FDA alerts patients regarding possible false negatives from COVID-19 tests offered at Curative sites, including in Texas

Curative mobile testing clinics are stationed at sites in the Houston, Austin and Dallas metropolitan areas, including in The Woodlands. (Courtesy The Woodlands Township)
Curative mobile testing clinics are stationed at sites in the Houston, Austin and Dallas metropolitan areas, including in The Woodlands. (Courtesy The Woodlands Township)

Curative mobile testing clinics are stationed at sites in the Houston, Austin and Dallas metropolitan areas, including in The Woodlands. (Courtesy The Woodlands Township)

A safety communication released Jan. 4 by the U.S. Food and Drug Administration alerts patients and health care providers to the risk of possible false results, particularly negative results, from Curative tests for SARS-Cov-2, the virus that causes COVID-19.

Curative testing sites are available at many locations in the Texas, including the Houston, Austin and Dallas areas. The tests are self-administered, according to the Curative website.

The FDA statement said the way the test is administered can be key to the test’s accuracy.

“To reduce the risk of false negative results, it is important to perform the test in accordance with its authorization and as described in the authorized labeling,” according to the FDA release. “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.”

In a statement, Curative said its test has been validated and is being offered under emergency use authorization. The company said the tests are labeled with the warnings, precautions and limitations reiterated by the FDA in its safety communication.


“The test performance and labeling ... have not changed, nor has the company observed any changes in test performance,” according to the statement. “We have been working with the agency to address their concerns and these limitations, and we will continue to work interactively with FDA through the Emergency Use Authorization process.”

Instructions on the Curative website show the test is collected by the patient by means of a mouth swab.

Curative said in a statement that Dr. Brian P. Monahan, the U.S. Congress’s attending physician, has noted that the issues cited by the FDA are not unique to the test Curative is using.

The FDA statement said the risk of false results includes delayed or lack of supportive treatment; a lack of monitoring for symptoms among those infected, their households and their contacts; and an increased risk of spread.

The FDA recommends that patients talk to their health care providers if they have concerns about their test results and that problems, such as suspected inaccurate results, be reported to the FDA.
By Vanessa Holt
A resident of the Houston area since 2011, Vanessa began working in community journalism in her home state of New Jersey in 1996. She joined Community Impact Newspaper in 2016 as a reporter for the Spring/Klein edition and became editor of that paper in March 2017 and editor of The Woodlands edition in January 2019.


MOST RECENT

Montgomery County continues to see new daily highs in active COVID-19 case counts as hospitalizations rise. (Community Impact staff)
Montgomery County COVID-19 total case count increases to over 34,000; active case count decreases by 1,500

The total COVID-19 case count across Montgomery County has surpassed 34,000.

The city of Shenandoah outlined several projects for the upcoming year. (Andrew Christman/Community Impact Newspaper)
Shenandoah announces 2021 projects including David Memorial Drive extension, water line replacement

One of the primary projects the city of Shenandoah will pursue this year will be the extension of David Memorial Drive to Hwy. 242.

Feeding Texas hosted a Jan. 19 webinar to discuss legislative highlights for the 87th Texas Legislature. (Screenshot courtesy Feeding Texas)
Food insecurity in Texas' 87th Legislature: Hunger relief organization Feeding Texas to propose legislation addressing hunger

Hunger relief organization Feeding Texas hosted a webinar Jan. 19 to discuss increasing funding and accessibility for the Supplemental Nutrition Assistance Program in the 87th legislative session.

13 new businesses that opened in 2020 or early 2021 to check out in The Woodlands area

Tommy Bahama Home opened in January, and stores including an Amazon 4-star opened in 2020 in The Woodlands area.

The Woodlands-area small business, major industries look at 2021 recovery prospects

Several circumstances, such as a growing health care employment sector and a robust commercial market, may have helped to protect The Woodlands from greater losses, area experts said.

COVID-19 vaccines
DATA: Texas has vaccinated about 9% of estimated Phase 1 recipients

Over 1.1 million individuals from the Phase 1 population, which is estimated to include 13.5 million individuals total, have received at least one dose.

Bob Popinski, policy director of Raise Your Hand Texas, shared the organization's top education priorities for the ongoing legislative session. (Courtesy Adobe Stock)
‘What does virtual learning and remote learning look like moving forward?': Raise Your Hand Texas policy director talks legislative priorities

Bob Popinski is the director of policy for Raise Your Hand Texas, an Austin-based organization committed to improving public education. He spoke with Community Impact Newspaper in late December about the 87th legislative session, which began Jan. 12.

The barbecue eatery is the second Killen's Restaurant Group venture to launch in The Woodlands area. (Courtesy Killen's Barbecue)
Killen's Barbecue launches new location serving The Woodlands area

The barbecue concept's second Greater Houston location opened Jan. 16 in Shenandoah.

(Courtesy Chipotle)
Chipotle opens location on Sawdust Road

The new location offers a Chipotlane, which allows customers to drive through and pick up their orders without leaving their vehicle.

Bayou City Art Festival Downtown is scheduled to return in person in October. (Courtesy Katya Horner/Bayou City Art Festival)
Bayou City Art Festival scheduled for in-person return in October

The Memorial Park version of the festival will be celebrated through alternative virtual and smaller in-person events.

The Conroe clinic was allocated 2,000 doses of Moderna Inc.'s COVID-19 vaccine the week of Jan. 18 because of its designation as a hub provider. (Courtesy Adobe Stock)
Conroe's Lone Star Family Health Center designated as COVID-19 vaccination hub, receives 2,000 doses

The facility was the sole Montgomery County provider to receive a vaccine allocation in the sixth week of statewide distribution.