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Module 1. Introduction

1 min read

This section explains basic concepts of Calibration and helps you understand how to assess Metric’s Calibration report and related statistics.

Calibration enables accurate IHC test results across different labs. Calibration is mandatory for all types of clinical lab testing except for IHC testing.

Calibration is a method that measures the sensitivity of an assay in your lab. which can then be compared to the sensitivity of other labs running the same assay.

The core benefits of implementing Calibration in your IHC lab include

  • Enabling the calculation of Lower limit of detection (LOD) and illustration of assay dynamic range.
  • Comparing your LOD with peer labs or published data.
  • Aligning different labs to one another for the same assay.
  • Aligning multiple instruments within a single lab to one another.
  • Aligning clinical trial sites with one another.
  • Verifying lot-to-lot reagent comparability.
  • Optimizing antibody dilution for maximal sensitivity and minimal background.
  • Troubleshooting complex IHC assay problems.

In keeping with established practice and federal regulations across clinical laboratory disciplines, calibration verification is performed:

  • At the time of initial assay deployment on each instrument.
  • Periodically, based on assay stability.
  • Following major instrument service.
  • Upon introduction of a new reagent lot.
  • If there is a QC failure, as part of troubleshooting.
Updated on August 10, 2026