• Purpose: To automate a Cytometric Bead Array (CBA) immunoassay developed to measure relative concentrations of serum antibodies against Tetanus (TT), Sperm Whale Myoglobin (SWM), and Keyhole Limpet Hemocyanin (KLH) in KLH-immunized volunteers.
• Method:
– Two scripts were developed for the Tecan comprising an “Automated-Plate” CBA assay method.
– The “Automated-Plate” method was investigated by parallel testing of serum samples analyzed by the reference “Manual-Tube” method.
• Sample Analysis: All samples were analyzed on a Becton Dickinson FACSCalibur flow cytometer equipped with a Cytek Automated Microsampler (AMS).
• Data Analysis: Data from the assay validation was analyzed to determine if the Automated-Plate method:
1. Showed statistical concordance with the reference method.
2. Met acceptance criteria defined in the assay protocol.
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