Abstract
Preanalytically altered test results are a challenge every laboratory has to face. The release of such results may be to the harm of the patient by triggering wrong clinical decision making in monitoring or treatment. On the other hand, their deletion also might be to the harm of the patient by delaying the time to decision making as the exact value sometimes is not even necessary but rather an answer to the question “Is it raised or lowered”. Based on this dilemma and forced to produce laboratory values without any clinical information on the respective patient, laboratories have developed their own preferred way on how to deal with preanalytically altered test results. Some release the value with a comment, some reject the value with or without a comment and others again provide only general information about the hemolytic sample. To date there is no guideline or standardization to this postanalytical topic. Therefore, with this opinion paper, we want to start the scientific discussion on this important issue by providing one possible method to overcome the lack of clinical information which the laboratory would need to correctly decide whether or not to release an altered test result. We suggest providing the clinician with all the information on the hemolytic sample and its impact on the respective parameter needed to make his/her own decision on the usage of the respective test result. We believe that reporting a preanalytically altered laboratory value including a respective comment is preferable to not reporting it.
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.
References
1. Carraro P, Plebani M. Errors in a stat laboratory: types and frequencies 10 years later. Clin Chem 2007;53:1338–42.10.1373/clinchem.2007.088344Suche in Google Scholar PubMed
2. Sandberg S, Fraser CG, Horvath AR, Jansen R, Jones G, Oosterhuis W, et al. Defining analytical performance specifications: consensus statement from the 1st strategic conference of the european federation of clinical chemistry and laboratory medicine. Clin Chem Lab Med 2015;53:833–5.10.1515/cclm-2015-0067Suche in Google Scholar PubMed
3. Gimenez-Marin A, Rivas-Ruiz F, Perez-Hidalgo Mdel M, Molina-Mendoza P. Pre-analytical errors management in the clinical laboratory: a five-year study. Biochem Med 2014;24:248–57.10.11613/BM.2014.027Suche in Google Scholar PubMed PubMed Central
4. Lippi G, Blanckaert N, Bonini P, Green S, Kitchen S, Palicka V, et al. Haemolysis: an overview of the leading cause of unsuitable specimens in clinical laboratories. Clin Chem Lab Med 2008;46:764–72.10.1515/CCLM.2008.170Suche in Google Scholar PubMed
5. CLSI EP7-A2. Interference testing in clinical chemistry; approved guideline, 2nd ed. Wayne, PA: Clinical and Laboratory Standards Institute, 2005.Suche in Google Scholar
6. CLSI C56-A. Hemolysis, icterus and lipemia/turbidity indices as indicators of interference in clinical laboratory analysis; approved guideline. Wayne, PA: Clinical and Laboratory Standards Institute, 2012.Suche in Google Scholar
©2017 Walter de Gruyter GmbH, Berlin/Boston
Artikel in diesem Heft
- Frontmatter
- Editorial
- Biomarkers of acute kidney injury: a step forward
- Reviews
- Biomarkers of acute kidney injury: the pathway from discovery to clinical adoption
- Prognostic value of glycated hemoglobin among patients with ST-segment elevation myocardial infarction: a systematic review and meta-analysis
- Opinion Paper
- Traceability in laboratory medicine: a global driver for accurate results for patient care
- Point
- To report or not to report: a proposal on how to deal with altered test results in hemolytic samples
- Counterpoint
- Reporting altered test results in hemolyzed samples: is the cure worse than the disease?
- Genetics and Molecular Diagnostics
- Early mixed hematopoietic chimerism detection by digital droplet PCR in patients undergoing gender-mismatched hematopoietic stem cell transplantation
- Comparison of Abbott RealTime genotype II, GeneMatrix restriction fragment mass polymorphism and Sysmex HISCL HCV Gr assays for hepatitis C virus genotyping
- General Clinical Chemistry and Laboratory Medicine
- The relationship between vacuum and hemolysis during catheter blood collection: a retrospective analysis of six large cohorts
- Evaluation of the Greiner Bio-One serum separator BCA Fast Clot tube
- Implementation and application of moving average as continuous analytical quality control instrument demonstrated for 24 routine chemistry assays
- Parathormone stability in hemodialyzed patients and healthy subjects: comparison on non-centrifuged EDTA and serum samples with second- and third-generation assays
- Association between plasma proANP and hyperuricemia in Chinese Han women: a cross-sectional study
- Activity of the liver enzyme ornithine carbamoyltransferase (OTC) in blood: LC-MS/MS assay for non-invasive diagnosis of ornithine carbamoyltransferase deficiency
- Detecting paraprotein interference on a direct bilirubin assay by reviewing the photometric reaction data
- Prediction of human iron bioavailability using rapid c-ELISAs for human plasma hepcidin
- Reference Values and Biological Variations
- Determination of glucose-6-phosphate dehydrogenase cut-off values in a Tunisian population
- Plasma levels of endothelin-1 and renal function among young and healthy adults
- Cancer Diagnostics
- A new strategy for calculating the risk of ovarian malignancy algorithm (ROMA)
- Laboratory characterization of leukemic cell procoagulants
- Diabetes
- Preparation, calibration and evaluation of the First International Standard for human C-peptide
- Hb variants in Korea: effect on HbA1c using five routine methods
- Letters to the Editor
- Pseudohyperkalemia in capillary whole-blood samples – an occasional error or a significant problem in a pediatric hospital?
- Elevation of creatine kinase is linked to disease severity and predicts fatal outcomes in H7N9 infection
- Analytical evaluation of point-of-care procalcitonin (PCT) and clinical performances in an unselected population as compared with central lab PCT assay
- Evaluation of an automated commercial ELISA method for calprotectin determination in pleural fluid
- The unfinished story of interference in thyroid hormones with Roche immunoassays: when prewashing procedures matter
- Effects of apixaban on prothrombin time, activated partial thromboplastin time and anti-Xa assays: a European survey
- Evaluation of a chemiluminescent immunoassay for urinary aldosterone on the DiaSorin LIAISON automated platform against RIA and LC-MS/MS
- Complex considerations when tendering for HbA1c analysers
Artikel in diesem Heft
- Frontmatter
- Editorial
- Biomarkers of acute kidney injury: a step forward
- Reviews
- Biomarkers of acute kidney injury: the pathway from discovery to clinical adoption
- Prognostic value of glycated hemoglobin among patients with ST-segment elevation myocardial infarction: a systematic review and meta-analysis
- Opinion Paper
- Traceability in laboratory medicine: a global driver for accurate results for patient care
- Point
- To report or not to report: a proposal on how to deal with altered test results in hemolytic samples
- Counterpoint
- Reporting altered test results in hemolyzed samples: is the cure worse than the disease?
- Genetics and Molecular Diagnostics
- Early mixed hematopoietic chimerism detection by digital droplet PCR in patients undergoing gender-mismatched hematopoietic stem cell transplantation
- Comparison of Abbott RealTime genotype II, GeneMatrix restriction fragment mass polymorphism and Sysmex HISCL HCV Gr assays for hepatitis C virus genotyping
- General Clinical Chemistry and Laboratory Medicine
- The relationship between vacuum and hemolysis during catheter blood collection: a retrospective analysis of six large cohorts
- Evaluation of the Greiner Bio-One serum separator BCA Fast Clot tube
- Implementation and application of moving average as continuous analytical quality control instrument demonstrated for 24 routine chemistry assays
- Parathormone stability in hemodialyzed patients and healthy subjects: comparison on non-centrifuged EDTA and serum samples with second- and third-generation assays
- Association between plasma proANP and hyperuricemia in Chinese Han women: a cross-sectional study
- Activity of the liver enzyme ornithine carbamoyltransferase (OTC) in blood: LC-MS/MS assay for non-invasive diagnosis of ornithine carbamoyltransferase deficiency
- Detecting paraprotein interference on a direct bilirubin assay by reviewing the photometric reaction data
- Prediction of human iron bioavailability using rapid c-ELISAs for human plasma hepcidin
- Reference Values and Biological Variations
- Determination of glucose-6-phosphate dehydrogenase cut-off values in a Tunisian population
- Plasma levels of endothelin-1 and renal function among young and healthy adults
- Cancer Diagnostics
- A new strategy for calculating the risk of ovarian malignancy algorithm (ROMA)
- Laboratory characterization of leukemic cell procoagulants
- Diabetes
- Preparation, calibration and evaluation of the First International Standard for human C-peptide
- Hb variants in Korea: effect on HbA1c using five routine methods
- Letters to the Editor
- Pseudohyperkalemia in capillary whole-blood samples – an occasional error or a significant problem in a pediatric hospital?
- Elevation of creatine kinase is linked to disease severity and predicts fatal outcomes in H7N9 infection
- Analytical evaluation of point-of-care procalcitonin (PCT) and clinical performances in an unselected population as compared with central lab PCT assay
- Evaluation of an automated commercial ELISA method for calprotectin determination in pleural fluid
- The unfinished story of interference in thyroid hormones with Roche immunoassays: when prewashing procedures matter
- Effects of apixaban on prothrombin time, activated partial thromboplastin time and anti-Xa assays: a European survey
- Evaluation of a chemiluminescent immunoassay for urinary aldosterone on the DiaSorin LIAISON automated platform against RIA and LC-MS/MS
- Complex considerations when tendering for HbA1c analysers