Antibody Test Quality Control Access® SARS-CoV-2 IgG Positive Level / Negative Level 3 X 4 mL

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