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Immunohistochemistry
(IHC) Testing Challenges

Testing Errors Affect Patients’ Lives

IHC Testing Error Rates Are >10X Higher Than For Other Types Of Clinical Labs

The Quality tools required to reduce IHC test error rates towards 1% have not been available until recently.

See What Causes These Error Rates

Reducing IHC Test Error Rates Requires Adoption of Two New Quality Methods: Calibration And Statistical Process Control (SPC)

The BCS Platform Provides Quality Tools That Address IHC Testing Challenges

The Quality tools required to reduce IHC test error rates
towards 1% have not been available until recently.

History Of Testing Error Rates

Other Types Of Clinical Labs Adopted Calibration And SPC Decades Ago And Test Error Rates Plummeted

History Of Quality Methods And Testing Error Rates For Clinical Labs

1.Levey, Stanley; Jennings, E. R. (November 1, 1950). “The use of Control Charts in the Clinical Laboratory”. American Journal of Clinical Pathology. 20 (11): 1059–1066. doi:10.1093/ajcp/20.11_ts.1059. PMID 14783086
2.Westgard, J. O., P. L. Barry, and M. R. Hunt (1981). “A Multi-rule Shewhart Chart for Quality Control in Clinical Chemistry”, Clinical Chemistry, vol. 27, pp. 493–501.
3.National Committee for Clinical Laboratory Standards. The reference system for the clinical laboratory: criteria for development and credentialing of methods and materials for harmonization and results; Approved guideline. NCCLS Document NRSCL 13-A Proposed1995/Approved 2000  NCCLS Wayne, PA.
4.WHO. Guidelines for the preparation, characterization and establishment of international and other standards and reference reagents for biological substances. WHO Technical Report Series 1990:181-214 WHO Geneva, Switzerland.
5.International Organization of Standardization. 2003. In vitro diagnostic medical devices—measurement of quantities in biological samples—metrological traceability of values assigned to calibrators and control materials. International standard ISO 17511:2003. ISO, Geneva, Switzerland

Demands On IHC Lab Testing Are Increasing

The IHC market is expected to grow rapidly between 2024 and 2034
The pipeline of new drug therapeutics is also growing rapidly.
Each new therapeutic requires companion diagnostics with better tailoring of assay sensitivity to clinical needs.
These new therapeutics will require IHC testing sensitivity that is considered unattainable today

IHC Community Leadership Endorses Adoption of Calibration And SPC

This adoption will reduce IHC testing errors

“Pathologists require objective information about their laboratory’s IHC stains daily or weekly so that corrective action can be taken promptly. In clinical immunoassay testing, such information is delivered in a timely fashion via quantitative controls and calibrators.”

Read the Full Editorial

 “….NSH firmly believes that it is time to take the steps necessary to improve the quality of clinical IHC practice based on the principles set forth by Magnani and Taylor. “

Read the Full Letter

“We can certainly draw an analogy to clinical immunoassay concepts like analytic range, calibrated controls, and specified quality control ranges with regular assay monitoring and incorporate these into the IHC lab.”

Read the Full Article

Boston Cell Standards Solves The IHC Testing Problem