Reference ranges for blood tests are determined using reliable statistical methods
Reference ranges for clinical blood tests are systematically determined using established parametric, nonparametric, and regression-based statistical methods applied to well-defined reference populations.
The retrieved papers consistently demonstrate that reference ranges for blood tests are established and verified using recognized statistical frameworks—such as parametric models, nonparametric percentiles, regression analysis, and robust methods—provided that appropriate sample sizes and selection criteria are met.
Arja Virtanen, Veli Kairisto, Esa Uusipaikka. Regression-based reference limits: determination of sufficient sample size. 1998. https://doi.org/10.1093/clinchem/44.11.2353
This study demonstrates that regression-based statistical methods can reliably determine covariate-dependent reference limits when adequate sample sizes are used.
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F. Apple, K. Schulz, Christian W. Schmidt, T. V. van Domburg, J. Fonville, F. de Theije. Determination of sex-specific 99th percentile upper reference limits for a point of care high sensitivity cardiac troponin I assay. 2021. https://doi.org/10.1515/cclm-2021-0262
The 99th percentile upper reference limits for high-sensitivity cardiac troponin assays are established using established nonparametric statistical methods on well-filtered healthy cohorts.
Lealem Gedefaw Bimerew, Tesfaye Demie, K. Eskinder, Aklilu Getachew Mamo, S. Bekele, Waqtola Cheneke, Zewdineh Sahlemariam, Wondimagegn Adisu, Yaregal Asres, T. Yemane, Girum Tesfaye, Getnet Tesfaw, Esayas Kebede Gudina, Z. Mekonnen. Reference intervals for hematology test parameters from apparently healthy individuals in southwest Ethiopia. 2018. https://doi.org/10.1177/2050312118807626
Statistical software and non-parametric tests like the Mann-Whitney U test are standardly applied to generate reliable population-specific hematology reference intervals.
Kulsoom Bahadur, A. Ijaz, M. Salahuddin, A. Alam. Determination of high sensitive cardiac troponin I 99th percentile upper reference limits in a healthy Pakistani population. 2020. https://doi.org/10.12669/pjms.36.6.2328
Non-parametric statistical methods are utilized to accurately determine upper reference limits for cardiac biomarkers in healthy populations.
Chaochao Ma, Xinlu Wang, L. Xia, Xinqi Cheng, L. Qiu. Effect of sample size and the traditional parametric, nonparametric, and robust methods on the establishment of reference intervals: Evidence from real world data.. 2021. https://doi.org/10.1016/j.clinbiochem.2021.03.006
Standard parametric, nonparametric, and robust statistical methods are evaluated to establish consistent reference intervals based on sample size requirements.
M. Hoq, L. Canterford, S. Matthews, G. Khanom, V. Ignjatovic, P. Monagle, S. Donath, J. Carlin. Statistical methods used in the estimation of age-specific paediatric reference intervals for laboratory blood tests: a systematic review.. 2020. https://doi.org/10.1016/j.clinbiochem.2020.08.002
This systematic review catalogs the various robust statistical methods and curve-fitting approaches used to determine continuous age-specific reference intervals.
Arja Virtanen, Veli Kairisto, Esa Uusipaikka. Parametric methods for estimating covariate-dependent reference limits. 2004. https://doi.org/10.1515/cclm.2004.124
Generalized linear models and parametric normal distribution theory serve as reliable statistical options for estimating covariate-dependent reference limits when properly verified.
M. A. Bildirici, Sedat Gülten, Neslihan Cihan Çalışgan. Determination of reference intervals of hemogram with advanced clinical parameters by indirect method on Sysmex XN-1000. 2023. https://doi.org/10.1515/tjb-2022-0287
Indirect methods utilizing non-parametric percentage estimation are successfully applied to calculate standard and advanced clinical parameter reference intervals.
Amine Jebbor, A. Zrara. Indirect Determination of Hematological Reference Intervals in Healthy Moroccan Adults Using Outpatient Data.. 2024. https://doi.org/10.7754/Clin.Lab.2024.230944
Nonparametric techniques combined with appropriate clinical selection criteria allow for the reliable indirect determination of hematological reference intervals.
Chandana Wickramaratne Kurukula Arachchi, Devika Champa Wijewickrama. Use of patient data in calculation of reference intervals for complete blood count parameters; how reliable?. 2021. https://doi.org/10.1080/00365513.2021.1949745
Standard statistical methods successfully calculate reference intervals from large patient databases, yielding results comparable to those from healthy subject studies.
Friščić I, Burazer I, Radeljak A, Perkov S, Kardum Paro MM. Verification of harmonized reference intervals in Croatia: is it time for a change?. 2026. https://doi.org/10.11613/bm.2026.020706
Standard guidelines are used to verify and validate laboratory reference intervals across hematology, coagulation, and clinical chemistry.
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