Multicenter performance evaluation of a second generation cortisol assay

Vogeser, Michael; Kratzsch, Jürgen; Bae, Yoon Ju; Bruegel, Mathias; Ceglarek, Uta; Fiers, Tom; Gaudl, Alexander; Kurka, Hedwig; Milczynski, Christoph; Knoll, Cristina Prat; Suhr, Anna Catharina; Teupser, Daniel; Zahn, Ingrid; Ostlund, Richard E.

doi:10.1515/cclm-2016-0400

Cited by 42 publications

(27 citation statements)

References 28 publications

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“…The introduction into the clinical practice of more modern methods for cortisol measurement, such as R2 that has been calibrated on GC-MS/MS, makes the interpretation of cortisol stimulatory tests even more difficult in the absence of new cut-offs. Indeed, it is well known that LC-MS/MS and GC-MS/MS, the gold standard procedures for steroid measurement due to their lower cross-reactivity with other steroids, provide lower cortisol concentrations than older assays [ 14 , 15 , 18 ]. As a consequence, the cortisol cut-off to diagnose AI needs to be redefined.…”

Section: Discussionmentioning

confidence: 99%

Minding the gap between cortisol levels measured with second-generation assays and current diagnostic thresholds for the diagnosis of adrenal insufficiency: a single-center experience

et al. 2020

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Purpose The current cut-offs for the diagnosis of adrenal insufficiency (AI) have been established using outdated immunoassays. We compared the cortisol concentrations measured with Roche Cortisol I (R1), the newly available Roche Cortisol II (R2), and liquid chromatography tandem mass spectrometry (LC-MS/MS), the gold standard procedure to measure steroids in patients undergoing the corticotropin (ACTH) test. Methods We enrolled 30 patients (age 47 ± 21 years) referred to undergo the ACTH test (1 or 250 μg). Cortisol was measured at 0, 30, and 60 min after stimulation with R1, R2, and LC-MS/MS. AI was diagnosed for R1-stimulated peak cortisol concentrations < 500 nmol/L. Results Mean cortisol concentrations measured with R2 and LC-MS/MS were comparable, while mean cortisol concentrations measured by R1 were higher than those of both R2 and LC-MS/MS (respectively, basal 411 ± 177, 287 ± 119, and 295 ± 119 nmol/L; at 30 min, 704 ± 204, 480 ± 132, and 500 ± 132 nmol/L; at 60 min, 737 ± 301, 502 ± 196, and 519 ± 201 nmol/L, p ≤ 0.01 for R1 vs. both R2 and LC-MS/MS at each point). Considering the 500 nmol/L cortisol peak cut-off, AI was diagnosed in 5/30 patients using R1 and in 12/30 using R2 (+ 140%). Based on the correlation between R1 and R2, the threshold of 500 nmol/L became 351 nmol/L (12.7 μg/dL) when cortisol was measured with R2, and 368 nmol/L (13.3 μg/dL) with LC-MS/MS. Conclusions The use of more specific cortisol assays results in lower cortisol concentrations. This could lead to misdiagnosis and overtreatment when assessing AI with the ACTH test if a different cut-off for cortisol peak is not adopted.

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Section: Discussionmentioning

confidence: 99%

Minding the gap between cortisol levels measured with second-generation assays and current diagnostic thresholds for the diagnosis of adrenal insufficiency: a single-center experience

et al. 2020

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“…ECLIA measurements of salivary and serum cortisol concentrations were performed using the Elecsys Cortisol Ⅱ on Modular Analytics E170 system (Roche Diagnostics K.K, Tokyo, Japan) [15,23]. Intra and inter-assay coefficients of variation were 4.1% and 4.3% for saliva and 0.7% and 1.5% for serum, respectively.…”

Section: Measurements Of Salivary and Serum Cortisol Concentrationsmentioning

confidence: 99%

Assessment of exercise-induced stress by automated measurement of salivary cortisol concentrations within the circadian rhythm in Japanese female long-distance runners

Ushiki

Tsunekawa

Shoho

et al. 2020

Preprint

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Background Overtraining syndrome, caused by prolonged excessive stress, results in reduced performance and cortisol responsiveness in athletes. It is necessary to collect saliva samples sequentially within circadian rhythm for assessing exercise stress by measuring cortisol concentrations, and automated cortisol measurements using electrochemiluminescence immunoassay (ECLIA) may be useful for measuring a large number of saliva samples. In this study, we evaluated the appropriate use of cortisol-based exercise stress assessment within the circadian rhythm, which may diagnose and prevent overtraining syndrome in athletes. Methods We collected saliva and sera from 54 healthy participants and analyzed the correlation between salivary cortisol concentrations measured by ECLIA and enzyme-linked immunosorbent assay (ELISA) or serum cortisol analysis. We also collected saliva continuously from 12 female long-distance runners on 2 consecutive days involving different intensities and types of exercise early in the morning and in the afternoon and measured salivary cortisol concentrations using ECLIA. Each exercise intensity of runners was measured by running velocities, Borg Scale score, and rate of change in the pulse rate by exercise. Results ECLIA-based salivary cortisol concentrations correlated positively with those detected by ELISA (ρ = 0.924, p < 0.001) and serum cortisol (ρ = 0.591, p = 0.001). In long-distance runners, circadian rhythm of salivary cortisol including peak after waking and decrease promptly thereafter were detected on both days by continuous saliva sampling. The rates of change in salivary cortisol concentrations were significantly lower after an early morning exercise than after an afternoon exercise on both days (day 1, p = 0.002 and day 2, p = 0.003). In the early morning exercise, the rate of change in salivary cortisol concentration was significantly higher on day 1 than on day 2 ( p = 0.034), similar to significant difference in running velocities ( p = 0.001). Conclusions Our results suggest that automated ECLIA-based salivary cortisol measurements are able to detect the athletes' circadian rhythm and compare the exercise stress intensities at the same times on different days, even in the early morning, possibly leading to prevention of overtraining syndrome.

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“…Compared to solid-phase enzyme linked immunosorbent assays (ELISA) and fluid-phase Luminex assays which require manual reagent addition and removal on multi-well plates, automated analyzers are proposed to have better repeatability (variability within the same assay) and intermediate precision (variability between different assays). The Fujirebio Lumipulse ® system and the Roche Elecsys ® have shown consistent inter-assay measures in the serum, with coefficient of variation (CV) in the range of 1.2–10% for hepatitis B antigens, ( Yang et al, 2016 ) tumor markers, ( Marlet and Bernard, 2016 ) cortisol, ( Vogeser et al, 2017 ) and interleukin-13 ( Palme et al, 2017 ). In the CSF, a recent multi-center study using synthetic Aβ42 peptides in artificial CSF reported inter-assay CV of <5% on the Elecys ® system, ( Bittner et al, 2016 ) but the intermediate precision of endogenous Aβ42 in human-derived CSF samples in these automated analyzers remains unknown.…”

Section: Introductionmentioning

confidence: 99%

Automation vs. Experience: Measuring Alzheimer’s Beta-Amyloid 1–42 Peptide in the CSF

Kollhoff

Howell

2018

Front. Aging Neurosci.

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Cerebrospinal fluid (CSF) biomarkers can enhance the early and accurate etiologic detection of Alzheimer’s disease (AD) even when symptoms are very mild, but are not yet widely available for clinical testing. There are a number of reasons for this, including the need for an experienced operator, the use of instruments mostly reserved for research, and low cost-effectiveness when patient samples do not completely fill each assay plate. Newer technology can overcome some of these issues through automated assays of a single patient sample on existing clinical laboratory platforms, but it is not known how these newer automated assays compare with previous research-based measurements. This is a critical issue in the clinical translation of CSF AD biomarkers because most cohort and clinicopathologic studies have been analyzed on older assays. To determine the correlation of CSF beta-amyloid 1–42 (Aβ42) measures derived from the automated chemiluminescent enzyme immunoassay (CLEIA, on Lumipulse® G1200), a bead-based Luminex immunoassay, and a plate-based enzyme-linked immunoassay enzyme-linked immunosorbent assay (ELISA), we analyzed 30 CSF samples weekly on each platforms over 3 weeks. We found that, while CSF Aβ42 levels were numerically closer between CLEIA and ELISA measurements, levels differed between all three assays. CLEIA-based measures correlated linearly with the two other assays in the low and intermediate Aβ42 concentrations, while there was a linear correlation between Luminex assay and ELISA throughout all concentrations. For repeatability, the average intra-assay coefficient of variation (CV) was 2.0%. For intermediate precision, the inter-assay CV was lower in CLEIA (7.1%) than Luminex (10.7%, p = 0.009) and ELISA (10.8%, p = 0.009), primarily due to improved intermediate precision in the higher CSF Aβ42 concentrations. We conclude that the automated CLEIA generated reproducible CSF Aβ42 measures with improved intermediate precision over experienced operators using Luminex assays and ELISA, and are highly correlated with the manual Aβ42 measures.

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Multicenter performance evaluation of a second generation cortisol assay

Cited by 42 publications

References 28 publications

Minding the gap between cortisol levels measured with second-generation assays and current diagnostic thresholds for the diagnosis of adrenal insufficiency: a single-center experience

Minding the gap between cortisol levels measured with second-generation assays and current diagnostic thresholds for the diagnosis of adrenal insufficiency: a single-center experience

Assessment of exercise-induced stress by automated measurement of salivary cortisol concentrations within the circadian rhythm in Japanese female long-distance runners

Automation vs. Experience: Measuring Alzheimer’s Beta-Amyloid 1–42 Peptide in the CSF

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