The IDS SARS-CoV-2 IgG is a chemiluminescent immunoassay intended for qualitative detection of IgG antibodies to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in human serum and plasma using the IDS-iSYS Multi-Discipline Automated System.
The IDS SARS-CoV-2 IgG is only for use under the Food and Drug Administration’s Emergency Use Authorization.
The IDS SARS-CoV-2 IgG is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. The IDS SARS-CoV-2 IgG should not be used to diagnose or exclude acute SARS-CoV-2 infection. 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, that meet requirements to perform moderate or high complexity tests.
Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities.