SLI Medical Acceptable Dating: we will ship >= 90 days
Sample Type
Human Serum / Plasma Sample
Specialty
Requires Refrigeration
Storage Requirements
Chemiluminescent Microparticle Immunoassay (CMIA)
Test Category
SARS-CoV-2 IgG
Test Method
Antibody Test
Test Name
41116010
Test Type
UNSPSC Code
Features
The SARS-CoV-2 IgG assay is ONLY for use under the Food and Drug Administration’s Emergency Use Authorization: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
The SARS-CoV-2 IgG assay is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2
indicating recent or prior infection; at this time
it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity
The SARSCoV-2 IgG assay should not be used to diagnose acute SARS-CoV-2 infection
Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988
42 U.S.C 263a
to perform moderate or high complexity test
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 acute SARS-CoV-2 infection
If acute infection is suspected
direct testing for SARS-CoV-2 is necessary
False positive results for SARS-CoV-2 IgG assay may occur due to cross-reactivity from pre-existing antibodies or other possible causes
Kit contents include: (100) Tests
