I. Description of the test

On November 9, 2021, a new coronavirus B.1.1.529 mutant strain was detected for the first time in South Africa from a case sample. 26 November, it was defined by WHO as the fifth "Variant of Concern" (VOC), named Omicron (Greek letters). ) mutant strain. As of the 28th, importation of this variant has been detected in South Africa, Israel, Belgium, Italy, the UK, Austria and Hong Kong, China.

AIVD was the first to complete the detection and analysis of the current major prevalent new coronavirus mutant strains, including alpha (B.1.1.7), Beta (B.1.531), Gamma (P.1), Delta (B.1.617.2, AY1, AY2, AY3), Eta (B.1.525), Lota (B.1.526), Zeta (P2), Kappa (B.1.617.1), Lambda (C.37, C371), Mu (B.1.621, B.1.621.1), Epsilon (B.1.427, B.1.429), Fin-796H, N.9, B.1.616, B.1.640, and the recent new release of Botswana (B1.1.429), Fin-796H, N.9, B.1.616, B.1.640 and the recently released mutant strains of Botswana/Hong Kong/South Africa Omicron (B1.1.529) and Congo/France B.1.640. AIVD's new coronavirus antigen detection reagent has the same sensitivity and specificity for the above-mentioned virus mutant strains.

Meanwhile, AIVD will continue to pay attention to the emergence of new coronavirus mutations at home and abroad, and evaluate the detection ability and product performance of AIVD's COVID-19 test kits against the mutated strains in a timely manner to ensure that the accuracy and sensitivity of the kits will not be affected.

II. Company Introduction

AIVD is a national high-tech enterprise specialized in providing total solutions from raw materials to reagents for global in vitro diagnostic reagent manufacturers. The company has passed the SGS ISO9001:2015 and ISO13485:2016 quality system certification, and is the only domestic manufacturer of diagnostic reagent raw materials that has obtained the dual certification.

AIVD has a strong technical R&D team, standard GMP production plant, efficient production team and professional after-sales service team to provide customers with a full set of technical solutions with professional and high quality services.

AIVD provides the following products.

1、Neo-coronavirus antigen/antibody large plate production

2、Neo-coronavirus antigen/antibody kit assembly

3、New coronavirus core material (antigen/antibody) production 

About AIVD

AIVD is a national high-tech enterprise specialized in providing overall technical solutions for global in vitro diagnostic reagent manufacturers. The core team members have rich experience in product development, production and registration. There are more than 100 members, among which more than 70% of the R&D staff are composed of PhD, master and undergraduate students. The existing site area is 5000 square meters, including 3000 square meters for R&D and 2000 square meters for production. Our products cover multiple platforms such as enzyme immunoassay, colloidal gold, fluorescence chromatography, chemiluminescence, immunoturbidimetry and molecular diagnostics. Avidi provides a full set of technical solutions for customers with professional and high quality services, including custom development of raw materials to OEM production; custom development of finished reagents to bulk packaging production; optimization of products to production processes. Since the establishment of the company, the team has successfully delivered a number of first-of-its-kind diagnostic reagents in China, and partially achieved the localization of imported raw materials.