BY PATIENCE IVIE IHEJIRIKA,
The Medical Laboratory Science Council of Nigeria (MLSCN), has said that no Rapid Test Kit for SARS-CoV-2 infection (COVID 19) is currently approved for use in Nigeria.
He also said that no antigen or antibody detection test kits was recommended for SARS-CoV-2 infection testing in Nigeria.
MLSCN Registrar, Tosan Erhabor, disclosed this at a press briefing on the report of the second batch pre-market validation of SARS-CoV-2 infection (COVID-19) test kits, yesterday in Abuja.
Erhabor, while noting that MLSCN regulates the Production, Importation, Sales and Stocking of Diagnostic Reagents, Equipment and Chemicals (Act 11 of 2003), added that, following the outbreak of the COVID–19 pandemic, the agency commenced the process of Validating Test Kits in the country for detecting SARS-CoV-2 infection.
According to him, MLSCN received a total of 43 brands of test kits for validation. The goal 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 regret that all the antigen and antibody test kits, rapid or otherwise, failed to meet the minimum acceptable criteria.
He, however, said that for a rapid test kit to be deployed for disease surveillance and diagnosis, Erhabor noted, 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 said.
Erhabor noted 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. Similarly, he noted that “Non-rapid antibody detection test kits had sensitivities and specificities below the acceptable minimum of 95 per cent and are, therefore, unsuitable for use as IVDs in Nigeria”.
He, however, noted that the PCR test kits evaluated had a relatively better performance than the antigen and antibody detection test kits.
“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,” he stressed.
For the purpose of PCR testing, the Registrar said that Viasure PCR kit is recommended as a first line test while Standard M may be used as second line test.
In view of these findings, he said it is pertinent to recommend the establishment and institutional participation in External Quality Assessment programme for COVID-19 testing in Nigeria.
MLSCN, according to Erhabor, has recommended that all indigenously-developed test kits for COVID-19 testing in the country should be submitted for validation to support standardisation and promote reliable and accurate test results.
The registrar, therefore cautioned against the use of any non-validated Rapid / PCR Test Kits for COVID-19 testing in the country, saying this will attract sanctions in accordance with the law.
He added that MLSCN was working closely with NCDC to ensure that the two (2) WHO pre-qualified Antigen Rapid Test Kits will go through validation as soon as they arrive the country.