FDA Authorizes Rapid COVID Tests That Delivers Results Within 10-15 Minutes
The U.S. Food and Drug Administration (FDA) authorized two rapid COVID tests which can be administered at home. Abbot's BinaxNOW and Quidel's QuickVue are the rapid tests that will soon be available for purchase without a prescription. The BinaxNOW is said to deliver results within 15 minutes while the QuickVue will deliver the results within 10 minutes, according to a USA Today report.
The authorization of the two COVID tests follows a separate authorization of an AI device that can detect underlying symptoms of COVID-19 who are asymptomatic. The said device is deemed to be the first machine learning-based COVID-19 diagnostic screening device and is only allowed to be administered by trained personnel.
2 COVID Tests Approved by FDA
The rapid test provided by Abbott initially required a medical expert to be administered. Soon after, FDA authorized the said kit to be administered at home, but a proctor should virtually watch the process. However, the new authorization from the FDA will allow the individual to administer the tests with themselves, according to an ABC News report.
On the other hand, Quidel's test is designed for people 14 years old and above. It can also be used by adults to collect specimens for children 2 years of age and above.
Before the authorization of the COVID tests from Abbott and Quidel, the only coronavirus test that can be bought without a prescription and is authorized by FDA is the one from Ellume. However, is still not available in the stores, according to an NPR report.
BinaxNOW should be administered twice over three days with 36 hours between each test. Quidel's test has the same conditions, but it should have a window of 24-36 hours in each testing.
"If you catch someone at the right time in their infection, testing more than once will give you opportunities to find any positive results," said Mary Rodgers, a principal scientist from Abbott. Rodgers also pointed out that the benefit of testing more than once gives confidence about the results.
Abbott plans to sell their tests for about $20, with officials from the company emphasizing that should be comparable or cheaper than other health tests. Meanwhile, Quidel noted that they will be announcing their retail partnerships in the coming weeks.
Accuracy of the COVID tests
The FDA has discussed the limitations of the accuracy of some rapid antigen tests because they may be subjected to false-positive results. That is why confirmation testing is still encouraged.
Rodgers explained that their BinaxNOW testing kit is "95%" accurate. Meanwhile, Quidel pointed out that the results of their QuikVue test kit are in agreement with PCR 83.5 percent at a time when the result is positive and 99.2 percent when the result is negative.
"Having an inexpensive over-the-counter test can stop the virus from spreading," said Dr. Michael Mina, an epidemiologist from Harvard. Mina also noted that detecting infectious people is granting them an opportunity to isolate accordingly.
Quidel noted that the company will open a factory that can accommodate the manufacture of 50 million of their FDA-approved COVID tests each month. Meanwhile, Abbott can make, and ship 50 million raps tests each month.
WATCH: This is how the new Abbott Labs COVID-19 rapid test works - from ABC 7 Chicago
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