{"title":"采用间接法计算甲状腺疾病的参考区间,并与参考变化值进行比较。","authors":"Zeynep Yildiz, Lale Köroğlu Dağdelen","doi":"10.11613/BM.2023.010704","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>The aim of the study was to calculate reference intervals (RIs) for thyroid stimulating hormone (TSH), free thyroxine (fT4) and free triiodothyronine (fT3) and evaluate the clinical significance of these intervals by use of reference change values (RCV) of the analytes.</p><p><strong>Materials and methods: </strong>Laboratory patient data between August and December 2021 were evaluated for the study. A total of 188,912 patients with TSH, fT4, fT3, anti-thyroid peroxidase antibodies (Anti-TPO) and anti-thyroglobulin antibodies (Anti-Tg) results were evaluated. All measurements were performed on Cobas c801 (Roche Diagnostics, Penzberg, Germany) using electrochemiluminescence immunoassay technology. Estimated RIs were compared with manufacturer's by means of RCVs of analytes.</p><p><strong>Results: </strong>Thyroid stimulating hormone values didn't differ significantly by gender and age. The combined RIs for whole group (N = 28,437) was found as 0.41-4.37 mIU/mL. Free T4 values (11.6-20.1 pmol/L, N = 13,479 in male; 10.5-19.5 pmol/L, N = 17,634 female) and fT3 values (3.38-6.35 pmol/L, N = 2,516 in male; 3.39-5.99 pmol/L, N = 3,348 pmol/L in female) significantly differed by gender (P < 0.050). Both fT4 and fT3 values also showed significant differences in age subgroups comparisons. So, male and female RIs were represented separately for age subgroups. When compared with manufacturer's RIs, TSH whole group and fT4 subgroups RIs didn't exceed the analytes' RCVs, but this difference was greater for fT3.</p><p><strong>Conclusions: </strong>Reference interval estimation by use of indirect method out of laboratory data may be more accurate than manufacturer provided RIs. This population based RIs evaluated using RCV of analytes may provide useful information in clinical interpretation of laboratory results.</p>","PeriodicalId":9021,"journal":{"name":"Biochemia Medica","volume":null,"pages":null},"PeriodicalIF":3.8000,"publicationDate":"2023-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9807239/pdf/","citationCount":"1","resultStr":"{\"title\":\"Reference intervals for thyroid disorders calculated by indirect method and comparison with reference change values.\",\"authors\":\"Zeynep Yildiz, Lale Köroğlu Dağdelen\",\"doi\":\"10.11613/BM.2023.010704\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>The aim of the study was to calculate reference intervals (RIs) for thyroid stimulating hormone (TSH), free thyroxine (fT4) and free triiodothyronine (fT3) and evaluate the clinical significance of these intervals by use of reference change values (RCV) of the analytes.</p><p><strong>Materials and methods: </strong>Laboratory patient data between August and December 2021 were evaluated for the study. A total of 188,912 patients with TSH, fT4, fT3, anti-thyroid peroxidase antibodies (Anti-TPO) and anti-thyroglobulin antibodies (Anti-Tg) results were evaluated. All measurements were performed on Cobas c801 (Roche Diagnostics, Penzberg, Germany) using electrochemiluminescence immunoassay technology. Estimated RIs were compared with manufacturer's by means of RCVs of analytes.</p><p><strong>Results: </strong>Thyroid stimulating hormone values didn't differ significantly by gender and age. The combined RIs for whole group (N = 28,437) was found as 0.41-4.37 mIU/mL. Free T4 values (11.6-20.1 pmol/L, N = 13,479 in male; 10.5-19.5 pmol/L, N = 17,634 female) and fT3 values (3.38-6.35 pmol/L, N = 2,516 in male; 3.39-5.99 pmol/L, N = 3,348 pmol/L in female) significantly differed by gender (P < 0.050). Both fT4 and fT3 values also showed significant differences in age subgroups comparisons. So, male and female RIs were represented separately for age subgroups. When compared with manufacturer's RIs, TSH whole group and fT4 subgroups RIs didn't exceed the analytes' RCVs, but this difference was greater for fT3.</p><p><strong>Conclusions: </strong>Reference interval estimation by use of indirect method out of laboratory data may be more accurate than manufacturer provided RIs. This population based RIs evaluated using RCV of analytes may provide useful information in clinical interpretation of laboratory results.</p>\",\"PeriodicalId\":9021,\"journal\":{\"name\":\"Biochemia Medica\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":3.8000,\"publicationDate\":\"2023-02-15\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9807239/pdf/\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Biochemia Medica\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.11613/BM.2023.010704\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"MEDICAL LABORATORY TECHNOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Biochemia Medica","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.11613/BM.2023.010704","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICAL LABORATORY TECHNOLOGY","Score":null,"Total":0}
Reference intervals for thyroid disorders calculated by indirect method and comparison with reference change values.
Introduction: The aim of the study was to calculate reference intervals (RIs) for thyroid stimulating hormone (TSH), free thyroxine (fT4) and free triiodothyronine (fT3) and evaluate the clinical significance of these intervals by use of reference change values (RCV) of the analytes.
Materials and methods: Laboratory patient data between August and December 2021 were evaluated for the study. A total of 188,912 patients with TSH, fT4, fT3, anti-thyroid peroxidase antibodies (Anti-TPO) and anti-thyroglobulin antibodies (Anti-Tg) results were evaluated. All measurements were performed on Cobas c801 (Roche Diagnostics, Penzberg, Germany) using electrochemiluminescence immunoassay technology. Estimated RIs were compared with manufacturer's by means of RCVs of analytes.
Results: Thyroid stimulating hormone values didn't differ significantly by gender and age. The combined RIs for whole group (N = 28,437) was found as 0.41-4.37 mIU/mL. Free T4 values (11.6-20.1 pmol/L, N = 13,479 in male; 10.5-19.5 pmol/L, N = 17,634 female) and fT3 values (3.38-6.35 pmol/L, N = 2,516 in male; 3.39-5.99 pmol/L, N = 3,348 pmol/L in female) significantly differed by gender (P < 0.050). Both fT4 and fT3 values also showed significant differences in age subgroups comparisons. So, male and female RIs were represented separately for age subgroups. When compared with manufacturer's RIs, TSH whole group and fT4 subgroups RIs didn't exceed the analytes' RCVs, but this difference was greater for fT3.
Conclusions: Reference interval estimation by use of indirect method out of laboratory data may be more accurate than manufacturer provided RIs. This population based RIs evaluated using RCV of analytes may provide useful information in clinical interpretation of laboratory results.
期刊介绍:
Biochemia Medica is the official peer-reviewed journal of the Croatian Society of Medical Biochemistry and Laboratory Medicine. Journal provides a wide coverage of research in all aspects of clinical chemistry and laboratory medicine. Following categories fit into the scope of the Journal: general clinical chemistry, haematology and haemostasis, molecular diagnostics and endocrinology. Development, validation and verification of analytical techniques and methods applicable to clinical chemistry and laboratory medicine are welcome as well as studies dealing with laboratory organization, automation and quality control. Journal publishes on a regular basis educative preanalytical case reports (Preanalytical mysteries), articles dealing with applied biostatistics (Lessons in biostatistics) and research integrity (Research integrity corner).