WASHINGTON-Americans will soon have two options over-the-counter Covid-19 tests as the FDA granted an Emergency Use Authorization (EUA) for an OTC rapid antigen test that will not require a doctor's prescription.
Acting on the guidelines of the Indian Council of Medical Research (ICMR), the state health department issued an order on Monday making it mandatory for people with Covid-19 symptoms to undergo RT-PCR test even if their results are negative through Rapid Antigen Test (RAT).
"While worldwide travellers are no longer eligible to receive a publicly funded COVID-19 test, we remain committed to ensuring that anyone who needs a test can get one quickly, at no cost", said Christine Elliott, Ontario's Minister of Health.
The home test connects with an app on the user's smartphone to interpret the results.
About 25 tests allow people to collect their own sample at home - a nasal swab or saliva - but then they are shipped to a laboratory.
In data submitted to the FDA, Ellume's home test correctly identified 95% of COVID-19 cases and had a 3% false positive rate among patients with symptoms when compared to a lab-based PCR test.
Similar to other antigen tests, a small percentage of positive and negative results from this test may be false, the FDA said. Patients who test positive and show no symptoms should be presumed positive until another test can confirm results, the FDA said.
Minnesota Sees Low COVID-19 Cases, Deaths For Second Straight Day
The preliminary seven-day statewide positivity for cases as a percent of total tests from December 7-13 is 8.7%. The province reached a record number of active cases at 10,039 and record number of hospitaliations with 359.
"The FDA strongly supports innovation in test development and we have worked tirelessly with test developers to support the shared goal of getting more accurate and reliable tests to Americans who need them".
In an interview, Ellume chief executive Sean Parsons said supply initially will be limited to 100,000, with plans to increase manufacturing to 1 million by the middle of next year. "However, the fact that it can be used completely at home and return results quickly means that it can play an important role in response to the pandemic".
Ellume's test looks for viral proteins shed by COVID-19, which is different from the gold-standard approach of tests that look for the genetic material of the virus.
Worldwide travelers will now be expected to pay for a coronavirus test to get the green light to fly out of Ontario, the minister of health said.
People who get a negative result but have coronavirus symptoms should follow up with a health professional, the FDA said. The mobile application requires individuals to input their zip code and date of birth, with optional fields including name and e-mail address, and reports the results as appropriate to public health authorities to monitor disease prevalence.
The Australian company Ellume expects to produce more than three million at-home coronavirus tests in January 2021.