The Medical Laboratory Science Council of Nigeria (MLSCN), has insisted that all indigenously-developed COVID-19 test kits should be submitted for validation in order to support standardization and promote reliable and accurate test results.
The Registrar of MLSCN, Dr. Tosan Erhabor, stated this at a media briefing on the outcome of the second batch of Pre-Market Validation of COVID-19 test kits recently carried out by the agency in Abuja, on Tuesday.
The MLSCN also recommended the establishment and institutional participation in External Quality Assessment programme for COVID-19 testing in Nigeria.
It would be recalled that following the outbreak of the COVID–19 pandemic, the MLSCN commenced the process of Validating Test Kits in Nigeria for detecting SARS-CoV-2 infection.
While presenting the report of the findings, the Dr. Erhabor noted that MLSCN received a total of 43 brands of test kits for validation.
The goal, according to him, was to determine the laboratory performance characteristics of Rapid/PCR Test Kits.
The Registrar noted that a total of 33 test kits and systems were validated, but expressed concerned that all the antigen and antibody test kits, rapid or otherwise, failed to meet the minimum acceptable criteria.
He further disclosed that the 22 rapid Test kits being reported had not met the expected performance characteristics of sensitivity and specificity to qualify them for deployment for the purposes of testing in disease surveillance and routine diagnosis.
“Non-rapid antibody detection test kits had sensitivities and specificities below the acceptable minimum of 95% and are, therefore, unsuitable for use as IVDs in Nigeria,” he stressed.
However, he said, the PCR test kits evaluated had a relatively better performance than the antigen and antibody detection test kits.
The Registrar, therefore, insisted that, for diagnosis, none of the antigen or antibody detection test kits is recommended for SARS-CoV-2 infection testing in Nigeria.
“No SARS-CoV-2 Rapid Test kit is currently approved for use in Nigeria, therefore, MLSCN cautions against the use of any non-validated Rapid / PCR Test Kits for COVID-19 testing as this will attract sanctions in accordance with the law,” he stressed.
He, however, explained that for a rapid test kit to be deployed for disease surveillance and diagnosis, it must be able to detect a disease-causing agent when it is present and to return a negative result if the causative agent is absent. “Therefore, for a kit to be considered reliable for laboratory diagnosis and disease surveillance, the kit should have a high sensitivity and specificity.
“A kit performing very well in one of these characteristics without the other renders it unsuitable for diagnostic testing,” he further explained.
The MLSCN boss assured that: “The validation of other Rapid / PCR Test Kits for SARS-CoV-2 Infection remains an ongoing process, as Nigerians will be informed when suitable test kits meet minimum validation requirements.”
He also charged both local and other manufacturers to improve on the standardization of their products so as to meet the minimum validation requirements to guarantee reliable, accurate, and timely test results.
“Importantly too, MLSCN will work closely with NCDC to ensure that the 2 WHO pre-qualified Antigen Rapid Test Kits go through validation as soon as they arrive the country.
“This will enable the country to expand the scope of access to quality COVID-19 testing as more sectors of the economy open,” the Registrar stressed.
MLSCN, however, assured the Federal and State Ministries of Health and the government of Nigeria of its commitment to ensuring quality healthcare delivery as envisioned in its statutory mandate.