
The Latest in Coronavirus (COVID-19) Testing Methods and Availability
Key takeaways:
We now have two main types of tests for coronavirus (COVID-19): molecular and serological.
The fastest test to be authorized by the FDA, created by Abbott, can return results in as little as 5 minutes.
The FDA has just issued the first authorization of an at-home collection molecular test kit by LabCorp.
Due to an influx of potentially unreliable serological antibody tests coming to market, the FDA now requires that these tests be authorized to remain on the market.
We now have two main types of tests: molecular and serological. The FDA has officially authorized over 30 manufacturers to make molecular tests, and over 10 manufacturers have been authorized to distribute serological tests.
Provider-administered saliva tests for coronavirus
Recently, the FDA authorized the first molecular test that uses saliva (instead of deep nose or throat swabs), developed by Rutgers’ RUCDR Infinite Biologics. These tests are as accurate as the swab-based tests, and they may help with the current shortage of testing swabs since patients just need to spit into a collection device.
At-home tests for coronavirus
The FDA authorized the first at-home collection molecular test, called Pixel by LabCorp, on April 20. The test kits contain supplies to collect samples, including a nasal swab which you send back to the lab for testing. Unlike other swab-based tests, Pixel uses swabs that only need to go as far as the nostril, instead of deeper into the nasal passage. A study led by the UnitedHealth Group suggests that results from self-collected testing are similar in accuracy to provider-collected testing.
https://www.fiercebiotech.com/medtech/labcorp-s-at-home-coronavirus-testing-kit-authorized-by-fda