On Monday, Hays County Judge Ruben Becerra took part in a press conference with representatives from MDBox and MRG Medical.
Local Hays County officials were in the dark when a press conference aired Monday afternoon to announce the formation of a COVID-19 Task Force initiative and more than 50,000 test kits able to be used by residents at their home with more on the way.
During Tuesday’s Commissioners’ Court meeting, Becerra said he was happy to announce Hays County would have access to thousands of COVID-19 tests.
According to officials, MDBox’s tests are only available through physician authorization and require physician instruction in order to operate.
MDBox said patients who have gone through the process to be evaluated by their telemedicine physicians and nurses will receive a one-time use code, which will allow them to make the purchase and receive the testing kits through delivery. The kits do not come with instructions on how to use ensuring patients rely on physicians to supervise and walk them through the process.
Henry Legere, MD, CEO and founder of Reliant Immune Diagnostics, said the tests are not Food and Drug Administration approved, but they are FDA cleared testing kits.
According to Legere, the company that manufactured the kits received a waiver in order to allow for their use to test for COVID-19, and Reliant confirmed the manufacturer’s letter of clearance before moving forward with the partnership with Hays County.
The name of the manufacturer was not disclosed nor was the letter issued by the FDA.
On March 20, the FDA began monitoring the market for any firms marketing products with fraudulent coronavirus diagnostic, prevention and treatment claims.
However, the FDA began expediting the review process for diagnostic tests in order to help combat COVID-19.
The organization has issued warnings in the past about the risk of inaccurate results from home-use devices.
The FBD’s Policy for Diagnostic Tests for Coronavirus Section IV.D states they do not intend to object to the development and distribution by commercial manufacturers, or development and use by laboratories, of serology tests to identify antibodies to SARS-CoV-2, where the test has been validated, notification is provided to the FDA and information along the lines of the following is included in the test reports:
- This test has not been reviewed by the FDA.
- Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
- Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
- Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
The policy does not apply to home testing.
Last week, the U.S. Food & Drug Administration released an announcement warning consumers about unauthorized fraudulent coronavirus tests that are being marketed for COVID-19 testing in the home.
The FDA has not authorized any test that is available to purchase for testing at home for COVID-19 at this time, according to FDA officials last week.
During the commissioners’ court meeting, Becerra accused Commissioner Walt Smith of “attempting to derail an agreement with one of the county’s providers in the supply chain.”
Smith said no county officials were aware of the partnership or even the discussions before Becerra’s appearance at yesterday’s press conference.
MDBox and MRG Medical initially reported the testing kits would be available online through H-E-B; however, a recent release states that the company is still looking into partnerships with retail outlets, and patients will be able to get the tests through their website once approved until further notice.
Becerra said he has acquired thousands of additional COVID-19 test kits for Hays County in an effort to increase the county’s “ability to understand the impact this virus is having” on the community.
“Monday, I purchased the first 2,000 of these tests,” Becerra said. “And priority will be given to front line, medical personnel and individuals exhibiting symptoms. A medical consultation is required, and test results will be available in approximately 15 minutes after they have been administered.”
According to yesterday’s press release, Hays County is to receive consulting and software from MDBox as well.
The company is not accepting insurance at this time in an effort to help ensure service is available to everyone, who needs it.
Dr. Legere said Reliant has acquired 50,000 testing kits and placed an order for an additional 500,000.
According to H-E-B’s Office of Public Affairs, the company had been in conversations with MDBox but no formal verbal or written agreement or contract had been discussed.
HEB officials stated, “the company has no pending business with the organization.”
Smith said he reached out to one of the organizations after yesterday’s press conference to ask about the agreement and was informed the organization was aware of the technology but there was no agreement.
Becerra did not provide commissioners with further details about the partnership citing he had “deliberately kept everyone out of the conversation to prevent the risk of sabotage” and to prevent giving residents false hope.
Only a few select individuals were involved in the partnership with Reliant and its telemedicine application MDBox.
Becerra said health care professionals were involved but did not identify anyone specifically.
Becerra refused to answer any other questions about the partnership or related matters posed by commissioners.