CLSI-based transference and verification of CALIPER pediatric reference intervals for 29 Ortho VITROS 5600 chemistry assays

Higgins, Victoria; Truong, Dorothy; Woroch, Amy; Chan, Man Khun; Tahmasebi, Houman; Adeli, Khosrow

doi:10.1016/j.clinbiochem.2017.12.011

Cited by 16 publications

(7 citation statements)

References 15 publications

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“…As mentioned in the Caliper's report about transferred RIs from Abbott to Ortho assays [34], Ca, CO 2 , Mg and LDH did not meet transference or veri cation criteria. Except these, the RIs of most corresponding analytes showed higher values, which might be attributed to racial and diet differences.…”

Section: Comparison To Other Studiesmentioning

confidence: 95%

Reference Intervals for 26 Common Biochemical Analytes in Term Neonates in Jilin Province, China

Wang

Zhu

Zhou

et al. 2020

Preprint

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Background: Biochemical analytes provide information for neonatal disease management and therapy, and population-based reference intervals (RIs) are essential to accurately interpret laboratory test results. This study aimed to establish local RIs for biochemical assays in term neonates.Methods: A total of 195 healthy term neonates from birth to 3rd day were recruited as reference individuals prospectively. Analytes of 26 common biochemistries were measured using the VITROS 5600 Integrated System. The 3-level nested ANOVA was performed to assess the need for partitioning RIs of each analytes, and RIs were derived by a nonparametric method or robust method. Multiple regression analysis was used to evaluate specific correlations between the analytes and individual characteristics including age, gender, gestational age, birthweight and delivery mode.Results: There were no between-sex differences in all analytes, whereas there were significant between-day-age differences in 6 analytes. Small between-delivery-mode differences were observed in the results for potassium, phosphate, and urea. The major related factor of most analytes was postnatal age. During the first 3 days, values of iron, lipids and lipoproteins increased; creatinine, urea, uric acid, creatine kinase and lactate dehydrogenase decreased; other analytes showed slight changes or relatively stable trends. Reference limits of some analytes, particularly lactate dehydrogenase and alkaline phosphatase, were significant different from adult and pediatric groups.Conclusions: RIs of 26 common biochemical analytes are established for term neonates aged 0 to 3 days in northeast China. Additionally, it is suggested that age-related changes should be valued in the clinical decision-making process for newborns.

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Section: Comparison To Other Studiesmentioning

confidence: 95%

Reference Intervals for 26 Common Biochemical Analytes in Term Neonates in Jilin Province, China

Wang

Zhu

Zhou

et al. 2020

Preprint

View full text Add to dashboard Cite

show abstract

“…As mentioned in the Caliper's report about transferred RIs from Abbott to Ortho assays [40], Ca, CO 2 , Mg and LDH did not meet transference or verification criteria. Except these, the RIs of most corresponding analytes showed higher values, which might be attributed to racial and diet differences.…”

Section: Comparison To Other Studiesmentioning

confidence: 96%

Reference intervals for 26 common biochemical analytes in term neonates in Jilin Province, China

et al. 2021

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Background Biochemical analytes provide information for neonatal disease management and therapy, and population-based reference intervals (RIs) are essential to accurately interpret laboratory test results. This study aimed to establish local RIs for biochemical assays in term neonates. Methods A total of 195 healthy term neonates from birth to 3rd day were recruited as reference individuals prospectively. Analytes of 26 common biochemistries were measured using the VITROS 5600 Integrated System. The 3-level nested ANOVA was performed to assess the need for partitioning RIs of each analyte, and RIs were derived by a nonparametric method or robust method. Multiple regression analysis was used to evaluate specific correlations between the analytes and individual characteristics including age, gender, gestational age, birthweight and delivery mode. Results There were no between-sex differences in all analytes, whereas there were significant between-day-age differences in 6 analytes. Small between-delivery-mode differences were observed in the results for potassium, phosphorus, and urea. The major related factor of most analytes was postnatal age. During the first 3 days, values of iron, lipids and lipoproteins increased; creatinine, urea, uric acid, creatine kinase and lactate dehydrogenase decreased; other analytes showed slight changes or relatively stable trends. Reference limits of some analytes, particularly lactate dehydrogenase and alkaline phosphatase, were significantly different from adult and pediatric groups. Conclusions RIs of 26 common biochemical analytes are established for term neonates aged 0 to 3 days in northeast China. Additionally, it is suggested that age-related changes should be valued in the clinical decision-making process for newborns.

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“…Where possible, reference intervals already established elsewhere should be used, providing quality conditions can be met. Transference of a reference value is the process of adapting a previously established reference interval to a new or updated test technique or test centre [ 2 , 32 , 69 ]. As an example, a centre previously established an ERG reference interval based on the 2004 Standard [ 70 ] using a 2.0 cd·s·m −2 flash, but wished to update their ERG test protocol to comply with the current stipulation of 3.0 cd·s·m −2 [ 12 ].…”

Section: Transference Of a Reference Intervalmentioning

confidence: 99%

Reference ranges for clinical electrophysiology of vision

Davis

Hamilton

2021

Doc Ophthalmol

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Introduction Establishing robust reference intervals for clinical procedures has received much attention from international clinical laboratories, with approved guidelines. Physiological measurement laboratories have given this topic less attention; however, most of the principles are transferable. Methods Herein, we summarise those principles and expand them to cover bilateral measurements and one-tailed reference intervals, which are common issues for those interpreting clinical visual electrophysiology tests such as electroretinograms (ERGs), visual evoked potentials (VEPs) and electrooculograms (EOGs). Results The gold standard process of establishing and defining reference intervals, which are adequately reliable, entails collecting data from a minimum of 120 suitable reference individuals for each partition (e.g. sex, age) and defining limits with nonparametric methods. Parametric techniques may be used under some conditions. A brief outline of methods for defining reference limits from patient data (indirect sampling) is given. Reference intervals established elsewhere, or with older protocols, can be transferred or verified with as few as 40 and 20 suitable reference individuals, respectively. Consideration is given to small numbers of reference subjects, interpretation of serial measurements using subject-based reference values, multidimensional reference regions and age-dependent reference values. Bilateral measurements, despite their correlation, can be used to improve reference intervals although additional care is required in computing the confidence in the reference interval or the reference interval itself when bilateral measurements are only available from some of subjects. Discussion Good quality reference limits minimise false-positive and false-negative results, thereby maximising the clinical utility and patient benefit. Quality indicators include using appropriately sized reference datasets with appropriate numerical handling for reporting; using subject-based reference limits where appropriate; and limiting tests for each patient to only those which are clinically indicated, independent and highly discriminating.

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CLSI-based transference and verification of CALIPER pediatric reference intervals for 29 Ortho VITROS 5600 chemistry assays

Cited by 16 publications

References 15 publications

Reference Intervals for 26 Common Biochemical Analytes in Term Neonates in Jilin Province, China

Reference Intervals for 26 Common Biochemical Analytes in Term Neonates in Jilin Province, China

Reference intervals for 26 common biochemical analytes in term neonates in Jilin Province, China

Reference ranges for clinical electrophysiology of vision

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