Product Description

The CoronaCheck rapid IgG-IgM combined antibody test kit is a lateral flow qualitative immunoassay for the rapid determination of the presence or absence of both anti- SARS-CoV-2-IgM and anti- SARS-CoV-2-IgG in human specimens (whole blood, serum, and plasma).  The test kit comes with a test cartridge, sample dilution buffer, and a package insert. The testing cartridge has three detection bands, including a distal control band that appears when the sample has flowed to the end of the testing strip. The presence of SARS-CoV-2 IgG and IgM antibodies are indicated by a red/purple line in the specific region indicated on the device.

Mechanism

The Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit is a rapid chromatographic immunoassay for the qualitative detection of IgM and IgG antibodies to SARS-CoV-2 in human serum, plasma or whole blood as an aid in the determination of exposure to SARS-CoV-2. The test is designed for field use by individuals trained in its use including but not limited to first responders and clinical staff at care facilities.

Results are for the identification of SARS-CoV-2 antibodies. Antibodies against SARSCoV-2 are generally detectable in serum, plasma and/or whole blood during the acute phase of infection. Positive results are indicative of current or prior infection. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

The Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit is intended for use by individuals trained in its use including but not limited to first responders and clinical staff at care facilities. The Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit is only for use under the Food and Drug Administration’s Emergency Use Authorization.