The most accurate home manufacturer COVID-19 (new coronavirus infection) Market tests show it has been excluded again from Biden administration policy Latest free order numbers Through COVIDTests.gov, the seventh relies on non-sensitive information. “Antigen” testis an inexpensive option commonly available on drugstore shelves.
Federal health officials justified this millions of dollars they spent Criticized device makers for the latest wave, citing the importance of subsidies for U.S. factories that can produce tests ahead of a new pandemic. request It has evaporated.
Taxpayer dollars primarily go to manufacturers of inexpensive rapid antigen tests, such as New Jersey’s Access Bio and California’s EyeHealth, rather than more accurate “molecular” alternatives that the Food and Drug Administration has also given the go-ahead for. There is.
A spokesperson for the Office of Strategic Preparedness and Response said in a statement that all tests being distributed “meet the sensitivity and specificity requirements established by the FDA.”
“ASPR prioritizes sourcing affordable, highly accurate, and domestically manufactured tests,” the spokesperson said.
What is the most accurate home test for COVID-19?
The FDA has currently authorized only four brands of over-the-counter molecular tests for COVID-19, which are the most accurate but also the most expensive options.
Pfizer’s Lucira sells a single-use test that detects both coronavirus and influenza with the lowest initial cost starting at $39.99. Results take about 30 minutes and each test is valid for 18 months, according to the FDA. Aptitude Medical Systems sells a “starter bundle” that comes with a reusable reader and two test kits for $99.97. Results take about 30 minutes and the test is valid for about 18 months, according to the FDA. Additional test kits cost $24.99. 3EO Health sells a “starter kit” that includes a reusable test device and two swabs for $195. Results take about 30 minutes and the test is valid for four months, according to the FDA. Additional swabs and “test keys” cost $39.90 for a two-pack. Cue Health sells reusable “readers” for $199. Test kits are currently out of stock on the company’s website. Results take about 20 minutes and the test is valid for about four months, according to the FDA.
Although these prices are many times higher than antigen test options, device manufacturers say COVID-19 tests are generally available for testing. flexible spending account or health savings account dollars, which may be reimbursed under some health insurance plans.
Molecular tests take longer to produce results because they require chemical reactions to be triggered to amplify traces of the virus that less accurate tests may miss.
This means that the advertised sensitivity, or accuracy in accurately detecting infection, is up to 90% or more, even when people have no symptoms of the virus.
In contrast, the FDA warns that Americans who rely on antigen tests should be prepared to use up multiple kits if they are concerned about possible infection.
Antigen options carry a high risk of false-negative results, especially early in the infection, so tests must be repeated several days after the first test is negative, officials said.
This distinction is important early in the treatment process. COVID-19 infectionwhen the CDC says people are most likely to be contagious. Most infectious virus is detected in patients “within a few days before or after” the onset of symptoms.
The CDC states: Latest guidance A negative antigen test result is an “option” that can help determine when it is safe to end isolation in the final stages of infection, and a “rough indication of whether you are still infectious” to others. Provide.
What brands of antigen tests does COVIDTests.gov ship?
Manufacturers of antigen tests for COVID-19 told CBS News they are still delivering kits to the federal government through ASPR awards over the past several years, including additional contracts with 10 manufacturers last year. He said that it would be possible.
Test kits are also being distributed “directly to health centers, long-term care facilities, food banks and other community locations,” an ASPR spokesperson said.
Among these brands, the following were able to obtain “traditional marketing authorization” from the FDA and continue selling their tests as emergency authorities scaled back their efforts in the wake of the pandemic:
CorDx sells a 2-pack for $14.99 that provides results in 10 minutes. iHealth Labs sells a 2-pack for $17.98 that provides results in 15 minutes. InBios International sells a two-pack for $8.50 that provides results in 20 minutes. Quidel Corporation sells a two-pack for $16.99. 10 minutes
Other tests, such as OraSure’s InteliSwab kit, are still under emergency use authorization. The “more accessible” test will again be offered free of charge to Americans who are blind or have low vision this year through the Department of Community Living.
ASPR says that although less accurate than molecular tests, this year’s antigen tests will still be able to “detect currently circulating COVID-19 variants.”
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