{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,3]],"date-time":"2026-06-03T20:41:24Z","timestamp":1780519284203,"version":"3.54.1"},"reference-count":23,"publisher":"Walter de Gruyter GmbH","issue":"8","license":[{"start":{"date-parts":[[2020,3,11]],"date-time":"2020-03-11T00:00:00Z","timestamp":1583884800000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,7,28]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec id=\"j_cclm-2019-1049_s_999\">\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>This is a second part of report on the IFCC global multicenter study conducted in Saudi Arabia to derive reference intervals (RIs) for 20 immunoassay analytes including five tumor makers, five reproductive, seven other hormones and three vitamins.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"j_cclm-2019-1049_s_998\">\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>A total of 826 apparently healthy individuals aged \u226518 years were recruited in three clinical laboratories located in western, central and eastern Saudi Arabia using the protocol specified for the global study. All serum specimens were measured using Abbott, Architect analyzers. Multiple regression analysis (MRA) was performed to explore sources of variation of each analyte: age, body mass index (BMI), physical exercise and smoking. The magnitude of variation of reference values (RVs) attributable to sex, age and region was calculated by ANOVA as a standard deviation ratio (SDR). RIs were derived by the parametric (P) method.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"j_cclm-2019-1049_s_997\">\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>MRA revealed that region, smoking and exercise were not relevant sources of variation for any analyte. Based on SDR and actual between-sex differences in upper limits (ULs), we chose to partition RIs by sex for all analytes except for \u03b1-fetoprotein and parathyroid hormone (PTH). Age-specific RIs were required in females for ferritin, estradiol, progesterone, testosterone, follitropin, luteotropin and prolactin (PRL). With prominent BMI-related increase, RIs for insulin and C-peptide were derived after excluding individuals with BMI\u2009&gt;\u200932 kg\/m<jats:sup>2<\/jats:sup>. Individuals taking vitamin D supplements were excluded in deriving RIs for vitamin D and PTH.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"j_cclm-2019-1049_s_996\">\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>RIs of major immunoassay analytes specific for Saudi Arabians were established in careful consideration of various biological sources of variation.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1515\/cclm-2019-1049","type":"journal-article","created":{"date-parts":[[2020,3,11]],"date-time":"2020-03-11T13:28:36Z","timestamp":1583933316000},"page":"1302-1313","source":"Crossref","is-referenced-by-count":17,"title":["Establishment of reference intervals for immunoassay analytes of adult population in Saudi Arabia"],"prefix":"10.1515","volume":"58","author":[{"given":"Anwar","family":"Borai","sequence":"first","affiliation":[{"name":"King Abdullah International Medical Research Center , King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City , Jeddah , Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6039-4537","authenticated-orcid":false,"given":"Kiyoshi","family":"Ichihara","sequence":"additional","affiliation":[{"name":"Faculty of Health Sciences , Yamaguchi University Graduate School of Medicine , Ube , Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abdulaziz","family":"Masaud","sequence":"additional","affiliation":[{"name":"King Abdullah International Medical Research Center , King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City , Jeddah , Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Waleed","family":"Tamimi","sequence":"additional","affiliation":[{"name":"King Abdullah International Medical Research Center , King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City , Jeddah , Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suhad","family":"Bahijri","sequence":"additional","affiliation":[{"name":"Faculty of Medicine, Department of Clinical Biochemistry , King Abdulaziz University , Jeddah , Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Armbuster","sequence":"additional","affiliation":[{"name":"Global Scientific Affairs, Abbott Diagnostics , Chicago, IL , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8699-3768","authenticated-orcid":false,"given":"Reo","family":"Kawano","sequence":"additional","affiliation":[{"name":"Faculty of Health Sciences , Yamaguchi University Graduate School of Medicine , Ube , Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ziad","family":"Baarmah","sequence":"additional","affiliation":[{"name":"King Abdullah International Medical Research Center , King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City , Jeddah , Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Faris","family":"Joatar","sequence":"additional","affiliation":[{"name":"King Abdullah International Medical Research Center , King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City , Jeddah , Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohammed","family":"Almohammadi","sequence":"additional","affiliation":[{"name":"King Abdullah International Medical Research Center , King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City , Jeddah , Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"374","published-online":{"date-parts":[[2020,3,11]]},"reference":[{"key":"2023033110393925392_j_cclm-2019-1049_ref_001","doi-asserted-by":"crossref","unstructured":"Borai A, Ichihara K, Al Masaud A, Tamimi W, Bahijri S, Armbuster D, et al. Establishment of reference intervals of clinical chemistry analytes for the adult population in Saudi Arabia: a study conducted as a part of the IFCC global study on reference values. Clin Chem Lab Med 2016;54:843\u201355.","DOI":"10.1515\/cclm-2015-0490"},{"key":"2023033110393925392_j_cclm-2019-1049_ref_002","doi-asserted-by":"crossref","unstructured":"Alqahatani M, Tamimi W, Aldaker M, Alenzi F, Tamim H, Alsadhan A. Young adult reference ranges for thyroid function tests on the Centaur immunoassay analyser. Br J Biomed Sci 2006;63:163\u20135.","DOI":"10.1080\/09674845.2006.11732744"},{"key":"2023033110393925392_j_cclm-2019-1049_ref_003","unstructured":"Alsuwadia AO, Farag YM, Al Sayyari AA, Mousa DH, Alhejaili FF, Al-Harbi AS, et al. Prevalence of vitamin D deficiency in Saudi adults. Saudi Med J 2013;34:814\u20138."},{"key":"2023033110393925392_j_cclm-2019-1049_ref_004","doi-asserted-by":"crossref","unstructured":"Rabah DM, Farhat KH, Al-Atawi MA, Arafa MA. Age-specific reference ranges of prostate-specific antigen among Saudi men as a representation of the Arab population. Med Princ Pract 2019;28:242\u201346.","DOI":"10.1159\/000497744"},{"key":"2023033110393925392_j_cclm-2019-1049_ref_005","doi-asserted-by":"crossref","unstructured":"Ichihara K. Statistical considerations for harmonization of the global multicenter study on reference values. Clin Chim Acta 2014;432:108\u201318.","DOI":"10.1016\/j.cca.2014.01.025"},{"key":"2023033110393925392_j_cclm-2019-1049_ref_006","doi-asserted-by":"crossref","unstructured":"Ichihara K, Boyd JC, Intervals ICoR, Decision L. An appraisal of statistical procedures used in derivation of reference intervals. Clin Chem Lab Med 2010;48:1537\u201351.","DOI":"10.1515\/CCLM.2010.319"},{"key":"2023033110393925392_j_cclm-2019-1049_ref_007","doi-asserted-by":"crossref","unstructured":"Ichihara K, Ceriotti F, Tam TH, Sueyoshi S, Poon PM, Thong ML, et al. The Asian project for collaborative derivation of reference intervals: (1) strategy and major results of standardized analytes. Clin Chem Lab Med 2013;51:1429\u201342.","DOI":"10.1515\/cclm-2012-0421"},{"key":"2023033110393925392_j_cclm-2019-1049_ref_008","doi-asserted-by":"crossref","unstructured":"Ichihara K, Ceriotti F, Kazuo M, Huang YY, Shimizu Y, Suzuki H, et al. The Asian project for collaborative derivation of reference intervals: (2) results of non-standardized analytes and transference of reference intervals to the participating laboratories on the basis of cross-comparison of test results. Clin Chem Lab Med 2013;51:1443\u201357.","DOI":"10.1515\/cclm-2012-0422"},{"key":"2023033110393925392_j_cclm-2019-1049_ref_009","doi-asserted-by":"crossref","unstructured":"Ozarda Y, Ichihara K, Barth JH, Klee G, Committee on Reference I, Decision Limits IFfCC, et al. Protocol and standard operating procedures for common use in a worldwide multicenter study on reference values. Clin Chem Lab Med 2013;51:1027\u201340.","DOI":"10.1515\/cclm-2013-0249"},{"key":"2023033110393925392_j_cclm-2019-1049_ref_010","doi-asserted-by":"crossref","unstructured":"Ichihara K. Statistical considerations for harmonization of the global multicenter study on reference values. Clin Chim Acta 2014;432:108\u201318.","DOI":"10.1016\/j.cca.2014.01.025"},{"key":"2023033110393925392_j_cclm-2019-1049_ref_011","doi-asserted-by":"crossref","unstructured":"Ichihara K, Boyd JC. An appraisal of statistical procedures used in derivation of reference intervals. Clin Chem and Lab Med 2010;48:1537\u201351.","DOI":"10.1515\/CCLM.2010.319"},{"key":"2023033110393925392_j_cclm-2019-1049_ref_012","doi-asserted-by":"crossref","unstructured":"Ichihara K, Itoh Y, Lam CW, Poon PM, Kim JH, Kyono H, et al. Sources of variation of commonly measured serum analytes in 6 Asian cities and consideration of common reference intervals. Clin Chem 2008;54:356\u201365.","DOI":"10.1373\/clinchem.2007.091843"},{"key":"2023033110393925392_j_cclm-2019-1049_ref_013","unstructured":"Fraser CG. Biological variation: from principles to practice. Washington, DC: AACC Press, 2001:1\u2013145."},{"key":"2023033110393925392_j_cclm-2019-1049_ref_014","doi-asserted-by":"crossref","unstructured":"Ichihara K, Kawai T. Determination of reference intervals for 13 plasma proteins based on IFCC international reference preparation (CRM470) and NCCLS proposed guideline (C28-P,1992): trial to select reference individuals by results of screening tests and application of maximal likelihood method. J Clin Lab Anal 1996;10:110\u20137.","DOI":"10.1002\/(SICI)1098-2825(1996)10:2<110::AID-JCLA9>3.0.CO;2-G"},{"key":"2023033110393925392_j_cclm-2019-1049_ref_015","unstructured":"The European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Biological Variation Database, 2018\u20132019. https:\/\/biologicalvariation.eu\/."},{"key":"2023033110393925392_j_cclm-2019-1049_ref_016","doi-asserted-by":"crossref","unstructured":"Klee GG, Ichihara K, Ozarda Y, Baumann NA, Straseski J, Bryant SC, et al. Reference Intervals: comparison of calculation methods and evaluation of procedures for merging reference measurements from two US Medical Centers. Am J Clin Pathol 2018;150:545\u201354.","DOI":"10.1093\/ajcp\/aqy082"},{"key":"2023033110393925392_j_cclm-2019-1049_ref_017","doi-asserted-by":"crossref","unstructured":"Ichihara K, Ozarda Y, Barth JH, Klee G, Qiu L, Erasmus R, et al. A global multicenter study on reference values: 1. Assessment of methods for derivation and comparison of reference intervals. Clin Chim Acta 2017;467:70\u201382.","DOI":"10.1016\/j.cca.2016.09.016"},{"key":"2023033110393925392_j_cclm-2019-1049_ref_018","doi-asserted-by":"crossref","unstructured":"Ichihara K, Ozarda Y, Barth JH, Klee G, Shimizu Y, Xia L, et al. A global multicenter study on reference values: 2. Exploration of sources of variation across the countries. Clin Chim Acta 2017;467:83\u201397.","DOI":"10.1016\/j.cca.2016.09.015"},{"key":"2023033110393925392_j_cclm-2019-1049_ref_019","doi-asserted-by":"crossref","unstructured":"Al-Buhairan AM, Oluboyede OA. Determination of serum iron, total iron-binding capacity and serum ferritin in healthy Saudi adults. Ann Saudi Med 2001;21:100\u20133.","DOI":"10.5144\/0256-4947.2001.100"},{"key":"2023033110393925392_j_cclm-2019-1049_ref_020","doi-asserted-by":"crossref","unstructured":"Souberbielle JC, Body JJ, Lappe JM, Plebani M, Shoenfeld Y, Wang TJ, et al. Vitamin D and musculoskeletal health, cardiovascular disease, autoimmunity and cancer: recommendations for clinical practice. Autoimmun Rev 2010;9:709\u201315.","DOI":"10.1016\/j.autrev.2010.06.009"},{"key":"2023033110393925392_j_cclm-2019-1049_ref_021","doi-asserted-by":"crossref","unstructured":"Ardawi MS, Sibiany AM, Bakhsh TM, Qari MH, Maimani AA. High prevalence of vitamin D deficiency among healthy Saudi Arabian men: relationship to bone mineral density, parathyroid hormone, bone turnover markers, and lifestyle factors. Osteoporos Int 2012;23:675\u201386.","DOI":"10.1007\/s00198-011-1606-1"},{"key":"2023033110393925392_j_cclm-2019-1049_ref_022","doi-asserted-by":"crossref","unstructured":"Al-Raddadi R, Bahijri S, Borai A, AlRaddadi Z. Prevalence of lifestyle practices that might affect bone health in relation to vitamin D status among female Saudi adolescents. Nutrition 2018;45:108\u201313.","DOI":"10.1016\/j.nut.2017.07.015"},{"key":"2023033110393925392_j_cclm-2019-1049_ref_023","unstructured":"Institute of Medicine, Food and Nutrition Board. Dietary reference intakes for calcium and vitamin D. Washington, DC: National Academy Press, 2010."}],"container-title":["Clinical Chemistry and Laboratory Medicine (CCLM)"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.degruyter.com\/view\/journals\/cclm\/58\/8\/article-p1302.xml","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.degruyter.com\/document\/doi\/10.1515\/cclm-2019-1049\/xml","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.degruyter.com\/document\/doi\/10.1515\/cclm-2019-1049\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,3,31]],"date-time":"2023-03-31T12:34:49Z","timestamp":1680266089000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.degruyter.com\/document\/doi\/10.1515\/cclm-2019-1049\/html"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,3,11]]},"references-count":23,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2020,3,3]]},"published-print":{"date-parts":[[2020,7,28]]}},"alternative-id":["10.1515\/cclm-2019-1049"],"URL":"https:\/\/doi.org\/10.1515\/cclm-2019-1049","relation":{},"ISSN":["1437-4331","1434-6621"],"issn-type":[{"value":"1437-4331","type":"electronic"},{"value":"1434-6621","type":"print"}],"subject":[],"published":{"date-parts":[[2020,3,11]]}}}