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具体信息可以参见下贴

https://zhuanlan.zhihu.com/p/104523064

https://zhuanlan.zhihu.com/p/105556482

On Feb 22^nd 2020, Wondfo One Step COVID-19 Antibody Test (Immunochromatography Assay) developed by Wondfo has successfully received CFDA certificate approved by National Medical Products Administration.

Designed for qualitative detection of SARS-CoV-2 antibodies in human serum, plasma, and whole blood samples, novel coronavirus  antibody detection reagent (Colloidal Gold Method) is regarded as auxiliary detection metrics towards on-site screening for suspected cases that have the negative results after nucleic acid testing. This rapid test can aid in the diagnosis of coronavirus infection and significantly shorten the detection time, yielding the results in 15 minutes.

China has approved two antibody detection reagent of novel coronavirus, a new method of detecting the disease, according to Zhong Nanshan, a prominent Chinese expert in respiratory disease, on Sunday.

Speaking to a medical team sent from Guangdong to Hubei via remote consultation, Zhong said the antibody detection reagent of novel coronavirus would help increase efficiency of testing the disease.

Guangzhou Wondfo Biotech Co, a company specialized in research and development, manufacturing and sales of rapid diagnostic reagents and related equipment, is one of the companies that has successfully developed the reagent.

The antibody detection reagent, or colloidal gold method, approved by the National Medical Products Administration, was one of the first batch of novel coronavirus antibody rapid test permitted to be used on the on-site coronavirus screening.

Novel coronavirus antibody detection reagent can detect both IgM and IgG, with positive result of IgM antibody indicating a recent infection, while positive result of IgG antibody signaling a longer or previous infection.

Designed for qualitative detection of novel coronavirus IgM and IgG antibodies in human serum, plasma and whole blood samples, this rapid test will effectively accelerate the on-site screening for suspected patients within 15 minutes with easier operation, according to the company.

Zhong, one of the leading specialists tackling the outbreak, said the testing method would be of great use to detecting novel coronavirus.

It will specially help us detect very fast patients infected with the novel coronavirus in Hubei province by using the antibody detection reagent – so it will help us better discover patients with the disease, said Zhong.

https://en.wondfo.com.cn/2020/02/24/china-greenlights-new-coronavirus-detection-method/