CLSI C56
Hemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of Interference in Clinical Laboratory Analysis
CLSI C56 provides essential guidance on using hemolysis, icterus, and lipemia/turbidity (HIL) indices to detect potential interferences in clinical laboratory testing. Closely aligned with CLSI EP07, this guideline explains how HIL alert indices are established, their strengths and limitations, and how automated HIL detection systems function. Designed for laboratory professionals, C56 enhances understanding of HIL-related interferences, ensuring accurate and clinically meaningful test results.
{{FormatPrice(currentPrice)}}
Free
{{FormatPrice(nonMemberPrice)}} List PriceClinical and Laboratory Standards Institute document C56-A—Hemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of Interference in Clinical Laboratory Analysis; Approved Guideline focuses on the intended usefulness and challenging issues of hemolysis, icterus, and lipemia/turbidity (HIL) indices as estimates of interference that may impact the validity and clinical utility of reportable patient results. C56 is closely aligned with CLSI document EP07; thus, the basic concepts for interference testing are briefly discussed in C56 to gain an understanding of the process by which HIL alert indices are established. Automated HIL systems currently available from various manufacturers are also described. This document enhances the continuous education of health care personnel by explaining the mechanisms of HIL interference, which in some cases include the noncorrelation of visual and (semi)quantitative HIL indices, the strengths and limitations of HIL measurements, and the verification of HIL indices in the clinical laboratory.
Hemolysis, icterus, and lipemia/turbidity (HIL) indices are often measured on serum and plasma, to assess sample quality. This document offers consensus guidelines for the use of automated HIL indices by laboratories, as an aid to annotating potentially affected results as well as the rejection of a specimen or result.
This guideline is intended for use by:
• Manufacturers responsible for establishing HIL indices and alert indices (cutoff values) for use in the automated HIL detection systems in their clinical laboratory instruments
• Laboratory directors, managers, supervisors and medical technologists for establishing or evaluating HIL indices and making judgments about the acceptability of specimens and test results.
C56 provides recommendations for:
• Establishing HIL indices to assess sample quality
• Estimating interference effects of hemoglobin, bilirubin, and turbidity to generate alert indices and gray zones
• Reporting (by manufacturers) interference effects of HIL in the reagent instructions for use (IFU)
• Establishing error flags for HIL interference
• Verifying HIL indices in the clinical laboratory
• Managing potential process outcomes of HIL measurements (reporting or rejecting specimens/results due to HIL interference).
This document provides a comprehensive review of the currently available automated HIL detection systems in clinical analyzers. C56 aims to enhance understanding of the mechanisms and interpretations of HIL indices and alert levels in the clinical laboratory. Procedures for investigating, identifying, and characterizing the effects of interfering substances on clinical chemistry test results are not discussed in detail in C56, as these are described in CLSI document EP07.
This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid and because of its value to the laboratory community, it is being retained in CLSI’s library.
This document is available in electronic format only.
A CLSI-IFCC joint project.
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.
CLSI C56QG
Free
Clinical and Laboratory Standards Institute document C56-A—Hemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of Interference in Clinical Laboratory Analysis; Approved Guideline focuses on the intended usefulness and challenging issues of hemolysis, icterus, and lipemia/turbidity (HIL) indices as estimates of interference that may impact the validity and clinical utility of reportable patient results. C56 is closely aligned with CLSI document EP07; thus, the basic concepts for interference testing are briefly discussed in C56 to gain an understanding of the process by which HIL alert indices are established. Automated HIL systems currently available from various manufacturers are also described. This document enhances the continuous education of health care personnel by explaining the mechanisms of HIL interference, which in some cases include the noncorrelation of visual and (semi)quantitative HIL indices, the strengths and limitations of HIL measurements, and the verification of HIL indices in the clinical laboratory.
Hemolysis, icterus, and lipemia/turbidity (HIL) indices are often measured on serum and plasma, to assess sample quality. This document offers consensus guidelines for the use of automated HIL indices by laboratories, as an aid to annotating potentially affected results as well as the rejection of a specimen or result.
This guideline is intended for use by:
• Manufacturers responsible for establishing HIL indices and alert indices (cutoff values) for use in the automated HIL detection systems in their clinical laboratory instruments
• Laboratory directors, managers, supervisors and medical technologists for establishing or evaluating HIL indices and making judgments about the acceptability of specimens and test results.
C56 provides recommendations for:
• Establishing HIL indices to assess sample quality
• Estimating interference effects of hemoglobin, bilirubin, and turbidity to generate alert indices and gray zones
• Reporting (by manufacturers) interference effects of HIL in the reagent instructions for use (IFU)
• Establishing error flags for HIL interference
• Verifying HIL indices in the clinical laboratory
• Managing potential process outcomes of HIL measurements (reporting or rejecting specimens/results due to HIL interference).
This document provides a comprehensive review of the currently available automated HIL detection systems in clinical analyzers. C56 aims to enhance understanding of the mechanisms and interpretations of HIL indices and alert levels in the clinical laboratory. Procedures for investigating, identifying, and characterizing the effects of interfering substances on clinical chemistry test results are not discussed in detail in C56, as these are described in CLSI document EP07.
This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid and because of its value to the laboratory community, it is being retained in CLSI’s library.
This document is available in electronic format only.
A CLSI-IFCC joint project.
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.