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Analytical verification and method comparison of the ADVIA Centaur® Intact Parathyroid Hormone assay
Esther Fernández-Galán1, Josep Lluís Bedini1, Xavier Filella1
1Department of Biochemistry and Molecular Genetics & Core Lab (CDB), Hospital Clínic, IDIBAPS, Barcelona, Catalonia, Spain.
Insights
The new Siemens ADVIA Centaur® Intact Parathyroid Hormone (iPTHm) assay shows excellent analytical performance and clinical agreement with the older iPTH assay. This validated iPTHm assay is suitable for replacing the existing method, ensuring reliable parathyroid hormone measurements.
Area of Science:
- Clinical Chemistry
- Immunoassay Development
- Endocrinology
Background:
- Intact parathyroid hormone (iPTH) levels are crucial for diagnosing and managing mineral and bone disorders.
- Existing iPTH assays may have limitations, necessitating the development and validation of novel methods.
- The Siemens ADVIA Centaur® platform is widely used for various immunoassays.
Purpose of the Study:
- To verify the analytical performance of the novel iPTH Siemens ADVIA Centaur® Intact Parathyroid Hormone (iPTHm) chemiluminescence immunoassay.
- To compare iPTH results from the iPTHm assay with the previous ADVIA Centaur® Parathyroid Hormone assay (iPTHp).
- To assess the clinical concordance and sample stability of the iPTHm assay.
Main Methods:
- Analytical performance was evaluated, including limit of detection (LoD), limit of quantitation (LoQ), reproducibility, and linearity.
- A comparative study involved 369 routine plasma samples, analyzed across different glomerular filtration rate (GFR) categories and in hemodialysis patients.
- Clinical concordance was assessed using the Kappa Index, and parathyroid hormone (PTH) stability was studied at 4°C.
Main Results:
- The iPTHm assay demonstrated LoD of 0.03 pmol/L and LoQ of 0.10 pmol/L, with intra- and inter-assay coefficients of variation (CV) between 2.3% and 6.2%.
- Excellent correlation (r=0.99) and low bias (-2.55%) were observed between iPTHm and iPTHp assays.
- High clinical concordance (Kappa Index = 0.874) was achieved, and PTH stability was confirmed for up to 14 days at 4°C.
Conclusions:
- The novel iPTHm assay exhibits acceptable analytical performance and strong clinical agreement with the established iPTHp assay.
- The iPTHm assay is a reliable replacement for the iPTHp assay in the laboratory setting.
- Plasma sample stability for PTH measurements is maintained for at least 14 days at 4°C using the iPTHm assay.
Objectives:
This study is the first verification of the novel iPTH Siemens ADVIA Centaur® Intact Parathyroid Hormone (iPTHm) chemiluminescence immunoassay based on monoclonal antibodies. We also compared the iPTH results obtained using this assay with the previous ADVIA Centaur® Parathyroid Hormone assay (iPTHp) based on polyclonal antibodies.
Design And Methods:
The analytical performance study of iPTHm assay included LoD, LoQ, intra- and inter-assay reproducibility, and linearity. A comparison study was performed on 369 routine plasma samples. The results were analyzed independently for patients with normal and abnormal GFR, as well as patients on hemodialysis. In addition, clinical concordance between assays was assessed. Finally, we studied PTH stability of plasma samples at 4°C.
Results:
For the iPTHm assay LoD and LoQ were 0.03pmol/L and 0.10pmol/L, respectively. Intra- and inter-assay CV were between 2.3% and 6.2%. Linearity was correct in the range from 3.82 to 203.08pmol/L. Correlation studies showed a good correlation (r=0.99) between iPTHm and iPTHp, with bias of -2.55% (IC -3.48% to -1.62%) in the range from 0.32 to 117.07pmol/L. Clinical concordance, assessed by Kappa Index, was 0.874. The stability study showed that differences compared to basal iPTH concentration did not exceed 20% in any of the samples analyzed.
Conclusions:
The iPTHm assay demonstrated acceptable performance and a very good clinical concordance with iPTHp assay, currently used in our laboratory. Thus, the novel iPTHm assay can replace the previous iPTHp assay, since results provided by both assays are very similar. In our study, the stability of iPTH is not affected by storage up to 14days.
