Individual EUAs for Antigen Diagnostic Tests for SARS-CoV-2

Reported by CCTV news on Oct. 16th, variety of countries need to enlarge the test method to speed up the diagnosis on COVID-19. Some of the countries used the faster and cheaper test methods to overcome the bottleneck of inadequate capability of nucleic acid testing. Millions of antigen reagent has been purchased by Italy, US, Canada, etc. There are 3 major methods for COVID-19 testing: nucleic acid detection, antibody detection and antigen detection. Each of the method has its advantage and disadvantage, which depends on the situational application. Because of the technological difficulties for specific antigen preparation, the successful used antigen reagent is far less than antibody reagent globally.

There are 57 COVID-19 testing products (49 reagent kits, 7 types of instrument and a testing software) emergently authorized by NMPA till Oct. 20th, 2020 with 24 types of nucleic acid reagent kits and 25 types of antibody testing kits without any antigen product approved. 22 types of reagent has been listed on WHO with 2 types of antigen products producing by a Korean company, SD Biosensor and Abbot.

284 types of COVID-19 EUA products approved by FDA with 56 of antibody and 6 antigen products from Abbott, Quidel, BD, LumiraDx, enalyte, Access Bio. Roche announced that a new antigen product will be launched at the end of the year applied the rapid chromatographic immunoassay method which can obtain the result in 15 minutes with 96.52% of sensitivity and 99.68% of specificity.

In China, over 430 companies have obtained the approval authorized by China Chamber of Commerce for Import & Export of Medicines & Health Products. But not to many companies whom research the antigen reagent, even none of them obtains the EUA from NMPA. The application rate of antigen reagent is lesser, but some Chinese IVD companies have gradually got the certificate abroad such as Wondfo, Snibe, Hotgene, Thalys, etc.

This table hereunder includes information about authorized SARS-CoV-2 antigen diagnostic tests that have been authorized individually. These EUAs have been issued for each individual test with certain conditions of authorization required of the manufacturer and authorized laboratories. 

Quidel Corporation

Issued date：Oct. 2nd, 2020

Approved product：Sofia 2 Flu + SARS Antigen FIA

Issued date：Jul. 17th, 2020

Approved product：Sofia 2 SARS Antigen FIA

Abbott Diagnostics Scarborough, Inc.

Issued date：Aug. 26th, 2020

Approved product：BinaxNOW COVID-19 Ag Card

Becton, Dickinson and Company (BD)

Issued date：Jul. 23rd, 2020

Approved product：BD Veritor System for Rapid Detection of SARS-CoV-2

Luminex Corporation

Issued date：Jul. 16th, 2020

Approved product：xMAP SARS-CoV-2 Multi-Antigen IgG Assay

LumiraDx UK Ltd.

Issued date：Aug. 18th, 2020

Approved product：LumiraDx SARS-CoV-2 Ag Test

Access Bio, Inc.

Issued date：Oct. 8th, 2020

Approved product：CareStart COVID-19 Antigen test

Genalyte, Inc.

Issued date：Oct. 8th, 2020

Approved product：Maverick SARS-CoV-2 Multi-Antigen Serology Panel v2

Although the precision of antigen detection is less than nucleic acid testing, but it has lower cost and detects the outer element of the virus to confirm whether or not the patient infected with the COVID-19 in 15-30 minutes which will enlarge the testing scale increasing the efficiency of diagnosis, especially the remote area and high infection rate region.

The antibody can not be detected at the beginning of the infection, so the patients on this stage cannot be screening. The antigen detection needs to be applied If it needs the immunoassay to screening.