Random checks on test kits

Random checks on test kits

Antigen test kits (ATKs) will be randomly inspected to make sure they meet requirements before distribution, says the Government Pharmaceutical Organisation (GPO).

The first batch of Sars-CoV-2 rapid antigen test kits, manufactured by Beijing Lepu Medical Technology in China, is scheduled to arrive next week with distribution likely to start from Sept 15.

Nuntakan Suwanpidokkul, a GPO's specialist in quality control, said the GPO will make a production inspection and issue a Certificate of Analysis (COA) if the test kits meet terms of reference (ToR).

The product samples will be sent for testing at a laboratory run by the faculty of medicine at Ramathibodi Hospital, Mahidol University and they must meet three criteria -- sensitivity, specificity and non-specificity -- to be distributed.

According to Ms Nuntakarn, the products will be tested using samples from Covid-19 patients. "If the ATK sets pass the testing, the GPO will deliver them to service units. If they don't, the supplier will send replacements which will also be tested," she said.

Ms Nuntakarn said the supplier is required to investigate any complaints from users, and report the findings to the GPO. If the product is recalled due to quality problems, the supplier is required to provide replacements.

She said the laboratory run by the faculty of medicine at Ramathibodi Hospital has tested more than 50 brands of ATKs which are approved for use by the Food and Drug Administration. She added the testing criteria for the ATKs are in line with the FDA's and drawn up by the Department of Medical Sciences and the Medical Technology Council.

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