Determination of hemolysis cut-offs for biochemical and immunochemical analytes according to their value
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and
Abstract
Background
All general biochemistry instruments allow the measure of hemolysis index (HI), and suppliers provide an acceptable HI for each assay without consideration of the analyte value or its clinical application. Our first objective was to measure the impact of hemolysis degree on plasma biochemical and immunochemical analytes to determine the maximum allowable HI for each of them using four calculation methods as significant bias in comparison to manufacturer’s data. The second objective was to assess whether the maximum allowable HI varied according to the analyte values.
Methods
Twenty analytes were measured in hemolyzate-treated plasma to determine the HI leading to a significant change compared to baseline value. Analytes were assessed at one (3 analytes), two (5 analytes) and three (12 analytes) values according to their sensitivity to hemolysis and their clinical impact. We used four calculation methods as significant limit from baseline value: the total change limit (TCL), the 10% change (10%Δ), the analytical change limit and the reference change value.
Results
Allowable HI was significantly different according to the threshold chosen for most analytes and was also dependent on the analyte value for alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, creatine kinase, iron, haptoglobin and high sensitivity troponin T. No hemolysis interference was observed for albumin, creatinine, C-reactive protein, and procalcitonin even at an HI value of 11 g/L.
Conclusions
This study highlights that TCL is the most appropriate calculation method to determine allowable HI in practice for biochemical and immunochemical parameters using Cobas 8000© from Roche Diagnostics. In addition, different allowable HI were found according to analyte value leading to optimization of resampling to save time in patient care.
Acknowledgments
We gratefully acknowledge all the laboratory technicians for their assistance.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: None declared.
Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
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Supplementary Material
The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2019-1228).
©2020 Walter de Gruyter GmbH, Berlin/Boston
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Articles in the same Issue
- Frontmatter
- Editorial
- Quality controls for serology: an unfinished agenda
- A modern and pragmatic definition of Laboratory Medicine
- Reviews
- Blood biochemical characteristics of patients with coronavirus disease 2019 (COVID-19): a systemic review and meta-analysis
- ISO/TS 20914:2019 – a critical commentary
- Mini Review
- Reporting of D-dimer data in COVID-19: some confusion and potential for misinformation
- Opinion Paper
- Implementation of metrological traceability in laboratory medicine: where we are and what is missing
- IFCC Recommendation
- Recommendation for performance verification of patient-based real-time quality control
- Genetics and Molecular Diagnostics
- Comparison of BCR-ABL1 quantification in peripheral blood and bone marrow using an International Scale-standardized assay for assessment of deep molecular response in chronic myeloid leukemia
- General Clinical Chemistry and Laboratory Medicine
- Risk assessment of the total testing process based on quality indicators with the Sigma metrics
- Determination of hemolysis cut-offs for biochemical and immunochemical analytes according to their value
- A computer model for professional competence assessment according to ISO 15189
- Traceability validation of six enzyme measurements on the Abbott Alinity c analytical system
- Evaluating the need for free glycerol blanking for serum triglyceride measurements at Charlotte Maxeke Johannesburg Academic Hospital
- Challenges of LC-MS/MS ethyl glucuronide analysis in abstinence monitoring of liver transplant candidates
- Changes in the result of antinuclear antibody immunofluorescence assay on HEp-2 cells reflect disease activity status in systemic lupus erythematosus
- Reference Values and Biological Variations
- Long-term biological variation estimates of 13 hematological parameters in healthy Chinese subjects
- Age-specific reference values improve the diagnostic performance of AMH in polycystic ovary syndrome
- Establishment of reference intervals for immunoassay analytes of adult population in Saudi Arabia
- Hematology and Coagulation
- Total haemoglobin – a reference measuring system for improvement of standardisation
- Laboratory testing for activated protein C resistance: rivaroxaban induced interference and a comparative evaluation of andexanet alfa and DOAC Stop to neutralise interference
- Cancer Diagnostics
- Identification of a four-gene methylation biomarker panel in high-grade serous ovarian carcinoma
- Performance comparison of two next-generation sequencing panels to detect actionable mutations in cell-free DNA in cancer patients
- Diabetes
- Availability and analytical quality of hemoglobin A1c point-of-care testing in general practitioners’ offices are associated with better glycemic control in type 2 diabetes
- Infectious Diseases
- Validation of a chemiluminescent assay for specific SARS-CoV-2 antibody
- Dynamic profile and clinical implications of hematological parameters in hospitalized patients with coronavirus disease 2019
- Does a change in quality control results influence the sensitivity of an anti-HCV test?
- Letters to the Editor
- Variability between testing methods for SARS-CoV-2 nucleic acid detection 16 days post-discharge: a case report
- L-index, more than a screening tool for hypertriglyceridemia
- Neutralization of biotin interference: preliminary evaluation of the VeraTest Biotin™, VeraPrep Biotin™ and BioT-Filter®
- Counting and reporting band count is unreliable practice due to the high inter-observer variability
- Cigarette smoking prior to blood sampling acutely affects serum levels of the chronic obstructive pulmonary disease biomarker surfactant protein D
- How reliable is the detection of anti-mitochondrial antibodies on murine triple-tissue?
- Further advices on measuring lipoprotein(a) for reducing the residual cardiovascular risk on statin therapy
