FDA: https://www.accessdata.fda.gov/cdrh_docs/presentations/maf/maf3318-a001.pdf
Anti-SARS-CoV-2 Rapid Test is a rapid, one-step lateral flow assay intended for the presumptive qualitative detection of IgM and IgG antibodies to the SARS-CoV-2 virus in patients suspected of a COVID-19 infection.
IgM antibodies are generated initially by the body as a result of infection at about the time symptoms appear. They will dissipate within approximately one month. IgG antibodies are generated by the body about one week after symptoms appear and last for an extended amount of time.
A rapid lateral flow immunoassay intended for the presumptive detection of IgM (early marker) and IgG (late marker) antibodies against the SARS-CoV-2 virus in plasma or serum.
This simple-to-use test requires no equipment or special expertise or training to implement.
•  Rapid Results – 15 minutes for a readout
•  No special equipment or facilities needed
•  Clear, easy-to-interpret results
•  Built-in controls
•  Room temperature storage
Sensitivity at >/= 15 days after onset of symptoms
IgM – 95.7%
IgG – 99.0%
Specificity
IgM – 99%
IgG – 99%