Abnova Expands COVID-19 IgM IgG Rapid Test with Finger Prick Utility and Production Capacity to 100K Per Month

Neihu, Taiwan (September 09, 2020)

Abnova announced today that it has expanded its COVID-19 Human IgM IgG Rapid Test with finger prick utility and production capacity to 100K per month. Majority of the COVID-19 human IgM IgG rapid tests is performed on the plasma, serum, or venous whole blood by certified clinical laboratories as required by the FDA. In order to bring the testing to the point-of-care (POC) settings, the rapid test needs to perform accurately and efficiency using finger prick blood while avoiding blood coagulation and interference. Abnova has successfully overcome this obstacle and also increased the production capacity to address the market demands.

The goal of the rapid test is to be fast and at point-of-care such as schools, airports, and businesses. Rapid tests performed at clinical laboratories are technically not rapid test. However, FDA has limited the utility and sample sources of the COVID-19 human IgM and IgG rapid test because of implementation, validation and interpretation concerns. This required stringency is even higher for a finger prick test which severely restricts its widespread use. Moreover, additional steps of utilizing a robust lancet to poke the finger and an accurate, disposable capillary tube to generate and collect 20ul of blood specimen for testing.

Another way to gain a widespread market adoption of COVID-19 human IgM IgG rapid test is its clinical application. Currently the test has been used to gain a knowledge of COVID-19 infection using antibody immunity as an index. However, the dominating method for COVID-19 diagnosis in the market is still the gold standard RT-PCR test. A supplementary clinical application is a screening test for antibody response to COVID-19 vaccines. Abnova has included a COVID-19 RBD protein in its rapid test to detect potential neutralizing antibodies which target this important sub-region of the Spike protein. As not all antibodies generated from a vaccine would be neutralizing, a positive screening test would then mandate a gold-standard, cell-based neutralizing antibody assay.