New Government Rules Trigger Demand for COVID Rapid Response Testing

CRL RAPID RESPONSE™ is a saliva-based molecular test, authorized by the FDA under an Emergency Use Authorization (EUA), that can be self-collected and shipped to our lab when it’s determined to be appropriate by a healthcare provider. The test can confirm if the virus is detected in the testee’s saliva.

• Collected samples are mailed to the lab for processing. Results are usually provided within 24 to 48 hours of receipt.
• Laboratories have been encouraged to develop and deploy screening tests, provided they file an application with the FDA for an Emergency Use Authorization (EUA) along with validation studies to support the efficacy and accuracy of their tests.

Warning: Not all coronavirus test kits have been reviewed by the FDA, and results from testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.

As long as there is a demand for them

No

No

Yes

Collected samples are mailed to the lab for processing. Results are usually provided within 24 to 48 hours of receipt.

It’s a saliva-based molecular test to determine the presence of the virus.

When the test taker registers their test kit, they will have the option to get results online or through their mobile phone.

Molecular results to determine active viruses are reported detected (positive) or undetected (negative). Saliva-based molecular testing provides evidence of an active, or recent, infection. The Rapid Response test does not provide a quantitative level of the virus or indicate the severity of the infection.

Samples must be received by the lab within six months of the date a kit was purchased.