SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control

This category consists of control materials used to verify the performance of in vitro diagnostic (IVD) assays that detect immunoglobulin G (IgG) antibodies to SARS-CoV-2 in clinical specimens. These controls are essential for ensuring the accuracy and reliability of COVID-19 antibody testing by providing a known reference point during assay validation and routine use.

Such control materials are regulated as IVD reagents and are typically supplied as stabilized, ready-to-use formulations designed for use with specific antibody detection platforms. They are not diagnostic tools themselves but are critical components in the quality control process for SARS-CoV-2 IgG assays, supporting consistent performance across tests and laboratories.