2018 China New Design Hematology machine - One Step Test for Novel Coronavirus (2019-nCoV) IgM/IgG Antibody – Merry

COVID-19 Rapid Test Kits

COVID-19 Rapid Test Kits

Intend Use:

◆Novel Coronavirus COVID-19 IgM/IgG Test Kit (Colloidal Gold) is an immunochromatographic assay for rapid, qualitative detection of severe acute respiratory syndrome coronavirus (SARS-CoV-2) IgG and IgM antibody in human whole blood, serum, plasma sample.

◆The test provides preliminary test results. The test is to be used as an aid in the diagnosis of coronavirus infection disease (COVID-19), which is caused by SARS-CoV-2.

◆This product is for in vitro diagnostic use only, for professional use only.

Working Principle:

◆Novel Coronavirus COVID-19 IgM/IgG Test Kit (Colloidal Gold) is based on the principle of capture immunoassay for determination of SARS- CoV-2 IgG and IgM antibodies in human whole blood, serum, plasma.

◆When the specimen is added into the test device, the specimen is absorbed into the device by capillary action.

◆If the sample contain novel coronavirus IgM antibody, the antibody combined with the colloidal gold labeled novel coronavirus antigen, and when the novel coronavirus IgM antibody level in the specimen is at or above the target cut-off, and the immune complex further binds to the coated anti-human IgM antibody in the M line and this produces a colored test band that indicates a positive result.

◆If the sample contain novel coronavirus IgG antibody, the antibody combined with the colloidal gold labeled novel coronavirus antigen, and when the novel coronavirus IgG antibody level in the specimen is at or above the target cut-off, and the immune complex further binds to the coated anti-human IgG antibody in the G line and this produces a colored test band that indicates a positive result.

◆If both M and G lines are colorless, a negative result is indicated. The card also contains a quality control line (line C), which must be colored regardless of the results of M line and G line. If line C does not appear, the test result is invalid and the sample needs to be retested.

◆When the novel coronavirus IgM and IgG antibody level in the specimen is zero or below the target cutoff, there is not a visible colored band in the Test Region (M and G) of the device. This indicates a negative result.

To serve as a procedure control, a colored line will appear at the Control Region (C), if the test has been performed properly.

Product detail:

◆One step test for Novel Coronavirus (2019-nCov) Ig</IgG Antibody. Colloidal Gold Assay.

◆Read test result directly do not require test equipment

◆Result shows in only 10 min at soonest

◆Sample types: finger-prick blood/whole blood/serum/plasma

◆Test both IgM and IgG to improve sensitivity

◆Use in combination with RT-PCR assay for better diagnosis

Parameters:

◆Positive coincidence rate: 89.55%;

◆Negative coincidence rate: 82.80%;

◆Total coincidence rate: 84.39%;