Excerpts of MLSCN Press Briefing on the outcome of the Second Batch of Pre-Market Validation of COVID-19 test kits

MLSCN regulates the Production, Importation, Sales and Stocking of Diagnostic Reagents, Equipment and Chemicals (Act 11 of 2003).

 Following the outbreak of the COVID–19 pandemic, the agency commenced the process of Validating Test Kits in Nigeria for detecting SARS-CoV-2 infection. 

 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  regrettably all the antigen and antibody test kits, rapid or otherwise, failed to meet the minimum acceptable criteria.  

 

However, 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.

 

Therefore, 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, the “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”. However, the PCR test kits evaluated had a relatively better performance than the antigen and antibody detection test kits. 

 

 

For diagnosis, none of the antigen or antibody detection test kits is recommended for SARS-CoV-2 infection testing in Nigeria.  

 

For the purpose of PCR testing, Viasure PCR kit is recommended as a first line test while Standard M may be used as second line test.  

However, “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”.  

 

Meanwhile, MLSCN has recommended as follows: 

•  All indigenously-developed test kits for COVID-19 testing in Nigeria should be submitted for validation to support standardization and promote reliable and accurate test results. 
• In view of these findings, it is pertinent to recommend the establishment and institutional participation in External Quality Assessment programme for COVID-19 testing in Nigeria. 

   

 In conclusion, MLSCN is working closely with NCDC to ensure that the two (2) WHO pre-qualified Antigen Rapid Test Kits  go through validation as soon as they arrive the country.