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27th February 2020  Author: Paul Carton

Shenzen Bioeasy Receive CE-Marking for its Lateral-Flow Ag and Ab SARS-CoV-2 Test Kits

Antibody testing performed on SARS-CoV-2 infected individuals up until now has mostly been used in research settings to establish links between cases close to the origins of the Wuhan Coronavirus outbreak. Antibodies produced by infected persons are specific for the novel coronavirus and remain in the body for several years even after the virus has been eliminated.

Most diagnostic kits that have been approved up until now have been molecular-based, targeting genes in the virus.

Shenzen Bioeasy Biotechnology is the first company to attain CE-marking for its COVID-19 lateral-flow immunoassay test kits. The following three kits have obtained certification: one antibody test; 2019-nCoV IgG/IgM Rapid Detection Kit and two rapid antigen test kits; 2019-nCoV Fluorescence Ag Rapid Antigen Test Kit and the 2019-nCoV Colloidal Gold Ag Rapid Test. All three tests can provide results in 15 mins. 

*On the 29th of March there were reports in the media, that national health authorities who had purchased one of these tests, could not rely on the results due to its poor accuracy upon validating them.This colloidal gold Ag test has now been withdrawn by the company.

The video below shows how to take a sample and how to its Fluorescence Ag test. 

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Date Published: 27th February 2020

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