The "LightPoweriVA SARS-CoV-2 kit 1st RT-rPCR Kit" produced by Viet A Technologies Joint Stock Company has been granted EUL code 0524-210-00 by WHO, the company said Sunday.
A medical staff extracts a pER 1 solution from the test kit as part of a coronavirus test. Photo by VnExpress.
The EUL procedure was established to expedite availability of diagnostics needed in public health emergencies. It helps procurement agencies and countries navigate the large presence of different devices on the market and access quality products.
The kits, which use reverse transcription polymerase chain reaction (RT-PCR), can detect the new coronavirus in droplets obtained from the respiratory tract and blood. They provide results faster and are easier to use than those used by the U.S. Centers for Disease Control and WHO, according to Vietnam's Ministry of Science and Technology.
They were developed successfully by the Vietnam Military Medical University and Viet A Company with funding from the science ministry.
The test kits were licensed by the Ministry of Health and put into mass production in Vietnam in early last month. A kit is good for 50 tests.
Phan Quoc Viet, General Director of Viet A, told VnExpress that having WHO’s approval will make it easier for the products to be exported to other countries. He said organizations such as the World Bank and the global organization Clinton Health Access (CHAI) will enlist Vietnam’s test kits in their Covid-19 supporting programs.
Last Tuesday, Vietnamese Covid-19 test kits also received CE certification and a Certificate of Free Sale from the U.K., which allows them to be sold in Europe.
"After being licensed by the UK Department of Health and Social Care, the Covid-19 test kit made by Viet A has been exclusively ordered by a distribution partner for distribution in the U.K., the U.S., India, Mexico and some countries in Europe to the tune of 1 million tests a month," Viet said.
The quality of Vietnam’s test kits have been evaluated to be on par with that of WHO kit and the US Center for Disease Control and Prevention (CDC), but they also offer other advantages including their specificity, stability, and adaptability with multiple types of testing equipment.
The current price of a test kit is VND400,000-600,000 ($17-26).
The kit is prepared in solution form to examine samples like nasopharynx, pleural fluid and blood. The results arrive in about an hour, excluding time spent on sample processing and extraction.
Last month around 20 countries and territories were negotiating purchase of the kits from Vietnam.
Viet A is set to export its products to Iran, Finland, Malaysia and Ukraine first, Viet had said, but further information about deals struck were not said at the time.
As of Sunday morning, Vietnam had conducted 212,142 tests. Of the country’s 270 Covid-19 patients, 230 have been discharged from the hospital.
Source: https://e.vnexpress.net/news/news/who-approves-made-in-vietnam-covid-19-test-kit-4090402.html
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