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Counting is the type of measurement that is free from uncertainty, provided the number of objects being counted does not change during the process. Such measurements result in exact numbers. By counting the eggs in a carton, for instance, one can determine exactly how many eggs are there in the carton. Similarly, the numbers of defined quantities are also exact. For example, 1 foot is exactly 12 inches, 1 inch is exactly 2.54 centimeters, and 1 gram is exactly 0.001 kilograms. Quantities...
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Evaluation of Serum Kappa Free Light Chain Reference Interval Using a New Stabilized Calibrator.

Derek Waggoner1, Katie Thoren1, Robert Maynard2

  • 1Department of Pathology and Laboratory Medicine, University of Miami Miller School of Medicine, Miami, FL, United States.

The Journal of Applied Laboratory Medicine
|January 16, 2026
PubMed
Summary

A reformulated kappa FLC calibrator did not verify the manufacturer's claimed reference interval (RI) or improve diagnostic ranges for healthy individuals. Updated guidelines for kappa FLC RI and FLC ratio diagnostic ranges are needed.

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Area of Science:

  • Clinical Chemistry
  • Immunodiagnostics
  • Hematology

Background:

  • Serum free light chains (FLC), including kappa FLC and lambda FLC, are crucial for diagnosing and monitoring plasma cell disorders.
  • Concerns about upward drift in kappa FLC measurements led to a reformulated calibrator by The Binding Site.
  • This study evaluates the impact of the new kappa FLC calibrator on reference intervals and diagnostic ranges.

Purpose of the Study:

  • Assess the effect of a reformulated kappa FLC calibrator on kappa FLC reference interval (RI).
  • Evaluate the impact on the diagnostic range of the kappa to lambda FLC ratio.
  • Determine if the new calibrator aligns with manufacturer-suggested intervals and diagnostic ranges.

Main Methods:

  • Serum samples from 124 healthy volunteers were analyzed using both new and prior kappa FLC calibrators on an Optilite analyzer.
  • Capillary electrophoresis screened for monoclonal proteins, and creatinine was measured to assess renal function.
  • Kappa FLC values and FLC ratios were compared between the two calibrator lots.

Main Results:

  • Minimal differences were observed in kappa FLC values between the new and prior calibrators.
  • Neither calibrator allowed for verification of the manufacturer-suggested kappa FLC RI in the study population.
  • The proportion of participants within the FLC ratio diagnostic range (0.26-1.65) was similar for both calibrators, with 6-7% exceeding the upper limit.

Conclusions:

  • The reformulated kappa FLC calibrator does not validate the manufacturer's claimed kappa FLC RI.
  • The new calibrator did not increase the number of healthy individuals within the FLC ratio diagnostic range.
  • Reevaluation and updating of kappa FLC RI and FLC ratio diagnostic ranges in consensus guidelines are recommended.