Beckman Coulter Antibody Test Quality Control Access® SARS-CoV-2 IgG Positive Level / Negative Level 3 X 4 mL - Box of 1 - C58964-BX

Beckman Coulter Antibody Test Quality Control Access® SARS-CoV-2 IgG Positive Level / Negative Le...

Features

• The Access 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
• 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
• 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 the QC value card for mean values and standard deviations (SD)
• QC1: Negative: TRIS buffer, defibrinated human plasma negative for anti-SARS-CoV-2 surfactant and protein (bovine), < 0.1% sodium azide and 0.5% ProClin 300
• QC2: Positive: TRIS buffer, defibrinated human plasma containing anti-SARS-CoV-2 IgG, surfactant and protein (bovine), < 0.1% sodium azide and 0.5% ProClin 300