Comparison of results from commercial assays for plasma CTX: The need for harmonization

Chubb, S. A. Paul; Mandelt, Christine; Vasikaran, Samuel

doi:10.1016/j.clinbiochem.2015.03.002

Cited by 22 publications

(14 citation statements)

References 14 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…β-CTX can also be measured by two automated methods, IDS-iSYS and Roche Elecsys® β-CrossLaps assay run on cobas e family instruments, as well as with a manual ELISA also marketed by IDS. Previous studies have, however, shown that there was significant disagreement between the results generated from patient samples by these three β-CTX assays [ 6 ]. Hence, in order to establish the clinical value of β-CTX as a reference bone resorption biomarker, harmonization of the results from different assays for these biomarkers is necessary.…”

Section: Introductionmentioning

confidence: 99%

A Multicenter Study to Evaluate Harmonization of Assays for C-Terminal Telopeptides of Type I Collagen (ß-CTX): A Report from the IFCC-IOF Committee for Bone Metabolism (C-BM)

et al. 2021

View full text Add to dashboard Cite

Background Biochemical bone turnover markers are useful tools to assess bone remodeling. C-terminal telopeptide of type I collagen (ß-CTX) has been recommended as a reference marker for bone resorption in research studies. Methods We describe the results of a multicenter study for routine clinical laboratory assays for ß-CTX in serum and plasma. Four centers (Athens GR, Copenhagen DK, Liege BE and Sheffield UK) collected serum and plasma (EDTA) samples from 796 patients presenting to osteoporosis clinics. Specimens were analyzed in duplicate with each of the available routine clinical laboratory methods according to the manufacturers’ instructions. Passing-Bablok regressions, Bland–Altman plots, V-shape evaluation method, and Concordance correlation coefficient for ß-CTX values between serum and plasma specimens and between methods were used to determine the agreement between results. A generalized linear model was employed to identify possible variables that affected the relationship between the methods. Two pools of serum were finally prepared and sent to the four centers to be measured in 5-plicates on 5 consecutive days with the different methods. Results We identified significant variations between methods and between centers although comparison results were generally more consistent in plasma compared to serum. We developed univariate linear regression equations to predict Roche Elecsys®, IDS-iSYS, or IDS ELISA ß-CTX results from any other assay and a multivariable model including the site of analysis, the age, and weight of the patient. The coefficients of determination (R2) increased from approximately 0.80 in the univariate model to approximately 0.90 in the multivariable one, with the site of analysis being the major contributing factor. Results observed on the pools also suggest that long-term storage could explain the difference observed with the different methods on serum. Conclusion Our results show large within- and between-assay variation for ß-CTX measurement, particularly in serum. Stability of the analyte could be one of the explanations. More studies should be undertaken to overcome this problem. Until harmonization is achieved, we recommend measuring ß-CTX by the same assay on EDTA plasma, especially for research purposes in large pharmacological trials where samples can be stored for long periods before they are assayed.

show abstract

Section: Introductionmentioning

confidence: 99%

A Multicenter Study to Evaluate Harmonization of Assays for C-Terminal Telopeptides of Type I Collagen (ß-CTX): A Report from the IFCC-IOF Committee for Bone Metabolism (C-BM)

et al. 2021

View full text Add to dashboard Cite

show abstract

“…One explanation could be due to the different analytical techniques used by the different laboratories. We quantified plasma CTX-I using the IDS iSYS which when compared with Roche Elecsys has poor agreement and systematic bias [38] therefore results between the two devices are not comparable. Both reference values and circadian variation data are also limited for the IDS iSYS.…”

Section: Discussionmentioning

confidence: 99%

The effect of intermittent running on biomarkers of bone turnover

Evans

Nevill

McLaren

et al. 2019

European Journal of Sport Science

View full text Add to dashboard Cite

Intermittent exercise might be an efficient means of exercise for improving bone strength and quality. The aim of our study was to examine the effect of intermittent running on bone turnover markers using altered exercise-to-rest intervals. Twelve males completed one control (no exercise), and three, 45-minute intermittent protocols (5 s, 20 s, and 80 s intervals) matched for distance and speed. Fasted venous blood samples were collected at baseline, 1 h, 2 h and 24 h post-exercise. Carboxyterminal crosslinked telopeptide (CTX-I) and procollagen type 1 amino terminal propeptide (P1NP) were used as markers of bone resorption and formation. After adjustment for baseline, CTX-I concentration at 1 h was higher (very likely to most likely small) for 5 s (30.2%; ±90% confidence limits: 10%), 20 s (2.9.0%; ±10%) and 80 s (32.0%; ±10%) compared to control. The very likely small effect remained for 5 s at 2 h (30.2%; ±15%). The effect for 20 s and 80 s was possibly trivial and possibly small/possibly trivial (~14.5%; ±~15%). Differences in P1NP concentrations were likely to very likely trivial (~7.4%; ±~7.6%). CTX-I concentration is affected acutely by intermittent running with short-interval (5 s) intermittent loading resulting in a prolonged attenuation in circadian rhythm of CTX-I up to 2 h that was not demonstrated as clearly by longer intervals despite matched internal and external training load.

show abstract

“…Currently, the commonly used serum bone markers, such as total Procollagen I N Terminal Peptide (PINP) (Pollmann et al 2007 ), the carboxy-terminal cross-linking telopeptide of type I collagen (β-CrossLaps) (Chubb et al 2015 ), N-terminal osteocalcin and 25-hydroxyvitamin D3 reflect the changes of bone metabolism. However, some bone turnover markers have a low sensitivity and specificity in the early diagnosis of osteopenia that did not meet requirements of non-invasive and specific early diagnosis of osteopenia in the clinical practice (Bhattacharyya et al 2008 ).…”

Section: Discussionmentioning

confidence: 99%

Weak cation exchange magnetic beads coupled with matrix-assisted laser desorption ionization-time of flight-mass spectrometry in screening serum protein markers in osteopenia

et al. 2016

View full text Add to dashboard Cite

The present study aimed at investigating the weak cation magnetic separation technology and matrix-assisted laser desorption ionization-time of flight-mass spectrometry (MALDI-TOF-MS) in screening serum protein markers of osteopenia from ten postmenopausal women and ten postmenopausal women without osteopenia as control group, to find a new method for screening biomarkers and establishing a diagnostic model for primary type I osteoporosis. Serum samples were collected from postmenopausal women with osteopenia and postmenopausal women with normal bone mass. Proteins were extracted from serum samples by weak cation exchange magnetic beads technology, and mass spectra acquisition was done by MALDI-TOF-MS. The visualization and comparison of data sets, statistical peak evaluation, model recognition, and discovery of biomarker candidates were handled by the proteinchip data analysis system software(ZJU-PDAS). The diagnostic models were established using genetic arithmetic based support vector machine (SVM). The SVM result with the highest Youden Index was selected as the model. Combinatorial Peaks having the highest accuracy in distinguishing different samples were selected as potential biomarker. From the two group serum samples, a total of 133 differential features were selected. Ten features with significant intensity differences were screened. In the pair-wise comparisons, processing of MALDI-TOF spectra resulted in the identification of ten differential features between postmenopausal women with osteopenia and postmenopausal women with normal bone mass. The difference of features by Youden index showed that the highest features had a mass to charge ratio of 1699 and 3038 Da. A diagnosis model was established with these two peaks as the candidate marker, and the specificity of the model is 100 %, the sensitivity was 90 % by leave-one-out cross validation test. The two groups of specimens in SVM results on the scatter plot could be clearly distinguished. The peak with m/z 3038 in the SVM model was suggested as Secretin by TagIdent tool. To provide further validation, the secretin levels in serum were analyzed using enzyme-linked immunosorbent assays that is a competitive inhibition enzyme immunoassay technique for the in vitro quantitative measurement of secretin in human serum.Electronic supplementary materialThe online version of this article (doi:10.1186/s40064-016-2276-4) contains supplementary material, which is available to authorized users.

show abstract

Comparison of results from commercial assays for plasma CTX: The need for harmonization

Cited by 22 publications

References 14 publications

A Multicenter Study to Evaluate Harmonization of Assays for C-Terminal Telopeptides of Type I Collagen (ß-CTX): A Report from the IFCC-IOF Committee for Bone Metabolism (C-BM)

A Multicenter Study to Evaluate Harmonization of Assays for C-Terminal Telopeptides of Type I Collagen (ß-CTX): A Report from the IFCC-IOF Committee for Bone Metabolism (C-BM)

The effect of intermittent running on biomarkers of bone turnover

Weak cation exchange magnetic beads coupled with matrix-assisted laser desorption ionization-time of flight-mass spectrometry in screening serum protein markers in osteopenia

Contact Info

Product

Resources

About