Access Bio, COVID-19 Antibody Rapid Test Kit, Obtains FDA Emergency Use Authorization Approval

[Asia Economy Reporter Eunmo Koo] Access Bio's rapid antibody test kit for the novel coronavirus infection (COVID-19) received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on the 26th.

On the 27th, an Access Bio official stated, "It took more time than expected to meet the standards that comply with the FDA's revised regulations, including performance evaluations by external institutions. However, due to the strengthened regulations, only 10 companies, including Access Bio, currently hold EUA approval for antibody test kits that simultaneously diagnose IgG and IgM separately."

In the early stages of the COVID-19 outbreak, the U.S. allowed the sale of antibody test kits without EUA approval as long as the product was registered with the FDA as an emergency measure. However, due to quality issues with products on the market, the system was changed to require EUA approval, similar to molecular diagnostic products.

Access Bio's CareStart COVID19 IgM/IgG rapid diagnostic kit, which received EUA approval this time, demonstrated excellent results with a sensitivity of 98.4% and specificity of 98.9% in clinical trials conducted at external clinical institutions. Furthermore, in performance evaluations commissioned by the FDA to the National Cancer Institute (NCI) for objective performance assessment, the kit showed a sensitivity of 100% and specificity of 97.5%, proving superior performance compared to other products.

Additionally, Access Bio, which owns the largest rapid diagnostic test kit production facility in the U.S., has been producing over 100 million malaria RDTs annually. The COVID-19 antibody test kit is expected to sufficiently meet the surging demand through a production process similar to that of malaria RDTs.

The CareStart COVID-19 IgM/IgG diagnostic kit is a point-of-care diagnostic product that delivers results within 10 to 15 minutes using a blood sample, enabling tracking of the extent of COVID-19 exposure in groups by detecting whether patients have formed antibodies against COVID-19.