FDA Warns Of Covid Test Delivering False Negatives
Patients and health care providers were alerted by the FDA about potentially incorrect results from Curative's lab-based test and urged re-testing.
Modern Healthcare:
FDA Issues Alert About False Negative Results With Curative COVID-19 Test
The Food and Drug Administration on Monday issued an alert to patients and healthcare providers warning them of a risk of false negative results with a SARS-CoV-2 laboratory-based test from San Dimas, California-based Curative. The agency asserted that the test, to which it granted Emergency Use Authorization in April, must be performed in accordance with its labeling to ensure correct results. "When the test is not performed in accordance with its authorization or as described in the authorized labeling, there is a greater risk that the results of the test may not be accurate," the FDA wrote in a safety communication. (1/4)
KXAN Austin:
Curative COVID-19 Test Can Have ‘False Negative Results,’ FDA Warns
The Food and Drug Administration warned patients and healthcare providers that some of Curative’s COVID-19 tests may be indicating people do not have the coronavirus when they really do. The notice posted on Monday urged healthcare providers to consider having their patients get “re-tested” if they received a test from this company recently. Curative said it is working with the FDA but is confident in its data. (Winkle and Travis, 1/4)
In other news about testing and quarantines —
USA Today:
Testing Positive For Coronavirus After Getting A Vaccine? Here's How Likely That Is And What To Know If It Happens
It’s still possible to test positive for the coronavirus even after getting vaccinated, experts said. Both the Pfizer-BioNTech and Moderna vaccines require two doses per patient to be fully effective. The first Pfizer-BioNTech dose is more than 50% effective in preventing COVID-19, and the second dose increases that protection to about 95%. The Centers for Disease Control and Prevention said it can take weeks for a person’s body to build up immunity after getting vaccinated. (Rodriguez, 1/5)
Salt Lake Tribune:
Health Officials Offering Free Rapid COVID-19 Testing Across The State
Free COVID-19 testing will be available this week in 15 counties across Utah. According to the Utah Department of Health, the free rapid antigen testing is being offered at locations chosen because they have a high rates of positive tests, have had lower numbers of tests conducted, untreated wastewater sampling shows the virus is spreading, and other surveillance data. UDOH is encouraging anyone with even mild COVID-19 symptoms to get tested, but the tests are available to everyone — even those who do not have any symptoms. (Pierce, 1/4)
CIDRAP:
7-Day Quarantine May Work For Some COVID Household Contacts
Interim study results published late last week in Morbidity and Mortality Weekly Report (MMWR) found that only 19% of people exposed to a COVID-19 patient in their home who had no symptoms nor a positive test result in the first 7 days of the patient's illness later tested positive—lending support for recently changed Centers for Disease Control and Prevention (CDC) guidelines. To shorten quarantine and improve compliance, a month ago the CDC revised its guidance and now recommends either 10 days of quarantine with no COVID-19 test or 7 days with a negative test result. But noting the risk of viral spread from people who develop symptoms or become infectious toward the end of the initially recommended 14-day quarantine, the researchers sought to quantify that risk. (1/4)
