Pediatric reference interval verification for common biochemical assays on the Abbott Alinity system

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Mary Kathryn Bohn ◽  
Siobhan Wilson ◽  
Alexandra Hall ◽  
Youssef Massamiri ◽  
Ed Randell ◽  
...  
Keyword(s):  
Clinical Laboratory ◽  
Package Insert ◽  
Reference Interval ◽  
Reference Intervals ◽  
Confidence Limits ◽  
Serum Samples ◽  
Laboratory Service ◽  
Biochemical Assays ◽  
Pediatric Healthcare ◽  
Abbott Architect

Abstract Objectives The quality of clinical laboratory service depends on quality laboratory operations and accurate test result interpretation based on reference intervals (RIs). As new analytical systems continue to be developed and improved, previously established RIs must be verified. The Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) has established comprehensive RIs for many biomarkers on several analytical systems. Here, published CALIPER RIs for 28 chemistry assays on the Abbott ARCHITECT were assessed for verification on the newer Alinity system. Methods An analytical validation was first completed to assess assay performance. CALIPER serum samples (100) were analyzed for 28 chemistry assays on the Alinity system. The percentage of results falling within published pediatric ARCHITECT reference and confidence limits was determined for each analyte. Based on Clinical and Laboratory Standards Institute (CLSI) guidelines, if ≥90% of test results fell within confidence limits of ARCHITECT assay RIs, they were considered verified. Results Of the 28 assays assessed, 26 met the criteria for verification. Reference values for calcium and magnesium did not meet the criteria for verification with 87% and 35% falling within previously established ARCHITECT confidence limits, respectively. However, both assays could be verified using pediatric RIs provided in the Abbott Alinity package insert. Conclusions In this study, CALIPER ARCHITECT RIs were verified on the Alinity system for several chemistry assays. These data demonstrate excellent concordance for most assays between the Abbott ARCHITECT and Alinity systems and will assist in the implementation of the Alinity system in pediatric healthcare institutions.

Pediatric reference interval verification for endocrine and fertility hormone assays on the Abbott Alinity system

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Mary Kathryn Bohn ◽  
Siobhan Wilson ◽  
Alexandra Hall ◽  
Khosrow Adeli
Keyword(s):  
Clinical Decision Making ◽  
De Novo ◽  
Reference Interval ◽  
Clinical Decision ◽  
Reference Intervals ◽  
Healthy Children ◽  
Confidence Limits ◽  
Test Results ◽  
Serum Samples ◽  
Abbott Architect

Abstract Objectives The Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) has developed an extensive database of reference intervals (RIs) for several biomarkers on various analytical systems. In this study, pediatric RIs were verified for key immunoassays on the Abbott Alinity system based on the analysis of healthy children samples and comparison to comprehensive RIs previously established for Abbott ARCHITECT assays. Methods Analytical performance of Alinity immunoassays was first assessed. Subsequently, 100 serum samples from healthy children recruited with informed consent were analyzed for 16 Alinity immunoassays. The percentage of test results falling within published CALIPER ARCHITECT reference and confidence limits was determined. If ≥ 90% of test results fell within the confidence limits, they were considered verified based on CLSI guidelines. If <90% of test results fell within the confidence limits, additional samples were analyzed and new Alinity RIs were established. Results Of the 16 immunoassays assessed, 13 met the criteria for verification with test results from ≥ 90% of healthy serum samples falling within the published ARCHITECT confidence limits. New CALIPER RIs were established for free thyroxine and prolactin on the Alinity system. Estradiol required special considerations in early life. Conclusions Our data demonstrate excellent concordance between ARCHITECT and Alinity immunoassays, as well as the robustness of previously established CALIPER RIs for most immunoassays, eliminating the need for de novo RI studies for most parameters. Availability of pediatric RIs for immunoassays on the Alinity system will assist clinical laboratories using this new platform and contribute to improved clinical decision-making.

Immunochemical methods for measurement of transferrin in serum: effects of analytical errors and inappropriate reference intervals on diagnostic utility.

1985 ◽  
Vol 31 (10) ◽  
pp. 1601-1605 ◽  
Author(s):  
Z L Bandi ◽  
I Schoen ◽  
D E Bee
Keyword(s):  
Serum Proteins ◽  
Reference Interval ◽  
Reference Intervals ◽  
Confidence Limits ◽  
Serum Samples ◽  
Normal Reference ◽  
Two Samples ◽  
Reference Preparation ◽  
Immunochemical Methods ◽  
Analytical Errors

Abstract We estimated analytical errors of the Calbiochem, Kallestad, Hyland, Meloy, Helena, and Beckman immunochemical methods for serum transferrin. Intermethod biases were determined by analysis of the "Reference Preparation for Serum Proteins" of the College of American Pathologists and by analysis of 106 patients' serum samples. We judged the acceptability of errors by comparing confidence limits for total errors with 1/4 of the normal reference intervals. The transferrin status of each patient's sample was interpreted by comparing the result of each method with the normal reference interval claimed by the corresponding manufacturer. We found that the combined effects of medically unacceptable analytical errors and inappropriate normal intervals caused results of the tested methods not to be interchangeable. The Calbiochem method identified 61 serum samples (57%) as having abnormally high transferrin concentrations. In contrast, for the same specimen, with the Meloy method we found abnormally high transferrin concentrations for only two samples (1.8%).

Pediatric reference intervals for 1,25-dihydroxyvitamin D using the DiaSorin LIAISON XL assay in the healthy CALIPER cohort

2018 ◽  
Vol 56 (6) ◽  
pp. 964-972 ◽  
Author(s):  
Victoria Higgins ◽  
Dorothy Truong ◽  
Nicole M.A. White-Al Habeeb ◽  
Angela W.S. Fung ◽  
Barry Hoffman ◽  
...  
Keyword(s):  
Children And Adolescents ◽  
Critical Role ◽  
Reference Interval ◽  
Reference Intervals ◽  
Biologically Active ◽  
Specific Reference ◽  
Healthy Children ◽  
Serum Samples ◽  
Dihydroxyvitamin D ◽  
1,25 Dihydroxyvitamin D

Abstract Background: 1,25-dihydroxyvitamin D (1,25(OH)2D), the biologically active vitamin D metabolite, plays a critical role in calcium and phosphate homeostasis. 1,25(OH)2D is measured to assess calcium and phosphate metabolism, particularly during periods of profound growth and development. Despite its importance, no reliable pediatric reference interval exists, with those available developed using adult populations or out-dated methodologies. Using the fully automated chemiluminescence immunoassay by DiaSorin, we established 1,25(OH)2D pediatric reference intervals using healthy children and adolescents from the CALIPER cohort. Methods: Serum samples from healthy subjects (0 to <19 years) were analyzed for 1,25(OH)2D using the DiaSorin LIAISON XL assay and age-specific reference intervals were established. The Mann-Whitney U-test was used to determine seasonal differences. Pooled neonatal and infantile samples were quantified using liquid chromatography tandem mass spectrometry (LC-MS/MS) to determine if elevated concentrations during the first year of life may be attributed to cross-reacting moieties. Results: Three reference interval age partitions were required with highest levels in subjects 0 to <1 year (77–471 pmol/L), which declined and narrowed after 1 year (113–363 pmol/L) and plateaued at 3 years (108–246 pmol/L). 1,25(OH)2D concentration was not significantly affected by seasonal variation or sex. Elevated 1,25(OH)2D concentrations in neonatal and infantile samples may be the result of an interfering substance. The absence of 3-epi-1,25-dihydroxyvitamin D in the pooled samples makes it unlikely to be the interfering moiety. Conclusions: Pediatric reference intervals for 1,25(OH)2D were established to improve test result interpretation in children and adolescents. 1,25(OH)2D is elevated in a proportion of neonates and infants, which may be the result of a cross-reacting moiety.

Reference intervals and biological variation for kallikrein 6: influence of age and renal failure

2012 ◽  
Vol 50 (5) ◽  
Author(s):  
Eduardo Martínez-Morillo ◽  
Anastasia Diamandis ◽  
Eleftherios P. Diamandis
Keyword(s):  
Renal Failure ◽  
Significant Positive Correlation ◽  
Reference Interval ◽  
Serum Marker ◽  
Reference Intervals ◽  
Biological Variation ◽  
Serum Samples ◽  
Positive Correlation ◽  
Reference Change Value ◽  
Kallikrein 6

AbstractKallikrein 6 (KLK6) is a serine protease involved in numerous cellular processes, up-regulated in many cancers and associated with some neurodegenerative disorders. The aim of this study was to establish a reference interval and estimate the biological variation of KLK6 in serum samples of adults. Furthermore, levels of this protein in patients with renal failure were also studied.Serum samples from healthy volunteers (n=136) were collected. Between 15 and 18 additional samples from four of these subjects were obtained over a period of 2 months. Samples from individuals (n=1043) who visited the University Health Network for a routine check-up were collected to study the association between KLK6 with age and gender. Samples from patients with renal failure (n=106) were also obtained and KLK6 and creatinine concentrations were analyzed by ELISA and an automated enzymatic method, respectively.The reference interval was established to be 1.04–3.93 ng/mL. The index of individuality was 0.43 and the reference change value was 35%. Only two serum samples would be required to estimate the homeostatic setting point of an individual. There is a weak but highly significant positive correlation between KLK6 and age (p<0.0001). Furthermore, there is a significant positive correlation between serum concentrations of KLK6 and creatinine (p<0.0001), in patients with renal failure.The established reference interval for KLK6 and the estimation of its biological variation will further aid in the clinical use of this protein as a serum marker of malignancy and other diseases.

scholarly journals Reference Intervals (RIs) of Lipid Parameters for Nepalese Population

2018 ◽  
Vol 6 (4) ◽  
pp. 366-372
Author(s):  
R.V. Mahato ◽  
R.K. Singh ◽  
A. M. Dutta ◽  
K. Ichihara ◽  
M. Lamsal
Keyword(s):  
Total Cholesterol ◽  
Reference Values ◽  
Clinical Laboratory ◽  
Local Population ◽  
Density Lipoprotein ◽  
Physical Exertion ◽  
Hdl Cholesterol ◽  
Reference Interval ◽  
Reference Intervals ◽  
Lipoprotein Cholesterol

Introduction: Reference interval (RIs) is the range of values provided by laboratory scientists in a convenient and practical form to support clinician in interpreting observed values for diagnosis, treatment and monitoring of a disease. Laboratories in Nepal uses RIs, provided in the kit inserts by the manufacturers or from the scientific literature, established for western/European population. It is well known that population across the globe differs physiologically, genetically; race, ethnically, lifestyle, food habits and diet which have great impact on the reference values. Thus, it is inappropriate to use RIs that do not represent the local population. This approach highlights for establishing reference values in Nepalese population using the IFCC-CRIDL guidelines published in (C28-A3). Objectives: The objective of this study is to analyze blood lipids concentration in apparently healthy Nepalese population to set up reference values for total cholesterol (TC), triglycerides (TG), High Density Lipoprotein-cholesterol (HDL-C) and Low Density Lipoprotein-cholesterol (LDL-C) and compare with the internationally recommended values. Methods: Reference individuals selected from healthy volunteers according to the IFCC/C-RIDL protocol in (C28 –A3). Volunteers were requested to avoid excessive physical exertion/exercise/excessive eating and drinking and fast overnight for 10-12 hour. Blood samples were collected from 120 subjects from each five centers of the country between 7:00-10:00 am, serum were separated and refrigerated at -20 in a cryo-vials. Finally, 617 samples were transported to Yamaguchi University, Graduate School of Medicine, Ube, Japan for analysis in dry Ice and 30 parameters were measured by fully automated biochemistry analyzer, Beckman Coulter (BC480) in the clinical laboratory. Results: A reference interval for each parameter was calculated from the 95% reference intervals ranging from 2.5% and 97.5% percentiles and, arithmetic mean + 2 SD were also calculated. The 95% reference range for total cholesterol (2.53-6.14), triglyceride was(0.42-3.32),for HDL Cholesterol was (0.28-1.46), for LDL was(1.05-4.00) and for VLDL was (0.054-0.92) for Nepalese population. Conclusion: Nepalese clinicians can take into consideration of reference lipid values of this study for diagnosis, treatment and monitoring of disease. Int. J. Appl. Sci. Biotechnol. Vol 6(4): 366-372

A multi-stage Gaussian transformation algorithm for clinical laboratory data.

1982 ◽  
Vol 28 (8) ◽  
pp. 1735-1741 ◽  
Author(s):  
J C Boyd ◽  
D A Lacher
Keyword(s):  
Mean Squared Error ◽  
Clinical Laboratory ◽  
Statistical Tests ◽  
Random Noise ◽  
Laboratory Data ◽  
Reference Interval ◽  
Reference Intervals ◽  
Distributed Data ◽  
Multi Stage ◽  
Positive Coefficients

Abstract We have developed a multi-stage computer algorithm to transform non-normally distributed data to a normal distribution. This transformation is of value for calculation of laboratory reference intervals and for normalization of clinical laboratory variates before applying statistical procedures in which underlying data normality is assumed. The algorithm is able to normalize most laboratory data distributions with either negative or positive coefficients of skewness or kurtosis. Stepwise, a logarithmic transform removes asymmetry (skewness), then a Z-score transform and power function transform remove residual peakedness or flatness (kurtosis). Powerful statistical tests of data normality in the procedure help the user evaluate both the necessity for and the success of the data transformation. Erroneous assessments of data normality caused by rounded laboratory test values have been minimized by introducing computer-generated random noise into the data values. Reference interval endpoints that were estimated parametrically (mean +/- 2 SD) by using successfully transformed data were found to have a smaller root-mean-squared error than those estimated by the non-parametric percentile technique.

NUMBER: standardized reference intervals in the Netherlands using a ‘big data’ approach

2018 ◽  
Vol 0 (0) ◽  
Author(s):  
Wendy P.J. den Elzen ◽  
Nannette Brouwer ◽  
Marc H. Thelen ◽  
Saskia Le Cessie ◽  
Inez-Anne Haagen ◽  
...  
Keyword(s):  
General Chemistry ◽  
Big Data ◽  
The Netherlands ◽  
Clinical Laboratory ◽  
Reference Interval ◽  
Clinical Decision ◽  
Reference Intervals ◽  
Test Results ◽  
Study Population ◽  
Set Up

AbstractBackgroundExternal quality assessment (EQA) programs for general chemistry tests have evolved from between laboratory comparison programs to trueness verification surveys. In the Netherlands, the implementation of such programs has reduced inter-laboratory variation for electrolytes, substrates and enzymes. This allows for national and metrological traceable reference intervals, but these are still lacking. We have initiated a national endeavor named NUMBER (Nederlandse UniforMe Beslisgrenzen En Referentie-intervallen) to set up a sustainable system for the determination of standardized reference intervals in the Netherlands.MethodsWe used an evidence-based ‘big-data’ approach to deduce reference intervals using millions of test results from patients visiting general practitioners from clinical laboratory databases. We selected 21 medical tests which are either traceable to SI or have Joint Committee for Traceability in Laboratory Medicine (JCTLM)-listed reference materials and/or reference methods. Per laboratory, per test, outliers were excluded, data were transformed to a normal distribution (if necessary), and means and standard deviations (SDs) were calculated. Then, average means and SDs per test were calculated to generate pooled (mean±2 SD) reference intervals. Results were discussed in expert meetings.ResultsSixteen carefully selected clinical laboratories across the country provided anonymous test results (n=7,574,327). During three expert meetings, participants found consensus about calculated reference intervals for 18 tests and necessary partitioning in subcategories, based on sex, age, matrix and/or method. For two tests further evaluation of the reference interval and the study population were considered necessary. For glucose, the working group advised to adopt the clinical decision limit.ConclusionsUsing a ‘big-data’ approach we were able to determine traceable reference intervals for 18 general chemistry tests. Nationwide implementation of these established reference intervals has the potential to improve unequivocal interpretation of test results, thereby reducing patient harm.

Pediatric reference intervals for alkaline phosphatase

2017 ◽  
Vol 55 (1) ◽  
pp. 102-110 ◽  
Author(s):  
Jakob Zierk ◽  
Farhad Arzideh ◽  
Rainer Haeckel ◽  
Holger Cario ◽  
Michael C. Frühwald ◽  
...  
Keyword(s):  
Alkaline Phosphatase ◽  
Phosphatase Activity ◽  
Alkaline Phosphatase Activity ◽  
Clinical Laboratory ◽  
Clinical Care ◽  
Tertiary Care ◽  
Laboratory Data ◽  
Reference Intervals ◽  
Photometric Method ◽  
Laboratory Service

Abstract Background: Interpretation of alkaline phosphatase activity in children is challenging due to extensive changes with growth and puberty leading to distinct sex- and age-specific dynamics. Continuous percentile charts from birth to adulthood allow accurate consideration of these dynamics and seem reasonable for an analyte as closely linked to growth as alkaline phosphatase. However, the ethical and practical challenges unique to pediatric reference intervals have restricted the creation of such percentile charts, resulting in limitations when clinical decisions are based on alkaline phosphatase activity. Methods: We applied an indirect method to generate percentile charts for alkaline phosphatase activity using clinical laboratory data collected during the clinical care of patients. A total of 361,405 samples from 124,440 patients from six German tertiary care centers and one German laboratory service provider measured between January 2004 and June 2015 were analyzed. Measurement of alkaline phosphatase activity was performed on Roche Cobas analyzers using the IFCC’s photometric method. Results: We created percentile charts for alkaline phosphatase activity in girls and boys from birth to 18 years which can be used as reference intervals. Additionally, data tables of age- and sex-specific percentile values allow the incorporation of these results into laboratory information systems. Conclusions: The percentile charts provided enable the appropriate differential diagnosis of changes in alkaline phosphatase activity due to disease and changes due to physiological development. After local validation, integration of the provided percentile charts into result reporting facilitates precise assessment of alkaline phosphatase dynamics in pediatrics.

scholarly journals Reference Intervals for Hematology and Clinical Chemistry for the African Elephant (Loxodonta africana)

2021 ◽  
Vol 8 ◽  
Author(s):  
Christine Steyrer ◽  
Michele Miller ◽  
Jennie Hewlett ◽  
Peter Buss ◽  
Emma H. Hooijberg
Keyword(s):  
National Parks ◽  
Clinical Chemistry ◽  
Clinical Pathology ◽  
Loxodonta Africana ◽  
Reference Interval ◽  
Reference Intervals ◽  
Small Sample ◽  
African Elephant ◽  
Serum Samples ◽  
American Society

The African elephant (Loxodonta africana) is listed as vulnerable, with wild populations threatened by habitat loss and poaching. Clinical pathology is used to detect and monitor disease and injury, however existing reference interval (RI) studies for this species have been performed with outdated analytical methods, small sample sizes or using only managed animals. The aim of this study was to generate hematology and clinical chemistry RIs, using samples from the free-ranging elephant population in the Kruger National Park, South Africa. Hematology RIs were derived from EDTA whole blood samples automatically analyzed (n = 23); manual PCV measured from 48 samples; and differential cell count results (n = 51) were included. Clinical chemistry RIs were generated from the results of automated analyzers on stored serum samples (n = 50). Reference intervals were generated according to American Society for Veterinary Clinical Pathology guidelines with a strict exclusion of outliers. Hematology RIs were: PCV 34–49%, RBC 2.80–3.96 × 1012/L, HGB 116–163 g/L, MCV 112–134 fL, MCH 35.5–45.2 pg, MCHC 314–364 g/L, PLT 182–386 × 109/L, WBC 7.5–15.2 × 109/L, segmented heterophils 1.5–4.0 × 109/L, band heterophils 0.0–0.2 × 109/L, total monocytes 3.6–7.6 × 109/L (means for “regular” were 35.2%, bilobed 8.6%, round 3.9% of total leukocytes), lymphocytes 1.1–5.5 × 109/L, eosinophils 0.0–0.9 × 109/L, basophils 0.0–0.1 × 109/L. Clinical chemistry RIs were: albumin 41–55 g/L, ALP 30–122 U/L, AST 9–34 U/L, calcium 2.56–3.02 mmol/L, CK 85–322 U/L, GGT 7–16 U/L, globulin 30–59 g/L, magnesium 1.15–1.70 mmol/L, phosphorus 1.28–2.31 mmol/L, total protein 77–109 g/L, urea 1.2–4.6 mmol/L. Reference intervals were narrower than those reported in other studies. These RI will be helpful in the future management of injured or diseased elephants in national parks and zoological settings.

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