Calibrator Access® SARS-CoV-2 IgG 2 mL For Calibrating the Access SARS-CoV-2 IgG Assay for the in vitro Qualitative Detection of SARS-CoV-2 IgG Antibodies in Human Serum and Plasma (Heparin, EDTA, Citrate) for use on the Access Family of Immunoassay

Features

• This product has been authorized by FDA under an EUA for use by laboratories certified under CLIA
• that meet requirements to perform moderate or high complexity tests: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations The Access 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 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 the Access SARS-CoV-2 IgG assay may occur due to cross-reactivity from pre-existing antibodies or other possible causes Provided ready to use Refer to calibration card for exact concentrations For In Vitro Diagnostic Use Rx Only Access SARS-CoV-2 IgG calibrators are provided as: negative and positive