Ping to you as per your request...
On June 12, 2020, FDA granted an amendment to the Emergency Use Authorization for the CDC diagnostic test for COVID 19 to address global shortages of materials needed to perform the test. This amendment provides alternatives for processing the test:
Four additional extraction reagents that can be used in the existing extraction methods
An additional extraction instrument and associated reagents
A new process that can be used in place of the extraction method when materials for the current method are limited
The CDC memo on the subject can be found here: https://www.cdc.gov/coronavirus/2019-ncov/lab/virus-requests.html
My question is: Could this change in testing procedure have influenced the change in the number of positive cases reported after the date of the change? Reported cases began increasing in the middle of June, but fatalities did not show much change until very recently.
Secondly, how does the data on sensitivity and specificity compare between the recently approved changes and the prior procedure?