Fred Ezeh, Abuja
Medical Laboratory Science Council of Nigeria (MLSCN), has confirmed that none of the Rapid Diagnostic Test (RDT) kits submitted by some vendors for validation and approval for COVID-19 test passed its validation test.
The Council, at a press conference in Abuja, disclosed that 11 In-vitro diagnostics, one Polymerase Chain Reaction (PCR) based kit, nine RDT kits (2 antigen based and 7 antibody based kits) and one viral transport medium, were received for validation at the MLSCN public health In-vitro diagnostic control laboratory, Yaba, Lagos.
It, however, said that, out of the seven antibody based RDT kits submitted for validation, only four met validation inclusion criteria, while the validation for the PCR based kits and antigen based RDT kits are ongoing.
The Council explained that, for a RDT kit to be deployed for disease surveillance and diagnosis, it must be able to detect a disease causing agent when presented and to return a negative result if the causative agent is absent.
Additionally, it must possess good sensitivity measures that will enable it detect the presence of the disease, and must, equally, have good specificty measures so that no interfering substances can lead to a false positive instead of negative results in the absence of the etiological agent of the disease.
MLSCN Registrar, Dr. Tosan Erhabor, who spoke at the press conference, explained that the objective of the validation exercise was to determine the sensitivity and specificity of the kits, its accuracy, and the inter-reader variability of the test results of the kits using the real-time Polymerase Chain Reaction (PCR) method as reference standard for detection of COVID-19.
He explained: “After thorough and careful validation exercise that was done with regards to global best practices, none of the four products met 95 percent generally acceptable minimum standard to stand a chance of deployment for COVID-19 testing.
“Therefore, none of the four RDT kits validated were approved for the purposes of diagnosis and surveillance of COVID-19 infection, neither were they approved for marketing in Nigeria.
“Nigerians are strongly discouraged from the use of any non-validated RDT kits for COVID-19 testing in Nigeria as it will attract sanctions in accordance with the law,” he said.
Meanwhile, the MLSCN boss has asked private medical laboratories seeking to provide COVID-19 testing through private arrangement to acquaint themselves with the revised guidelines for such operations to avoid severe sanctions from the Council.
He promised that the Nigeria Centre for Disease Control (NCDC) and its partners would continue to support the provision of reagents and consumables so that testing is conducted at no cost to the patient.