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SARS-CoV-2 Rapid Test Kit obtain customs import and export qualification

Poptime:2020-04-29 Page View:1981

On the evening of April 25, the Ministry of Commerce, the General Administration of customs and the State Administration of Market Supervision issued announcement No. 12 of 2020 on “Further Strengthening the export quality supervision of epidemic prevention materials”. The announcement pointed out that the products promised to meet the quality standards and safety requirements of the importing countries (regions), could be checked and released on the basis of the list of production enterprises with foreign standard certification or registration provided by the Ministry of Commerce.           

SARS-CoV-2 IgG/IgM Antibody Rapid Test Kit which is produced by our company (Time Resolved Fluorescence Immunochromatographic Assay) is introduced to the list of Customs export enterprises.          

Website: www.cccmhpie.org.cn

SARS-CoV-2 IgG/IgM Antibody Rapid Test Kit(Time Resolved Fluorescence Immunochromatographic Assay) was developed and tested in the end of February. On March 25, which obtained CE certification from MHRA and EU market access qualification (MHRA: IVD001126).

Guangjing Biotechnology Co., Ltd. always strives for survival with quality, development with integrity and efficiency with service. Its mass production kits have obtained CE certification and ISO13485 system certification of the European Union. It has been clinically verified and used in clinical institutions in many countries of the European Union, and has obtained good evaluation. It has cooperated with many international institutions.

SARS-CoV-2 IgG/IgM Antibody Rapid Test Kit is capable of completing the sampling, testing and giving results within 10 minutes based on the global exclusive patent time resolved fluorescence immunochromatography (PCR) technology platform. It does not need sample amplification and culture to achieve rapid qualitative and quantitative detection of bedside. Meanwhile, it also detects novel coronavirus disease (COVID-19) virus IgG and IgM antibody; it has greater clinical advantages in the determination of plasma therapeutic antibody content, observation of vaccine immune response, screening of asymptomatic patients with novel coronavirus infection, resumption of labor and resumption of school screening.      

High precision: The time resolution of uniform nanoparticle can effectively eliminate background interference and background interference signal, so that the precision of detection results is high.            

Ultra sensitive: The sensitivity can reach pg / ml. It can be used in the early diagnosis of microantigen and antibody.          

Quantitative detection: Compared with colloidal gold , Time Resolved Fluorescence Immunochromatographic Assay detection items can be quantified and the accuracy of the detection can be improved.          

Wide applicability: whole blood (including peripheral blood), plasma and serum can be used for detection.           

We are looking forward to working with medical institutions and channel providers at home and abroad to help prevent and control the global new crown epidemic, and work together to fight the epidemic!

Mar. 2014

CFDA approvals for five immunoassay reagents adaptable to most chemical analyzers were obtained

Feb. 2014

CFDA approvals for time-resolved fluorescence immunochromatographic analyzer were obtained

Sep. 2013

Lumigenex passed The first Food and Drug Administration by the Suzhou Municipal Quality Management System Assessment