Serum indices: managing assay interference

Area of Science:

• Clinical Chemistry
• Laboratory Medicine
• Analytical Biochemistry

Background:

• Clinical laboratories frequently encounter haemolysis, icterus, and lipaemia (HIL) in patient samples.
• Automated chemistry analysers use spectrophotometry for rapid HIL sample identification.
• Accurate quantification of HIL interference is vital for reliable diagnostic results.

Purpose of the Study:

• To emphasize the importance of rational alert limits for HIL interference.
• To address the need for harmonization of HIL sample handling across laboratory networks and analytical platforms.
• To guide laboratories in managing HIL interferences effectively.

Main Methods:

• Utilizing spectrophotometric measurements on automated chemistry analysers for HIL index measurement.
• Conducting interference testing experiments to establish sound alert limits.
• Performing initial verification and ongoing quality control testing for index accuracy.
• Analyzing interference mechanisms to predict and confirm assay variations.

Main Results:

• Technical advances enable rapid and accurate identification of HIL samples.
• Harmonization requires considering analytical aspects and inter-manufacturer assay variations.
• Verification and quality control ensure accuracy and manage inter-analyser biases.
• Interference testing confirms predicted similarities or quantifies differences in HIL effects.

Conclusions:

• Setting rational alert limits based on interference testing is essential for accurate HIL quantification.
• Harmonization of HIL sample handling across platforms is achievable through careful consideration of analytical and inter-manufacturer factors.
• A rigorous approach to HIL interference testing translates analytical progress into improved patient care.