Product Description

 

REAGEN^™ This kit is used for the qualitative detection of COVID-19 antibodies in human serum, plasma and venous whole blood samples in vitro. It is only used as a supplementary detection indicator for suspected cases of COVID-19 negative nucleic acid detection or used in conjunction with nucleic acid detection in the diagnosis of suspected cases. It cannot be used as a basis for the diagnosis and exclusion of pneumonitis caused by COVID-19 infection. It is not suitable for screening of the general population. Restricted to medical institutions. A positive test result requires further confirmation. A negative test result does not rule out the possibility of infection..

 

 

Mechanism of Reaction

 

REAGEN^™ The COVID-19 IgM & IgG detection reagent uses the principle of specific binding of antigens and antibodies and immunochromatographic techniques. The reagent contains an anti-human IgM monoclonal antibody fixed in the test area (T) on the test strip in advance. (T1) and anti-human IgG monoclonal antibody (T2) and goat anti-chicken IgY in the QC region and anti-COVID-19 IgM specific protein-conjugated colloidal gold (M.nC- GC gold label conjugate) and chicken IgY coupled colloidal gold. During the test, the specimen is dropped into the reagent sample well (S). The sample moves to the detection line by capillary chromatography. If there is an IgM antibody against COVID-19 in the sample, it will be combined with the M.nC-GC gold label conjugate to form an IgM-M.nC-GC complex. This complex continues to migrate forward under the action of chromatography and is captured by an anti-human IgM monoclonal antibody fixed to the T1 line in advance, forming a wine-red band, indicating that IgM is positive for COVID-19; if anti-COVID- The IgG antibody of 19, under the action of capillary chromatography, also binds to M.nC-GC and is captured by the T2 line. It also forms a burgundy band, indicating that the IgG of COVID-19 is positive; if T1 and / If T2 does not show color, the sample is COVID-19 negative; and COVID-19 IgM & IgG detection reagent contains a built-in quality control line. Regardless of whether IgM & IgG is present in the specimen, a wine-red band will appear in the quality control area ( C). The burgundy band shown in the quality control area (C) is the criterion for judging whether there are enough samples and whether the chromatography process is smooth.

 

Kit Contents, Storage and Shelf Life

 

The REAGEN™ COVID-19 Strip Test Kit has the capacity for 20/40 determinations. The shelf life is 6 months when the kit is properly stored.. 

 

Kit Contents	Amount	Storage
COVID-19 test cards	20/40	4~30℃ (Dry and Dark)
Sample Diluent	1vial
Disposable plastic straws	20/40
Manual	1

REAGEN LLC is an indrustry-leading biomedical enterprise focused on designing and producing a broad range of ELISA kits, including clinical diagnostic kits, food and feed safety kits, and veterinary disease kits. we also manufacture microplate readers, plate washers, and related instruments and equipment.