COVID-19: All Submitted Rapid Test Kits Failed Validation Requirements- MLSCN
The Medical Laboratory Science Council of Nigeria , MLSCN has urged local and foreign manufactures of COVID-19 test kits to improve on standard to meet validation requirements for accurate test results.
The Registrar, Doctor Tosan Erhabor made the plea at a news conference on the outcome of the second batch of pre- market validation of COVID-19 test kits in Abuja.
Doctor Erhabor who noted that twenty two rapid test kits submitted for validation did not meet the expected performance of Rapid testing in disease surveillance and routine diagnosis for COVID nineteen test in Nigeria.
“The highest sensitivity of 60.4% 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%.
“Although some of the kits demonstrated relatively good specificities of up to 100%, 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.”
The registrar stressed that the council would collaborate with Nigeria Center for Disease Control to ensure the two World Health Organizations pre-qualified antigen rapid test kits also go through validation as soon as they arrived the country.
According to him “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.”
“The PCR test kits are designed to detect two or three genes of SARS-CoV-2. All of them are in multiplex PCR format. They are all reverse transcriptase Real-Time PCR. The PCR test evaluated had a relatively better performance than the antigen and antibody detection test kits.”
“MLSCN will work closely with NCDC to ensure that the two 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 NINETEEN testing as more sectors of the economy open.”
Dr. Erhabor who also noted that rapid test kits to be deployed for disease surveillance and diagnosis 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 reaffirmed the councils commitment towards ensuring quality healthcare delivery in the country.
In a goodwill massage a representative of Nigerian Center for Disease Control Mr. Akinpelu Afolabi who said the two organisations cannot do it alone solicit the support of Nigerians to ensure that non validated test kits are reported for adequate sanctions.