COVID-19: FG raises alarm over fake rapid test kits

EFFORTS by the Federal Government to hurry up testing for COVID-19 might have suffered a set- again after 4 items of Rapid Test Kits (RTKs) submitted to find out their efficacy failed to fulfill minimal necessities.


The implication is that Nigeria stays with out an accepted rapid test equipment.



Government warned that anybody discovered advertising any kind of RTKs can be sanctioned accordingly.


Nigeria’s confirmed circumstances shot up by 387 on Friday taking the entire variety of infections to 9302.


A breakdown of the brand new circumstances as launched by the National Centre for Disease Control (NCDC) exhibits that Lagos State had 254 adopted by FCT with 29, Jigawa-24 , Edo-22 and Oyo -15.


The relaxation are: Rivers-14, Kaduna-11 ,Borno-6, Kano-3 ,Plateau-2 ,Yobe-2, Gombe-2, Bauchi-2, and Ondo-1.


A complete of 2697 have been discharged thus far whereas 261 deaths have occurred.


In Cross River State, the federal government accused the federal authorities of not supporting the state’s preventive efforts, which have made it the one state with none recorded case of coronavirus within the nation.


Health Commissioner Betta Edu protested in Calabar that each one the state was getting have been stress and knocks after doing “its greatest to stop COVID 19.”

The Registrar/CEO of the Medical Laboratories Science Council of Nigeria (MLSCN), Dr. Tosan Erhabor, who gave an replace on the validation of COVID-19 Rapid Test Kits (RTKs) stated that the merchandise examined “fell under the widely acceptable minimal for Invitro Diagnostics (IVD) sensitivity and specificity of 95 per cent).

“Therefore, none have been accepted for the needs of prognosis and surveillance in Nigeria.”

He stated: “A complete of 11 In-Vitro Diagnostics; one Polymerase Chain Reaction based mostly equipment, 9 Rapid Test Kits (2 Antigen based mostly and seven Antibody based mostly kits) and one Viral Transport Medium (VTM), have been obtained for validation on the MLSCN Public Health In-Vitro Diagnostics Control Laboratory, Yaba, Lagos, Nigeria.


“However, out of the seven (7) antibody-based RTKs submitted for validation, solely Four of the RTKs met validation inclusion standards. The validation of the PCR based mostly kits and Antigen based mostly Rapid Test Kits are ongoing.


“The test kits have been evaluated based mostly on sensitivity, specificity and accuracy. The first product scored 29, 94 and 45.eight per cent respectively. The second scored 51.4, 81.6 and 61 per cent; the third scored 22.1, 90.2, 49.2 per cent; whereas the fourth scored 37.7, 85.1 and 55.6 per cent.


“From the outcomes, the efficiency traits of the 4 COVID-19 Rapid Test Kits validated fell under the widely acceptable minimal for Invitro Diagnostics (IVD) sensitivity and specificity of 95 per cent). Therefore, none have been accepted for the needs of prognosis and surveillance in Nigeria.

“It turned clear from the standardised validation performed by MLSCN that the producers’ claims as contained within the product insert about Sensitivity, Specificity and Accuracy aren’t at all times appropriate.

“In this case, we noticed a major normal deviation, a sign that Rapid Test kits that aren’t validated poses larger dangers of offering false optimistic and damaging outcomes.”


He stated some producers whose merchandise failed the validation standards agreed to re-work their RTKs for them to fulfill validation requirements.


Once they’re returned for contemporary validation, the company will look at them, he stated.


Erhabor added: “Though all of the Rapid Test kits validated fulfilled the requirement to carry out laboratory test with out the necessity of apparatus and have been capable of produce leads to lower than twenty (20) minutes, nonetheless, for a rapid test equipment to be deployed for illness surveillance and prognosis, it should be capable to detect a disease-causing agent when it’s current and to return a damaging consequence if the causative agent is absent.


“Therefore, for a equipment to be thought of dependable for laboratory prognosis and illness surveillance, the equipment ought to have a excessive sensitivity and specificity.


“A equipment performing very nicely in considered one of these traits with out the opposite renders it unsuitable for diagnostic testing. It can also be unsuitable if each traits are low.


“The 4 kits on this report haven’t met the anticipated efficiency traits of sensitivity and specificity to qualify their deployment for the needs of testing in illness surveillance and routine prognosis.


“The 4 Rapid Test Kits validated thus far aren’t accepted for the needs of prognosis and surveillance of SARS-CoV-2 Infection in Nigeria. They are subsequently not accepted for advertising in Nigeria. No SARS-CoV-2 Rapid Test equipment is at the moment accepted to be used in Nigeria.”


He warned in opposition to the usage of any non-validated Rapid Test Kits for COVlD-19 testing in Nigeria.

Violations will entice sanctions,he stated.

He additionally unveiled pointers for personal sector medical laboratories looking for to supply COVID-19 testing.

“Prospective Private Medical laboratories for COVlD-19 testing have to be granted approval by MLSCN in collaboration with NCDC in accordance with this pointers,” he stated..

“However, these not granted this particular approval and proceed to conduct COVlD-19 testing, can be thought of to have contravened the provisions of Section 4 (h) of MLSCN Act ‘Medical Laboratories Regulations for Inspection, Approval, Monitoring and Accreditation,’ and can be sanctioned in step with the provisions of the stated regulation.”

The Director-General of the NCDC, Dr. Chikwe Ihekweazu, defined that even when the rapid test kits are validated to be used in Nigeria, it doesn’t imply that the testing algorithm will shift from the gold normal – the PCR. At greatest, RTKs will simply be a information.

Represented by the Director of Laboratory Services of the NCDC, Mrs. Nwando Mba, he stated: “The non-public sector is a crucial a part of any nation’s economic system and improvement. In order for us to correctly deal with the COVID-19 scourge, it can be crucial that each one palms be on deck.


“We are sure to deploy the Gene Expert machine which is our third prong within the response to COVID-19 in Nigeria. We have obtained the Gene Expert in-country and what we now have to do is to validate these Gene Experts and be sure that what they declare it’s doing is what it’ll do for Nigerians. That can be our subsequent section.”

Cross River accuses FG of discrimination

The Cross River State Government yesterday accused the Federal Government of not supporting the preventive efforts which have made it the one state with none recorded case of COVID-19.


Health Commissioner Betta Edu advised reporters in Calabar that the state has “performed its greatest to stop COVID 19, and all that we get is stress and knocks.”


Edu who doubles as Chairman of the State’s Covid-19 Response Team added: “Maybe we should always withdraw our staff from our borders. Maybe we should always step again and start to reel out figures in hundreds to please some folks and be politically appropriate.

“It is alleged that the federal authorities is refusing to help a state which is doing every part to stop COVID 19, and as an alternative insinuating we’re protecting issues up.”


He pleaded with the federal authorities, significantly the National Centre for Disease Control (NCDC) and the Presidential Task Force on COVID-19 to help prevention.“Prevention ought to be your delight and never your disgrace. We hereby go away our destiny in your palms,” she stated.

She stated the key behind the state’s achievement was embarking on sensitization early and placing a construction in place earlier than the primary recorded case of the illness within the nation.

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