Colloidal Gold-Based
Rapid detection within 10 min. No testing equipment required.
 
	
CE certified
	
FDA registration
	
HSA certified
	
National Medical Products Administration approved
	
Singapore HSA approved
	
FDA Philippines approved
	
Chinese FDA approved - one of SIX allowed to be exported by CFDA
 
PRODUCT NAME
2019-nCoV IgG / IgM Detection Kit (Colloidal Gold-Based).
 
CATALOG NUMBER & SIZE
C6603C: 50 tests / kit.
 
INTENDED USE
This product is intended for the detection of 2019-Novel Coronavirus (2019-nCoV). It is an in vitro diagnostic test for the qualitative detection of IgG / IgM antibodies to the SARS-CoV-2 in human serum, plasma, and whole blood (venipuncture) samples collected by healthcare professionals at the point-of-care.
 
BACKGROUND
2019-Novel Coronavirus belongs to the new coronavirus of the genus β, which has an envelope, the particles are round or oval, often polymorphic, and the diameter is 60-140nm. Its genetic characteristics are significantly different from SARSr-CoV and MERSr-CoV. Current research shows that it has more than 85% homology with bat SARS-like coronavirus (bat-SL-CoVZC45). After infection with 2019-nCoV, the common symptoms are fever, fatigue, dry cough, dyspnea etc. Some patients present with more severe symptoms including, acute respiratory distress syndrome, septic shock, metabolic acidosis that is difficult to correct, and coagulation disorders. Some patients have mild symptoms and no fever. Most patients have a good prognosis, while a few are in critical condition or even die.
Both IgM and IgG are immunoglobulins which are produced by the immune system to provide protection against the 2019-nCoV. The level of IgM antibody begins to rise within 1 week and achieves the peak at 2-3 weeks after the initial infection. IgG appears later than IgM (usually in 14 days after infection) and achieves the peak at 5 weeks, lasting for 6 months or even several years.
 
PRINCIPLE OF DETECTION
This product is based on capture and solid-phase immunochromatography methods for determination. The specimen (whole blood / serum / plasma) flows from the blood separator through to the conjugate release pad (which occurs the conjugation reaction between IgG / IgM antibody in the specimen and the antigen colloidal gold of 2019-nCoV to form an immune complex of IgG / IgM antibody and colloidal gold-labeled antigen) due to capillary action. Then migrate to a capture zone of nitrocellulose membrane-immobilized antibody (mouse-anti-human IgM antibody, T1 line) to form an immune complex of colloidal gold-labeled antigen, IgM antibody and mouse-anti-human IgM antibody, thereby generating a T1 red line. The unreacted immune complex continues to flow upward, will be captured by the mouse-an- ti-human IgG antibodies (T2 line) to form an immune complex of colloidal gold-labeled antigen, IgG antibody and mouse-anti- human IgG antibody, thereby generating a T2 red line. The remaining uncaptured immune complex moves upward, combining with C line (quality control line) to indicate the completion of this reaction.