Author: Scarlett Publish Time: 2022-06-09 Origin: Site
Aotearoa New Zealand Ministry of Health approved on Goldsite SARS-CoV-2 Antigen Kit (Colloidal Gold) for self-testing, allowing Goldsite make the list of one of the 18 manufacturers get approved for legal market in NZ, by 10 June, 2022.
This kit is designed to detect new coronavirus infections within 12 minutes and can be used for rapid and effective screening of large populations in the community. Even children and the elderly can self-collect their own samples, which is convenient and can avoid cross-contamination in mass screening. Rapid antigen tests (RATs) are currently Aotearoa New Zealand’s primary testing tool for people with COVID-19 symptoms or household contacts. Testing is free for those with symptoms and/or who are household contacts.
Back in November 2021, GODLSITE SARS-COV-2 ANTIGEN KIT (COLLOIDAL GOLD) was certified by the EU regulator under CE 1434 for home self-testing, which was not easy to obtain and required the provision of a clinical validation report and layperson's usability of the product to the Notified Body of the European Union. A series of technical documents, such as a clinical validation report and a layman's usability report, are required to prove that the product is effective and safe for market use. The Hong Kong Government has also published the GOLDSITE Antigen Rapid Test as a recommended brand on the Government's COVID-19 information page.
Up to now, GOLDSITE RAT has been approved for home use in many major European markets such as UK, France, Germany, Belgium, Switzerland, New Zealand, Spain and Italy, HK, Macao, Saudi Arabia and so on, making its name aloud from home and abroad.