Nascop reckons that increased demand for the kits has seen a rise in imports of equipment that lack regulatory approval.
Aids self-testing kits that lack government approval have flooded the local market raising the possibility of misdiagnosis.
The National Aids and STIs Control Programme (Nascop) has raised the alarm over the high number of the kits sold in the local market without government approval of safety and efficacy.
Two brands of the kits labelled OraQuick and INSTI are approved for sale in Kenya for about Sh500 in private hospitals.
But Nascop reckons that increased demand for the kits has seen a rise in imports of equipment that lack regulatory approval.
“A wrongly done or interpreted test could lead to false negatives, a case where the tester is infected but gets a result that he is not — or false positives in the opposite situation,” said Mary Mugambi, head of testing at Nascop.
Approval of the kits is done by the Kenya Medical Laboratory Technicians and Technologists Board (KMLTTB).
KMLTTB Chairman Abel Onyango said the kits are illegally imported and sold.
“They are a cause for public health concern since they are likely to give varying results that are not credible, which will only cause panic among those who test,” he said.