The FDA Just Issued a Warning About This COVID Measure
The agency says one coronavirus test may not provide correct results.
Preventing the spread of the coronavirus is an essential step in controlling the pandemic. Testing has long been one of the primary areas of focus, as people are advised to isolate if they receive a positive result to avoid spreading COVID to anyone else. However, this method may not be foolproof—particularly depending on the type of test used. In fact, the Food and Drug Administration (FDA) just issued a warning about the possibility of inaccurate results with one specific COVID test. Keep reading to find out which test the organization is concerned about, and for more coronavirus news, If This Part of Your Body Hurts, You Could Have COVID.
Read the original article on Best Life.
The FDA says Curative tests have the ability to produce false negative results.
The FDA issued a warning on Jan. 4 to alert patients and healthcare providers of false results from the Curative COVID test. According to the report, this COVID test is particularly prone to giving false negative results "when the test is not performed in accordance with its authorization or as described in the authorized labeling." Manufactured by Curative, this real-time PCR test is meant to provide results within 48 hours. However, the FDA says that the test is often not used under the correct circumstances, which creates a "greater risk" of inaccurate results.
A Curative spokeswoman told Best Life, "We are hoping to be able to share more data very soon and are cooperating with the FDA on this matter." And for more COVID warnings, Dr. Fauci Just Issued This Warning About Another New COVID Strain.
The test is not intended for use by everyone.
According to the FDA, Curative tests should be administered by a trained healthcare worker and should only be used on symptomatic patients within 14 days of their COVID symptom onset. During a clinical study for this test, all false negatives were seen in patients who were asymptomatic at the time of their test.
The FDA says that a negative result from a Curative test doesn't necessarily mean you don't have the virus, and it "should not be used as the sole basis for treatment or patient management decisions." The test should mainly be used to confirm the virus in those who are already experiencing telltale COVID symptoms. And for more up-to-date information, sign up for our daily newsletter.
There are several risks that could result from a false negative.
The FDA issued this warning because there are adverse effects related to getting a false negative. "Risks to a patient of a false negative result include: delayed or lack of supportive treatment, lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community, or other unintended adverse events," the FDA stated. And for more coronavirus risks, These People Are More at Risk of Catching the New COVID Strain, Study Finds.
The Curative tests are being used in various areas across the country.
As a Los Angeles-based startup, Curative tests thousands of Los Angelenos every day, the Los Angeles Business Journal reports. However, the company also has testing sites in Florida and Texas. And according to NBC, Curative recently expanded to Washington, D.C. to test Congressional members following a spike in COVID cases in Congress.
If you have concerns about your results and are worried that you were tested with a Curative test, the FDA says you should contact your healthcare provider. Also, you should have received a fact sheet alongside your test results report with the test name displayed on it so you can confirm the manufacturer. And for more guidance from the FDA, The FDA Just Ruled You Can't Do These 4 Things With the COVID Vaccines.