Access Bio announced on the 25th that it has received emergency use approval from the US Food and Drug Administration (FDA) for an All-In-One Corona Antibody Rapid Diagnostic Kit.
The approved product is CareStart™ EZ COVID-19 IgM/IgG, which is a product made by combining an all-in-one device developed by Atomo Diagnostics in Australia and a corona antibody diagnostic strip from AccessBio.
This product diagnoses the current and past corona infection by checking whether or not the body is formed within 15-20 minutes with a simple finger blood sampling.
In addition, as the components necessary for diagnosis are installed in the device, the convenience of diagnosis has been greatly improved, and in the clinical trial conducted for this emergency use approval, the sensitivity recorded 97% and 100% for IgG and IgM, respectively. The figure shows 100% for both IgG and IgM, demonstrating excellent performance.
According to a company official, “As vaccination is accelerating, the demand to check whether or not antibodies are formed is increasing. With this approval as an opportunity, our products will be usefully used in small hospitals with high accessibility and clinics in pharmacies.” He continued, “As the possibility of a third vaccination is emerging as a prediction of the re-spreading of the coronavirus this fall, we expect that the antibody diagnosis will help the timing of the third vaccination.”
Atomo Executive Director John Kelly said, “Access Bio’s Corona Antibody Rapid Diagnosis Kit, which adopted Atomo’s all-in-one diagnostic kit platform, obtained emergency use approval from the US FDA and is widely used in various non-laboratory facilities in the US. We are happy to be able to use it,” he said.
In addition, "Atomo expects to further expand its partnership with Access Bio, including joint development of other diagnostic kits in the future."
Meanwhile, Access Bio is in the process of obtaining emergency use approval for the COVID-19 antigen self-diagnostic kit in the United States. It has successfully completed clinical trials and is being reviewed by the FDA.
Access Bio's corona antigen self-diagnostic kit is capable of diagnosing various corona mutations, including the delta mutation from India, the beta mutation from South Africa, and the alpha mutation from the UK, which has a stronger contagious power than the existing Corona 19 virus.
(20min delay)