They’ve been banned in the EU, but the Thai government says the cheap antigen test kits from NovaGen can be used here because they’ve been approved by the Thai Food and Drug Administration. Sirikul Methivirangsan from the Government Pharmaceutical Organisation says the reason they’re banned in the EU is due to the bloc requiring some additional paperwork.
According to a Bangkok Post report, Sirikul says the EU has recently changed the rules on ATK registration and now requires extra documents before it can approve the NovaGen kits. As the manufacturer has not yet updated its licence, the kits were removed from sale last month. NovaGen antigen test kits are made by HangZhou AllTest Biotech in China. Sirikul says the firm has now submitted the extra paperwork required by the EU.
“We’ve contacted the company regarding the case and been told that the company has already submitted the required document for EU consideration. When approved, it will create more confidence in the product. But the product has already been certified by the Thai FDA so it is effective for use.”
The Thai Food and Drug Administration has also come out in support of NovaGen, with Dr Surachok Tangwiwat saying in order to win FDA approval, all ATKs must show at least 90% sensitivity and 98% specificity.
“No brand can give 100% accuracy. The product approved by the FDA has a false positive rate of around 1 – 2%.”
The FDA says it has now approved 193 antigen test kits from 100 manufacturers, which can be used for home testing. The agency has also approved another 93 ATKs for professional use, including NovaGen, which was approved in July.
In related news, the Bangkok Post reports that the FDA has teamed up with online retailers Lazada, Shopee, and HDmall on safety standards for ATKs sold on the sites. The retailers will provide a link to the FDA’s website where customers can verify that the kits are genuine.
For more information on Covid-19 Insurance, CLICK HERE.
SOURCE: Bangkok Post