22 COVID-19 rapid test kits fail validation
Twenty two rapid test kits presented to the Medical Laboratory Science Council of Nigeria have failed to meet the minimum validation requirements for COVID-19 testing in the country.
The registrar of the council, Tosan Erhabor, disclosed this yesterday while giving a progress report on the pre-market validation of SARS-CoV-2 infection (COVID-19) test kits at the council’s headquarters in Abuja.
He said: “The 22 rapid test kits have not met the expected performance characteristics of sensitivity and specificity to qualify for deployment for testing in disease surveillance and routine diagnosis .”
The registrar said the council received a total of 43 brands of tests kits for validation and that 33 test kits and systems were validated, but that all the antigen and antibody test kits, rapid or otherwise failed to meet the minimum acceptable criteria.
According to him, as a result of this, no SARSCoV-2 Rapid Test Kit is currently approved for use in Nigeria. He also said none of the antigen or antibody detection test kits is recommended for SARS-CoV-2 infection testing in Nigeria.
He said the PCR test kits evaluated had a relatively performance than the antigen and antibody test kits.
He said: “For a rapid test kit to be deployed for disease surveillance and diagnosis, it must be able to detect a diseasecausing agent when it is present and to return a negative result if the causative agent is absent.
“In other words, the kit must possess good sensitivity to be able to detect the presence of the disease, and good specificity, so that no interfering substances can lead to a false positive instead of true negative results in the absence of the etiological agent of the disease.
“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. It is also unsuitable if both characteristics are low.”