FDA grants emergency use authorization for fastest available molecular point-of-care test for novel coronavirus (March 27) – Abbott has received emergency use authorization (EUA) for the fastest available molecular point-of-care test for the detection of COVID-19, delivering positive results in as little as five minutes and negative results in 13 minutes. The new Abbott ID NOW COVID-19 test runs on Abbott’s ID NOWTM platform—a lightweight box (6.6 pounds and the size of a small toaster). The plan is to ramp up production to deliver 50,000 ID NOW COVID-19 tests per day, beginning next week, to the U.S. healthcare system.
Coronavirus SARS CoV-2 testing in the US (March 27) – CDC site
Mystery In Wuhan: Recovered Coronavirus Patients Test Negative … Then Positive (March 27) – Some of those who retested positive appear to be asymptomatic carriers — those who carry the virus and are possibly infectious but do not exhibit any of the illness’s associated symptoms — suggesting that the outbreak in Wuhan is not close to being over.
Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV (March 26) – The U.S. FDA issued an Emergency Use Authorization (EUA) for BGI’s Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV. It is intended for the qualitative detection of SARS-CoV-2 which can return results within three hours.
The First U.S. Company Has Announced an Upcoming Home COVID-19 Test (March 18) – Everlywell, a home testing company that offers dozens of lab tests to consumers, is adding a COVID-19 test beginning on March 23.
LabCorp Launches Test for Coronavirus Disease 2019 (COVID-19) (March 9) – The LabCorp 2019 Novel Coronavirus (COVID-19), NAA Test is for Use by Clinicians with Patients Who Meet COVID-19 Evaluation Criteria. LabCorp does not currently collect specimens for the test. Patients for whom testing has been ordered should not be sent to a LabCorp location to have a specimen collected. Instead, an appropriate specimen should be collected at the healthcare facility where the patient was seen and the test was ordered. The specimen should be sent to LabCorp using standard procedures. Test results will be available in 3-4 days. More information about the test, including specimen collection and packaging requirements, is available on their website.