No rapid test kit approved for use in Nigeria, lab council insists

AS the number of confirmed cases of the novel Coronavirus (COVID-19) rises across the world and the race for a solution intensifies, with different countries seeking local remedies, the Medical Laboratory Science Council of Nigeria (MLSCN) has insisted that no Rapid Test Kit has been approved for COVID-19 tests in the country.
The MLSCN Act 11 of 2003 (CAP M25 LFN 2004), Section 4 (b) and (e) mandates MLSCN to regulate medical laboratory science practice in Nigeria, as well as regulate the production, importation, sales and stocking of diagnostic reagents, equipment and chemicals in the country.
Registrar and Chief Executive Officer (CEO) of MLSCN, Dr. Tosan Erhabor had on May 29 cautioned against the use of any non-validated Rapid Test Kits for COVlD-19 testing in Nigeria, warning that such would attract sanctions in accordance with the law, as no Rapid Test Kit has been approved for such use in the country.
This was re-echoed by a medical /molecular microbiologist and National Publicity Secretary of Association of Medical Laboratory Scientists of Nigeria (AMLSN) Dr. Casmir Ifeanyi, who told The Guardian that as a professional group pivotal to medical laboratory testing, AMLSN was committed to local production of rapid diagnostic kits, but would not want to achieve cheap political point when dealing with the issues of health and science, because science is evidently a matter of data, scientific fact and figures.
He argued: “The procedure is that if you have produced a kit, you must subject it to validation, whether it is produced by an individual or a government agency or whatever institution so called, it must be validated, in keeping with international standards and our national laws.
“If that has not been done, then the use and promotions of such kits would be against national law, regulatory processes and international best practices, and of course, if put to use will mean endangering lives of the citizens.”
The AMLSN spokesman insisted that if such kits have been produced, for other inter-agency collaboration and relationship, they should make the kits available to the body statutorily empowered to do the validation. They should make the kit available to the Medical Laboratory Council of Nigeria to evaluate. They cannot ignore the issue of evaluating the kit.
“The Minister of Science and Technology, while receiving the product, directed that it should be validated and that is very commendable. In fact, best validation is a batch-to-batch testing of what we have produced locally and what we have been importing overtime to see how it will perform.
“So, as a professional group, we want to commend the minister for being at the forefront in finding home-grown solution to this particular challenge. However, we want to strongly advise that whatever his ministry and the inter-ministerial department are able to bring onboard must be made to go through the ethical requirement of validation and approval by other sister agencies before they are deployed.”
He added: “As a professional group pivotal to medical laboratory testing, we would love to encourage, and of course, we are committed to local production rapid diagnostic kits. If we say a product is manufactured locally, what percentage of the materials utilised in the process is locally sourced and indigenous to the country.
“We need to ask ourselves what is the volume of local materials that have been used in that production. You cannot be claiming you have produced a material when all you have is a syndicate, which you have produced. If we say we had produced something locally, it simply means we would have used a phenomenal material isolated from the Nigeria variance of the COVID-19 virus to have formed the development of all materials factored into production.
“For the COVID-19 in Nigeria, it is regrettably so that we have enormous politicking. It is all about outsmarting one another to see what political profit or edge they can have. That is the challenge we face as a country.
“This is about one of the very recent amalgamation of different sectors into intervening in a global challenge. While we commend the fact that we were able to muster a more effort at addressing the pandemic, I want to appeal to our technocrats, ministers and head of inter-ministerial department to eschew politics and let us put service to fatherland.
“This is a health matter and the health of Nigerians must supersede and must come first before any another interest, if we are able to produce things locally, whether it is rapid diagnostic test kits or other diagnostic materials, that will go a long way in helping our country.”
He recalled that the organisation, during its mid-term review, pointed out that what is needed is to find a more cost-effective way in rapidly expanding the country’s capacity to provide testing to the average Nigerian, noting: “It only when we have tested significantly that we can make a very reliable inferential scientific decision that will guide the intervention in Nigeria.”
Nigeria, in a bid to address its local manufactured, recently unveiled a viral Ribonucleic Acid (RNA) extraction kit for the identification of SARS-CoV-2, the causative agent for COVID-19, to accelerate the capacity to test people and help effectively manage the pandemic.
At the event, Minister of Science and Technology, Dr. Ogbonnaya Onu said: “The RNA Swift has amazing precision for the detection of SARS-COV-2 and will be commercially available at a price that places it ahead of competitors, in terms of sensitivity and affordability.”
He said the innovation was borne out of a need in the agricultural sector to test Nigerian farmers and labourers, adding that in the coming months, five million farmers would be tested with the kits from the first 10 million kits to be produced.
Minister of Health, Dr. Osagie Ehanire, during the Presidential Taskforce (PTF) on COVID-19 briefing last Monday, acknowledged that the development of RNA extraction kits and its validation has been relayed to him and he was proud of it, but asked the Nigeria Centre for Disease Control (NCDC) to evaluate the kits, as it would be a further step in reducing dependence on imported commodities.
The Medical Laboratory Council, not long ago, said result of some of the antibody-based rapid test kit for COVID-19 showed that the four that complied with the regulatory and ethical requirements did not pass the validation test, because none of them made the 95-95 criteria.
“So, none of the current rapid test kits we have in Nigeria, according to the Council, has been approved for use. The clandestine use of rapid test kits have been linked to death of some prominent people in the Federal Capital Territory (FCT), including the head of a parastatal that died recently due to COVID-19 and undercover findings revealed that he was being tested with rapid test kit.
“We need to know how dangerous and deadly it is to continue to use the rapid test kit to diagnose COVID-19. The World Health Organisation (WHO) is yet to recommend any rapid test kit for use. We agree that some countries are using that, but we must separate use for surveillance and use for diagnosis.”
He added: “There is no politics; there is science, and we are defining standard based on empirical evidence. The point must be made that there would be no time we would allow or promote or encourage or endorse the indiscriminate use of rapid test kit.
“The reason is that the SARS-2 coronavirus is a high viral agent and affects bio-safety requirement for testing for COVID-19. Whatever specimen or testing device you are using, it must conform to bio-safety level two stringent requirements for such type of virus agent, because when you throw caution to the wind and comprise bio-safety instructions, the impact on the community will be very overwhelming.
“We cannot reduce COVID-19 testing to the way we carry out pregnancy testing. Anybody promoting that is indeed compromising the health of Nigerians and must be stopped forthwith.”
Source: The Guardian

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