Breakthrough testing standard developed for COVID-19 RATs

IN a world first, James Cook University researchers have developed a new way to rate the effectiveness of Rapid Antigen Tests (RATs), which could lead to more reliable testing of patients.

The study highlights the wildly varying accuracy of RATs and has prompted calls by the JCU team and others for better quality assurance of the tests.

JCU researchers used a fluorescent protein to develop a new reference standard to check RAT performance.

The team selected ten RATs for evaluation. They used a COVID-19 fluorescent protein to determine each test’s lowest detectable amount of COVID-19 protein.

Out of the 10 RATs analysed, only two returned consistently positive readings at the lowest concentration of COVID-19 protein used.

While a recent Canadian study proposed a reference standard for RATs, JCU Associate Professor of Molecular and Cell Biology Patrick Schaeffer said the JCU study was the first of its kind to develop a standard and implement it to compare RATs.

“This reference standard has allowed us to make very simple and efficient quality control assessments,” Prof Schaeffer said.

“At the moment, RAT performance is based on what the manufacturer says, but they have never been compared using the same standardised COVID-19 protein.

“Currently, the Therapeutic Goods Administration and World Health Organisation request that manufacturers disclose the analytical sensitivity of their RATs, but they are not cross-checked in an independent lab.”

Associate Prof Schaeffer said the study’s results highlighted an urgent need for the TGA and WHO to push for a standard reference material to compare the accuracy of hundreds of different RAT brands.

“We need a reliable reference standard to rank all current and future RAT devices and ensure that their performance is accurately communicated to healthcare providers and the public,” he said.

“We believe our fluores-