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Start Over Descriptor "Panel of sera" Topic clinical chemistry
3 results on '"Panel of sera"'

1. Utility of a panel of sera for the alignment of test results in the worldwide multicenter study on reference values.

Author

Ichihara, Kiyoshi, Ozarda, Yesim, Klee, George, Straseski, Joely, Baumann, Nikola, and Ishikura, Kiyohide

Subjects
*SERAS (Computer system), *CLINICAL chemistry, *CLINICAL pathology, *REGRESSION analysis, *SKEWNESS (Probability theory)
Abstract

Background: In a planned International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) worldwide study on reference intervals (RIs), a common panel of serum samples is to be measured by laboratories from different countries, and test results are to be compared through conversion using linear regression analysis. This report presents a validation study that was conducted in collaboration with four laboratories. Methods: A panel composed of 80 sera was prepared from healthy individuals, and 45 commonly tested analytes (general chemistry, tumor markers, and hormones) were measured on two occasions 1 week apart in each laboratory. Reduced major-axis linear regression was used to convert reference limits ( LL and UL). Precision was expressed as a ratio of the standard error of converted LL or UL to the standard deviation (SD) comprising RI (approx. 1/4 of the RI width corresponding to between-individual SD). The allowable and optimal levels of error for the SD ratio (SDR) were set as ≤0.250 and ≤0.125, respectively, in analogy to the common method of setting limits for analytical bias based on between-individual SD. Results: The values for the calculated SDRs depended upon the distribution patterns of test results: skewness toward higher values makes SDRLL lower and SDRUL higher. However, the CV of the regression line slope, CV( b), is less affected by skewness. The average of SDRLL and SDRUL (aveSDR) correlates closely with CV( b) (r=0.995). The aveSDRs of ≤0.25 and ≤0.125 corresponds approximately to CV( b) values of ≤11% and ≤5.5%, respectively. For all results (i.e., n=80), conversion was allowable (optimal) in 98% (89%) of the analytes, as judged by CV( b). Resampling studies using random subsets of data with a data size (n) of 70 to 20 revealed that SDRs and CV( b) gradually increase with reduction of n, especially with n ≤30. Conclusions: CV( b) is a robust estimator for judging the convertibility of reference values among laboratories, even with a skewed distribution. Assuming 40 sera to be a practical size for the panel, reference values of 89% (80%) of analytes examined were made comparable by regression analysis with the allowable (optimal) level of precision. [ABSTRACT FROM AUTHOR]

Published
2013
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2. Utility of a panel of sera for the alignment of test results in the worldwide multicenter study on reference values

Author

Nikola A. Baumann, Yesim Ozarda, George G. Klee, Joely A. Straseski, Kiyoshi Ichihara, Kiyohide Ishikura, Uludağ Üniversitesi/Tıp Fakültesi/Biyokimya Anabilim Dalı., Özarda, Yeşim, and AAL-8873-2021

Subjects
Luteinizing hormone, Male, Pathology, Folic acid, Blood sampling, Clinical Biochemistry, Low density lipoprotein cholesterol, Standard deviation, Clinical chemistry, Method comparison, Reference Values, Resampling, Clinical Chemistry, Thyrotropin, Chemical Species, Statistics, Panel of sera, Prealbumin, Urea, Chemical analysis, Protein blood level, High density lipoprotein cholesterol, Accuracy, Priority journal, Immunoassay, Blood Specimen Collection, Estradiol, Panel study, Urea nitrogen blood level, Transferrin, Validation study, Calculation, Regression analysis, General Medicine, Middle Aged, Multicenter study, Regression, Healthy Volunteers, Normal human, Analytical error, Cholesterol, Cholesterol blood level, Human experiment, Creatinine, Calibration, Female, Human, Laboratory test, Adult, Quality Control, medicine.medical_specialty, Nitrogen, Iron, Robust statistics, Phosphate, Chloride, Triacylglycerol, Article, Reference interval, Young Adult, Linear regression, Analytic method, medicine, Humans, Tumor marker, Aged, Alpha fetoprotein, Ferritin, Sample size, business.industry, Albumin, Protein, Sodium, Biochemistry (medical), Amylase, Bilirubin, Follitropin, Multicenter study (topic), Reduced major-axis regression, Prolactin, Glucose, Standard error, Skewness, Reference values, Carcinoembryonic antigen, Potassium, Linear Models, Calcium, Medical laboratory technology, Hormone blood level, Laboratories, business, Uric acid, Controlled study, Reference value, Blood Chemical Analysis
Abstract

Background: In a planned International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) worldwide study on reference intervals (RIs), a common panel of serum samples is to be measured by laboratories from different countries, and test results are to be compared through conversion using linear regression analysis. This report presents a validation study that was conducted in collaboration with four laboratories. Methods: A panel composed of 80 sera was prepared from healthy individuals, and 45 commonly tested analytes (general chemistry, tumor markers, and hormones) were measured on two occasions 1 week apart in each laboratory. Reduced major-axis linear regression was used to convert reference limits (LL and UL). Precision was expressed as a ratio of the standard error of converted LL or UL to the standard deviation (SD) comprising RI (approx. 1/4 of the RI width corresponding to between-individual SD). The allowable and optimal levels of error for the SD ratio (SDR) were set as

Published
2013

3. Protocol and standard operating procedures for common use in a worldwide multicenter study on reference values

Author

Kiyoshi Ichihara, Julian H. Barth, George G. Klee, Yesim Ozarda, Uludağ Üniversitesi/Tıp Fakültesi/Biyokimya Anabilim Dalı., Özarda, Yeşim, and AAL-8873-2021

Subjects
Serum, Blood sampling, Standardization, Proposal, Clinical Biochemistry, cross-check study, Reference Values, Clinical Chemistry, Thyrotropin, Chemical Species, Ethnicity, Medicine, Priority journal, Blood Specimen Collection, Tubes, General Medicine, Healthy Volunteers, Normal human, Test (assessment), Calibration, Collected reference values, Statistical treatment, Human, Quality Control, medicine.medical_specialty, Specimens, Operating procedures, Blood storage, MEDLINE, Harmonization, Clinical Chemistry Tests, Article, Health status, Humans, Medical physics, panel of sera, Protocol (science), standardization, Questionnaire, Sample size, business.industry, Biochemistry (medical), Reference intervals, Individuals, reference interval, Multicenter study (topic), Approved recommendation 1987, multicenter study, Multicenter study, Sample size determination, harmonization, Medical laboratory technology, business, Laboratories, Reference value
Abstract

The reference intervals (RIs) given in laboratory reports have an important role in aiding clinicians in interpreting test results in reference to values of healthy populations. In this report, we present a proposed protocol and standard operating procedures (SOPs) for common use in conducting multicenter RI studies on a national or international scale. The protocols and consensus on their contents were refined through discussions in recent C-RIDL meetings. The protocol describes in detail (1) the scheme and organization of the study, (2) the target population, inclusion/exclusion criteria, ethnicity, and sample size, (3) health status questionnaire, (4) target analytes, (5) blood collection, (6) sample processing and storage, (7) assays, (8) cross-check testing, (9) ethics, (10) data analyses, and (11) reporting of results. In addition, the protocol proposes the common measurement of a panel of sera when no standard materials exist for harmonization of test results. It also describes the requirements of the central laboratory, including the method of cross-check testing between the central laboratory of each country and local laboratories. This protocol and the SOPs remain largely exploratory and may require a reevaluation from the practical point of view after their implementation in the ongoing worldwide study. The paper is mainly intended to be a basis for discussion in the scientific community. Japan Society for the Promotion of Science (24256003)

Published
2012

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