By Doosuur Iwambe
The Medical Laboratory Science Council of Nigeria (MLSCN) has expressed regrets that out of the 43 validation test kits for the novel Coronavirus disease it has examined so far, at least 33 failed to meet the minimum acceptable criteria.
To this end, the MLSCN has called on local and foreign manufacturers of COVID-19 test kits to take urgent steps to improve on the standard of their products to meet up with the minimum validation requirement.
Speaking while addressing a news conference on the outcome of the second batch of the pre-market validation of covid-19 test kits recently carried out in Abuja, the MLSCN Registrar Dr. Tosan Erhabor insisted that the 22 test kits which has been reportedly functioning efficiently in Nigeria is yet to meet the expected performance.
Consequently, the registrar said that, for diagnosis, none of the antigen or antibody detection test kits is recommended for COVID-19 testing in Nigeria.
“For the purpose of Polymerase Chain Reaction (PCR) testing, Viasure PCR kit is recommended as a first line rest, while standard M may be used for the second line test”, Dr Erhabor said.
He further caution against the use of any non-validation rapid PCR tests kits for COVID-19 testing in Nigeria saying, defaulters will be sanctioned.
While stressing the need for all indigenously developed test kits for COVID-19 in Nigeria to be submitted for validation, Dr. Erhabor added that it is only by doing so that Nigeria will be able to win the fight against the pandemic.
He said, ” the MLSCN recieved a total of 43 brands of test kits for validation. The goal was to determine the labouratory performance characteristics of Rapid/PCR test kits.
“A total of 33 tests kits and system were validated. Unfortunately, all the antigen and antibody test kits, rapid or otherwise, failed to meet the minimum acceptable criteria.
“All indigenously developed tests kits for COVID-19 testing in Nigeria should be submitted fo validation to support standardisation 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 program for COVID-19 testing in Nigeria.”
He further reaffirmed that the MLSCN is working closely with the Nigeria Center for Disease Control (NCDC) to ensure that the two WHO pre-qualified Antigen rapid tests kits will go through validation as soon as its arrives the country.