NIH mobilizes national innovation initiative for COVID-19 diagnostics (April 29) – With a $1.5 billion investment from federal stimulus funding, the newly launched Rapid Acceleration of Diagnostics (RADx) initiative will infuse funding into early innovative technologies to speed development of rapid and widely accessible COVID-19 testing.
LabCorp COVID-19 Antibody Tests Available Nationwide with No Upfront Out-of-Pocket Costs (April 27) – Locations include nearly 2,000 LabCorp patient service centers including more than 100 LabCorp at Walgreens locations, and thousands of physicians’ offices. These tests have not been reviewed by the FDA but are being offered by LabCorp in accordance with the public health emergency guidance issued by the FDA on March 16.
Coronavirus Antibody Tests: Can You Trust the Results? (April 24) – A team of scientists worked around the clock to evaluate 14 antibody tests. A few worked as advertised. Most did not.
COVID-19 Testing Project (April 24) – Antibody tests for prior exposure to SARS-CoV-2 virus are urgently needed. We are performing head-to-head comparisons of commercially available lateral flow assays (also known as rapid serology tests) and ELISA immunoassays. Importantly, we include an evaluation of test performance by time from symptom onset. Our goal is to provide an ongoing resource for reliable tests to inform the scientific and medical community, policy makers, and the general public.
Covid-19 antibody tests face a very specific problem (April 22) – Dozens of antibody tests for immunity to Covid-19 have been released onto the market around the world, so far with little regulatory oversight. This is set to change, with the FDA, CDC and NIH saying last week that they will work together to validate the accuracy of the tests on sale in the US. These agencies have not stated what level of accuracy they might consider sufficient, and by no means all manufacturers of these antibody blood tests have released data on their products’ sensitivity and specificity.
What is the best way to test for COVID-19 (April 22) – The numbers of diagnostic tests for SARS-CoV-2 are exploding.* These tests detect either viral RNA or antibodies to virus particles. But, which is best? That, of course, depends on what question is being asked.
False Negatives in Quick COVID-19 Test Near 15 Percent: Study (April 21) – Clinicians have raised questions about the accuracy of available COVID-19 tests.
The Broad Institute COVID-19 Diagnostic Processing Dashboard – In late March 2020, Broad Institute rapidly converted our large-scale genomics facility into a center that can process SARS-CoV-2 tests. Working in partnership with the Commonwealth of Massachusetts, Massachusetts State Public Health Laboratory, and medical facilities in the Commonwealth, the Broad’s CLIA-certified lab processes samples collected from patients in Massachusetts and beyond.
LabCorp Capacity Reaches Average Current Daily Volume of Tests Received (April 5) – The company is now able to perform about 35,000 – 40,000 tests per day and expects capacity to increase assuming supplies are available. Importantly, LabCorp’s capacity is now meeting the average current daily volume of tests we are receiving at our labs. The company has performed approximately 500,000 tests since first making our COVID-19 test available on March 5th.
BD to offer fingerstick antibody blood test for COVID-19 (April 2) – BD will begin offering a point-of-care antibody assay, which operates like a combination of a blood glucose test and a home pregnancy test. Using just a fingerstick of blood, the small test strip provides results within 15 minutes, showing multiple lines for a positive reading and a single line for negative.
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.