Establishment of Korean Pediatric Reference Intervals for Estradiol using Ultra-High-Performance Liquid Chromatography-Tandem Mass Spectrometry

•First established reference intervals for estradiol using a UHPLC-MS/MS-based method in South Korea.•Serum samples from 634 pediatric patients, including neonates, infants, children, and adolescents.•The highly analytical sensitive UHPLC-MS/MS method was useful for estradiol determination in childr...

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Veröffentlicht in:Clinical biochemistry 2023-03, Vol.113, p.52-58
Hauptverfasser: Won, Eun Jeong, Yi, Ahram, Ko, Young Jin, Kim, Serim, Kang, Seong-Ho, Park, Geon, Jang, Sook-Jin
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container_start_page 52
container_title Clinical biochemistry
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creator Won, Eun Jeong
Yi, Ahram
Ko, Young Jin
Kim, Serim
Kang, Seong-Ho
Park, Geon
Jang, Sook-Jin
description •First established reference intervals for estradiol using a UHPLC-MS/MS-based method in South Korea.•Serum samples from 634 pediatric patients, including neonates, infants, children, and adolescents.•The highly analytical sensitive UHPLC-MS/MS method was useful for estradiol determination in children. Ultra-high-performance liquid chromatography-tandem mass spectrometry (UHPLC–MS/MS) is a reliable and accurate method for measuring steroid hormone levels. There is an increasing need for sensitive and precise methods to measure estradiol in pediatric patients. Here, we established reference intervals for estradiol in healthy children using a UHPLC–MS/MS-based method for the first time in South Korea. Serum estradiol was measured using a Sciex Triple QuadTM 6500 + UHPLC–MS/MS (Sciex, Framingham, MA, USA). Reference intervals for estradiol were established according to the CLSI document EP28-A3c:2008. The reference intervals were validated using serum samples from 634 pediatric patients, including neonates, children, and adolescents. Among them, 389 specimens were used in analysis of the specimen acceptance time. Statistical analysis was performed using MedCalc (MedCalc, Ostend, Belgium) and Analyse–it (Analyse–it Software Ltd., Leeds, United Kingdom) software. Reference intervals for boys (n = 297) were 
doi_str_mv 10.1016/j.clinbiochem.2023.01.004
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Ultra-high-performance liquid chromatography-tandem mass spectrometry (UHPLC–MS/MS) is a reliable and accurate method for measuring steroid hormone levels. There is an increasing need for sensitive and precise methods to measure estradiol in pediatric patients. Here, we established reference intervals for estradiol in healthy children using a UHPLC–MS/MS-based method for the first time in South Korea. Serum estradiol was measured using a Sciex Triple QuadTM 6500 + UHPLC–MS/MS (Sciex, Framingham, MA, USA). Reference intervals for estradiol were established according to the CLSI document EP28-A3c:2008. The reference intervals were validated using serum samples from 634 pediatric patients, including neonates, children, and adolescents. Among them, 389 specimens were used in analysis of the specimen acceptance time. Statistical analysis was performed using MedCalc (MedCalc, Ostend, Belgium) and Analyse–it (Analyse–it Software Ltd., Leeds, United Kingdom) software. Reference intervals for boys (n = 297) were <16.6, <7.3, <19.0, <30.5, 7.6–96.5, and 10.6–134.4 pmol/L among those aged <1, 1–5, 6–9, 10–11, 12–14, and 15–17 years, respectively. Reference intervals for girls (n = 337) were <114.7, <24.2, <34.8, 8.0–177.0, 10.4–480.5, and 9.1–486.7 pmol/L among those aged <1, 1–5, 6–9, 10–11, 12–14, and 15–17 years, respectively. Overall, there was no effect of specimen acceptance time on estradiol measurements in boys or girls, except for that in the group aged 10–11 years. The reference intervals for healthy children were validated using a UHPLC–MS/MS-based method. 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Ultra-high-performance liquid chromatography-tandem mass spectrometry (UHPLC–MS/MS) is a reliable and accurate method for measuring steroid hormone levels. There is an increasing need for sensitive and precise methods to measure estradiol in pediatric patients. Here, we established reference intervals for estradiol in healthy children using a UHPLC–MS/MS-based method for the first time in South Korea. Serum estradiol was measured using a Sciex Triple QuadTM 6500 + UHPLC–MS/MS (Sciex, Framingham, MA, USA). Reference intervals for estradiol were established according to the CLSI document EP28-A3c:2008. The reference intervals were validated using serum samples from 634 pediatric patients, including neonates, children, and adolescents. Among them, 389 specimens were used in analysis of the specimen acceptance time. Statistical analysis was performed using MedCalc (MedCalc, Ostend, Belgium) and Analyse–it (Analyse–it Software Ltd., Leeds, United Kingdom) software. 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Ultra-high-performance liquid chromatography-tandem mass spectrometry (UHPLC–MS/MS) is a reliable and accurate method for measuring steroid hormone levels. There is an increasing need for sensitive and precise methods to measure estradiol in pediatric patients. Here, we established reference intervals for estradiol in healthy children using a UHPLC–MS/MS-based method for the first time in South Korea. Serum estradiol was measured using a Sciex Triple QuadTM 6500 + UHPLC–MS/MS (Sciex, Framingham, MA, USA). Reference intervals for estradiol were established according to the CLSI document EP28-A3c:2008. The reference intervals were validated using serum samples from 634 pediatric patients, including neonates, children, and adolescents. Among them, 389 specimens were used in analysis of the specimen acceptance time. Statistical analysis was performed using MedCalc (MedCalc, Ostend, Belgium) and Analyse–it (Analyse–it Software Ltd., Leeds, United Kingdom) software. Reference intervals for boys (n = 297) were <16.6, <7.3, <19.0, <30.5, 7.6–96.5, and 10.6–134.4 pmol/L among those aged <1, 1–5, 6–9, 10–11, 12–14, and 15–17 years, respectively. Reference intervals for girls (n = 337) were <114.7, <24.2, <34.8, 8.0–177.0, 10.4–480.5, and 9.1–486.7 pmol/L among those aged <1, 1–5, 6–9, 10–11, 12–14, and 15–17 years, respectively. Overall, there was no effect of specimen acceptance time on estradiol measurements in boys or girls, except for that in the group aged 10–11 years. The reference intervals for healthy children were validated using a UHPLC–MS/MS-based method. The highly analytical sensitive UHPLC–MS/MS method may be useful for estradiol determination in pediatric patients.]]></abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>36627011</pmid><doi>10.1016/j.clinbiochem.2023.01.004</doi><tpages>7</tpages></addata></record>
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subjects Adolescent
Child
Chromatography, High Pressure Liquid
Estradiol
Female
High-performance liquid chromatography-tandem mass spectrometry (UHPLC–MS/MS)
Humans
Infant, Newborn
Male
Reference intervals
Reference Values
Software
Tandem Mass Spectrometry - methods
title Establishment of Korean Pediatric Reference Intervals for Estradiol using Ultra-High-Performance Liquid Chromatography-Tandem Mass Spectrometry
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