南非一家三级医院第二代和第三代甲状旁腺激素检测方法的比较。

Comparison of second and third-generation parathyroid hormone assays at a tertiary hospital in South Africa.

作者信息

Nhlapo Nokuthula, Jacob Doreen, Khoza Siyabonga, Maphayi Mpho R

机构信息

Department of Chemical Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.

Department of Chemical Pathology, National Health Laboratory Service, Johannesburg, South Africa.

出版信息

Afr J Lab Med. 2025 Aug 30;14(1):2700. doi: 10.4102/ajlm.v14i1.2700. eCollection 2025.

DOI:10.4102/ajlm.v14i1.2700

PMID:40937300

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12421447/

Abstract

BACKGROUND

Parathyroid hormone (PTH) measurement is key for diagnosing parathyroid disorders, and for management of chronic kidney disease. Available PTH assays include second (intact PTH) and third (PTH 1-84) generations. Data comparing interchangeable use are insufficient.

OBJECTIVE

The objective of this study was to compare intact and 1-84 PTH assays to determine the difference in analytical performance and impact on clinical interpretation.

METHODS

A method comparison was done on residual samples with PTH requests (06 April 2022 - 21 September 2022) from a tertiary hospital in South Africa. Parathyroid hormone was measured using both intact PTH and 1-84 PTH assays. Clinical performance was compared in the diagnosis of hypo- and hyperparathyroidism, and in pre-dialysis and dialysis chronic kidney disease patients.

RESULTS

Among 481 samples, intact PTH had a higher median concentration than PTH 1-84 (9.85 pmol/L vs. 8.51 pmol/L, < 0.0001), but the two showed good correlation ( = 0.994, < 0.0001). Regression analysis revealed systematic (intercept = 0.887 pmol/L [95% confidence interval: 0.788 - 1.005]) and proportional differences (slope = 0.713 pmol/L, [95% confidence interval: 0.703 - 0.723]), with increased deviations at higher concentrations. The average bias was 18.5%, exceeding allowable limits. Among the 276 patients (170 women, 106 men, age range: 18-89 years) included in the clinical study, interpretation was unchanged.

CONCLUSION

A bias was observed between the PTH assays, indicating that they should not be used interchangeably. However, no changes in clinical interpretation were observed when one assay was used over the other.

WHAT THIS STUDY ADDS

The study confirms the recommendation by Kidney Disease: Improving Global Outcomes for the use of assay-specific upper limit of normal instead of generic cut-off in dialysis patients. This study further highlights the need for standardisation of PTH assays.

摘要

背景

甲状旁腺激素（PTH）检测对于甲状旁腺疾病的诊断以及慢性肾脏病的管理至关重要。现有的PTH检测方法包括第二代（完整PTH）和第三代（PTH 1-84）。关于可互换使用的数据并不充分。

目的

本研究的目的是比较完整PTH和PTH 1-84检测方法，以确定分析性能的差异以及对临床解读的影响。

方法

对南非一家三级医院2022年4月6日至2022年9月21日有PTH检测需求的剩余样本进行方法比较。使用完整PTH和PTH 1-84检测方法测量甲状旁腺激素。比较了在甲状旁腺功能减退和亢进诊断中以及透析前和透析慢性肾脏病患者中的临床性能。

结果

在481个样本中，完整PTH的中位浓度高于PTH 1-84（9.85 pmol/L对8.51 pmol/L，<0.0001），但两者显示出良好的相关性（=0.994，<0.0001）。回归分析显示存在系统差异（截距=0.887 pmol/L [95%置信区间：0.788 - 1.005]）和成比例差异（斜率=0.713 pmol/L，[95%置信区间：0.703 - 0.723]），且在较高浓度下偏差增加。平均偏差为18.5%，超过了允许限度。在纳入临床研究的276名患者（170名女性，106名男性，年龄范围：18 - 89岁）中，解读没有变化。