1. Limitations of the Hoffmann method for establishing reference intervals using clinical laboratory data
- Author
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Yaqi Lv, Ying Zhang, Guocheng Wang, Yaguang Peng, Weibo Ma, and Xiaoxia Peng
- Subjects
Adult ,Male ,030213 general clinical medicine ,Adolescent ,Clinical Biochemistry ,Thyrotropin ,General Medicine ,Free thyroxine ,Middle Aged ,Reference Standards ,030204 cardiovascular system & hematology ,Reference intervals ,Thyroxine ,03 medical and health sciences ,Laboratory test ,0302 clinical medicine ,Sample size determination ,Thyroid hormones ,Statistics ,Humans ,Female ,Value (mathematics) ,Blood Chemical Analysis ,hormones, hormone substitutes, and hormone antagonists ,Mathematics - Abstract
OBJECTIVE To examine the effect of different limits of acceptability on the Hoffmann method for selecting "healthy" populations from laboratory test data. METHODS Thyroid stimulating hormone (TSH) and free thyroxine (FT4) were measured in Shunyi Maternal and Children's Hospital of Beijing Children's Hospital. The sample size of participants of TSH and FT4 for reference intervals (RIs) establishment was 10,864 and 10,799, respectively. RIs were calculated by Hoffmann method with different acceptable deviations (α value). The validation data was collected prospectively and the out-of-range (OOR) values were calculated to examine the applicability of RIs with different acceptable deviations. The sample size for RIs validation was 880 and 867, respectively. The RIs were considered as valid when OOR was
- Published
- 2019