US Government Set To Relaunch Free At-Home COVID-19 Tests Program

Elevated levels of the COVID-19 virus in wastewater samples have prompted the Biden-Harris administration to dust off its free testing program in preparation for the fall and winter. The US Postal Service will begin shipping the testing kits in September.

COVID AT HOME TEST
• Source: Shutterstock

While it’s no longer considered a pandemic, COVID-19 has not gone away.

In fact, the Centers for Disease Control and Prevention reports “very high” levels of the virus in wastewater samples across the US. The CDC says it can detect traces of the virus in sewage samples even if symptoms have not been reported in that community. This data can serve as an early warning of potential spread.

In response to the spike, the Biden-Harris administration says it will relaunch a free testing program which first sent out test kits in January 2022. President Biden first announced the program in December 2021. (Also see "Biden Promises 500 Million COVID-19 Tests As Omicron Threatens To Overwhelm US Health Care System" - Medtech Insight, 21 December, 2021.)

The policy continued sending out additional testing kits throughout 2022 and into 2023.

Now the policy, which allows US households to order up to four free at-home tests through the Department of Health’s Administration for Strategic Preparedness and Response (ASPR) website, will ramp up again toward the end of September with the tests being shipped via US mail.

The new tests, which are designed to detect current variants of the virus, can be taken at home and provide results within 15 to 30 minutes.

“At-home tests are the future of diagnosing disease,” the department says. “Reporting your result — whether negative or positive — helps your nation learn how to use those test results effectively.” — US Department of Health

Additionally, the CDC recommends all Americans older than 6 months get an updated COVID-19 vaccine for the fall and winter to protect against more serious outcomes of infection. However, the government says the tests will work on individuals of any vaccine status.

The government further advises individuals consult the FDA website for expirations dates on all authorized tests before use, as many older COVID-19 tests have expired.

The CDC recommends those testing positive follow the latest guidelines to prevent spreading the disease.

ASPR also notes that the at-home tests are antigen tests, not polymerase chain reaction, or PCR, tests. While antigen tests produce results more quickly than PCRs, they are not as accurate.

Though positive antigen results are accurate and reliable, a single negative result does not necessarily rule out infection. Therefore, the FDA advises people experiencing COVID-19 symptoms see negative results on at least two tests 48 hours apart before considering themselves free of the disease, while people without symptoms should take at least three tests.

A single PCR test, according to the FDA, can confirm an antigen result.

In total, ASPR says the government has sent out more than 900 million tests to households across the country. Health officials have maintained that testing is essential for keeping the virus at bay.

The Department of Health also requests Americans taking the tests to report their results.

“At-home tests are the future of diagnosing disease,” the department says. “Reporting your result — whether negative or positive — helps your nation learn how to use those test results effectively.”

More from Regulation

EU Commissioner: Medtech Regulations Assessment To Wrap Up by End 2025

 

Pediatric devices and IVDs are to be a priority. And the European Health Data Space regulation is seen as critical in supporting digital technologies and AI in transforming care.

Rapid Action Required For Medtech Compliance With EU Batteries Regulation

 

As deadlines approach, the regulatory landscape for medtech batteries is set to change, with an emphasis on sustainability and ethical practices.

US FDA Should Regulate ‘Dangerous’ Prescription Software Platform As A Medical Device, Says Patient Advocacy Group

The Doctor Patient Forum says the US FDA should regulate a scoring platform from Bamboo Health intended to help clinicians calculate risk for opioid abuse as a medical device to ensure patient safety.

Urgent Call for Leadership In EU Medtech To Steer Through Regulatory Challenges

 

EU medtech trade associations present detailed arguments for the European Commission’s 'targeted evaluation' of medtech regulations, highlighting the need for immediate course correction.

More from Policy & Regulation

New FDA Commissioner Makary Could Face Turbulent Waters

 

Stakeholders are pleading for newly confirmed FDA Commissioner Martin Makary to stand up for the agency's high scientific standards and staff as he begins his term.

Research Finds Benefit From DME Suppliers For People Living With Diabetes

 
• By 

People living with diabetes who receive continuous glucose monitors (CGMs) through medical supply firms show higher compliance, lower costs of care, and fewer hospitalizations after one year than those who use pharmacies, a new study shows.

EU Commissioner: Medtech Regulations Assessment To Wrap Up by End 2025

 

Pediatric devices and IVDs are to be a priority. And the European Health Data Space regulation is seen as critical in supporting digital technologies and AI in transforming care.