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KMID : 1100720230430010055
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Annals of Laboratory Medicine
2023 Volume.43 No. 1 p.55 ~ p.63
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Indirect Method for Estimation of Reference Intervals of Inflammatory Markers
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Kang Tae-Won
Yoo Jea-Eun
Jekarl Dong-Wook
Chae Hyo-Jin
Kim Myung-Shin
Park Yeon-Joon
Oh Eun-Jee
Kim Yong-Goo
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Abstract
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Background: The direct method for reference interval (RI) estimating is limited due to the requirement of resources, difficulties in defining a non-diseased population, or ethical problems in obtaining samples. We estimated the RI for inflammatory biomarkers using an indirect method (RII).
Methods: C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) and presepsin (PSEP) data of patients visiting a single hospital were retrieved from April 2009 to April 2021. Right-skewed data were transformed using the Box-Cox transformation method. A mixed population of non-diseased and diseased distributions was assumed, followed by latent profile analysis for the two classes. The intersection point of the distribution curve was estimated as the RI. The influence of measurement size was evaluated as the ratio of abnormal values and adjustment (n×bandwidth) of the distribution curve.
Results: The RIs estimated by the proposed RII method (existing method) were as follows: CRP, 0?4.1 (0?4.7) mg/L; ESR, 0?10.2 (0?15) mm/hr and PSEP, 0?411 (0?300) pg/mL. Measurement sizes ≥2,500 showed stable results. An abnormal-to-normal value ratio of 0.5 showed the most accurate result for CRP. Adjustment values ≤5 or >5 were applicable for a measurement size <25,000 or ≥25,000, respectively.
Conclusions: The proposed RII method could provide additional information for RI verification or estimation with some limitations.
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KEYWORD
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Reference range, Latent variable modeling, Statistical data interpretation, Statistical distributions
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