Population-Specific Reference Intervals for Whole-Blood GSH/GSSG Ratio in Healthy Emirati Adults According to CLSI and ISO 15189 Guidelines.

Q2 Medicine
Sushma Ravindra Umrao, Sampathkumar Elangovan, Muhammad Raza Qureshi, Muhammad Masoud Alam, Farhan Ashraf, Shafaath Husain Syed Mohammed, Mohamed Sayed Tharammal, Faiz Ul Amin, Mohammed Munir Khan
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引用次数: 0

Abstract

Background: The glutathione redox system, expressed as the ratio of reduced glutathione (GSH) to oxidized glutathione (GSSG), is a key indicator of cellular oxidative status. Manufacturer-provided reference intervals are typically derived from non-local populations and may not be applicable across different ethnic and geographic groups.

Objective: To characterize the distribution of whole-blood GSH/GSSG ratio in healthy Emirati adults using ultra-high-performance liquid chromatography (UHPLC) and to establish population-specific reference intervals in accordance with CLSI C28-A3 and ISO 15189 guidelines.

Methods: In this cross-sectional study, whole-blood samples from 120 apparently healthy Emirati adults were analyzed using a commercial UHPLC assay. The GSH/GSSG ratio was calculated for each participant. Due to non-normal distribution, reference intervals were derived using a nonparametric approach. Both the conventional 95% reference interval (2.5th-97.5th percentiles) and the central 90% interval (5th-95th percentiles) were calculated. Bootstrap resampling (20,000 iterations) was used to estimate 95% confidence intervals for the central 90% limits.

Results: The GSH/GSSG ratio demonstrated a right-skewed distribution with a median (IQR) of 4.76 (3.58-6.77). Most participants (89.2%) had values below the manufacturer-reported reference interval (10-15), with only 5.0% within this range. The nonparametric 95% reference interval was 1.66-28.40. The central 90% interval was 2.53-17.20, with bootstrap 95% confidence intervals of 2.21-2.97 (lower) and 14.92-19.73 (upper).

Conclusion: Manufacturer-provided reference intervals do not reflect the distribution observed in healthy Emirati adults. Population-specific reference intervals are therefore necessary. Reporting both 95% and 90% intervals, supported by bootstrap estimates, enhances clinical interpretation for both diagnostic and screening applications.

根据CLSI和ISO 15189指南,阿联酋健康成人全血GSH/GSSG比率的人群特异性参考区间
背景:谷胱甘肽氧化还原系统以还原性谷胱甘肽(GSH)与氧化性谷胱甘肽(GSSG)的比值表示,是细胞氧化状态的关键指标。制造商提供的参考区间通常来自非本地人口,可能不适用于不同的种族和地理群体。目的:利用超高效液相色谱法(UHPLC)表征阿联酋健康成人全血GSH/GSSG比值的分布,并根据CLSI C28-A3和ISO 15189指南建立人群特异性参考区间。方法:在这项横断面研究中,使用商业UHPLC分析了120名明显健康的阿联酋成年人的全血样本。计算每位参与者的GSH/GSSG比值。由于非正态分布,参考区间采用非参数方法推导。计算常规95%参考区间(2.5 ~ 97.5百分位数)和中心90%区间(5 ~ 95百分位数)。Bootstrap重采样(20,000次迭代)用于估计中心90%极限的95%置信区间。结果:GSH/GSSG呈右偏态分布,中位数(IQR)为4.76(3.58 ~ 6.77)。大多数参与者(89.2%)的值低于制造商报告的参考区间(10-15),只有5.0%在此范围内。非参数95%参考区间为1.66 ~ 28.40。中央90%区间为2.53 ~ 17.20,bootstrap 95%置信区间为2.21 ~ 2.97(下),14.92 ~ 19.73(上)。结论:制造商提供的参考间隔不能反映在健康的阿联酋成年人中观察到的分布。因此,有必要确定特定于人口的参考间隔。在bootstrap估计的支持下,报告95%和90%的间隔,增强了诊断和筛查应用的临床解释。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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CiteScore
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