Sep 17, 2020 12:00:00 PM       by Dennis Miao

FDA OKs Abbott's COVID-19 Rapid Test Kit

In a press release on August 26th, 2020, Abbott Laboratories announced that they were issued an emergency use authorization (EUA) by the FDA for their new, rapid point-of-care COVID-19 antigen test. Branded as the “BinaxNOW COVID-19 Ag Card”, the test is unique compared to the more prevalent molecular-based detection tests for COVID-19 in that it utilizes a lateral flow assay, similar to traditional over-the-counter pregnancy tests. Contained in a portable, credit-card sized device, Abbott claims that the test can deliver results in as little as 15 minutes, representing a significant reduction in time compared to RT-PCR-based tests that have turnaround times on a scale of hours rather than minutes.

 


May 7, 2020 6:20:55 PM       by Dennis Miao

COVID-19 Detection Methods: Nucleic Acid vs. IgM/IgG Antibody Tests

There is no doubt that the coronavirus is the hottest topic as of late, having dominated media headlines and having fundamentally changed the way that we live and work. As the outbreak of the coronavirus continues to worsen across the globe, the demand for COVID-19 detection is therefore ever-increasing.


Mar 27, 2020 5:56:35 PM       by Lingyi Tong

FDA Allows Distribution of COVID-19 Test Kit Before EUA

The current coronavirus (COVID-19) pandemic is an unprecedented public health emergency in the U.S. Even though medical professionals are working around the clock to conduct testing, the problem still remains to be a shortage of diagnostic kits. Aimed to improve the limited diagnostic capability and to fight against the COVID-19 public health crisis, the FDA issued several emergency policies since late February.