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Related Experiment Video

Updated: Aug 15, 2025

Ex Vivo Red Blood Cell Hemolysis Assay for the Evaluation of pH-responsive Endosomolytic Agents for Cytosolic Delivery of Biomacromolecular Drugs

Ex Vivo Red Blood Cell Hemolysis Assay for the Evaluation of pH-responsive Endosomolytic Agents for Cytosolic Delivery of Biomacromolecular Drugs

Published on: March 9, 2013

Reducing Specimen Rejection Rates Using Concentration-Dependent Hemolysis Rejection Thresholds.

Nga Yeung Tang^1,2,3, Kelly R Mitchell⁴, Sarah E Groboske⁴

¹Department of Pathology, The University of Chicago, Chicago, IL.

The Journal of Applied Laboratory Medicine

|January 2, 2023

Summary

This summary is machine-generated.

Implementing concentration-dependent hemolysis rejection limits for clinical assays significantly reduces sample rejection rates. This tailored approach improves efficiency and maintains test result quality compared to standard cutoffs.

Keywords:

hemolysis interference preanalytical error specimen rejection total allowable error

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Area of Science:

Clinical Chemistry
Laboratory Medicine
Biomedical Engineering

Background:

Hemolysis is a common interference in clinical laboratory testing.
Standardized rejection limits may lead to unnecessary sample rejections.
Middleware solutions enable customized, analyte-specific rejection criteria.

Purpose of the Study:

To develop and evaluate concentration-dependent, analyte-specific hemolysis rejection limits.
To assess the impact of these novel limits on specimen rejection rates.
To compare the efficiency of customized limits versus standard package insert cutoffs.

Main Methods:

Hemolysis interference studies were conducted at various analyte concentrations for three key assays.
Rejection limits were designed based on total allowable error (TAE) and clinical significance.
Specimen rejection rates were compared using standard vs. concentration-dependent limits over a three-month period.

Main Results:

Novel concentration-dependent thresholds were established for aspartate aminotransferase (AST), lactate dehydrogenase (LDH), and direct bilirubin (DBIL).
These thresholds reduced rejection rates for AST from 9.3% to 1.3%, LDH from 31.4% to 4.8%, and DBIL from 19.9% to 7.1%.
The implementation demonstrated a substantial decrease in specimen rejection.

Conclusions:

Concentration-dependent, analyte-specific hemolysis rejection thresholds are effective in reducing specimen rejection rates.
This approach enhances laboratory efficiency without compromising the quality of diagnostic test results.
Customized rejection criteria offer a superior alternative to universal cutoffs for hemolysis interference.