{"id":"https://openalex.org/W2397023918","doi":"https://doi.org/10.1373/clinchem.2016.256511","title":"Reference Intervals: Strengths, Weaknesses, and Challenges","display_name":"Reference Intervals: Strengths, Weaknesses, and Challenges","publication_year":2016,"publication_date":"2016-05-27","ids":{"openalex":"https://openalex.org/W2397023918","doi":"https://doi.org/10.1373/clinchem.2016.256511","mag":"2397023918","pmid":"https://pubmed.ncbi.nlm.nih.gov/27230874"},"language":"en","primary_location":{"id":"doi:10.1373/clinchem.2016.256511","doi":"https://doi.org/10.1373/clinchem.2016.256511","is_oa":false,"landing_page_url":"https://doi.org/10.1373/clinchem.2016.256511","pdf_url":null,"source":{"id":"https://openalex.org/S139212996","display_name":"Clinical Chemistry","issn_l":"0009-9147","issn":["0009-9147","1530-8561"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-2","medline","norway-2","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320272","host_organization_name":"American Association for Clinical Chemistry","host_organization_lineage":["https://openalex.org/P4310320272"],"host_organization_lineage_names":["American Association for Clinical Chemistry"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Clinical Chemistry","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref","pubmed"],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5112321997","display_name":"W. Greg Miller","orcid":"https://orcid.org/0000-0002-6395-4755","observed_orcids":["https://orcid.org/0000-0002-6395-4755"]},"institutions":[{"id":"https://openalex.org/I184840846","display_name":"Virginia Commonwealth University","ror":"https://ror.org/02nkdxk79","country_code":"US","type":"education","lineage":["https://openalex.org/I184840846"]}],"countries":["US"],"is_corresponding":true,"raw_author_name":"W Greg Miller","raw_affiliation_strings":["Department of Pathology, Virginia Commonwealth University, Richmond, VA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Pathology, Virginia Commonwealth University, Richmond, VA","institution_ids":["https://openalex.org/I184840846"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5111904978","display_name":"Gary L. Horowitz","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I1316535847","display_name":"Beth Israel Deaconess Medical Center","ror":"https://ror.org/04drvxt59","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I1316535847"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Gary L Horowitz","raw_affiliation_strings":["Department of Pathology, Beth Israel Deaconess Medical Center, Boston, MA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Pathology, Beth Israel Deaconess Medical Center, Boston, MA","institution_ids":["https://openalex.org/I1316535847"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5010393338","display_name":"Ferruccio Ceriotti","orcid":"https://orcid.org/0000-0002-0958-5354","observed_orcids":["https://orcid.org/0000-0002-0958-5354"]},"institutions":[{"id":"https://openalex.org/I4210133214","display_name":"IRCCS Ospedale San Raffaele","ror":"https://ror.org/039zxt351","country_code":"IT","type":"healthcare","lineage":["https://openalex.org/I4210133214","https://openalex.org/I4210153126"]}],"countries":["IT"],"is_corresponding":false,"raw_author_name":"Ferruccio Ceriotti","raw_affiliation_strings":["Former Chair of the IFCC Committee on Reference Intervals and Decision Limits (2006\u20132010) and collaborator in the CLSI document EP 28-A3, and Clinical Laboratory Service, San Raffaele Hospital, Milano, Italy"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Former Chair of the IFCC Committee on Reference Intervals and Decision Limits (2006\u20132010) and collaborator in the CLSI document EP 28-A3, and Clinical Laboratory Service, San Raffaele Hospital, Milano, Italy","institution_ids":["https://openalex.org/I4210133214"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5109306889","display_name":"James K. Fleming","orcid":"https://orcid.org/0000-0001-7677-1053","observed_orcids":["https://orcid.org/0000-0001-7677-1053"]},"institutions":[{"id":"https://openalex.org/I2801558778","display_name":"LabCorp (United States)","ror":"https://ror.org/03zsdhz84","country_code":"US","type":"company","lineage":["https://openalex.org/I2801558778"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"James K Fleming","raw_affiliation_strings":["Vice President and Director, Department of Science and Technology, Laboratory Corporation of America, Holdings, Elon, NC"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Vice President and Director, Department of Science and Technology, Laboratory Corporation of America, Holdings, Elon, NC","institution_ids":["https://openalex.org/I2801558778"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5077472317","display_name":"Neil L. Greenberg","orcid":"https://orcid.org/0000-0003-4550-2971","observed_orcids":["https://orcid.org/0000-0003-4550-2971"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Neil Greenberg","raw_affiliation_strings":["Principal Consultant, Neil Greenberg Consulting, LLC, Rochester, NY, and Convenor, ISO/TC212 Working Group 2"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Principal Consultant, Neil Greenberg Consulting, LLC, Rochester, NY, and Convenor, ISO/TC212 Working Group 2","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5051708837","display_name":"Alexander Katayev","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I2801558778","display_name":"LabCorp (United States)","ror":"https://ror.org/03zsdhz84","country_code":"US","type":"company","lineage":["https://openalex.org/I2801558778"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Alexander Katayev","raw_affiliation_strings":["Associate Vice President and Director, Clinical Science Assessment, Department of Science and Technology, Laboratory Corporation of America Holdings, Elon, NC"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Associate Vice President and Director, Clinical Science Assessment, Department of Science and Technology, Laboratory Corporation of America Holdings, Elon, NC","institution_ids":["https://openalex.org/I2801558778"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5031044005","display_name":"Graham R.D. Jones","orcid":"https://orcid.org/0000-0001-9109-7255","observed_orcids":["https://orcid.org/0000-0001-9109-7255"]},"institutions":[{"id":"https://openalex.org/I31746571","display_name":"UNSW Sydney","ror":"https://ror.org/03r8z3t63","country_code":"AU","type":"education","lineage":["https://openalex.org/I31746571"]},{"id":"https://openalex.org/I4210087284","display_name":"St Vincent's Hospital Sydney","ror":"https://ror.org/000ed3w25","country_code":"AU","type":"healthcare","lineage":["https://openalex.org/I4210087284"]}],"countries":["AU"],"is_corresponding":false,"raw_author_name":"Graham R D Jones","raw_affiliation_strings":["Chemical Pathologist, SydPath, Department of Chemical Pathology, St. Vincent's Hospital, Sydney, and Associate Professor, Faculty of Medicine, University of New South Wales, Sydney, Australia"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Chemical Pathologist, SydPath, Department of Chemical Pathology, St. Vincent's Hospital, Sydney, and Associate Professor, Faculty of Medicine, University of New South Wales, Sydney, Australia","institution_ids":["https://openalex.org/I31746571","https://openalex.org/I4210087284"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5018359159","display_name":"William Rosner","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I78577930","display_name":"Columbia University","ror":"https://ror.org/00hj8s172","country_code":"US","type":"education","lineage":["https://openalex.org/I78577930"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"William Rosner","raw_affiliation_strings":["Professor of Medicine, Department of Medicine, Columbia University, College of Physicians and Surgeons, New York, NY"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Professor of Medicine, Department of Medicine, Columbia University, College of Physicians and Surgeons, New York, NY","institution_ids":["https://openalex.org/I78577930"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5050042609","display_name":"Ian Stuart Young","orcid":"https://orcid.org/0000-0003-3890-3152","observed_orcids":["https://orcid.org/0000-0003-3890-3152","https://orcid.org/0000-0002-6838-4835"]},"institutions":[{"id":"https://openalex.org/I126231945","display_name":"Queen's University Belfast","ror":"https://ror.org/00hswnk62","country_code":"GB","type":"education","lineage":["https://openalex.org/I126231945"]},{"id":"https://openalex.org/I4210130048","display_name":"Royal Victoria Hospital","ror":"https://ror.org/03rq50d77","country_code":"GB","type":"healthcare","lineage":["https://openalex.org/I1289110261","https://openalex.org/I4210130048"]}],"countries":["GB"],"is_corresponding":false,"raw_author_name":"Ian S Young","raw_affiliation_strings":["Professor of Medicine, Department of Medicine, Queen's University, Belfast, Wellcome Research Laboratories Mulhouse Building, Royal Victoria Hospital, Belfast, UK"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Professor of Medicine, Department of Medicine, Queen's University, Belfast, Wellcome Research Laboratories Mulhouse Building, Royal Victoria Hospital, Belfast, UK","institution_ids":["https://openalex.org/I126231945","https://openalex.org/I4210130048"]}]}],"institutions":[],"countries_distinct_count":4,"institutions_distinct_count":9,"corresponding_author_ids":["https://openalex.org/A5112321997"],"corresponding_institution_ids":["https://openalex.org/I184840846"],"apc_list":{"value":4636,"currency":"USD","value_usd":4636},"apc_paid":null,"fwci":3.4201,"has_fulltext":false,"cited_by_count":37,"citation_normalized_percentile":{"value":0.90275,"is_in_top_1_percent":false,"is_in_top_10_percent":true},"cited_by_percentile_year":{"min":88,"max":99},"biblio":{"volume":"62","issue":"7","first_page":"916","last_page":"923"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11314","display_name":"Clinical Laboratory Practices and Quality Control","score":0.9994999766349792,"subfield":{"id":"https://openalex.org/subfields/3607","display_name":"Medical Laboratory Technology"},"field":{"id":"https://openalex.org/fields/36","display_name":"Health Professions"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T11314","display_name":"Clinical Laboratory Practices and Quality Control","score":0.9994999766349792,"subfield":{"id":"https://openalex.org/subfields/3607","display_name":"Medical Laboratory Technology"},"field":{"id":"https://openalex.org/fields/36","display_name":"Health Professions"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T11890","display_name":"Scientific Measurement and Uncertainty Evaluation","score":0.00019999999494757503,"subfield":{"id":"https://openalex.org/subfields/3105","display_name":"Instrumentation"},"field":{"id":"https://openalex.org/fields/31","display_name":"Physics and Astronomy"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},{"id":"https://openalex.org/T13309","display_name":"Reliability and Agreement in Measurement","score":0.0,"subfield":{"id":"https://openalex.org/subfields/1804","display_name":"Statistics, Probability and Uncertainty"},"field":{"id":"https://openalex.org/fields/18","display_name":"Decision Sciences"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/reference-values","display_name":"reference values","score":0.9869999885559082},{"id":"https://openalex.org/keywords/reference-population-selection","display_name":"reference population selection","score":0.7820000052452087},{"id":"https://openalex.org/keywords/laboratory-developed-tests","display_name":"laboratory-developed tests","score":0.5590000152587891},{"id":"https://openalex.org/keywords/in-vitro-diagnostic-devices","display_name":"in vitro diagnostic medical devices","score":0.8109999895095825},{"id":"https://openalex.org/keywords/sample-size-requirements","display_name":"sample size requirements","score":0.4779999852180481},{"id":"https://openalex.org/keywords/clinical-laboratory-reporting","display_name":"clinical laboratory reporting","score":0.44200000166893005},{"id":"https://openalex.org/keywords/measurement-standardization","display_name":"measurement standardization","score":0.4749999940395355}],"concepts":[{"id":"https://openalex.org/C2780182762","wikidata":"https://www.wikidata.org/wiki/Q1630279","display_name":"Guideline","level":2,"score":0.7130354642868042},{"id":"https://openalex.org/C2908647359","wikidata":"https://www.wikidata.org/wiki/Q2625603","display_name":"Population","level":2,"score":0.5699977874755859},{"id":"https://openalex.org/C2777267654","wikidata":"https://www.wikidata.org/wiki/Q3519023","display_name":"Test (biology)","level":2,"score":0.5316752791404724},{"id":"https://openalex.org/C105795698","wikidata":"https://www.wikidata.org/wiki/Q12483","display_name":"Statistics","level":1,"score":0.5215190052986145},{"id":"https://openalex.org/C2985213535","wikidata":"https://www.wikidata.org/wiki/Q1626599","display_name":"Reference values","level":2,"score":0.5031811594963074},{"id":"https://openalex.org/C44519122","wikidata":"https://www.wikidata.org/wiki/Q2296168","display_name":"Medical laboratory","level":2,"score":0.4914754629135132},{"id":"https://openalex.org/C44249647","wikidata":"https://www.wikidata.org/wiki/Q208498","display_name":"Confidence interval","level":2,"score":0.47995784878730774},{"id":"https://openalex.org/C198531522","wikidata":"https://www.wikidata.org/wiki/Q485146","display_name":"Sample (material)","level":2,"score":0.47072234749794006},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.45661184191703796},{"id":"https://openalex.org/C2778067643","wikidata":"https://www.wikidata.org/wiki/Q166507","display_name":"Interval (graph theory)","level":2,"score":0.4329037070274353},{"id":"https://openalex.org/C2777910003","wikidata":"https://www.wikidata.org/wiki/Q1707292","display_name":"Asymptomatic","level":2,"score":0.4162200093269348},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.3984578847885132},{"id":"https://openalex.org/C19527891","wikidata":"https://www.wikidata.org/wiki/Q1120908","display_name":"Medical physics","level":1,"score":0.3979354500770569},{"id":"https://openalex.org/C142724271","wikidata":"https://www.wikidata.org/wiki/Q7208","display_name":"Pathology","level":1,"score":0.3213033676147461},{"id":"https://openalex.org/C33923547","wikidata":"https://www.wikidata.org/wiki/Q395","display_name":"Mathematics","level":0,"score":0.2718100845813751},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.16532960534095764},{"id":"https://openalex.org/C99454951","wikidata":"https://www.wikidata.org/wiki/Q932068","display_name":"Environmental health","level":1,"score":0.15177863836288452},{"id":"https://openalex.org/C86803240","wikidata":"https://www.wikidata.org/wiki/Q420","display_name":"Biology","level":0,"score":0.14497852325439453},{"id":"https://openalex.org/C185592680","wikidata":"https://www.wikidata.org/wiki/Q2329","display_name":"Chemistry","level":0,"score":0.0},{"id":"https://openalex.org/C151730666","wikidata":"https://www.wikidata.org/wiki/Q7205","display_name":"Paleontology","level":1,"score":0.0},{"id":"https://openalex.org/C114614502","wikidata":"https://www.wikidata.org/wiki/Q76592","display_name":"Combinatorics","level":1,"score":0.0},{"id":"https://openalex.org/C43617362","wikidata":"https://www.wikidata.org/wiki/Q170050","display_name":"Chromatography","level":1,"score":0.0}],"mesh":[{"descriptor_ui":"D000073537","descriptor_name":"Biological Variation, Population","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D002983","descriptor_name":"Clinical Competence","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D012015","descriptor_name":"Reference Standards","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D012016","descriptor_name":"Reference Values","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D019411","descriptor_name":"Clinical Laboratory Techniques","qualifier_ui":"Q000295","qualifier_name":"instrumentation","is_major_topic":false},{"descriptor_ui":"D019411","descriptor_name":"Clinical Laboratory Techniques","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":true}],"locations_count":2,"locations":[{"id":"doi:10.1373/clinchem.2016.256511","doi":"https://doi.org/10.1373/clinchem.2016.256511","is_oa":false,"landing_page_url":"https://doi.org/10.1373/clinchem.2016.256511","pdf_url":null,"source":{"id":"https://openalex.org/S139212996","display_name":"Clinical Chemistry","issn_l":"0009-9147","issn":["0009-9147","1530-8561"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-2","medline","norway-2","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320272","host_organization_name":"American Association for Clinical Chemistry","host_organization_lineage":["https://openalex.org/P4310320272"],"host_organization_lineage_names":["American Association for Clinical Chemistry"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Clinical Chemistry","raw_type":"journal-article"},{"id":"pmid:27230874","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/27230874","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Clinical chemistry","raw_type":"Journal Article"}],"best_oa_location":null,"sustainable_development_goals":[{"score":0.8048999905586243,"display_name":"Good health and well-being","id":"https://metadata.un.org/sdg/3"}],"study_designs":[],"awards":[{"id":"https://openalex.org/G783127938","display_name":"Peer support to encourage adoption and maintenance of Mediterranean diet: a feasibility and pilot study.","funder_award_id":"MR/J000388/1","funder_id":"https://openalex.org/F4320334626","funder_display_name":"Medical Research Council"}],"funders":[{"id":"https://openalex.org/F4320334626","display_name":"Medical Research Council","ror":"https://ror.org/03x94j517"}],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W4392236279","https://openalex.org/W3194256073","https://openalex.org/W3129109225","https://openalex.org/W2802841668","https://openalex.org/W2898176437","https://openalex.org/W4363646321","https://openalex.org/W3035768985","https://openalex.org/W7214699572","https://openalex.org/W2297073812","https://openalex.org/W2186052508"],"abstract_inverted_index":{"A":[0,221,926,1794,2284,4545,4776,4798,5026,5101,5125,5155,5717,5745,5817],"reference":[1,65,98,125,140,260,313,380,468,552,606,667,711,844,912,1051,1549,1710,1939,2011,2037,2383,2746,2805,3389,3991,4295,4317,4336,4459,4917,4982,5149,5183,5355,5392,5699,5712,5743,5805,5829,5974,5986],"interval":[2,40,830,3794,5191,5975],"(RI)10":[3],"is":[4,14,27,49,68,133,181,225,273,364,506,614,638,753,794,799,866,897,903,998,1011,1041,1061,1076,1133,1143,1156,1181,1209,1281,1324,1373,1567,1648,1706,1755,1806,1828,1917,1975,1994,1999,2039,2067,2103,2129,2274,2292,2330,2369,2496,2524,2527,2547,2664,2674,2728,2808,2818,2846,2995,3055,3063,3079,3121,3194,3219,3407,3575,3624,3665,3746,3761,3774,3795,3811,3851,3965,4003,4043,4177,4202,4319,4374,4380,4418,4443,4497,4548,4621,4714,4723,4787,4792,4845,5104,5128,5158,5188,5227,5309,5326,5362,5504,5511,5532,5607,5676,5751,5756,5896],"a":[5,10,18,42,64,90,111,139,160,235,258,308,312,366,379,394,409,473,577,587,604,642,666,696,933,1001,1038,1047,1057,1190,1379,1443,1611,1671,1743,1747,1863,1937,2078,2106,2201,2211,2276,2295,2331,2387,2549,2553,2599,2736,2745,2756,2804,2859,2878,2927,3173,3302,3322,3377,3397,3410,3462,3489,3561,3625,3630,3654,3666,3684,3808,3826,3848,3898,3921,3934,3952,3984,3990,3995,4004,4031,4035,4039,4060,4063,4111,4119,4272,4360,4435,4445,4505,4509,4515,4521,4541,4550,4567,4589,4595,4608,4649,4721,4748,4750,4753,4772,4811,4927,4946,4954,4974,4981,4998,5020,5056,5083,5094,5105,5189,5222,5310,5328,5369,5376,5390,5446,5450,5458,5526,5572,5596,5621,5631,5660,5679,5742,5776,5785,5794,5809,5824,5834,5840,5845,5867,5940,5945],"standard":[6,1476,2075],"component":[7],"of":[8,58,70,97,106,138,146,150,202,250,311,408,421,467,475,545,550,560,610,651,665,698,828,839,887,894,976,1017,1050,1062,1162,1198,1232,1265,1307,1331,1389,1409,1428,1441,1464,1496,1499,1522,1532,1561,1593,1664,1688,1695,1719,1763,1791,1817,1862,1962,2018,2133,2146,2166,2207,2262,2266,2298,2326,2349,2352,2357,2424,2436,2485,2500,2542,2608,2632,2636,2641,2647,2657,2685,2718,2725,2735,2751,2761,2767,2771,2814,2841,2855,2874,2891,2904,2919,2940,2966,3023,3076,3085,3110,3126,3132,3135,3155,3158,3175,3183,3200,3255,3263,3321,3342,3372,3379,3382,3404,3464,3521,3569,3572,3583,3606,3657,3668,3673,3711,3724,3750,3791,3876,3897,3920,3926,3954,3987,4034,4079,4087,4118,4132,4143,4192,4208,4274,4314,4320,4327,4365,4372,4390,4398,4406,4434,4439,4453,4479,4499,4578,4600,4610,4657,4684,4687,4696,4703,4732,4738,4771,4912,4919,4956,5054,5108,5116,5169,5178,5181,5204,5221,5234,5252,5266,5270,5312,5330,5337,5352,5372,5434,5464,5501,5509,5522,5528,5575,5590,5593,5630,5635,5641,5681,5688,5695,5708,5747,5768,5788,5813,5819,5836,5843,5861,5870,5939,5960],"reporting":[9,5353],"laboratory":[11,36,59,75,112,236,271,361,644,690,1070,1094,1124,1175,1323,1354,1486,1744,1812,2038,2080,2107,2203,2388,2537,2900,2954,3060,3357,3544,3585,3661,3686,3719,3754,4220,4258,4357,4712,4812,4958,5010,5046,5205,5216,5361,5548,5667],"result":[12,540,1705,2860,3922,5142,5289,5308,5325,5430,5825,5926,5941],"and":[13,178,192,197,386,479,483,497,562,566,570,595,662,765,776,780,813,816,842,891,909,924,941,960,986,1019,1149,1201,1243,1346,1395,1407,1446,1604,1682,1728,1759,1830,1837,1849,1991,2001,2047,2150,2259,2269,2305,2377,2417,2493,2638,2643,2650,2667,2671,2678,2716,2758,2791,2850,2857,2894,2938,2945,2970,2990,3054,3069,3147,3150,3203,3229,3271,3275,3364,3384,3391,3416,3426,3453,3503,3616,3687,3697,3737,3793,3832,3879,3908,4021,4038,4057,4084,4092,4107,4126,4277,4293,4329,4396,4402,4423,4425,4508,4538,4582,4619,4626,4774,4804,4870,4934,4939,4960,5022,5093,5185,5199,5246,5318,5342,5379,5405,5438,5470,5882,5920,5983],"important":[15,508,681,749,1677,2996,4709],"to":[16,29,50,86,142,155,230,242,275,279,290,315,334,369,431,437,487,491,558,639,648,694,702,728,786,800,849,853,871,880,904,917,931,939,963,988,999,1004,1013,1023,1065,1079,1095,1114,1126,1145,1158,1204,1211,1304,1326,1357,1377,1417,1437,1494,1509,1575,1614,1625,1641,1644,1655,1659,1757,1798,1807,1821,1831,1878,1936,1943,1952,2020,2034,2064,2069,2076,2094,2104,2118,2130,2186,2371,2411,2440,2456,2489,2498,2504,2520,2538,2561,2564,2589,2602,2614,2628,2690,2701,2740,2744,2803,2847,2881,2960,2973,2997,3065,3082,3095,3129,3278,3289,3319,3358,3362,3367,3493,3497,3517,3596,3602,3677,3695,3701,3716,3732,3743,3857,3873,3915,3933,4024,4196,4205,4264,4312,4470,4474,4558,4563,4571,4588,4661,4717,4744,4765,4806,4873,4879,4885,4968,4973,4997,5004,5040,5078,5090,5122,5230,5259,5284,5364,5417,5419,5445,5449,5461,5543,5551,5562,5582,5586,5615,5714,5737,5758,5765,5799,5807,5827,5853,5885,5888,5914,5921,5951,5965],"transform":[17],"numerical":[19],"value":[20,1523,4601,4975,4999,5143,5276,5357,5549,5560,5567,5574,5606,5634,5779],"into":[21,1701,5349],"clinically":[22,1676],"meaningful":[23,157,184,4426,5533],"information.":[24],"An":[25,1732,2121,3512],"RI":[26,53,132,233,411,433,461,495,521,582,613,1098,1430,1448,1458,1512,1734,1801,1827,1881,2156,2329,2392,2428,2567,2585,2844,2962,2992,3103,3283,3491,3513,3810,3850,3929,3957,3964,4304,4507,4527,4597,4809,4835,4883,4893,5374,5503,5645,5749,5783],"intended":[28,671,3094],"inform":[30],"the":[31,39,55,95,103,147,203,215,226,244,248,324,337,347,351,376,399,406,418,476,538,618,635,656,659,670,675,688,720,755,771,774,788,802,809,811,817,822,826,829,840,851,855,888,892,900,911,943,948,968,974,989,996,1008,1015,1066,1072,1080,1085,1128,1134,1139,1160,1163,1170,1174,1184,1196,1206,1230,1240,1247,1263,1275,1282,1289,1308,1317,1322,1332,1349,1353,1362,1387,1405,1410,1414,1419,1421,1429,1438,1451,1456,1481,1488,1497,1500,1530,1533,1556,1559,1564,1590,1594,1601,1616,1632,1639,1686,1696,1708,1737,1741,1750,1761,1792,1811,1818,1822,1826,1833,1839,1884,1893,1900,1904,1915,1926,1960,1966,1970,1982,1997,2002,2029,2041,2052,2073,2089,2134,2143,2161,2182,2188,2205,2222,2228,2240,2255,2263,2289,2306,2311,2315,2319,2324,2327,2350,2378,2382,2397,2406,2412,2422,2448,2451,2475,2483,2486,2501,2506,2518,2536,2540,2543,2566,2574,2577,2625,2630,2634,2644,2683,2691,2714,2762,2765,2775,2794,2811,2815,2824,2833,2838,2842,2865,2868,2872,2899,2902,2909,2912,2916,2967,2984,2988,3015,3066,3083,3091,3108,3124,3133,3136,3140,3153,3156,3159,3181,3192,3197,3232,3235,3241,3244,3261,3265,3269,3279,3304,3310,3343,3388,3392,3506,3530,3535,3570,3637,3651,3658,3680,3722,3728,3748,3753,3778,3785,3789,3796,3840,3895,3911,3924,3940,3955,3962,4054,4072,4077,4085,4116,4130,4133,4141,4160,4167,4193,4209,4218,4249,4289,4294,4303,4325,4335,4345,4370,4382,4388,4394,4404,4414,4451,4457,4463,4475,4502,4576,4623,4662,4666,4685,4688,4694,4697,4701,4704,4706,4730,4736,4767,4819,4830,4832,4841,4861,4881,4910,4993,5005,5038,5045,5062,5067,5087,5091,5098,5109,5113,5117,5123,5138,5141,5145,5152,5162,5167,5175,5179,5182,5231,5250,5261,5264,5274,5278,5286,5291,5299,5303,5315,5319,5323,5335,5338,5350,5354,5373,5382,5386,5420,5428,5432,5435,5462,5471,5487,5499,5507,5514,5520,5535,5569,5587,5591,5612,5643,5666,5685,5689,5696,5711,5730,5735,5748,5753,5766,5772,5782,5803,5828,5859,5876,5879,5934,5937,5970],"clinical":[32,360,446,621,643,661,710,952,1069,1086,1093,1123,1423,1485,1591,1665,1906,2079,2202,2469,2788,2852,3539,3584,3690,3699,3936,3979,4055,4073,4082,4123,4187,4231,4240,4262,4290,4366,4391,4415,4486,4510,4516,4536,4543,4572,4591,4616,4633,4667,4698,4718,4827,5655,5811,5864],"care":[33,3540,3917],"provider":[34],"that":[35,67,72,74,109,212,414,509,523,535,645,678,821,950,1330,1348,1455,1661,1920,2044,2280,2293,2405,2450,2495,2499,2525,2562,2580,2591,2921,2964,2999,3041,3062,3474,3508,3537,3546,3764,3768,3777,3784,4158,4180,4324,4384,4583,4604,4622,4903,5013,5035,5171,5186,5397,5473,5600,5617,5752,5823,5899,5923],"values":[37,61,1902,1990,3681,3720,4713,4770,5088,5331,5497,5523,5552,5594,5668,5907,5917],"within":[38,5277,5332],"indicate":[41,4909,5808],"nondiseased":[43,91,1266,4347],"condition.":[44],"The":[45,163,547,751,790,837,1130,1254,1876,2062,2235,2512,2612,2655,2723,2778,3074,3253,3296,3369,3402,4309,4491,4671,4986,5494],"most":[46,356,619,969,1120,2138,4210,5296],"common":[47,548,1912,1938,2703,2719,2843,2892,2951,3000,3257,3315,3331,3373,3405,3440,3490,4144,4834,5686],"approach":[48,902,1010,1193,2003,2845,3046,3114,4042,4292,4297,4311,4350,4383,4417,4461,4800,5028,5755],"base":[51],"an":[52,131,135,144,232,251,303,317,331,432,443,612,626,631,730,760,1024,1043,1097,1101,1470,1511,1652,1764,1800,1880,1889,1944,1977,2155,2584,3099,3282,3577,3775,3927,3967,4376,4526,4560,4808,4891,5129,5395,5502,5910],"on":[54,102,340,359,375,674,1404,1740,1824,1883,1968,2072,2257,2730,3169,3206,3293,3951,4053,4071,4076,4186,4230,4483,4637,4682,5166,5653,5905],"central":[56,148,5176,5690],"95%":[57,149,5177],"test":[60,76,113,161,539,1277,3830,4259,5217,5236,5275,5288,5293,5307,5387,5401,5409,5429,5475,5906,5946],"observed":[62,4689,5524,5633],"for":[63,89,158,183,195,228,234,262,323,383,542,581,608,658,669,706,770,831,1037,1091,1106,1223,1252,1259,1311,1314,1344,1361,1483,1555,1628,1651,1674,1784,1804,1847,1903,2210,2333,2535,2552,2598,2669,2681,2706,2774,2784,2793,2867,2949,2987,3014,3033,3101,3190,3267,3337,3519,3529,3580,3613,3629,3653,3708,3727,3735,3752,3958,3989,3997,4045,4113,4140,4254,4334,4359,4387,4400,4447,4467,4540,4602,4652,4810,4836,4868,4924,5086,5097,5243,5466,5513,5534,5568,5657,5669,5723,5858],"population":[66,141,261,314,607,668,1082,1171,1967,2307,2379,2416,2768,3390,3394,4037,4337,4460,4506,4596,5184,5527,5644,5700,5713],"free":[69],"diseases":[71,80],"influence":[73,110,1687,4086,5202],"result.":[77,162,3311,5294,5388,5847],"Because":[78,2421],"many":[79,744,2785,3187,5474,5538],"are":[81,208,328,353,388,458,503,747,876,1111,1355,1398,1609,1622,1693,1972,2057,2098,2233,2318,2359,2409,2454,2695,2713,2828,2836,2947,2965,3105,3142,3171,3213,3308,3317,3414,3433,3449,3456,3477,3484,3534,3559,3594,3609,3713,3780,3804,3842,3861,4018,4030,4102,4109,4151,4224,4428,4585,4605,4904,5014,5367,5403,5411,5424,5763,5874],"asymptomatic,":[82],"it":[83,373,865,1060,1089,1155,1372,1754,2086,2368,2394,2533,2595,2663,2673,3120,4201,4529,4740,4791,5060,5948],"becomes":[84,167,1256],"difficult":[85,2370,2534,4211,4743],"qualify":[87],"people":[88],"condition,":[92],"thus":[93],"biasing":[94],"selection":[96,1016,1861,4332],"individuals.":[99,5670],"Furthermore,":[100],"information":[101,807,1562,1702,1742,2530,2572,2592,3245,3420,3424,3786,4734],"full":[104],"complement":[105],"disease":[107,686,4080,4343,5790,5814],"conditions":[108,528,2054,2827,2835,3476],"may":[114,119,217,536,679,691,740,1034,1053,1300,1662,1669,2190,2237,2956,3002,3514,3930,3970,4069,4189,4242,5018,5540,5580,5619,5797,5821,5850],"be":[115,120,156,219,266,280,472,555,680,741,847,930,958,979,1035,1054,1195,1236,1250,1270,1302,1327,1492,1518,1573,1587,1663,1670,1768,1844,1856,1956,2005,2033,2116,2158,2192,2225,2431,2463,2587,2782,2896,2923,2958,2983,3005,3011,3031,3096,3117,3285,3320,3350,3354,3376,3444,3494,3515,3702,3816,3855,3874,3886,3971,3976,4095,4190,4206,4243,4471,4520,4599,4628,4644,4742,4763,4780,4802,4989,5030,5077,5479,5583,5620,5715,5721,5800,5822,5851,5932,5963],"unknown.":[116],"Thus,":[117],"RIs":[118,216,245,278,322,348,391,404,739,882,977,1167,1242,1315,1621,1668,1692,1766,1971,2066,2173,2189,2209,2220,2244,2258,2291,2346,2443,2453,2461,2523,2617,2660,2704,2752,2763,2773,2883,2888,3001,3078,3170,3210,3239,3258,3332,3374,3406,3441,3726,3771,3838,3878,3975,4029,4108,4234,4315,4373,4620,4680,5271],"influenced":[121],"by":[122,172,247,282,350,1084,1173,1187,1246,1279,1321,1352,1413,1520,1529,1589,1600,1631,1770,1860,1932,2151,2250,2314,2465,2482,2676,2697,2708,2870,2877,2898,3058,3152,3247,3396,3683,3788,3820,3833,4607,5241,5506,5678,5929],"inappropriately":[123],"selected":[124,1074],"populations.":[126,712,3044,4441],"Another":[127,4613],"limitation":[128,2286],"in":[129,205,214,252,270,296,341,440,573,617,743,833,867,885,907,1100,1119,1141,1426,1461,1467,1503,1749,1888,1895,1965,1984,2007,2083,2175,2239,2287,2302,2381,2468,3035,3051,3056,3098,3139,3211,3231,3238,3243,3309,3409,3437,3542,3611,3660,3721,3770,3837,3864,3894,3905,3923,4007,4050,4159,4213,4217,4246,4271,4282,4302,4323,4344,4356,4369,4393,4403,4450,4654,4665,4693,4950,5052,5064,5120,5133,5136,5219,5302,5375,5431,5525,5537,5553,5595,5624,5628,5665,5927,5944,5954,5968,5976],"determining":[130],"obtaining":[134,910],"adequate":[136,649],"sample":[137,164,310,579,700,1003,1032,1075,2108],"make":[143,1685,2131,4895],"estimate":[145],"results":[151,1148,1627,1645,1660,1721,1928,2742,3499,3524,3545,3553,3571,3707,3779,3792,3803,3841,3860,3912,3988,4260,4902,5012,5180,5218,5237,5402,5410,5476,5709,5739,5771],"with":[152,287,336,393,442,526,641,733,763,805,857,914,936,1287,1329,1469,1506,1535,1546,1606,1922,2015,2447,2517,2754,2926,3025,3215,3429,3693,3706,3825,3913,4248,4261,4456,4494,4534,4794,4860,5112,5161,5545,5855],"suitable":[153,259,309,578,601,1002,1202,1581,1803,2705,2772],"uncertainty":[154,5139,5201,5938],"interpreting":[159,3543,5969],"size":[165,580,3007],"requirement":[166,227,264],"even":[168,616,1286,2180,2800,2906],"larger":[169,5451],"when":[170,1138,1383,1392,2181,2858,2907,3635,3888,4725],"partitioning":[171],"sex,":[173,684,1786,3339],"age,":[174,683,1785,3338],"ethnicity,":[175,3340],"menstrual":[176],"cycle,":[177],"other":[179,484,860,1367,1396,1789,2445,2825,4088,4961,4994,5554],"parameters":[180],"necessary":[182,1090,1303,4724],"RIs.":[185,199,300,1582,2120,2364,2952,3233,3556,3598,4145,4169,4728],"CLSI":[186,438,1188,1478],"Guideline":[187,1479],"EP28-A3c":[188,439],"describes":[189],"consensus":[190,1475,4833],"approaches":[191,204,1113,1185,1386,4212,4449],"some":[193,201,1788,2251,2434,4733,4849,5070],"limitations":[194,2717,5764],"establishing":[196,297,611,2648,2950,3268],"verifying":[198,299,2323,2682],"However,":[200,1371,2082,2799,3119,3436,4200,4413,4848,5295,5761],"this":[206,370,1153,1273,1584,2196,2606,3113,3744,4008,4495,4889,5625,5890],"guideline":[207],"statistically":[209,464,493],"underpowered":[210,3207],"such":[211,624,946,1867,2208,2366,2686,2755,4727,5055,5253],"uncertainties":[213,838],"not":[218,365,428,513,796,877,961,1301,1781,1898,1976,1995,2191,2309,2601,2829,3003,3195,3457,3862,4019,4152,4556,4971,5051,5398,5406,5478],"appreciated.":[220],"particularly":[222],"challenging":[223,615],"situation":[224,1255,2236,3745,5135],"laboratories":[229,1713,2012,2139,2470,2581,3040,3248,3643,3773,3907,4653,4966,5242,5256],"establish":[231,316,703,729,881,1418,1580,2021,2187,2505,2702,4197,4265,4766],"developed":[237],"measurement":[238,1489,1501,2183,2213,2487,2710,2747,2806,3160,3527,5118,5200,5304,5979],"procedure":[239,1490,1502,2184,5980],"(MP)":[240],"or":[241,298,445,1365,1473,1545,1551,1578,1654,1778,1780,1787,1948,2177,2344,2401,3018,3021,3222,3470,3567,3644,3828,3893,4075,4081,4097,4226,4639,4752,5147,5151,5224,5603,5698,5863,5866],"verify":[243,1096,1127,1577,1760,1879,1953,2065,2119,2204,2404,2583],"proposed":[246,1186,1245,1278,2328,2407],"manufacturer":[249,306,333,352,400,737,1039,1058,1248,1416,1453,1531,1566,2600],"vitro":[253,342,5977],"diagnostic":[254,343,3738,4454,4675,4962,5978],"(IVD)":[255],"MP.":[256,1164],"Identifying":[257],"either":[263,1576,3819],"can":[265,302,401,824,1249,1431,1516,1735,1767,1843,1855,2115,2157,2224,2430,2895,2922,3115,3284,3442,3504,3675,3815,3885,3974,4011,4094,4598,4642,4762,4965,4988],"very":[267,1257,2090,2163,4361,5584],"challenging.":[268],"Evolution":[269],"practice":[272,549,622,1872,2093,2197,2519,2613,2656,3254,3691,5705],"needed":[274,769,1210],"enable":[276],"appropriate":[277,761,783,937,1025,3698,4535],"adopted":[281],"laboratories.":[283,745,2886,3800],"We":[284,1886,4010,5366],"asked":[285],"experts":[286],"different":[288,699,1177,1918,2006,2008,2282,2709,2776,2882,2885,2943,2979,3526,3548,3573,3642,3725,3799,3809,3849,3906,4611,5080,5718,5740],"perspectives":[289],"address":[291],"issues":[292,722,778,3536],"we":[293,1698,3299,3307,4022,4104,5414,5423],"all":[294,1288,3039,3501,5399,5407,5759,5770],"face":[295,719,3538,3723],"How":[301,2199,3973],"IVD":[304,332,456,489,632,716,1102,1415,1452,1565,2169],"device":[305,717,1103,2170],"get":[307,1000,5418,5456],"RI?":[318],"Ferruccio":[319,1116,2215,2721,3550,4000,4984],"Ceriotti:":[320,1117,2216,2722,3551,4001,4985],"\u201cThe":[321],"quantities":[325],"being":[326,1598,1771,3162,4462],"determined\u201d":[327],"required":[329,890,1036,1574,5964],"from":[330,603,653,859,1056,1214,1433,1537,1563,1810,1919,2110,2160,2221,2444,2764,2884,3107,3356,3360,3365,3421,3500,3525,3798,3978,3983,4566,4678,4691,4818,4992,5710,5741,5831],"comply":[335],"European":[338],"Directive":[339],"medical":[344,596,628,1607,3631,4065,4236,4286,5163],"devices.":[345],"Moreover,":[346],"provided":[349,413,738,848,1528,2911],"probably":[354,875,1012],"those":[355,403,501,543,574,1244,1358,3036,3043,3334,4198],"commonly":[357,795,1623,3177,3714,3766,4586],"used":[358,572,742,1251,1320,1360,1624,2117,2185,2226,2376,2380,2503,2563,3445,3516,4044,4281,4664,4764,4805],"reports.":[362,5973],"There":[363,746,2097,2546,3593,4002,4442,5895],"single":[367,1048,4590,5084],"answer":[368],"critical":[371],"question,":[372],"depends":[374,1882],"measurand.":[377,672,1557,3532,5570],"If":[378,995,1108,1165,1450,1892,1925,1981,2832,3330,3961,5936],"system":[381,2807,5034],"exists":[382],"calibration":[384,1934,2230,2491,3111],"traceability":[385,1954,2231,2492,2649,2802,2816,4656],"there":[387,1647,2526,3218,3455,3483,3623,3664,3994,4223,5187,5618,5762],"published":[389,2174,2442,2452,2507],"well-characterized":[390],"obtained":[392,1241,2753],"well-standardized":[395],"MP":[396,416,563,1044,1140,1319,1336,1466,1723,1751,2043,2374,2477,2502,2558,2738,2914,2929,3086,3216,3227,3802],"(\u201ctraceable":[397],"RIs\u201d),":[398],"provide":[402,801,1146,2521,2615,2741,2848,5394],"without":[405,2361,2901,5833],"need":[407,693,1508,1650,1877,2063,2551,2903,3872,4106,5798],"new":[410,2437,2458,2476,2913,5632],"study":[412,434,1369,1382,1393,2279,4438],"its":[415,2390,4127],"has":[417,646,1176,2478,2915,3047,3260,3902,4268,4278,4351,4553,4871,5784,5839],"same":[419,721,990,1738,1901,1905,2042,2578,2917,3067,3531,3638,3729,3797,4134,4250,5754],"level":[420,2607,2918],"standardization.":[422],"For":[423,630,2026,3938,4146,4914,5774],"nonstandardized":[424],"measurands,":[425],"I":[426,2515,3472,4156,5049,5647],"do":[427,872,2095,4967,5544],"see":[429,2688,5650],"alternatives":[430],"performed":[435,516,797,2249],"according":[436],"collaboration":[441],"academic":[444,627,4285],"center.":[447,629],"James":[448,1293,2336,2931,3587,4170,5207],"K.":[449,1294,2337,2932,3588,4171,5208],"Fleming":[450,1295,2338,2933,3589,4172,5209],"&":[451,1296,2339,2934,3590,4173,5210],"Alexander":[452,1297,2340,2935,3591,4174,5211],"Katayev:":[453,1298,2341,2936,3592,4175,5212],"Many":[454,2168],"quality-oriented":[455],"manufacturers":[457,490,718,874,2017,2171,2944],"already":[459],"performing":[460,782],"studies":[462,496,502,515,522,583,1338,2245,2304,2429,2963,3128,4125,4641,4761],"using":[463,517,2040,3641,4239,4316,4410],"significant":[465,3458,3485,5622,5661],"numbers":[466,650,889,1700],"subjects.":[469,4348,5530],"It":[470,505,1299,2994,3760,4176],"should":[471,554,846,1235,1339,1491,2200,2395,2462,2781,3854,4519,5393,5455,5477],"responsibility":[474,735],"US":[477,5981],"Food":[478,5982],"Drug":[480,5984],"Administration":[481,5985],"(FDA)":[482],"regulatory":[485,510,1006,2353],"bodies":[486],"require":[488,512,1305,3554],"perform":[492,1378,2389],"powered":[494],"deny":[498],"approvals":[499,2356],"if":[500,982,1316,2227,2593,2801,4059,5066,5599],"inadequate.":[504],"also":[507,692,2792,3259,3560,4203,4991,5733],"agencies":[511],"only":[514,1131,1283,2471,3443,4431,4707,5174],"disease-free":[518],"subjects,":[519],"but":[520,965,1169,1974,2975,3010,4016,4115,4562,4822,4906,4978,5002,5484,5556,5732,5793],"include":[524,918,3180,3333,4575,5173,5684],"subjects":[525,1018,2113,3024],"predefined":[527,3026],"like":[529,4090,5416],"pregnancy,":[530],"diabetes,":[531],"kidney":[532],"disease,":[533,1678,5838],"etc.":[534],"affect":[537],"interpretation":[541,3696,5203],"categories":[544],"patients.":[546],"literature":[551,2178,2223,2345],"citations":[553],"avoided":[556],"due":[557,2880,4884],"lack":[559,2351,3520,3667,4577],"standardization":[561,2920,3566],"comparability":[564,1337],"data,":[565],"unknown":[567],"statistical":[568,784,818,1291,3985,4041,4679],"power":[569],"assumptions":[571],"studies.":[575,3208,4487,4963],"Obtaining":[576,600],"could":[584,1194,1269,2013,4801,5029,5720],"potentially":[585,4375,4865],"involve":[586],"collaborative":[588],"effort":[589,1411,1571,1716,5651],"between":[590,1239,3225,3387,3487,3679,3772,3891,4504,4615,4769],"contract":[591,934,1014],"research":[592],"organizations,":[593],"biobanks,":[594],"societies.":[597],"Neil":[598,1401,2419,3072,3646,4307,5492],"Greenberg:":[599,1402,2420,3073,3647,4308,5493],"samples":[602,652,1394,1907,3903],"well-documented":[605],"purposes":[609],"comprehensive":[620,1447,2425,4484],"setting,":[623],"as":[625,723,768,920,922,947,1746,1802,1851,1868,2023,2568,2570,3090,3287,3461,4253,4432,4854,4942,5016,5443,5918],"manufacturer,":[633],"often":[634,1517,1610,2819,3220,4429,5901],"best":[636,869,901,4194],"solution":[637,1916,2031,2986,5157],"collaborate":[640,905],"access":[647],"individuals":[654,1052,1217,1234,2149,2299],"fulfilling":[655],"specifications":[657],"predetermined":[660,4328],"demographic":[663,708],"characteristics":[664,677],"Depending":[673,1403],"sampling":[676],"(e.g.,":[682,1218,1477,1703,5791,5815],"race/ethnicity,":[685],"history),":[687],"collaborating":[689],"collect":[695],"number":[697,1264,2165,2297,3174,4273,5447,5680],"sets":[701],"specific":[704,2016,4040,4064],"ranges":[705,767],"multiple":[707,3953],"and/or":[709,1391,5333],"Graham":[713,1618,2509,3164,3757,4488,5671],"R.D.":[714,1619,2510,3165,3758,4489,5672],"Jones:":[715,1620,2511,3166,3759,4490,5673],"any":[724,1366,1815,2334,2556,3688,3880,5032,5134],"organization":[725],"setting":[726,3256,4181,4221],"out":[727,1022,4342],"RI,":[731,1420,2050,4821],"however,":[732],"greater":[734,4826],"since":[736,4528],"two":[748,2826],"aspects.":[750],"first":[752,2779],"doing":[754],"job":[756],"well,":[757,798],"i.e.,":[758,3783,5322],"selecting":[759],"population,":[762,810,5598],"age":[764,1848,4091],"sex":[766,1850,4093],"analyte,":[772],"managing":[773],"preanalytical":[775,812,1020,2053,3380],"analytical":[777,814,4136,4182,5316,5320],"correctly":[779,3717],"then":[781,1179,1941,2957,3346],"analysis":[785,4252],"derive":[787,2565,4807],"intervals.":[789,3327],"second":[791,2692,5102],"aspect,":[792],"which":[793,1825,1969,2036,2077,2114,2124,2137,3191,4647,5137,5359,5727],"end":[803,1067,2466,4702,5589],"user":[804,823,852,1068],"sufficient":[806,1055,1157],"about":[808,2555,2573,4710,4735,5363],"processes,":[815],"processes":[819],"so":[820,4067],"assess":[825,1758,1799,1832,2539],"suitability":[827,1762,2206,2325,2684],"use":[832,1064,1142,1197,1312,1463,1521,1681,1805,1985,2132,2172,2707,2734,3034,3057,3182,3199,3212,3612,4128,4142,4326,5079,5265,5687],"their":[834,868,1465,1504,1679,1720,2049,2457,3347,3614,3618,4046,4299,4658,4715,5439,5547,5559,5563],"own":[835,2391,2414,5564],"laboratory.":[836,1087,1602,2316,2335,3398],"upper":[841,1709,3956,5146,5804],"lower":[843,5148],"limits":[845,1388,3432,3949,4101,4150,4163,4918,5500],"allow":[850,2889],"compare":[854],"intervals":[856,1637,1690,2408,3185,3204,3270,3316],"data":[858,1199,1213,1536,1809,3104,3277,3298,4228,4251,4368,4427,4481,4581],"sources.":[861],"William":[862,1874,2610,3328,4669],"Rosner:":[863,1875,2611,3329,4670],"Although":[864],"interests":[870],"so,":[873,1109],"ideally":[878],"equipped":[879],"properly,":[883],"both":[884,4448,4931,4951,5702],"terms":[886,5220],"difficulty":[893,2635,2646],"deciding":[895,5883],"who":[896,1040,3901,3909],"\u201cnormal.\u201d":[898,5412],"Perhaps":[899],"(both":[906],"defining":[908],"population)":[913],"thought":[915],"leaders":[916],"statisticians":[919],"well":[921,2569,4178,4355],"laboratorians":[923],"clinicians.":[925],"possible":[927,1191,2100,2557,3385],"alternative":[928,2122],"would":[929,957,966,978,1955,2004,2032,2971,3030,3353,3375,4741,4815,4894,5036,5076,5415,5648,5728,5949,5962],"hire":[932],"firm":[935],"expertise":[938],"define":[940,4058,4852],"obtain":[942,3418,4012],"samples,":[944,3383],"e.g.,":[945,2622,3824,5082],"ones":[949],"supervise":[951],"trials.":[953,4668],"Both":[954,4288],"these":[955,2303,3127,3475,3709,3859,4017,4147,5347,5871,5916,5955],"solutions":[956,3742],"expensive":[959],"trivial":[962],"initiate,":[964],"yield":[967,1899,1986],"reliable":[970],"values.":[971,2167,5073],"Of":[972],"course,":[973],"usefulness":[975],"greatly":[980],"enhanced":[981],"MPs":[983,1910,1983,2019,2438,2941,3068,3093,3137,3574,4659],"were":[984,2300],"harmonized":[985,1923,1931,2849,3106,4882],"traceable":[987,1147,1166,1935,2743],"standard.":[991],"Ian":[992,2059,2652,3399,3868,4756,5892],"S.":[993,2060,2653,3400,3869,4757,5893],"Young:":[994,2061,2654,3401,3870,4758,5894],"intention":[997],"meet":[1005,1340],"requirements,":[1007,2400],"easiest":[1009],"aspects":[1021],"third":[1026,5126],"party":[1027],"supplier.":[1028],"More":[1029],"than":[1030,3250,3325,3982,4525],"one":[1031,1694,2312,4191,4207,4498,4876,5925],"collection":[1033],"marketing":[1042],"globally.":[1045],"While":[1046,1667,5571],"source":[1049,3193],"perspective,":[1059],"limited":[1063,1493],"unless":[1071],"manufacturer's":[1073,1104,1309,1363,2290,3201],"demographically":[1077],"similar":[1078,4799],"patient":[1081,2869,3562,3639,3900,5024,5063,5516,5627],"served":[1083,1172,1351,1599,2313,3395,4353],"Is":[1088,3993],"every":[1092],"included":[1099,1268,2301,3097,3138,5943],"instructions":[1105,1310],"use?":[1107,1115],"what":[1110,2373,3607,4103,4746,5510,5518,5658],"practical":[1112,1192,1284,2812,3741],"Yes,":[1118],"cases":[1121,5539],"each":[1122,1484,3998,5193,5467],"needs":[1125,1592,3492,4062,5614],"RI.":[1129,1765,2508,2545,4862,5124,5339,5911,5935],"exception":[1132],"case,":[1135,1154,1274,4890],"indicated":[1136,2024],"previously,":[1137],"able":[1144,2739,2959,5852],"\u201ctraceable":[1150],"RIs.\u201d":[1151],"In":[1152,1272,1334,2253,2365,2576,2822,3845,4513,4729,4829,4888,5195],"evaluate":[1159],"trueness":[1161],"exist,":[1168],"characteristics,":[1178],"verification":[1180,1306,1381,1427,1495,1515,2905,3131],"needed.":[1182,1852],"Besides":[1183,5007],"EP23-A3c,":[1189],"mining":[1200],"programs":[1203,1228],"analyze":[1205,1808],"data.":[1207],"Care":[1208],"select":[1212],"presumably":[1215],"healthy":[1216,1233,1865,2112,2148,5697],"blood":[1219],"donors,":[1220],"presurgical":[1221],"screening":[1222,1227],"elective":[1224],"surgery,":[1225],"workplace":[1226],"where":[1229,1262,1646,2355,2474,2856,3412,3427,3446,3454,3663,3839,3847,4222,4549,4784,5422,5642,5884],"prevalence":[1231],"high).":[1237],"Comparison":[1238],"verification.":[1253,1513,2609],"complicated":[1258],"esoteric":[1260],"tests,":[1261,4455,5011],"patients":[1267,1595,1869,3413,3615,4399,5832],"low.":[1271,5225],"binomial":[1276],"EP23-A3c":[1280],"verification,":[1285,1724],"inherent":[1290,5301],"limitations.":[1292],"claims":[1313,3154],"corresponding":[1318],"proven":[1325],"standardized/harmonized":[1328],"manufacturer.":[1333],"addition,":[1335,2254,2823,5196],"quality":[1341,1408,1525,1540,1560,1726,1730,1946,2399,2541,2969,3324,4183,4255],"performance":[1342,1384,2423],"criteria":[1343,4333],"bias":[1345,1385,1748,1816,2559,3228],"ensure":[1347,3130,3858],"populations":[1350,1359,3022,3037,4318],"comparable":[1356,2851],"studies,":[1364],"donor":[1368],"source.":[1370],"usually":[1374,2528,4419]},"counts_by_year":[{"year":2026,"cited_by_count":4},{"year":2025,"cited_by_count":8},{"year":2024,"cited_by_count":6},{"year":2023,"cited_by_count":4},{"year":2022,"cited_by_count":1},{"year":2021,"cited_by_count":6},{"year":2020,"cited_by_count":2},{"year":2018,"cited_by_count":4},{"year":2017,"cited_by_count":2}],"updated_date":"2026-11-12T12:28:57.059296","created_date":"2016-06-24T00:00:00"}
