They’ve been banned in the EU, however the Thai authorities says the cheap antigen take a look at kits from NovaGen can be used here as a result of they’ve been permitted 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 further paperwork.
According to a Bangkok Post report, Sirikul says the EU has recently modified the foundations on ATK registration and now requires additional paperwork earlier than it can approve the NovaGen kits. As the producer has not yet up to date its licence, the kits were faraway from sale last month. NovaGen antigen check kits are made by HangZhou AllTest Biotech in China. Sirikul says the agency has now submitted the additional paperwork required by the EU.
“We’ve contacted the company concerning the case and been advised that the company has already submitted the required document for EU consideration. When accredited, it’s going to create more confidence within the product. But the product has already been licensed by the Thai FDA so it is efficient for use.”
The Thai Food and Drug Administration has additionally come out in help 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 may give 100% accuracy. The product approved by the FDA has a false constructive fee of round 1 – 2%.”
The FDA says it has now permitted 193 antigen test kits from one hundred producers, which can be utilized for home testing. The agency has also permitted one other ninety three ATKs for professional use, including NovaGen, which was accredited in July.
In related information, the Bangkok Post reports that the FDA has teamed up with on-line retailers Lazada, Shopee, and HDmall on safety standards for ATKs sold on the sites. Value will present a hyperlink to the FDA’s website the place customers can confirm that the kits are genuine.
For more information on Covid-19 Insurance, CLICK HERE.
SOURCE: Bangkok Post