COVID-19: FG Raises Alarm Over Fake Test Kits

Efforts by the Federal Government to speed up testing for COVID-19 may have suffered a set- back after four units of Rapid Test Kits (RTKs) submitted to determine their efficacy failed to meet minimum requirements.

The implication is that Nigeria remains without an approved rapid test kit.

Government warned that anyone found marketing any type of RTKs would be sanctioned accordingly.

Nigeria’s confirmed cases shot up by 387 on Friday taking the total number of infections to 9302.

A breakdown of the new cases as released by the National Centre for Disease Control (NCDC) shows that Lagos State had 254 followed by  FCT with 29, Jigawa-24 , Edo-22 and Oyo -15.

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

A total of 2697 have been discharged so far while 261 deaths have occurred.

In Cross River State, the government accused the federal authorities of  not supporting the state’s preventive efforts, which have made it the only state without any recorded case of coronavirus in the country.

Health Commissioner Betta Edu protested in Calabar that all the state was getting were pressure and knocks after doing “its best to prevent COVID 19.”

The Registrar/CEO of the Medical Laboratories Science Council of Nigeria (MLSCN), Dr. Tosan Erhabor, who gave an update on the validation of COVID-19 Rapid Test Kits (RTKs) said that the products examined “fell below the generally acceptable minimum for Invitro Diagnostics (IVD) sensitivity and specificity of 95 per cent).

“Therefore, none were approved for the purposes of diagnosis and surveillance in Nigeria.”

He said: “A total of 11 In-Vitro Diagnostics; one Polymerase Chain Reaction based kit, nine Rapid Test Kits (2 Antigen based and 7 Antibody based kits) and one Viral Transport Medium (VTM), were received for validation at the MLSCN Public Health In-Vitro Diagnostics Control Laboratory, Yaba, Lagos, Nigeria.

“However, out of the seven (7) antibody-based RTKs submitted for validation, only 4 of the RTKs met validation inclusion criteria. The validation of the PCR based kits and Antigen based Rapid Test Kits are ongoing.

“The test kits were evaluated based on sensitivity, specificity and accuracy. The first product scored 29, 94 and 45.8 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; while the fourth scored 37.7, 85.1 and 55.6 per cent.

“From the results, the performance characteristics of the four COVID-19 Rapid Test Kits validated fell below the generally acceptable minimum for Invitro Diagnostics (IVD) sensitivity and specificity of 95 per cent). Therefore, none were approved for the purposes of diagnosis and surveillance in Nigeria.

“It became clear from the standardised validation done by MLSCN that the manufacturers’ claims as contained in the product insert about Sensitivity, Specificity and Accuracy are not always correct.

“In this case, we observed a significant standard deviation, an indication that Rapid Test kits that are not validated poses higher risks of providing false positive and negative results.”

He said some manufacturers whose products failed the validation criteria agreed to re-work their RTKs for them to meet validation standards.

Once they are returned for fresh validation, the agency will examine them, he said.

Erhabor added: “Though all the Rapid Test kits validated fulfilled the requirement to perform laboratory test without the need of equipment and were able to produce results in less than twenty (20) minutes, however, for a rapid test kit to be deployed for disease surveillance and diagnosis, it 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.

“Therefore, for a kit to be considered reliable for laboratory diagnosis and disease surveillance, the kit should have a high sensitivity and specificity.

“A kit performing very well in one of these characteristics without the other renders it unsuitable for diagnostic testing. It is also unsuitable if both characteristics are low.

“The four kits in this report have not met the expected performance characteristics of sensitivity and specificity to qualify their deployment for the purposes of testing in disease surveillance and routine diagnosis.

“The four Rapid Test Kits validated so far are not approved for the purposes of diagnosis and surveillance of SARS-CoV-2 Infection in Nigeria. They are therefore not approved for marketing in Nigeria. No SARS-CoV-2 Rapid Test kit is currently approved for use in Nigeria.”

He warned against the use of any non-validated Rapid Test Kits for COVlD-19 testing in Nigeria.

Violations will attract sanctions,he said.

He also unveiled guidelines for private sector medical laboratories seeking to provide COVID-19 testing.

“Prospective Private Medical laboratories for COVlD-19 testing must be granted approval by MLSCN in collaboration with NCDC in accordance with this guidelines,” he said..

“However, those not granted this special approval and proceed to conduct COVlD-19 testing, will be considered to have contravened the provisions of Section 4 (h) of MLSCN Act ‘Medical Laboratories Regulations for Inspection, Approval, Monitoring and Accreditation,’ and will be sanctioned in line with the provisions of the said regulation.”

The Director-General of the NCDC, Dr. Chikwe Ihekweazu, explained that even if the rapid test kits are validated for use in Nigeria, it does not mean that the testing algorithm will shift from the gold standard – the PCR. At best, RTKs will just be a guide.

Represented by the Director of Laboratory Services of the NCDC, Mrs. Nwando Mba, he said: “The private sector is an important part of any nation’s economy and development.  In order for us to properly tackle the COVID-19 scourge, it is important that all hands be on deck.

“We  are bound  to  deploy the Gene Expert machine which is our third prong in the response to COVID-19 in Nigeria. We have received the Gene Expert in-country and what we have to do is to validate those Gene Experts and ensure that what they claim it is doing is what it will do for Nigerians. That will be our next phase.”