In immunoassay quality control, which component is used to confirm the assay's calibration within established criteria?

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Calibrators are used to confirm that the assay’s calibration is valid. They are materials with known concentrations of the analyte run in the same way as patient samples, and they establish the standard curve that links signal to concentration. By measuring calibrators and verifying that their reported values match the assigned concentrations within predefined acceptance criteria, you verify that the calibration is accurate across the assay’s range. This ensures patient results are reported on a correct scale.

Positive controls show the assay can detect a known positive signal, and negative controls ensure there is no signal when the analyte is absent, which tests general assay functionality rather than calibration accuracy. Replicate samples help assess precision and reproducibility, not the accuracy of the calibration curve itself.