TGA Investigates COVID-19 Tests and Emerging Variants

Australia’s Therapeutic Goods Administration (TGA) is conducting a postmarket review of all COVID-19 point-of-care and laboratory tests listed in the Australian Register of Therapeutic Goods to ensure that they can detect emerging SARS-CoV-2 genetic variants.

The presence of genetic variants of the coronavirus in a patient sample can potentially change the performance of a COVID-19 test, the agency said, adding that tests relying on the detection of multiple regions of the coronavirus genome may be less impacted by genetic variations than tests that rely on detection of only a single region.

“Laboratory and health professionals should be aware that genetic variants of SARS-CoV-2 may yield false-negative test results and that the use of [polymerase chain reaction] tests that use multiple genetic targets to determine a final result are less likely to be impacted by increased prevalence of genetic variants,” the TGA said.