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The U.S. Food and Drug Administration ( FDA ) has authorized the first over - the - parry compounding trial for bothinfluenzaand COVID-19 , the agencyannouncedon Feb. 24 . However , the psychometric test ’s maker recently charge for failure , so it ’s indecipherable whether the company has the resources to rage up manufacturing and sell the test on a declamatory scale , STAT reported .
The single - use , at - home test kit , made by the California - headquartered party Lucira Health , can differentiate between the two major case of flu viruses — influenza A and influenza B vitamin — as well as detect SARS - CoV-2 , thevirusthat causes COVID-19 . The test uses nasal swob samples and provides results in 30 hour or less ; it ’s intended for use in individuals who ’ve developedsigns and symptoms of a respiratory tract infection .
The FDA issued an emergency use authorization for a new test that detects both flu and COVID-19.
" In individuals with symptoms , the Lucira COVID-19 & Flu Home Test right distinguish 99.3 % of negative and 90 % of positive Influenza A sample distribution , 100 % of electronegative and 88.3 % of positivistic COVID-19 samples and 99.9 % of negative Influenza B samples , " the FDA statement reads .
The agency notice that , since influenza B virus are broadcast at extremely abject grade equate with grippe A , " there are currently not enough case of Influenza B circulating to include in a clinical bailiwick . " Because of this , Lucira confirm that its test can discover influenza B-complex vitamin by using " throw " virus , not take straight off from patients but rather spring up in a research lab mise en scene . The FDA granted an " pinch use authorization " for the test based on this data , but to pull in full FDA blessing , Lucira will need to collect patient samples to confirm that their test reliably detects flu B in material - world context , the FDA said .
Related : Could we ever eradicate the flu ?
All rapid diagnostic tryout produce some false positive — where a person examine positive when they ’re not really infect — and false negatives — where they essay minus despite being infect , the FDA take down . That said , Lucira ’s psychometric test does use " nucleic battery-acid gain " technology , which magnifies the amount of virus in the swab sample , making it more likely to detect both influenza and COVID-19 than a typical speedy test , STAT reported .
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Those who test negative on a Lucira trial run , especially for COVID-19 or influenza B , should consider confirming their result with a more - sore laboratory test , like one that use PCR , the FDA say . " mortal who quiz negative and continue to experience symptoms of feverishness , cough and/or truncation of breath may still have a respiratory infection and should try follow up care with their health care supplier . "
Lucira has n’t unwrap the price of its at - home test , accord to STAT .
