A global multicenter study on reference values: 1. Assessment of methods for derivation and comparison of reference intervals

Ichihara, Kiyoshi; Özarda, Yeşim; Barth, Julian H.; Klee, George G.; Qiu, Ling; Erasmus, Rajiv T; Borai, Anwar; Evgina, S. A.; Ashavaid, Tester F.; Khan, Dilshad Ahmed; Schreier, Laura; Rolle, Reynan; Shimizu, Yoshihisa; Kimura, Shogo; Kawano, Reo; Armbruster, David; Mori, Keiichiro; Yadav, Binod Kumar

doi:10.1016/j.cca.2016.09.016

Cited by 78 publications

(62 citation statements)

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“…As parameters routinely used for clinical interpretation, reference intervals were first described in 1969 (1) and defined as prediction intervals that include the central 95% of reference values (2). It is necessary to establish RIs for common analytes at large three-level general hospitals because the concentration of a given analyte may be affected by various factors such as gender, age, and ethnicity, among others (3).…”

Section: Introductionmentioning

confidence: 99%

Gender- and age-specific reference intervals of common biochemical analytes in chinese population – derivation using real laboratory data

Wang

Zou

et al. 2019

Journal of Medical Biochemistry

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Summary Background Indirect sampling methods are not only inexpensive but also efficient for establishing reference intervals (RIs) using clinical data. This study was conducted to select fully normal records to establish age- and gender-specific RIs for common biochemical analytes by laboratory data mining. Methods In total, 280,206 records from 2014 to 2018 were obtained from Peking Union Medical College Hospital. Common biochemical analytes [total protein, albumin, total bilirubin (TBil), direct bilirubin (DBil), alanine aminotransferase (ALT), glutamyltranspeptidase (GGT), alkaline phosphatase (ALP), aspartate aminotransferase (AST), lactate dehydrogenase (LDH), potassium, sodium, chlorine, calcium, urea, glucose, uric acid (UA), inorganic phosphorus, creatinine (Cr), total cholesterol, triglyceride, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol] were measured using an automatic analyzer. Sources of variation were identified by multiple regression analysis. The 2.5th and 97.5th percentiles were calculated as the lower and upper limits of the RIs, respectively. Results Metode indirektnog uzorkovanja nisu samo jeftine, već su i efikasne za uspostavljanje referentnih intervala (RI) korišćenjem velike količine kliničkih podataka. Ova studija je sprovedena sa ciljem da se odaberu potpuno normalni pojedinačni zapisi da bi se utvrdio RI za starost i pol za zajedničke biohemijske analite pomoću laboratorijski dobijenih podataka. Conclusions Ukupno je uzeto 280.206 pojedinačnih rezultata u periodu od 2014. do 2018. godine iz bolnice Peking Union Medical College-a. Uobičajeni biohemijski analiti [ukupni protein, albumin, ukupni bilirubin (TBil), direktni bilirubin (DBil), alanin aminotransferaza (ALT), glutamiltranspeptidaza (GGT), alkalna fosfataza (ALP), aspartat aminotransferaza (AST), laktat dehidrogenaza (LAT) kalijum, natrijum, hlor, kalcijum, ureja, glukoza, mokraćna kiselina (UA), neorganski fosfor, kreatinin (Cr), ukupni hole sterol, trigliceridi, lipoprotein holesterola visoke gustine i lipoprotein holesterola niske gustine] mereni su korišćenjem automatskog analizatora. Izvori varijacije identifikovani su višestrukom regresionom analizom. Postoci (2,5 i 97,5) su izračunati kao donja i gornja granica RI, svaki ponaosob.

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Section: Introductionmentioning

confidence: 99%

Gender- and age-specific reference intervals of common biochemical analytes in chinese population – derivation using real laboratory data

Wang

Zou

et al. 2019

Journal of Medical Biochemistry

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“…For international comparison, the use of a panel of sera is set as the key strategy for aligning test results among laboratories ( 3 ). The global RIs project initiated by C-RIDL involving many countries, including Turkey, aimed to promote harmonized derivation of reliable country-specific RIs through multicentre studies and to compare reference values (RVs) among the countries using these strategies ( 4 ). We joined the global project and conducted a nationwide multicentre study to establish RIs of the Turkish population for biochemical parameters and to explore sources of variation in RVs, including regionality ( 5 ).…”

Section: Introductionmentioning

confidence: 99%

A nationwide multicentre study in Turkey for establishing reference intervals of haematological parameters with novel use of a panel of whole blood

et al. 2017

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IntroductionA nationwide multicentre study was conducted to establish well-defined reference intervals (RIs) of haematological parameters for the Turkish population in consideration of sources of variation in reference values (RVs).Materials and methodsK2-EDTA whole blood samples (total of 3363) were collected from 12 laboratories. Sera were also collected for measurements of iron, UIBC, TIBC, and ferritin for use in the latent abnormal values exclusion (LAVE) method. The blood samples were analysed within 2 hours in each laboratory using Cell Dyn and Ruby (Abbott), LH780 (Beckman Coulter), or XT-2000i (Sysmex). A panel of freshly prepared blood from 40 healthy volunteers was measured in common to assess any analyser-dependent bias in the measurements. The SD ratio (SDR) based on ANOVA was used to judge the need for partitioning RVs. RIs were computed by the parametric method with/without applying the LAVE method.ResultsAnalyser-dependent bias was found for basophils (Bas), MCHC, RDW and MPV from the panel test results and thus those RIs were derived for each manufacturer. RIs were determined from all volunteers’ results for WBC, neutrophils, lymphocytes, monocytes, eosinophils, MCV, MCH and platelets. Gender-specific RIs were required for RBC, haemoglobin, haematocrit, iron, UIBC and ferritin. Region-specific RIs were required for RBC, haemoglobin, haematocrit, UIBC, and TIBC.ConclusionsWith the novel use of a freshly prepared blood panel, manufacturer-specific RIs’ were derived for Bas, Bas%, MCHC, RDW and MPV. Regional differences in RIs were observed among the 7 regions of Turkey, which may be attributed to nutritional or environmental factors, including altitude.

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“…AFP, CEA, CA125, and PRL didn't show significant between-country differences according to the global paper results (SDR of 0.12, 0.13, 0.21 and 0.12 for males and 0.18, 0.15, 0.05 and 0.14 for females, respectively) [18]. For CA-125, the UL for females in the Asian study was higher than those provided in the Russian study and both were higher than UL provided by the manufacturer in the instruction for use.…”

Section: ) Distinction Between Ris and Cdlsmentioning

confidence: 76%

“…In any case, it should be noted, that there is no common RI and the fluctuation of UL range could make from 2.5 to 5.5 mIU/ml. It is apparent that, Cortisol exhibits a slight between-country difference (SDR of 0.28 for male, 0.29 for female) [18].…”

Section: ) Distinction Between Ris and Cdlsmentioning

confidence: 97%

Sources of variation and establishment of Russian reference intervals for major hormones and tumor markers

Ruzhanskaya¹,

Ichihara

Evgina³

et al. 2020

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ObjectivesA multicenter study was organized to explore sources of variation (SVs) of reference values (RVs) for 24 major immunochemistry analytes and to determine reference intervals (RIs) for the Russian population. MethodsAccording to IFCC Committee on Reference Intervals and Decision Limits (C-RIDL) protocol, 793 healthy volunteers were recruited in St. Petersburg, Moscow, and Yekaterinburg. Serum samples were tested for five tumor markers, 19 hormones and related tests by Beckman Coulter's UniCel DxI 800 immunochemistry analyzer. SVs were explored using multiple regression analysis and ANOVA. Standard deviation ratio (SDR) of 0.4 was used as primary guide for partitioning RIs by gender and age. ResultsSDR for between-city difference was <0.4 for all analytes. Secondary exclusion of individuals was done under the following conditions: for female sex-hormones, those with contraceptives (8%); for CA19-9, those supposed to have negative Lewis blood-group (10.5%); for insulin, those with BMI≥28 kg/m 2 (29.9%); for the thyroid panel, those with anti-thyroid antibodies (10.3% in males; 24.5% in females).Gender-specific RIs were required for all analytes except CA19-9, CA15-3, thyroid-related tests, parathyroid hormone, and insulin. Age-specific RIs were required for α-fetoprotein and all sex-hormones except testosterone. RIs were generally derived by parametric method after Gaussian transformation using modified Box-Cox formula. Exceptions were growth hormone, estradiol, and progesterone, for which nonparametric method was required due to bimodal distribution and/or insufficient detection limit. ConclusionRIs for major hormones and tumor markers specific for the Russian population were derived based on the up-to-date internationally harmonized protocol by careful consideration of analyte-specific SVs. Word count: 250 words

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A global multicenter study on reference values: 1. Assessment of methods for derivation and comparison of reference intervals

Abstract: The collaborative study enabled us to evaluate rational methods for deriving RIs and comparing the RVs based on real-world datasets obtained in a harmonized manner.

Cited by 78 publications

References 18 publications

Gender- and age-specific reference intervals of common biochemical analytes in chinese population – derivation using real laboratory data

Gender- and age-specific reference intervals of common biochemical analytes in chinese population – derivation using real laboratory data

A nationwide multicentre study in Turkey for establishing reference intervals of haematological parameters with novel use of a panel of whole blood

Sources of variation and establishment of Russian reference intervals for major hormones and tumor markers

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