A biotech startup with minimal research and development operations in Nigeria, Eurekan Biotechnologies, says its technically-optimised simple Nucleic Acid Amplification Test with an average run time of 30 minutes for COVID-19 has been validated by the World Health Organisation, Nigeria Centre for Disease Control and African Centre of Excellence for Genomics of Infectious Diseases.
Director General of the Nigeria Centre for Disease Control, Dr. Chikwe Ihekweazu, confirmed the validation, warning, however, that validation is not the same thing as approval.
A press statement made available to PUNCH HealthWise and signed by the founder of Eurekan Biotechnologies, Dr. Olumide Adenmosun, states that the rapid molecular diagnostic kit utilises low-cost laboratory materials and consumables to conduct NAAT at an isothermal temperature with no need for expensive thermocyclers or real-time polymerase chain reaction (rt-PCR) equipment.
He said the results can subsequently be visually read from an observable colour change in the reaction tube right at the point of testing.
With a barrage of testing kits flooding the market, the Nigerian microbiologist and bioengineer said he had been able to adapt, optimise and validate in Nigeria – a colourimetric molecular diagnostic testing kit for COVID-19 which has been christened CoVAMP (CoVID-19 colourimetric isothermal AMPlification).
“The preliminary validation exercise was conducted back in May 2020 on SARS-CoV-2 positive samples in partnership with the African Centre of Excellence for Genomics of Infectious Diseases at Redeemers University, Ede. ACEGID is also an independent World Bank-funded, WHO reference centre and a Nigeria Centre for Disease Control collaborating laboratory for COVID-19 diagnosis,” he said.
He stated that additional validations of the CoVAMP kit were conducted at NCDC Reference Laboratory from July to November 2020.
Adenmosun expressed concerns that testing for COVID-19 has been particularly difficult in Sub-Saharan Africa because most clinical diagnostic labs in the region cannot afford the required equipment needed to conduct molecular diagnostic assays, which remain the gold standard for COVID-19 diagnosis.
He disclosed that the machines required to run a quantitative RT-PCR assay – which is the gold standard currently in use for detecting SARS-CoV-2 – have a cost range of between $10,000 and $50,000.
Furthermore, the scientist noted that the consumables and other reagents required for the assays are not widely available as global supplies cannot meet up with demands across the world.
“In contrast, CoVAMP colourimetric isothermal amplification kits by Eurekan Biotechnologies can, however, run on cost-effective laboratory equipment such as heating block or a water bath.
“Following ribonucleic acid purification from samples suspected of SARS-CoV-2 – which can be done with existing standard RNA purification kits, or by using a five-minute dilution buffer included with CoVAMP; a simple NAAT can be performed at a single constant temperature within 30 minutes. Following isothermal amplification of SARS-COV-2 genes from suspected samples, results can be visually read off from a colour change in the tiny reaction tube – at the point of testing,” he said.
According to him, the validation tests conducted in Nigeria with live COVID-19 samples at ACEGID and NCDC National Reference Lab showed that the 30-min test has comparable results to existing reference tests in use for COVID-19 diagnosis.
“This strongly suggests that the kit can be reliably used on clinical samples in resource-limited settings/laboratories within Nigeria and other countries in Africa for COVID-19 diagnosis.
“With the stringent requirements for adoption of diagnostic kits by NCDC and other regulatory agencies within and beyond Nigeria, CoVAMP is also being validated as a CE-marked in vitro diagnostic (CE-IVD) medical device. A CE-mark may be regarded as the equivalence of a United States Food and Drug Administration or NAFDAC’s approval for a medical kit but by European Union regulators,” he said.
He expressed optimism that given the need for Nigeria to ramp up testing in Nigeria as the COVID-19 pandemic persists, Eurekan Biotechnologies can be able to quickly deploy 100,000 CoVAMP tests within a four to eight-week lead time, as a ready to use CE-IVD kit.
When contacted to authenticate the claim of Eurekan Biotec, Director General of the Nigeria Centre for Disease Control, Dr. Chikwe Ihekweazu, reaffirmed that NAAT was validated at its reference lab.
“Yes, our National Reference Lab was one of the labs that validated a NAAT by Eurekan Biotech.
“The validation tests conducted in our lab showed that the test has comparable results to existing reference tests in use for COVID-19 diagnosis. We do similar validation exercises for several tests,” he stated.
He, however, warned that the NCDC validation of the molecular diagnostic test did not in any way connote approval.
“However, this has not been approved for use yet, within our context,” he said.
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