NO MORE RT-PCR?: CDC withdraws EUA for COVID-19 test; Sands says it will be “logistical switch”

NASSAU, BAHAMAS — The withdrawal of the Centers for Disease Control and Prevention’s (CDC) emergency use authorization (EUA) of its real-time RT-PCR COVID-19 tests by the end of this year will present a “logistical switch” for The Bahamas, according to former Minister of Health Dr Duane Sands.

However, the surgeon suggested the change in testing is a non-issue.

In a July 21 alert, the CDC advised that after December 31, 2021, it will withdraw its request to the Food and Drug Administration (FDA) for EUA of the real-time RT-PCR diagnostic panel test, which was introduced last February to detect the presence of COVID-19.

It recommended that laboratories using RT-PCR transition to a test that can differentiate the coronavirus from influenza viruses.

It said it provided the advance notice for clinical laboratories to have adequate time to select and implement one of the many FDA-authorized alternatives.

“In preparation for this change, CDC recommends clinical laboratories and testing sites that have been using the CDC 2019-nCoV RT-PCR assay select and begin their transition to another FDA-authorized COVID-19 test,” read the statement.

“CDC encourages laboratories to consider adoption of a multiplexed method that can facilitate detection and differentiation of SARS-CoV-2 and influenza viruses.

“Such assays can facilitate continued testing for both influenza and SARS-CoV-2 and can save both time and resources as we head into influenza season.

“Laboratories and testing sites should validate and verify their selected assay within their facility before beginning clinical testing.”

The FDA issued 59 EUAs for tests for detection of COVID-19.

It has established a reference panel for analysis of the sensitivity of a range of tests to the virus.

It said while the reference panel helps to determine the comparative performance among authorized tests, it is not a replacement for the analytical and clinical validation recommendations by the FDA.

The range of FDA-approved tests include antigen and molecular tests; serology, antibody and other adaptive immune response tests, such as T-cell immune response; as well as tests that detect biomarkers related to inflammation.

Earlier this year, a US study suggested the presence of COVID-specific effector T-cells is likely a predictor of an individual’s ability to recover from severe COVID-19.