Product Description

REAGEN^™ This kit is used for the qualitative detection of  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  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  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 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- 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 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 ; 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 is positive; if T1 and / If T2 does not show color, the sample is negative; and 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™  Strip Test Kit has the capacity for 20/40 determinations. The shelf life is 6 months when the kit is properly stored..