Harmonization of commercial assays for PINP; the way forward

Vasikaran, Samuel; Bhattoa, Harjit Pal; Eastell, Richard; Heijboer, Annemieke C.; Jørgensen, Niklas Rye; Makris, Konstantinos; Ulmer, Candice Z.; Kanis, John А.; Cooper, Cyrus; Silverman, Stuart; Cavalier, Étienne

doi:10.1007/s00198-020-05310-6

Cited by 15 publications

(9 citation statements)

References 81 publications

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“…One of the major issues that impede the implementation of these bone turnover markers (BTMs) in clinical practice is the lack of standardization between the different methods available on the market. For PINP, we have recently shown that the two automated methods, IDS-iSYS (Boldon, UK), and Roche Elecsys® total P1NP assay run on cobas e family instruments (Mannheim, Germany) provided results that could be used interchangeably, allowing the application of similar reference ranges whatever the method, which is an important finding for the routine use of biomarkers outside the United States [ 4 , 5 ]. Indeed, in that country, the only approved method is the Orion UniQ manual radio-immunoassay (Espoo, Finland), which presents a significant proportional bias compared to the two automated methods.…”

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

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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.

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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

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“…Several measurement methods for the serum P1NP assay are available globally, including manual immunoassays manufactured by Orion Diagnostics (Finland) measuring intact P1NP; that of Uscn, Life Science (China) measuring total P1NP; and automated assays manufactured by Immunodiagnostics Systems (IDS, UK) measuring intact P1NP and by Roche (Germany) measuring total P1NP [ 21 , 22 , 23 ]. Considering that the analytical method for serum P1NP assays used in clinical laboratories in Korea is an automated electrochemiluminescence immunoassay manufactured by Roche, the validation of the analytical methods used in this study will contribute to the generalizability of this study and the standardization of data about biomarkers in osteoporosis treatment in the Korean population [ 2 , 8 , 21 , 22 ].…”

Section: Discussionmentioning

confidence: 99%

Intra-Individual Changes in Total Procollagen-Type 1 N-terminal Propeptide in a Korean Adult Population

Choi

Lee

2022

Diagnostics

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We aimed to investigate intra-individual changes in total procollagen-type 1 N-terminal pro-peptide (P1NP), a biochemical marker of bone turnover, to understand patient populations and test utilization in a Korean adult population while considering different definitions of least significant changes by sex, age, and medical institution type. Overall, 31,501 P1NP tests were performed on 24,644 Korean adults (3389 men and 21,255 women) with a median age of 68.9 years (interquartile range, IQR, 61.2–77.2) for osteoporosis evaluation. Among these, 1331 (5.4%) patients (127 men and 1204 women) underwent ≥3 follow-up P1NP measurements. The median follow-up period was 12.5 months (IQR, 11.7–15.9). Among 1331 patients, 64.4% experienced a decrease in P1NP and 35.6% experienced an increase in P1NP during follow-up. Among these, the proportion of patients who experienced serum P1NP changes ≥ 14.4% from baseline was 92.3%, and the proportion of patients who achieved ≤40 ng/mL (a median level of premenopausal Korean women) during follow-up was 31.8%. The overall proportion of patients that experienced a serum P1NP change exceeding the least significant change during follow-up was not significantly different by the type of medical institution.

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“…Meanwhile, the research shows that the choice of OP treatment medicine should be based on bone metabolic markers [24] [40]. Low conversion medicine are mainly promoting bone metabolism, while high conversion medicine are mainly inhibiting bone resorption [40]. The results show that zoledronic acid combined with teriparatide is better than the single medicine group in improving bone metabolism markers PINP and β-CTX.…”

Section: Zoledronic Acid Combined With Teriparatide In the Prevention Of Recurrent Fracture After Pkpmentioning

confidence: 99%

The Clinical Effect of Zoledronic Acid Combined with Teriparatide in Perverting Recurrent Fracture of Osteoporotic Vertebral Compressive Fractures in the Elderly after Percutaneous Kyphoplasty

Zhao¹,

Yang²,

Zhang³

2021

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Background: Zoledronic acid and teriparatide have been proved to be effective in improving bone metabolism and preventing fractures, but there is no clear clinical report on the efficacy of their combined application. Purpose: To discuss the clinical effect of zoledronic acid combined with teriparatide in perverting recurrent fracture of osteoporotic vertebral compressive fractures (OVCF) in the elderly after percutaneous kyphoplasty (PKP). Method: A randomized clinical trial was conducted at the First Affiliated Hospital of Hebei North University in China from September 2018 and September 2019. A total of 60 patients with OVCF were enrolled in the study (zoledronic acid: 20 cases; teriparatide: 20 cases; zoledronic acid + teriparatide: 20 cases). Observe and compare the changes of bone mineral density (BMD), pro-collagen type I N-terminal propeptide (PINP) and cross-linked C-terminal telopeptide of type I collagen (β-CTX) before surgery, 6 months and 1 year after surgery. At the same time, secondary fracture events and adverse reaction events were recorded during the follow-up period. Results: After normalized treatment, the bone metabolism indexes of PINP and β-CTX were improved and BMD was increased in three groups. Adverse Reactions: There was no statistical significance in the incidence of fever, gastrointestinal reactions and myalgia among the three groups (P > 0.05). The incidence of recurrent fractures in group A was higher than that in group C (P < 0.05), but there was no significant difference between group B and group C (P > 0.05). Conclusion: Zoledronic

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Harmonization of commercial assays for PINP; the way forward

Cited by 15 publications

References 81 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)

Intra-Individual Changes in Total Procollagen-Type 1 N-terminal Propeptide in a Korean Adult Population

The Clinical Effect of Zoledronic Acid Combined with Teriparatide in Perverting Recurrent Fracture of Osteoporotic Vertebral Compressive Fractures in the Elderly after Percutaneous Kyphoplasty

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