Blood testing is a routine medical practice all over the world. However, increased cases of misdiagnosis have raised fears about the reliability and safety of test kits in the country.
While health experts say only safe blood gives healthy results, sub-standard and faulty screening kits currently in use in the country pose a major risk for patients and practitioners.
The rising number of misdiagnoses indicates that there are still test kits in the market that flout Government regulations and standards.
Investigations by The Standard reveal that the Kenya Medical Laboratory Technicians and Technologists Board (KMLTTB), charged with regulating medical screening kits in the country, is often overlooked or defied by some companies that push sub-standard or non-validated products into the market.
The board is authorised to screen, validate, certify and register products used in medical laboratories. But this role has since been overshadowed by other bodies.
Test kits used by the Kenya National Blood Transfusion Service (KNBTS), for example, are evaluated by the National Aids and STIs Control Programme (Nascop), yet the body that was established in 1987 is only supposed to spearhead the Ministry of Health's interventions in the fight against HIV and Aids.
Not evaluated
Although Nascop is located next to the Division of National Public Health Laboratory Services, the kits were not evaluated by the lab. But KNBTS Director Margaret Oduor argues that the kits were in the market before KMLTTB was given the mandate to evaluate and issue certificates.
"Ideally, there should not be an issue because the two bodies are not autonomous and both operate under the same ministry," she says.
Speaking to The Standard, the local representative of Anjiwa Company Ltd, distributors of OraQuick Jilani Yawa, an oral swab HIV testing kit that does not require blood samples, also admitted to not having a certificate yet the product is sold in various chemists.
Abel Onyango, the KMLTTB chairman, says the test performance of an imported disease testing kit may be influenced by various factors — human, environmental, temperature, humidity and burden of disease or prevalence in a particular setting
"The kits need to be checked and to ensure that they do not cause any problems to the user. We also make sure that the kits do what distributors allege lest we end up with cases of misdiagnosis," he says.