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1 毫克 overnight 地塞米松抑制试验后血清皮质醇检测的性能。

Serum cortisol assay performance following the 1 mg overnight dexamethasone suppression test.

机构信息

Department of Clinical Biochemistry, Wythenshawe Hospital, Manchester University NHS Foundation Trust, Manchester, UK.

Department of Clinical Biochemistry, Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust, Manchester, UK.

出版信息

Ann Clin Biochem. 2023 Nov;60(6):386-395. doi: 10.1177/00045632231179560. Epub 2023 Jun 30.

Abstract

BACKGROUND

The 1 mg overnight dexamethasone suppression test (ONDST) is recommended for the differential diagnosis of Cushing's syndrome and the investigation of adrenal incidentalomas. Despite documented variation in serum cortisol immunoassay performance, little has been published regarding its effect on the ONDST.

AIMS

Assess the performance of three immunoassay platforms (Roche Elecsys II, Abbott Alinity & Siemens Centaur) when compared to a liquid chromatography tandem mass spectrometry (LC-MS/MS) method.

METHODS

Samples ( = 77) sent to the laboratory as part of an ONDST were retrieved prior to disposal, anonymized, and analysed on all platforms. Samples with factors impacting immunoassay analysis quality were excluded. Results were statistically compared to an LC-MS/MS method that previously demonstrated excellent comparability to a candidate reference method.

RESULTS

The Roche gen II showed a mean bias of -2.4 nmol/L and a Passing-Bablok fit of y = -0.9 + 0.97x. This was not affected by sex. The Abbott showed a mean bias -18.8 nmol/L, and a fit of y = -11.3 + 0.88x. This bias was -20.7 nmol/L in females versus -17.2 nmol/L in males. The Siemens had a mean bias of 2.3 nmol/L and a fit of y = 1.4 + 1.07x. This bias was 5.7 nmol/L in males versus -1.0 nmol/L in females.

CONCLUSIONS

Clinicians should be aware of the method-dependent variation that exists within serum cortisol analysis during the ONDSTs. Roche and Siemens aligned more closely with LC-MS/MS while the Abbot may cause a reduction in ONDST sensitivity. This data supports assay-specific cut-offs for the ONDST.

摘要

背景

1 毫克 overnight dexamethasone suppression test(ONDST)推荐用于库欣综合征的鉴别诊断和肾上腺意外瘤的研究。尽管血清皮质醇免疫分析的性能存在差异,但关于其对 ONDST 的影响的研究却很少。

目的

评估三种免疫分析平台(罗氏 Elecsys II、雅培 Alinity 和西门子 Centaur)与液相色谱串联质谱(LC-MS/MS)方法相比的性能。

方法

在丢弃之前,从实验室作为 ONDST 的一部分发送的样品被检索出来,进行匿名处理,并在所有平台上进行分析。排除影响免疫分析分析质量的因素的样品。结果与之前证明与候选参考方法具有极好可比性的 LC-MS/MS 方法进行统计学比较。

结果

罗氏 gen II 显示平均偏差为-2.4 nmol/L,Passing-Bablok 拟合为 y = -0.9 + 0.97x。这不受性别的影响。雅培显示平均偏差-18.8 nmol/L,拟合为 y = -11.3 + 0.88x。这种偏差在女性中为-20.7 nmol/L,在男性中为-17.2 nmol/L。西门子的平均偏差为 2.3 nmol/L,拟合为 y = 1.4 + 1.07x。这种偏差在男性中为 5.7 nmol/L,在女性中为-1.0 nmol/L。

结论

临床医生应意识到在 ONDST 期间血清皮质醇分析中存在的依赖于方法的变化。罗氏和西门子与 LC-MS/MS 更一致,而雅培可能会降低 ONDST 的敏感性。该数据支持 ONDST 的特定检测限。

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