Free at home clinical-laboratory testing for COVID-19 has been provided in the past, but this time the federal government wants to manufacture as many tests as possible in the US
Pathologists and clinical laboratory managers may be interested to learn that the US market is about to be flooded with millions of at-home COVID-19 rapid tests. The federal government has contracted with 12 US-based test manufacturers to produce 200 million at-home self-tests aimed at detecting “currently circulating COVID-19 variants” through the end of this year, according to a US Department of Health and Human Services (HHS) news release.
Through the Administration for Strategic Preparedness and Response (ASPR), HHS is investing $600 million to fund the self-tests, which are available for delivery through a reopening of the COVID.Gov/Test website.
Federal officials want to head off “supply chain issues” that developed in the past with reliance on tests made overseas, and to address a possible COVID-19 surge during the fall and winter, the Associated Press (AP) reported.
In fact, 500 million tests have already been distributed through US government channels to long-term care facilities, schools, and low-income senior housing.
“Manufacturing COVID-19 tests in the United States strengthens our preparedness for the upcoming fall and winter seasons, reduces our reliance on other countries, and provides good jobs to hardworking Americans,” said Assistant Secretary for Preparedness and Response Dawn O’Connell, JD (above), in an HHS news release. “ASPR’s investments in these domestic manufacturers will increase availability of tests in the future.” With the federal government preparing for what it expects to be a surge in demand for COVID-19 testing, clinical laboratories may want to track the CDC’s weekly reports on the number of positive COVID-19 cases as this year’s influenza season progresses. (Photo copyright: Administration for Strategic Preparedness and Response.)
In Vitro Diagnostics Test Makers Get Government Gigs
This is not the first time federal officials sent out free COVID-19 tests to consumers. According to the AP, more than 755 million tests went out to US households in previous efforts to fight the spread of infections. But unlike those tests, these tests will be manufactured entirely within the US.
The government’s latest wave of free tests is meant to “complement ASPR’s ongoing distribution of free COVID-19 tests to long-term care facilities, low-income senior housing, uninsured individuals, and underserved communities, with 500 million tests provided to date through these channels,” the HHS news release noted.
Both large and lesser-known in vitro diagnostics (IVD) manufacturers were selected by the federal government to receive funding. They include:
- Access Bio, Somerset, N.J., $88.7 million
- Advin Biotech, San Diego, $4.5 million
- Azure Lab Services, Texas, $61.2 million
- CorDx, San Diego, $86.4 million
- iHealth Labs, Sunnyvale, Calif., $167 million
- InBios International, Seattle, $20.7 million
- Kwell Laboratories, Jurupa Valley, Calif., $31.4 million
- MaximBio, Rockville, Md., $49.5 million
- OraSure Technologies, Bethlehem, Penn., $5.7 million
- Princeton BioMeditech, Junction, N.J., $28.7 million
- QuidelOrtho, San Diego, $28.6 million
- Sekisui Diagnostics, Burlington, Mass., $20.5 million
HHS advises people to take the test at the first sign of symptoms (fever, sore throat, runny nose, others), after coming into contact someone who has COVID-19, or prior to gathering with a group, as a preventative to spread of the coronavirus.
Tracking New BA.2.86 COVID Variant
Currently, the federal Centers for Disease Control and Prevention (CDC) is tracking BA.2.86 (aka, Pirola), a new SARS-CoV-2 variant.
According to CDC’s latest Respiratory Viruses Update:
- Reporting laboratories say existing antibodies work against the BA.2.86 variant.
- The variant does not appear to be linked in the US with increasing infections or hospitalizations.
- It is “unclear how easily BA.2.86 spreads” relative to other variants.
- BA.2.86 has been detected in nine states: Colorado, Delaware, Michigan, Ohio, Pennsylvania, Virginia, Washington, and in wastewater in New York and Ohio, as well as in other countries.
For week ending Sept. 23, the CDC reported the following statistics compared to the prior week:
- 19,079 COVID-19 hospitalizations, down 3.1%.
- Total hospitalizations: 6.3 million.
- 2.7% of total deaths were due to COVID-19, up 8%.
- COVID-19 test positivity rate was 11.6%, down 1.1%.
- 1.8% of emergency department visits were diagnosed with COVID-19, down 11.7%.
According to Verywell Health, BA.2.86 carries more than 30 mutations.
“Even with a lot of mutations, there are a lot of spots in the virus that can be recognized by our immune system, and there are many shared mutations as well. There will be some protection from new vaccine booster as well as prior infections,” Rajendram Rajnarayanan, PhD, Assistant Dean of Research and Associate Professor, Basic Sciences, Arkansas State University, told Verywell Health.
During an online media briefing conducted by the World Health Organization (WHO), Maria Van Kerkhove, PhD, COVID-19 Technical Lead at WHO, said that the variant could be classified by WHO as a “variant of concern” in the event of widespread circulation.
COVID-19, an Endemic Disease?
It’s worth noting that the common cold, influenza, SARS, and SARS-CoV-2 are all in the coronavirus family, and thus closely related with similar symptoms. It would not be a surprise that SARS-CoV-2 joins those other viruses as an endemic virus with a similar yearly cycle of infection rates.
If that happens, and no surge in infections appears that would motivate orders for the new COVID-19 at-home tests, the government may find itself with a lot of unused tests at the end of the year. The US Food and Drug Administration (FDA) is aware of this possibility and provides a website where people can check to see if their test has an extended expiration date.
Plus, folks who are tired of the pandemic may not respond at all to the government’s insistence to prepare for possible surges in infection rates.
“Whether or not people are done with it, we know the virus is there, we know that it’s circulating. We know, if past is prologue, it’ll circulate to a higher degree and spread, and cases will go up in the fall and winter seasons,” said Assistant Secretary for Preparedness and Response Dawn O’Connell, JD, in the HHS new release. “Anticipating that that would be true again, or something similar, we want to make sure the American people have these tools.”
Clinical laboratories may want to prepare as well. Many people are not comfortable with at-home self-testing and prefer to have their local medical labs perform the tests.
—Donna Marie Pocius
Related Information:
Free COVID Testing Will Fade with US Health Emergency in May