Nano-CheckTM COVID-19 IgG/IgM Antibody Test is a rapid immunoassay for the qualitative detection of human IgG/IgM antibodies against SARS-CoV-2 in human whole blood, plasma and serum sample as an aid in the clinical diagnosis of patients with suspected SARS-CoV-2 infection. For prescription use only.
Test Principle
The membrane strip contains two test lines and one control line.
Antibody against human IgM and antibody against human IgG for test lines, goat anti-chicken IgY antibody for the control line.
A dye pad is placed at the end of the membrane containing gold colloidal particle coupled with recombinant SARS-CoV-2 antigen and gold colloidal particle coupled with chicken IgY
Nano-CheckTM COVID-19 IgG/IgM Antibody Test is a rapid immunoassay for the qualitative detection of human IgG/IgM antibodies to SARS-CoV-2 in human whole blood (venipuncture), plasma (Heparin/EDTA) and serum sample collected in CLIA certified laboratory or by healthcare workers at the point care.
The Nano-CheckTM COVID-19 IgG/IgM Antibody Test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent 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. Results must be combined with clinical observations, patient history, and epidemiological information.
False positive results may occur due to cross-reactivity from pre-existing antibodies or other possible causes.
At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity
Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform moderate and high complexity tests.
