PRODUCTS


INTENDED USE

The SARS-CoV-2IgM/IgG Rapid (Colloidal Gold) is intended to be used by trainedprofessionals to qualitatively determine SARS-CoV-2 IgM and IgG antibodies inserum or plasma or whole blood by the mean of a colloidal gold-basedimmunochromatography assay. The test results of SARS-CoV-2 IgM/IgG combinedwith other clinical manifestations and other laboratory test results is helpfulfor the diagnosis of suspected SARS-CoV-2 infection. The test results ofSARS-CoV-2 IgM/IgG should not be the sole basis for diagnosis. The IgMantibodies to SARS-CoV-2 are usually detected in the blood a few days after theinitial infection, although the level of this antibody during the infection hasnot been carefully verified. The IgG antibody against SARS-CoV-2 can bedetected after infection. The positive results of both IgG and IgM may appearafter infection, indicating acute or current/recent infection.

 

The SARS-CoV-2IgM/IgG Rapid (Colloidal Gold) is based on but limited to US laboratoriescertified under the Clinical Laboratory Improvement Amendment of 1988 (CLIA), 42U.S.C. 263A, which is certified by US laboratories, and have performed moderateand high complexity tests. Laboratories in the United States and itsterritories must report all positive results to the appropriate public healthauthorities. The CLIA classification of this device is equivalent to that ofother serologic side flow tests with medium complexity.

 

Thenegative results do not exclude SARS-CoV-2 infection and should not be the onlybasis for patient management decisions. IgM antibody to SARS-CoV-2 may not bedetected in the first few days of infection, the sensitivity of the SARS-CoV-2IgM/IgG Rapid (Colloidal Gold) at the stage of infection is not clear.

 

Thefalse positive results of IgM and IgG antibodies to SARS-CoV-2 may be due tothe cross reaction of previously existing antibodies or other possible causes.At present, it is not clear how long IgM or IgG antibody to coronaviruses canlast after infection.

 

specifications:

The SARS-CoV-2 IgM/IgG Rapid (Colloidal Gold) has 2 specifications: 1 test per box and 25 tests per box as listed in the following Table.

 

     Table 1. Specifications

Catalogue number

C00101

C00125

Kit Size (test)

1

25

Content

sample diluent

1

25

Test cartridge*

Microdropper*

Desiccant*

1

25

1

25

1

25

IFU leaflet

1

1


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