
If the laboratories were certified by the government, why are they producing different Covid-19 results?
An email by the school management to the staff after receiving the Kemri results says operations will remain as they were.
“Dear team, further to the tests by the Public health team, results have come back…negative. The school will run as normal. The common areas that were closed are now open,” the email to the staff seen by the Nation says.
The management also indicated that work should resume and those in self-isolation will have to continue as per the doctor’s instructions.
“The teaching staff were to fly to the United Kingdom on Thursday but had to cancel the flight when the Lancet results were released. It is embarrassing. One wonders what Lancet is up to,” one of the teachers told the Nation.
Lancet is also being investigated for “misdiagnosing” Kiambu MP Jude Njomo’s mother.
The family hurriedly buried its matriarch after being told she died of Covid-19.
A repeat of the test at Nairobi Hospital returned negative results, prompting the lawmaker to ask the Ministry of Health to investigate the contradicting results.
The samples were taken a day after the Lancet results.
“I wonder how many Kenyans have been given wrong results. How many Kenyans are in quarantine because of wrong results? How many labs are this careless?” Mr Njomo asked.
‘SENSITIVE AND SPECIFIC’
Lancet’s East Africa CEO Ahmed Kalebi, however, insists that the Sars-CoV-2 PCR tests done at a cost of Sh8,849 are 100 percent sensitive and specific.
In a Facebook post, Dr Kalebi said the incident of disparities was not unique and that the facility has been audited by three government institutions.
These controversies have since seen him appear before the Senate Health Committee to answer to queries.
“We do appreciate the concerns raised by such discordance in results, which we’ve tried to explain scientifically through newsletters to our esteemed clients, medical colleagues taking care of them and the general public. We’ve also shared independent research studies and evaluations which have demonstrated that positive test results from the Seegene Allplex assay (similar to the one used at PLK) can be missed by other assays (such as those used by various labs in Kenya) and this is particularly so for cases that have low viral loads,” he said.
Dr Kalebi, however, insisted that after an extensive review and audit of the results, they were found to be accurate and thus “no false-positive reporting from us.”
The disparities between test results for Covid-19, he added, can arise due to differences in the concentration of material in the sample tested, the sensitivity of the assays used as well as the technical quality processes in the laboratory.
“We conduct quality control checks on all our tests and have also undertaken international external quality assurance (EQA) for Covid-19 to verify the accuracy of our testing,” he added.
“Considering the high sensitivity and the specificity of the assay we use that has been confirmed at 100 percent clinical sensitivity and 100 percent clinical specificity, it is not surprising that cases of detected viral RNA at our lab end up being called negative with other assays particularly for those with low viral loads representing late stages of infection that other labs can miss,” added Dr Kalebi.