The Medical Laboratory Science Council of Nigeria (MLSCN) has stated the test kits recently developed by the Nigeria Institute for Pharmaceutical Research and Development (NIPRD) and the Nigeria Institute of Medical Research (NIMR) cannot be deployed for COVID-19 test as they were yet to be validated.
It further stated it was working closely with the Nigeria Centre for Disease Control (NCDC) to ensure that the two World Health Organization’s (WHO’s) pre-qualified antigen rapid test kits go through validation as soon as they arrive in the country. Of the 33 brands of rapid/PCR test kits evaluated by the MLSCN, all of them failed to meet the minimum acceptable criteria in terms of sensitivity and specificity.
The agency stressed that none of the test kits is recommended for SARS-CoV-2 (covid-19) infection testing in Nigeria.
Speaking in Abuja on the report of the second batch pre-market validation of covid-19 test kits in Nigeria, the Registrar and Chief Executive Officer of MLSCN, Dr. Tosan Erhabor, said: “The two test kits that are on CNN and that have been trending have not been subjected to validation by the Medical Laboratory Science Council of Nigeria.
“For us as an organisation, when we heard of those breakthroughs we were excited and reached out to our sister organisations, congratulating them for their wonderful feat. We’re still using this medium to call on NIPRD and NIMR to subject their kits for validation. You cannot produce the kit, validate it yourself, and you say it should be used in our country. That is not the process.
“We are calling on them and we are waiting to partner with them. We will be the first to announce that Nigeria has gotten the breakthrough.”
Speaking on the outcome of the validation tests carried out, Erhabor said that the agency received a total of 43 brands of test kits validation.
He said the goal was to determine the laboratory performance characteristics of the Rapid/PCR test kits.
He said: “A total of 33 test kits and systems were validated. All the antigen and antibody test kits, rapid or otherwise, failed to meet the minimum acceptable criteria.
“The 22 rapid test kits being reported upon, while having fulfilled the requirement of rapid test kits, have not met the characteristics of sensitivity and specificity to qualify for deployment for purposes of testing in disease surveillance and routine diagnosis.
“The highest sensitivity of 60.4 percent found in these kits is too low to be used in the detection of SARS-CoV-2 infection. It is also far below the generally acceptable minimum in-vitro diagnostics (IVD) sensitivity and specificity of 95 percent.
“Although some of the kits demonstrated relatively good specificities of up to 100 percent, but these same kits have poor sensitivities making them unsuitable as IVDs. Similarly, the non-rapid antibody detection test kits had poor sensitivities and specificities and are therefore unsuitable for use as IVDs in Nigeria.”
He stated no COVID-19 rapid test kit is approved for use in Nigeria, and cautioned against the use of any non-validated rapid/PCR test kits.
source: MedicalWorldNigeria
