Local researchers improve coronavirus testing accuracy
A new coronavirus nucleic acid reference material developed by Shanghai researchers has been approved for use in testing kits, the city's market watchdog announced on Monday.
The new material includes coronavirus RNA and is meant to improve the accuracy of results from nucleic acid tests, said the Shanghai Administration for Market Regulation.
Developed by Shanghai Institute of Measurement and Testing Technology (SIMTT) affiliated with the administration, it has been approved as a national-level reference material by the State Administration for Market Regulation.
“Biological reference materials are like balancing weights, which test whether a reading is accurate," said Liu Gang, a researcher at the institute.
"The material reduces the possibility of 'false negative' results," he said.
There have been more than 100 types of coronavirus nucleic acid test kits developed by local biomedical enterprises, but their accuracy has varied, said Liu.
Older tests relied on ultraviolet spectrophotometery as the basis for their results, said Liu, who explained that such methods lack the reliability of reference standards based on RNA.
"However, RNA reference material research was a big challenge because RNA molecules are not stable. Reliable and accurate RNA quantitative data was also lacking," said Liu.
It usually takes between 18 months and two years to develop and approve a national-level reference material, although in this case a priority channel opened by national market regulators has shortened the process to two months, said Xu Lai, deputy director of the Shanghai Administration for Market Regulation.
The reference material has already been supplied to local disease control and prevention centers and enterprises, and has also been supplied overseas amid the spread of the coronavirus globally, SIMTT said.
Rapid-testing technologies used in Italy and South Korea have already used the RNA reference material, SIMTT said.
The daily production capacity of the reference material is 1,000 sets.
A number of nucleic acid test kit producers like Shanghai ZJ Bio-Tech Co and Shanghai GeneoDx Biotech Co, universities such as Xiamen University and Hunan University, and Ruijin Hospital have used the reference material for free as well, according to market administrators.