Australian's Therapeutic Goods Administration (TGA)

Australia Investigating COVID-19 Tests’ Ability to Catch New Viral Variants

February 5, 2021

Australia’s Therapeutic Goods Administration (TGA) is conducting a postmarket review of all COVID-19 point-of-care and laboratory tests listed in its register to ensure they can detect new coronavirus variants.

The presence of genetic variants of SARS-CoV-2 in a patient sample has the potential to impact 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 affected by genetic variations than tests that rely on detecting just a single region.

Genetic variants of SARS-CoV-2 “may yield false-negative test results,” but 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,” TGA said.

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