Against Pandemic: Goldsite’s SARS-CoV-2 IgM / IgG kit was approved by EU 

On March 12, Shenzhen Goldsite’s SARS-CoV-2 IgM / IgG kit (using time-resolved fluorescence immunoassay) has been approved

by EU with CE marked.

CE stands for CONFORMITE EUROPEENNE. The CE mark indicates that the product complies with all relevant directives of the European Commission and symbolizes compliance with EU laws. Obtaining the CE mark allows the product to circulate freely in the European Economic Area and has access to the EU market. 

Goldsite’s SARS-CoV-2 IgM / IgG kit is equipped with Goldsite GT-100 Time-Resolved Fluorescence Immunoassay Analyzer for the qualitative detection of IgM and IgG antibody in human serum and plasma samples.

IgM is the first antibody to appear in the acute infection stage caused by pathogens such as SARS-CoV-2 and can normally be detected 3 days after the onset of symptoms. IgG is produced in the middle or later stage of the infection but provides long-term protection. In the latest 7th edition of the Diagnosis and Treatment Guideline on the Novel Coronavirus Disease (COVID-19), the SARS-CoV-2 IgG/IgM is recommended as an aid of the diagnosis of the COVID-19. By comparing with the gold standard PCR method that typically takes hours, the detection of antibodies in blood samples effectively avoids direct contact with the highly infectious samples and delivers results in a much faster way.

GT-100 Time-Resolved Fluorescence Immunoassay Analyzer (CE marked) is compact and portable. This analyzer employs the time-resolved fluorescence immunoassay (TRFIA) method that delivers highly sensitive results and has least interference from the background signal. In the SARS-CoV-2 Kit, by using the elegantly designed cartridge, only a tiny amount of sample (20 μL) is required for a single test with no additional reagents needed. Results can be quickly obtained within 12 minutes. In addition, a combination of S (spike) and N (nucleocapsid) viral proteins are used as the capturing antigens such that the IgM and IgG to both antigens could be detected which would significantly increase the test sensitivity and reduce the false negative rate. In a word, the kit would greatly help the early identification of suspected COVID-19 patients leading to better disease control.

Recently we are witnessing more countries has become the epidemic center in Europe, indicating that this threat is not only faced by one country but the whole human community because the virus has no passport and travels without border restriction. For the past 2 months, China has been taking effective measures to contain the spread of the virus, along with the medical staff, research institutions and biotech companies have been also fighting at the frontline. As a social responsible company, Goldsite has been committed to making high-quality products accessible worldwide to help improve public health globally. So far we have provided solutions for more than 40 countries and regions, such as the United Kingdom, Italy, Sweden, South Korea, Spain, India, Turkey, and Mexico and so on. In this COVID-19 epidemic, Goldsite promises to continue playing the responsible and active role in fighting against the war.