Vietnamese COVID-19 test kits receive EU seal of approval

April 21, 2020 - 20:27

A kit, that can theoretically be used to test on 50 people, meets all the criteria on virus sensitivity, specificity and accuracy set by the World Health Organisation.

Việt Nam's domestically made COVID-19 test kits, jointly developed by Việt Á Corporation and the Military Medical University. — VNA/VNS Photo Dương Giang

HÀ NỘI — COVID-19 test kits produced in Việt Nam have been approved by the UK and EU.

Phan Quốc Việt, Director-General of Việt Á Corporation, made the announcement on Tuesday regarding the joint-effort between the company and the Military Medical University that debuted on March 5.

A kit, comprising 50 separate tests that can theoretically be used to for SARS-CoV-2 on 50 people, meets all the criteria on virus sensitivity, specificity and accuracy set by the World Health Organisation (WHO).

The full timescale for the RT-PCR test kit to produce a result, either negative or positive for SARS-CoV-2, is a little over two hours.

Production costs have been funded by the Ministry of Science and Technology, so the price of each kit remains at an affordable VNĐ400,000-600,000 (US$17.06-25.59) per test.

While the UK officially left the EU on January 31 this year, the EU’s pharmaceutical legal framework is still applicable in the UK until the end of 2020.

Việt said that after the receiving the CE marking from the UK’s Department of Health and Social Care in line with Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, the company's UK-based partner Redcliffe Bioscience Holdings Limited was selected as an authorised distributor to sell the products in the UK, India, Mexico, the US and certain European countries.

It said one million test kits would be supplied a month for these countries.

A single SARS-CoV-2 test in the 50-test kit. — VNA/VNS Photo Dương Giang

In March, 20 countries began negotiations to buy the test kits from Việt Nam.

Việt Á said had already fulfilled export orders for 4,000 test kits from Iran and 300 from Ukraine.

Hà Nội City has placed an order of 4,000 test kits from Việt Á for its own use and to donate to Italy, one of the countries hit hardest by the novel coronavirus pandemic.

Việt Á Corp said that it could produce 10,000 test kits a day and ramp up production to three times that amount to meet domestic and export demands.

The RT-PCR diagnostic method is the internationally recommended testing method. Quick tests that offer results within 10-15 minutes have been deemed to be less accurate. — VNS