The impact of hemolysis on Ortho-Clinical Diagnostic's ECi and Roche's elecsys immunoassay systems

Clin Chim Acta. 2004 Oct;348(1-2):181-7. doi: 10.1016/j.cccn.2004.05.017.

Abstract

Background: Hemolysis is regularly encountered in clinical specimens and often interferes with a variety of laboratory test methods. Although not widely recognized, immunoassays based on nonisotopic detection systems can also be affected by hemolysis. For this reason, we investigated the effect of differing amounts of hemolysis across a range of values for several immunoassays on the Ortho-Clinical Diagnostics ECi and Roche Elecsys platforms.

Methods: Hemolysate was prepared from whole blood and spiked at varying concentrations into pooled patient serum samples for different analytes.

Results: Out of the 21 analytes tested, six (28.6%) exhibited significant increases or decreases in measured concentrations with increasing amounts of hemolysis.

Conclusions: Although immunoassays are generally thought to be impervious to hemolysis interference, hemolysis can interfere in immunoassay testing platforms. For these reasons, we recommend that laboratories conduct hemolysis interference studies for all laboratory test protocols.

Publication types

  • Comparative Study

MeSH terms

  • Blood Specimen Collection
  • Hemolysis*
  • Humans
  • Hydrocortisone / blood
  • Immunoassay / methods*
  • Prostate-Specific Antigen / blood
  • Reagent Kits, Diagnostic
  • Testosterone / blood
  • Troponin I / blood
  • Troponin T / blood
  • Vitamin B 12 / blood

Substances

  • Reagent Kits, Diagnostic
  • Troponin I
  • Troponin T
  • Testosterone
  • Prostate-Specific Antigen
  • Vitamin B 12
  • Hydrocortisone