The Therapeutic Goods Administration (TGA) has fined two pharmaceutical companies over low quality rapid antigen tests (RATs).

Eight infringement notices totalling $106,560 have been issued to Hough Pharma Pty Ltd for allegedly failing to provide information on the safety and performance of three COVID-19 rapid antigen tests (RATs), while competitor 2San Pty Ltd has copped five infringement notices totalling $66,600 for allegedly failing to provide information demonstrating the ongoing minimum level of sensitivity of two RATs.

The TGA has accused both companies of “serial non-compliance”. 

The fines come in the wake of a post-market review into antigen and RATs currently being sold in Australia.

The experts say that a variant of the COVID-19 virus arises from mutations in the SARS-CoV-2 virus of the genome and may alter the structure of the expressed viral protein.

“As a result, test kits may no longer be able to sensitively detect the virus, leading to false negative results,” the TGA says. 

Tests made by 2San and Hough will remain on the list of tests approved in Australia while a review is underway. 

COVID-19 tests must meet technical specifications including “a clinical sensitivity of at least 80% (for specimens collected within seven days of symptom onset) and a clinical specificity of at least 98%.”

As testing continues, the TGA is posting the ongoing results of its post-market RAT review.