This product is for the professional use, only to be sold for Governments and private companies related to pharmaceutical areas.
Lateral flow immunoassay for the detection of IgG and IgM antibodies of SARS-CoV-2 Virus (COVID-19).
Manufactured in our partner´s state of art plant, based in Beijing (China) where diagnostic test kits are produced with the highest advanced technology for more than 20 years.
Our Chinese partner has the following certifications: Certification for the COVID 19 test: CE Approved by TUV. Manufacturing company under ISO 13485 norms. Our partner has in Beijing the following: Business license and Medical Device Production License.
We can ship from Beijing to all over the World, under minimum orders of 25,000 pcs (We only ship directly from our partner´s factory in China, as we do not stock these products).
The COVID-19 IgG/IgM Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG and IgM antibodies of COVID-19 in human serum, plasma or whole blood.
It falls under the IVD 98/79 European Directive, as an In Vitro Diagnostic product.
Coronavirus (CoV) belongs to order Nidovirales, family Coronavirus, and is divided into α、β、γ three genera. The α、β genera is only pathogenic to mammals, while the γ genus mainly causes infection in birds. CoV is mainly transmitted by direct contact with secretions, by aerosol or droplet, and there is also evidence that it can be transmitted by fecal-oral route.
So far, there have been seven types of human coronavirus (HCoV) that cause respiratory diseases in humans: HCoV-229E, HCoV-OC43, SARS-CoV, HCoV-NL63, HCoV-HKU1, MERS-CoV and SARS-CoV-2 is an important pathogen of human respiratory tract infection. Among them, the SARS-CoV-2 by wuhan viral pneumonia cases were found, the clinical manifestation of systemic symptoms such as fever, fatigue, dry cough, dyspnea, etc., can rapidly develop severe pneumonia, respiratory failure, acute respiratory distress syndrome, septic shock and multiple organ failure, severe alkali metabolic disorders, etc., and even life threatening.
Comparing 300 samples with similar methodological detection kits, the diagnostic sensitivity of IgM test is 96.3% -97.7%; the diagnostic specificity is 97.6%; the total compliance is 97.0-97.7%. The diagnostic sensitivity of IgG test is 95.8%; diagnostic specificity is 96.2% -96.8%; total compliance is 96.0% -96.3%.