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Understanding and managing interferences in clinical laboratory assays: the role of laboratory professionals

  • Martina Zaninotto und Mario Plebani ORCID logo EMAIL logo
Veröffentlicht/Copyright: 17. Oktober 2019
Clinical Chemistry and Laboratory Medicine (CCLM)
Aus der Zeitschrift Clinical Chemistry and Laboratory Medicine (CCLM) Band 58 Heft 3

Abstract

The recently raised concerns regarding biotin interference in immunoassays have increased the awareness of laboratory professionals and clinicians of the evidence that the analytical phase is still vulnerable to errors, particularly as analytical interferences may lead to erroneous results and risks for patient safety. The issue of interference in laboratory testing, which is not new, continues to be a challenge deserving the concern and interest of laboratory professionals and clinicians. Analytical interferences should be subdivided into two types on the basis of the possibility of their detection before the analytical process. The first (type 1) is represented by lipemia, hemolysis and icterus, and the second (type 2), by unusual constituents that are not undetectable before analysis, and may affect the matrix of serum/plasma of individual subjects. Type 2 cannot be identified with current techniques when performing the pre-analytical phase. Therefore, in addition to a more careful evaluation and validation of the method to be used in clinical practice, the awareness of laboratory professionals should be raised as to the importance of evaluating the quality of biological samples before analysis and to adopt algorithms and approaches in the attempt to reduce problems related to erroneous results due to specific or non-specific interferences.

Keywords: analytical interferences; biotin; immunoassays; patient safety; quality; quality assurance
Corresponding author: Prof. Mario Plebani, Department of Laboratory Medicine, University-Hospital of Padova, Padova, Italy, Phone: 0498212792

  1. Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

  2. Research funding: None declared.

  3. Employment or leadership: None declared.

  4. Honorarium: None declared.

  5. 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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Received: 2019-08-23
Accepted: 2019-09-15
Published Online: 2019-10-17
Published in Print: 2020-02-25

©2020 Walter de Gruyter GmbH, Berlin/Boston

Artikel in diesem Heft

  1. Frontmatter
  2. Editorial
  3. Progress in understanding the use of human chorionic gonadotropin as a tumor marker
  4. Reviews
  5. Biomarkers for prostate cancer: prostate-specific antigen and beyond
  6. Gut microbiome investigation in celiac disease: from methods to its pathogenetic role
  7. Opinion Papers
  8. Understanding and managing interferences in clinical laboratory assays: the role of laboratory professionals
  9. A step forward in identifying the right human chorionic gonadotropin assay for testicular cancer
  10. EFLM Opinion Paper
  11. Validation and verification of examination procedures in medical laboratories: opinion of the EFLM Working Group Accreditation and ISO/CEN standards (WG-A/ISO) on dealing with ISO 15189:2012 demands for method verification and validation
  12. Guidelines and Recommendations
  13. An updated protocol based on CLSI document C37 for preparation of off-the-clot serum from individual units for use alone or to prepare commutable pooled serum reference materials
  14. General Clinical Chemistry and Laboratory Medicine
  15. Highly accurate and explainable detection of specimen mix-up using a machine learning model
  16. Impact of delta check time intervals on error detection capability
  17. Effect of long-term frozen storage and thawing of stool samples on faecal haemoglobin concentration and diagnostic performance of faecal immunochemical tests
  18. A more accurate prediction to rule in and rule out pre-eclampsia using the sFlt-1/PlGF ratio and NT-proBNP as biomarkers
  19. Macro vitamin B12: an underestimated threat
  20. Evaluation of the primary biliary cholangitis-related serologic profile in a large cohort of Belgian systemic sclerosis patients
  21. High frequency of anti-parietal cell antibody (APCA) and intrinsic factor blocking antibody (IFBA) in individuals with severe vitamin B12 deficiency – an observational study in primary care patients
  22. DOAC-Remove abolishes the effect of direct oral anticoagulants on activated protein C resistance testing in real-life venous thromboembolism patients
  23. Cancer Diagnostics
  24. How comparable are total human chorionic gonadotropin (hCGt) tumour markers assays?
  25. Diabetes
  26. Measurement accuracy of two professional-use systems for point-of-care testing of blood glucose
  27. Letters to the Editor
  28. Human chorionic gonadotropin in oncology: a matter of tight (bio)marking
  29. More robust analytical evidence should support the selection of human chorionic gonadotropin assays for oncology application
  30. Letter in reply to the letter to the editor of Ferraro S and Panteghini M with the title “More robust analytical evidence should support the selection for human chorionic gonadotropin assays for oncology application”
  31. Definition of analytical quality specifications for serum total folate measurements using a simulation outcome-based model
  32. Alarmed by misleading interference in free T3 and free T4 assays: a new case of anti-streptavidin antibodies
  33. A root cause analysis of ‘falsely elevated’ oxygen saturation: investigation of pneumatic tube transport and differences between estimated and measured saturation in a critical patient population
  34. The chaos of serologic markers in interstitial pneumonia with autoimmune features can be corrected by the laboratory physician
  35. Vitamin A and E gender and age stratification in adults
  36. Detection of monoclonal B-lymphocytosis: interest of cellular population data and CytoDiff™ analysis
  37. Urinary reference intervals for gadolinium in individuals without recent exposure to gadolinium-based contrast agents
  38. Molecular diagnosis of toxoplasmosis: evaluation of automated DNA extraction using eMAG® (bioMérieux) on buffy coat, cerebrospinal and bronchoalveolar lavage fluids
  39. Retraction
  40. Retraction of: The Effect of a Gender Difference in the Apolipoprotein E Gene DNA Polymorphism on Serum Lipid Levels in a Serbian Healthy Population
https://doi.org/10.1515/cclm-2019-0898
Schlagwörter für diesen Artikel
analytical interferences; biotin; immunoassays; patient safety; quality; quality assurance

Artikel in diesem Heft

  1. Frontmatter
  2. Editorial
  3. Progress in understanding the use of human chorionic gonadotropin as a tumor marker
  4. Reviews
  5. Biomarkers for prostate cancer: prostate-specific antigen and beyond
  6. Gut microbiome investigation in celiac disease: from methods to its pathogenetic role
  7. Opinion Papers
  8. Understanding and managing interferences in clinical laboratory assays: the role of laboratory professionals
  9. A step forward in identifying the right human chorionic gonadotropin assay for testicular cancer
  10. EFLM Opinion Paper
  11. Validation and verification of examination procedures in medical laboratories: opinion of the EFLM Working Group Accreditation and ISO/CEN standards (WG-A/ISO) on dealing with ISO 15189:2012 demands for method verification and validation
  12. Guidelines and Recommendations
  13. An updated protocol based on CLSI document C37 for preparation of off-the-clot serum from individual units for use alone or to prepare commutable pooled serum reference materials
  14. General Clinical Chemistry and Laboratory Medicine
  15. Highly accurate and explainable detection of specimen mix-up using a machine learning model
  16. Impact of delta check time intervals on error detection capability
  17. Effect of long-term frozen storage and thawing of stool samples on faecal haemoglobin concentration and diagnostic performance of faecal immunochemical tests
  18. A more accurate prediction to rule in and rule out pre-eclampsia using the sFlt-1/PlGF ratio and NT-proBNP as biomarkers
  19. Macro vitamin B12: an underestimated threat
  20. Evaluation of the primary biliary cholangitis-related serologic profile in a large cohort of Belgian systemic sclerosis patients
  21. High frequency of anti-parietal cell antibody (APCA) and intrinsic factor blocking antibody (IFBA) in individuals with severe vitamin B12 deficiency – an observational study in primary care patients
  22. DOAC-Remove abolishes the effect of direct oral anticoagulants on activated protein C resistance testing in real-life venous thromboembolism patients
  23. Cancer Diagnostics
  24. How comparable are total human chorionic gonadotropin (hCGt) tumour markers assays?
  25. Diabetes
  26. Measurement accuracy of two professional-use systems for point-of-care testing of blood glucose
  27. Letters to the Editor
  28. Human chorionic gonadotropin in oncology: a matter of tight (bio)marking
  29. More robust analytical evidence should support the selection of human chorionic gonadotropin assays for oncology application
  30. Letter in reply to the letter to the editor of Ferraro S and Panteghini M with the title “More robust analytical evidence should support the selection for human chorionic gonadotropin assays for oncology application”
  31. Definition of analytical quality specifications for serum total folate measurements using a simulation outcome-based model
  32. Alarmed by misleading interference in free T3 and free T4 assays: a new case of anti-streptavidin antibodies
  33. A root cause analysis of ‘falsely elevated’ oxygen saturation: investigation of pneumatic tube transport and differences between estimated and measured saturation in a critical patient population
  34. The chaos of serologic markers in interstitial pneumonia with autoimmune features can be corrected by the laboratory physician
  35. Vitamin A and E gender and age stratification in adults
  36. Detection of monoclonal B-lymphocytosis: interest of cellular population data and CytoDiff™ analysis
  37. Urinary reference intervals for gadolinium in individuals without recent exposure to gadolinium-based contrast agents
  38. Molecular diagnosis of toxoplasmosis: evaluation of automated DNA extraction using eMAG® (bioMérieux) on buffy coat, cerebrospinal and bronchoalveolar lavage fluids
  39. Retraction
  40. Retraction of: The Effect of a Gender Difference in the Apolipoprotein E Gene DNA Polymorphism on Serum Lipid Levels in a Serbian Healthy Population
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