INNOVITA 2019 nCoV Ab test

Tuesday, May 26, 2020

Due to the current situation caused by the coronavirus pandemic around the world, Fagron is working intensively to find solutions to the problems caused by coronavirus, both in the field of seeking therapeutic solutions and in the field of diagnosing coronavirus. We are pleased to inform you that the INNOVITA 2019 nCoV Ab test is now available in Croatia.

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INNOVITA 2019 nCoV Ab test is intended for the qualitative detection of IgM and IgG antibodies against 2019 Novel Coronavirus (2019-nCoV) in human serum/plasma/venous whole blood specimen. It is used as a supplementary detection indicator for suspected nucleic acid negative results or in conjunction with nucleic acid detection in the diagnosis of suspected cases. A positive test result requires further confirmation. This product is intended for clinical use and emergency reserve during the COVID-19 epidemic outbreak since December 2019. It is recommended to conduct a comprehensive analysis of the condition based on the patient’s clinical manifestations and other laboratory tests.

Principle: the kit detects 2019-nCoV IgM and IgG antibodies by immuno-capture method. The nitrocellulose membrane is coated by mouse-anti human monoclonal IgM antibodies, mouse-anti human monoclonal IgG antibodies, and goat-anti-mouse IgG antibodies. The recombinant 2019-nCoV antigen and mouse IgG antibodies are labeled with colloidal gold as a tracer.

After addition of the specimens, if 2019-nCoV IgM antibodies are present, the antibodies will bind to colloidal gold-coated 2019-nCoV antigens to form compounds, which are further captured by pre-coated mouse-anti human IgM antibodies to form new compounds, and generate purple line (T). If 2019-nCoV IgG antibodies are present in specimen, the antibodies will bind to colloidal gold-labeled 2019-nCoV antigens to form compounds, and further form new compounds by binding to pre-coated mouse-anti human monoclonal IgG antibodies, which give rise to purple line (T). The binding of colloidal gold-labeled mouse IgG antibodies with goat-anti-mouse IgG antibodies will present purple line, which is used as the control line (C).

The clinical trial of this product is based on the clear diagnosis / exclusion criteria of the disease identified in the “COVID-19 Diagnosis and Treatment Program”. Clinical research was conducted in 5 institutions and the total cases were 447. Using this kit, 110 cases out of 126 clinically confirmed cases are positive, with the sensitivity of 87.3% (95% CI: 80.40% to 92.0%); 62 cases of clinically excluded cases are totally negative with the specificity of 100% (95% CI: 94.20% to 100%).