COVID-19 pandemic has fundamentally changed the way people live and work around the world. Millions of people have been infected with no end in sight. There is a huge demand to expand the diagnostic capacity, and PCR-based tests alone can hardly meet the requirement.

Immunodiagnostic methods are valid alternatives to the PCR test. The target for immunodiagnostics can be either SARS-CoV-2 antigens (antigen test), or antibodies against these antigens (antibody test). So far, the FDA has approved 25 antibody tests under EUA. Most of the tests are built on lateral flow assay format. The antibody tests reveal the history of exposure and can be helpful for sero-surveillance studies. However, the presence of antibodies doesn’t mean the person is carrying the SARS-CoV-2 virus, nor does it mean she’s protected against future infection. Hence, the use of antibody tests is limited, and the result from such tests must be interpreted with caution.

Antigen tests can specifically tell whether the tested individual carries the virus or not. However, there are many challenges to develop antigen tests. The detection sensitivity issue is prominent, as the quantity of viral antigens is very low. Besides, the antigen assay depends on the availability of very specific antibodies. So far, only Quidel and Becton Dickinson (BD)’s antigen tests have received FDA EUA. The sensitivity of both products is around ~85%. Regardless of the challenges, antigen tests are of greater interest because it directly tells the presence of the infection. It’s a faster, easier, and less expensive alternative to the PCR-testing.

The overarching goal of this webinar series is to provide a platform where new technologies can be shared among research and industrial leaders. The invited speakers are industrial and academic scientists working on a variety of novel diagnostic assays. The scope of the webinars include assays that:
1. detect the virus itself, or viral antigens, with high specificity and sensitivity
2. can allow high-throughput testing
3. can simultaneously detect multiple antigens and/or antibodies
4. use different detection systems than colloidal gold

https://clinicaltrials.gov/ct2/who_table