CDC withdrawing its request for emergency use authorization for its COVID-19 PCR diagnostic test does not mean the test failed

On July 21st, 2021, a Lab Alert issued by the U.S. Centers for Disease Control and Prevention (CDC)’s Center for Surveillance, Epidemiology, and Laboratory Systems announced that the CDC would be withdrawing its request for emergency use authorization for its COVID-19 PCR diagnostic test after December 2021. Claims regarding the misuse of the COVID-19 PCR test have been circulating for quite some time. This Lab Alert has rekindled these claims, using it as validation that the test is inaccurate. Many are also citing this statement in the Lab Alert: “CDC encourages laboratories to consider adoption of a multiplexed method that can facilitate detection and differentiation of SARS-CoV-2 and influenza viruses” and using it as validation that the test cannot differentiate the difference between SARS-CoV-2 and the flu virus.

It should be noted that the Lab Alert only pertains to the CDC’s own COVID-19 diagnostic PCR test. A spokesperson from the CDC has explained that the performance of the CDC’s RT-PCR test for detecting COVID-19 didn’t suffer from any problems. They have withdrawn their RT-PCR test because there are better tests that have since been developed which can process more samples within a given time. There are also tests that can now detect more than one pathogen. The COVID-19 PCR test specifically detects the presence of the genetic material from SARS-CoV-2. The genetic sequence of the flu virus is different from the SARS-CoV-2 virus and wouldn’t be detected by a COVID-19 PCR test.

As reported by Angelo Fichera on

In explaining the CDC’s decision to end the use of its own PCR test at the end of 2021, Kristen Nordlund, an agency spokeswoman, in an email to us cited “the availability of commercial options for clinical diagnosis of SARS-CoV-2 infection, including multiplexed (discussed here) and high-throughput options” — referring to technologies that use an automated process to administer hundreds of tests per day.

“Although the CDC 2019 Novel Coronavirus (2019 nCoV) Real-Time RT-PCR Diagnostic Panel met an important unmet need when it was developed and deployed and has not demonstrated any performance issues, the demand for this test has declined with the emergence of other higher-throughput and multiplexed assays,” Nordlund said.

She continued: “CDC is encouraging public health laboratories (PHL) to adopt the CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay to enable continued surveillance for both influenza and SARS-CoV-2, which will save both time and resources for PHL.”