Evaluating sample stability in the clinical laboratory with the help of linear and non-linear regression analysis
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Joachim K.W. Pum
Abstract
As it is common practice for laboratories to store patient samples for a predefined period, allowing clinicians to request additional tests on previously collected samples, knowledge about sample stability is indispensable for the laboratorian. A common approach to estimating the maximum storage time is to use a discrete study design, measuring the analyte of interest at various time-points and then checking for significant differences with the help of a statistical test, such as Student’s t-test, Wilcoxon’s test or an analysis of variance (ANOVA) test. Because only discrete time intervals are considered, stability data can just be approximated. Alternatively, a continuous study design, as described by the Clinical and Laboratory Standards Institute (CLSI) for performing stability experiments for in vitro diagnostic reagents, can also be adopted by the clinical laboratory to evaluate the stability of biological samples. The major advantage of this approach is that it allows laboratories to define individual stability limits for different medical situations and offers more flexibility when choosing time-points for measurements. The intent of this paper is to demonstrate the evaluation of sample stability in the clinical laboratory with a continuous study design implemented with linear or non-linear regression analysis. Appropriate statistical modeling and acceptance criteria are presented, stability functions are described briefly, and checking the overall validity of the results is discussed.
Author contributions: The author has 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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Artikel in diesem Heft
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Artikel in diesem Heft
- Frontmatter
- Editorial
- Towards a personalized assessment of vitamin D status
- Reviews
- Circulating tumor DNA and their added value in molecular oncology
- Telomere length determinants in childhood
- Opinion Papers
- Serum or plasma? An old question looking for new answers
- Evaluating sample stability in the clinical laboratory with the help of linear and non-linear regression analysis
- General Clinical Chemistry and Laboratory Medicine
- Simultaneous measurement of 25(OH)-vitamin D and 24,25(OH)2-vitamin D to define cut-offs for CYP24A1 mutation and vitamin D deficiency in a population of 1200 young subjects
- How well do Croatian laboratories adhere to national recommendations for laboratory diagnostics of chronic kidney disease (CKD)?
- Underfilling of vacuum blood collection tubes leads to increased lactate dehydrogenase activity in serum and heparin plasma samples
- Calcium state estimation by total calcium: the evidence to end the never-ending story
- The use of faecal immunochemical testing in the decision-making process for the endoscopic investigation of iron deficiency anaemia
- Measurement uncertainty of β-lactam antibiotics results: estimation and clinical impact on therapeutic drug monitoring
- Practical approach to method verification in plasma and validation in cerebrospinal fluid under accreditation using a flexible scope in molecular virology: setting up the HIV, HBV and HCV Aptima™ Quant Dx assays
- Plasma neurofilament light chain is associated with mortality after spontaneous intracerebral hemorrhage
- Comparison of the diagnostic performance of two automated urine sediment analyzers with manual phase-contrast microscopy
- Development and validation of LC-MS/MS methods to measure tobramycin and lincomycin in plasma, microdialysis fluid and urine: application to a pilot pharmacokinetic research study
- Reference Values and Biological Variations
- Cord blood S100B: reference ranges and interest for early identification of newborns with brain injury
- Hematology and Coagulation
- Validation and standardization of the ETP-based activated protein C resistance test for the clinical investigation of steroid contraceptives in women: an unmet clinical and regulatory need
- Cancer Diagnostics
- Next-generation sequencing for tumor mutation quantification using liquid biopsies
- Cardiovascular Diseases
- Evolution of the slopes of ST2 and galectin-3 during marathon and ultratrail running compared to a control group
- Letters to the Editor
- Biological variation of two serum markers for preeclampsia prediction
- Daily monitoring of a control material with a concentration near the limit of detection improves the measurement accuracy of highly sensitive troponin assays
- Are patients adequately informed about procedures for 24-h urine collection?
- Interferences in free thyroxine concentration using the Roche analytical platform: improvement of the third generation?
- Procedures for the diagnosis of macro-follicle stimulating hormone (FSH) in a patient with high serum FSH concentrations
- False-positive result of immunochromatographic (IC) strip test for the diagnosis of α-thalassemia in samples with autoantibodies
- Sample dilution for soluble interleukin-2 receptor α measurement: comparison of two different matrices
- The growing problem of predatory publishing: a case report
- Cerebrospinal fluid lactate levels according to the site of puncture
