Abstract
References
- 1 Fraser CG. Test result variation and the quality of evidence-based clinical guidelines. Clinica chimica acta; international journal of clinical chemistry. 2004;346:19-24. DOI:10.1016/j.cccn.2003.12.032
- 2 Simundic AM and Lippi G. Preanalytical phase--a continuous challenge for laboratory professionals. Biochemia medica. 2012;22:145-9.
- 3 Ricós C, Perich C, Minchinela J, et al. Application of biological variation–a review. Biochemia medica. 2009;19:250-9.
- 4 Ricos C, Alvarez V, Cava F, et al. Current databases on biological variation: pros, cons and progress. Scandinavian journal of clinical and laboratory investigation. 1999;59:491-500.
- 5 Fraser CG. Reference change values. Clinical chemistry and laboratory medicine. 2011;50:807-12. DOI:10.1515/cclm.2011.733
- 6 Fraser CG. Biological variation: from principles to practice: Amer. Assoc. for Clinical Chemistry; 2001.
- 7 Petersen PH, Sandberg S, Fraser CG, et al. Influence of index of individuality on false positives in repeated sampling from healthy individuals. Clinical chemistry and laboratory medicine. 2001;39:160-5. DOI:10.1515/cclm.2001.027
- 8 Carobene A, Roraas T, Solvik UO, et al. Biological Variation Estimates Obtained from 91 Healthy Study Participants for 9 Enzymes in Serum. Clinical chemistry. 2017;63:1141-50. DOI:10.1373/clinchem.2016.269811
- 9 Aarsand AK, Diaz-Garzon J, Fernandez-Calle P, et al. The EuBIVAS: Within- and Between-Subject Biological Variation Data for Electrolytes, Lipids, Urea, Uric Acid, Total Protein, Total Bilirubin, Direct Bilirubin, and Glucose. Clinical chemistry. 2018;64:1380-93. DOI:10.1373/clinchem.2018.288415
- 10 Carlsen S, Petersen PH, Skeie S, et al. Within-subject biological variation of glucose and HbA(1c) in healthy persons and in type 1 diabetes patients. Clinical chemistry and laboratory medicine. 2011;49:1501-7. DOI:10.1515/cclm.2011.233
Abstract
Purpose: The present study was set out to investigate the effect of test repetition within the biological variation perspective by addressing reanalyzing an individual sample on total variation. This study also demonstrated to what extent a laboratory result of an individual reflects a homeostatic set-point.
Methods: The total variation values were determined for different coefficients of analytical variation (CVA) corresponding optimum (CVA = 0.25 x CVI), desirable (CVA = 0.5 x CVI), and minimum (CVA = 0.25 x CVI) limits of performance specifications for imprecision. The effect of a number of analytical measurements on the total variation for a single sample was simulated. Furthermore, the percentage of closeness to the true homeostatic setting point (D) was determined for commonly used 27 analytes.
Results: This study showed that the total variation reduction with reanalysis of an individual sample was lower than 19%, 10%, and 3% for the tests meeting the minimum, desirable and optimum level of specification limits, respectively. Furthermore, the reduction was only 9.4%, 5.1%, and 1.5% for duplicate analysis of an individual sample at the abovementioned limits.
Conclusion: This study demonstrated that test repetition has a negligible effect on the total variation, especially when analytical performance meets optimum and desirable performance specifications. D values reported in this study can guide laboratory professionals and clinicians about to what extent a result of an individual reflects homeostatic set-point.
References
- 1 Fraser CG. Test result variation and the quality of evidence-based clinical guidelines. Clinica chimica acta; international journal of clinical chemistry. 2004;346:19-24. DOI:10.1016/j.cccn.2003.12.032
- 2 Simundic AM and Lippi G. Preanalytical phase--a continuous challenge for laboratory professionals. Biochemia medica. 2012;22:145-9.
- 3 Ricós C, Perich C, Minchinela J, et al. Application of biological variation–a review. Biochemia medica. 2009;19:250-9.
- 4 Ricos C, Alvarez V, Cava F, et al. Current databases on biological variation: pros, cons and progress. Scandinavian journal of clinical and laboratory investigation. 1999;59:491-500.
- 5 Fraser CG. Reference change values. Clinical chemistry and laboratory medicine. 2011;50:807-12. DOI:10.1515/cclm.2011.733
- 6 Fraser CG. Biological variation: from principles to practice: Amer. Assoc. for Clinical Chemistry; 2001.
- 7 Petersen PH, Sandberg S, Fraser CG, et al. Influence of index of individuality on false positives in repeated sampling from healthy individuals. Clinical chemistry and laboratory medicine. 2001;39:160-5. DOI:10.1515/cclm.2001.027
- 8 Carobene A, Roraas T, Solvik UO, et al. Biological Variation Estimates Obtained from 91 Healthy Study Participants for 9 Enzymes in Serum. Clinical chemistry. 2017;63:1141-50. DOI:10.1373/clinchem.2016.269811
- 9 Aarsand AK, Diaz-Garzon J, Fernandez-Calle P, et al. The EuBIVAS: Within- and Between-Subject Biological Variation Data for Electrolytes, Lipids, Urea, Uric Acid, Total Protein, Total Bilirubin, Direct Bilirubin, and Glucose. Clinical chemistry. 2018;64:1380-93. DOI:10.1373/clinchem.2018.288415
- 10 Carlsen S, Petersen PH, Skeie S, et al. Within-subject biological variation of glucose and HbA(1c) in healthy persons and in type 1 diabetes patients. Clinical chemistry and laboratory medicine. 2011;49:1501-7. DOI:10.1515/cclm.2011.233
Details
| Primary Language | English |
|---|---|
| Subjects | Biochemistry and Cell Biology (Other) |
| Journal Section | Research Article |
| Authors | |
| Early Pub Date | October 14, 2021 |
| Publication Date | January 1, 2022 |
| Submission Date | November 14, 2021 |
| Published in Issue | Year 2022Volume: 13 Issue: 1 |
