Description
The Access SARS-CoV-2 IgM Antibody Test targets antibodies that recognize the receptor binding domain (RBD) of the spike protein which SARS-CoV-2 uses to bind to a human cell receptor. The IgM antibody test demonstrated 99.9% specificity against 1,400 negative samples and 98.3% sensitivity at 15-30 days post-symptom onset, and provides information about an individual's immune status with a positive predicative value of 95.5% in a population with disease incidence as low as 3%.
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Features
•Assay Format: 2x100 determinations
•Calibrator Format: C0-C1, 2 levels, 1 vial/level, 2 mL/vial
•QC Format: QC1-QC2, 2 levels, 3 vials/level, 4 mL/vial
•Sample volume: 10uL
•Open pack stability: 28 days
•Calibration stability: 28 days
•Time-to-first result (approx.): 37 minutes
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Specifications
• Assay Format: 2x100 determinations
• Calibrator Format: C0-C1, 2 levels, 1 vial/level, 2 mL/vial
• QC Format: QC1-QC2, 2 levels, 3 vials/level, 4 mL/vial
• Sample volume: 10uL
• Open pack stability: 28 days
• Calibration stability: 28 days
• Time-to-first result (approx.): 37 minutes
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