Eurekan Biotechnologies – a biotech startup with minimal research and development (R&D) operations in Nigeria, has been able to assemble and technically optimise a simple nucleic acid amplification test (NAAT) with an average run time of 30 minutes for severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) – which is the causative agent for coronavirus disease (COVID-19).
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. Results can thereafter be read visually from an observable colour change in the reaction tube right at the point of testing.
With a barrage of testing kits flooding the market, Eurekan Biotech led by Olumide Adenmosun – a Nigerian microbiologist and bioengineer, has been able to adapt, optimise and validate in Nigeria – a colorimetric molecular diagnostic testing kit for COVID-19 which they have named CoVAMP (CoVID-19 colorimetric 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 (ACEGID) at Redeemer’s University (RUN), Ede. ACEGID is also an independent World Bank funded, WHO reference center and a Nigeria Centre for Disease Control (NCDC) collaborating laboratory for COVID-19 diagnosis. ACEGID will also be a collaborating partner with Eurekan Biotech for continued technical support in the event of a national deployment for the kit in Nigeria. Additional validations of the CoVAMP kit were conducted at NCDC from July to November 2020.
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 to conduct molecular diagnostic assay, which remain the gold standard for COVID-19 diagnosis. The machines required to run a quantitative RT-PCR assay could have a cost range between $10,000 and$50,000. Furthermore, 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 colorimetric isothermal amplification kits can, however, run on cost-effective laboratory equipment such as heating block or a water bath. Following ribonucleic acid (RNA) 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.
The validation tests conducted in Nigeria with live COVID-19 samples showed that the 30-minute 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-mark in vitro diagnostic (CE-IVD) medical device. A CE-mark may be regarded as the equivalence of a United States Food and Drug Administration (US-FDA) or Nigeria’s National Agency for Food & Drug Administration & Control (NAFDAC) approval for a medical kit but by European Union regulators. However, with a focus on national deployment within Nigeria, CoVAMP will also seek appropriate authorisations for decentralised diagnostics use within the country.
With the need for Nigeria to ramp up testing in Nigeria as the COVID-19 pandemic persists, Eurekan Biotechnologies will be able to quickly deploy 100,000 CoVAMP tests within a 4 to 8-week lead time, as a ready-to-use CE-IVD kit. Conditions for such point of care testing deployment may, however, require appropriate clinical laboratory improvement and amendments to be in place at such sites – as guided by the WHO and the appropriate regulatory authorities in Nigeria.
Adenmosun is a pioneering alumnus of Bowen University, Nigeria, a Bioengineer and currently a Microbiology instructor and doctoral candidate at Florida Atlantic University, USA. He is also the Founder/CEO of Eurekan Biotechnologies and DNAEnsemble. He can be reached at firstname.lastname@example.org
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