Ensuring Reliable HIL Detection: Why Quality Control Matters for Patient Safety

The Impact of HIL on Sample Integrity

Haemolysis (H), icterus (I) and lipemia (L) (HIL) are among the most common pre-analytical interferences in clinical chemistry testing. They can significantly affect the accuracy of laboratory results and compromise clinical decision-making. If not detected, these interferences can result in erroneous reporting, inappropriate clinical intervention, delayed or missed diagnoses, and unnecessary follow-up testing; all of which increase risk to patient safety and place additional burden on healthcare systems.

From a laboratory perspective, undetected HIL interference also undermines quality assurance, complicates result interpretation, and weakens confidence in reported data, making effective detection and monitoring of HIL assay performance a critical component of risk management and patient-centred care.

Visual inspection was historically used to detect HIL, but this approach is subjective and unreliable, with high observer-to-observer variability. Today, most automated chemistry analysers include built-in HIL detection, enabling objective identification of interfered samples. As laboratories increasingly rely on these automated systems, ensuring their accuracy through quality control is essential.

Why Quality Control for HIL Is Critical

There is no universal standard for how HIL indices are measured, and different analysers use different detection principles. This variability introduces risk, particularly when interferences occur at low levels that may still cause clinically relevant bias.

The ISO 15189:2022 standard places greater emphasis on risk-based quality management and error prevention. Accurate identification of HIL before analysis is therefore vital to protect result integrity and patient safety.

Research Study: Commercial Controls for HIL test: evaluating analytical performance on the Alinity c Analyzer

A recent study by Lukić et al. evaluated the analytical performance of Randox Serum Indices Controls on the Abbott Alinity c analyser.

Four levels of control were tested daily over 40 working days and assessed using Levey-Jennings charts, mean values and coefficients of variation (CV).

Key findings:

• All qualitative HIL classifications matched the manufacturer-assigned levels.
• All quantitative results fell within specified ranges.
• Most values remained within ±2SD.
• Average CVs were:
  • Haemolysis: 2.6% (excluding very low L1 values)
  • Icterus: 2.9%
  • Lipemia: 1.9%

These results confirm stable performance in clinically relevant ranges and support the use of commercial controls for routine monitoring. Supporting their use in routine quality control and ensuring accurate patient results.

Published on De Gruyter Brill:
https://www.degruyterbrill.com/document/doi/10.1515/cclm-2025-1331/html

Acusera Serum Indices Control, Supporting Reliable HIL Monitoring

Randox is the only provider of true IQC for Haemolytic, Icteric and Lipemic (HIL) testing on automated systems. Each vial contains all three interferents at four different levels, reflecting real patient sample variation while maximising consolidation.

With a 14-day open vial stability, it delivers accurate performance checks with less waste and greater efficiency. Patient sample interferents are not all the same level, so neither should your IQC.

Analytes:
Haemolysis (H) | Icterus (I) | Lipemia (L)

Format:
Lyophilised

Kit size:

4 × 5 ml

Key benefits:

• Lyophilised for enhanced stability
• Manufactured using human serum, ensuring a commutable matrix
• 14-day reconstituted stability and 2-year shelf life
• True third-party control for unbiased performance assessment

For more information, visit: https://www.randox.com/core-disciplines/quality-control/serum-indices-quality-control

Conclusion: Protecting Result Integrity and Patient Safety

Accurate detection of haemolysis, icterus and lipemia is essential to ensuring reliable laboratory results. As automated HIL testing becomes standard practice, robust quality control is critical to managing risk, meeting accreditation requirements and safeguarding patient care.

By using validated controls such as Acusera Serum Indices Control, laboratories can maintain confidence in their HIL systems and ensure that clinical decisions are based on accurate, high-quality data.