Saliva-based tests are especially convenient compared to nasal or oropharyngeal swabs making it easier for people to self-test.The COVID-19 Antigen Test is an in vitro immunochromatographic method for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens from the saliva of individuals suspected of COVID-19.The SARS-CoV-2 Rapid Antigen Test is a reliable, rapid chromatopgraphic immunoassay for the qualitative detection of specific antigens of SARS-CoV-2 present in the human nasopharynx.

Intend Use:

◆Applied for detection for an number of suspected cases and asymptomatic patients.

◆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.

Sampling method

◆Whole Blood, Serum, Plasma

Working Principle:

◆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.

◆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%;

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