CDC touts 3 strategies to reduce false positives with coronavirus antibody tests
May 27, 2020 -- The U.S. Centers for Disease Control and Prevention (CDC) has updated its general guidance on serology testing, providing information on its role and tips on maximizing positive predictive value.  Discuss
What we know about SARS-CoV-2 immunity so far
May 26, 2020 -- U.K. virologists have reviewed over 40 studies on SARS-CoV-2 immunity and discussed how this current knowledge about immune responses can inform virus control strategies. They shared their analysis in an article published in the Journal of General Virology on May 20.  Discuss
FDA pulls plug on wayward coronavirus antibody tests
May 22, 2020 -- The U.S. Food and Drug Administration (FDA) has published the names of 28 coronavirus antibody tests that may no longer be marketed or distributed, as part of its crackdown on the quality of products introduced on an emergency basis during the pandemic.  Discuss
CDC flags shortcomings of antibody tests in reopening guidelines
May 21, 2020 -- The U.S. Centers for Disease Control and Prevention (CDC) acknowledged high interest in antibody tests as businesses go back to work, while highlighting their limitations and many unknowns in reopening guidelines.  Discuss
AACC objects to FDA's at-home virus kit clearance, following go-ahead for Everlywell
May 21, 2020 -- The American Association for Clinical Chemistry (AACC) has notified the U.S. Food and Drug Administration (FDA) that it objects to the agency's recent emergency use authorization of an "unproven" at-home coronavirus collection kit.  Discuss
Blood gas lab testing is one of a few winners, amid sagging volumes overall
May 19, 2020 -- At a time of declining volume across the board due to COVID-19, a survey of laboratories shows that blood gas testing is one of the few lab test "winners," reports Bruce Carlson, publisher of Kalorama Information.  Discuss
Researchers validate antibody test for malaria, try similar approach for COVID-19
May 18, 2020 -- An antibody blood test has been validated for an increasingly common and troublesome type of malaria, an international team reported in Nature Medicine on May 11. A similar approach is now being explored in COVID-19, with potential for the development of a better antibody diagnostic for community surveillance, investigators suggested.  Discuss
FDA-authorized antibody tests fall short in comparative study
May 15, 2020 -- Commercial serology tests from PerkinElmer subsidiary Euroimmun and Abbott fell short of expectations in a comparative study of specimens, underscoring the need for independent validation, lab experts reported in the journal Clinical Chemistry online May 13.  Discuss
FDA alert leaves Abbott's ID Now rapid coronavirus test down -- but not out
May 15, 2020 -- The U.S. Food and Drug Administration (FDA) is working with Abbott Diagnostics to address reports of false negatives from the company's ID Now rapid point-of-care diagnostic for COVID-19.  Discuss
New POC test performs well for chlamydia, gonorrhea in women
May 14, 2020 -- A rapid point-of-care (POC) test for chlamydia and gonorrhea demonstrated excellent performance in women and good performance in men in a comparative study funded by its manufacturer and published online May 14 in JAMA Network Open.  Discuss