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

The median home price in the Round Rock, Pflugerville and Hutto area has risen considerably since last October. (Brian Rash/Community Impact Newspaper)
CI TEXAS ROUNDUP: Home sales, costs in Round Rock, Pflugerville and Hutto remain hotter than Greater Austin; Halal Guys opens in Pearland and more top news

Take a look at the top five trending stories across Community Impact Newspaper’s coverage areas in Texas as of Nov. 29.

Alluring Selfie Lounge offers 20 themed backgrounds, such as an airplane interior, a beach and lifeguard stand, a ball pit and floral backdrops. (Ben Thompson/Community Impact Newspaper)
Interactive museum Alluring Selfie Lounge now open in The Woodlands Mall

Alluring Selfie Lounge offers 20 themed backgrounds, such as an airplane interior, a beach and lifeguard stand, a ball pit and floral backdrops.

Kokomos is a Mexican restaurant that features a menu with a Caribbean flair. (Courtesy Kokomos)
Locally owned Mexican restaurant Kokomos now open in Oak Ridge North

Gary and Belinda Sipp, locals to The Woodlands area for nearly 40 years, opened Kokomos on Nov. 22 in the Oak Ridge North area at 26850 I-45 N., Spring.

Montgomery County municipalities continue to receive increased sales tax allocations from the previous year as Texas recovers from the COVID-19 pandemic. (Jishnu Nair/Community Impact Newspaper)
Conroe receives over $6 million in November state sales tax allocations; Montgomery County cities show continual year over year growth

Montgomery County municipalities continue to receive increased sales tax allocations from the previous year as Texas recovers from the COVID-19 pandemic.

TxDOT will hold public meetings in December to discuss improvements to stretches of FM 1488 in Montgomery County. (Chandler France/Community Impact Newspaper)
TxDOT to hold public meetings to discuss FM 1488 improvements from I-45 to Mostyn Drive in early December

The meetings will be virtual with an in-person component, and the will discuss proposed improvements along FM 1488 from I-45 to Mostyn Drive in Montgomery County.

Commissioners on Nov. 22 voted to approve a density change to preliminary plans for The Preserve, a neighborhood that city documents said could include 565 single-family homes at the northeast corner of Teel and Panther Creek Parkways. (Courtesy city of Frisco)
CI TEXAS ROUNDUP: Neighborhood near PGA Frisco could see larger lots; ERCOT says Texas power grid ready for expected winter demand and more top news

Take a look at the top five trending stories across Community Impact Newspaper’s coverage areas in Texas as of Nov. 24.

A health expert with Baylor College of Medicine provides advice to stay safe and healthy while celebrating Thanksgiving with family. (Karolina Grabowska/Pexels)
Baylor College of Medicine: Tips for staying safe and healthy this Thanksgiving as the pandemic continues

Check out some helpful advice from a medical expert on how to stay safe and healthy during Thanksgiving.

Texas Gov. Greg Abbott sits beside Samsung CEO Dr. Kinam Kim as he announces the company is brining a $17 billion facility to Taylor. (Screnshot via KXAN)
Samsung makes it official: Announcement from Governor's Mansion confirms $17B facility coming to Taylor

Nearly a year after Williamson County officials began pitching Samsung to bring a megafacility to the area, the electronics giant has made it official.

Bill Curci is a chief operating partner for Shuck Me, a seafood restaurant in Fort Worth. (Bailey Lewis/Community Impact Newspaper)
CI TEXAS ROUNDUP: Fort Worth restaurant Shuck Me is fishing- and family-centric; a guide to Houston's 2021 Thanksgiving Day Parade and more top news

Take a look at the top five trending stories across Community Impact Newspaper’s coverage areas in Texas as of Nov. 23.

PTSD Foundation of America seeks to reduce veteran suicides

An average of 17.2 veterans died by suicide daily in 2019—a 36% increase from 2001, according to a report released by the U.S. Department of Veterans Affairs in September.

Hebrews Coffeehouse specializes in coffee flights, an assortment of four specialty coffees with flavors changed every two weeks. (Courtesy Hebrews Coffeehouse)
From coffee trailer to storefront: Meet the owners of Hebrews Coffeehouse on FM 1488

​​​​​​​“Once we had a coffeehouse and people were coming into that house-type environment and then you start to see relationships flourish, that’s what makes our hearts beat,” Geoff said. “Coffee was a catalyst for that.”