Moving from the second to the third generation Roche PTH assays: what are the consequences for clinical practice?
-
Anne Marie Dupuy
Abstract
Background
The determination of parathyroid hormone (PTH) is essential for exploring phosphocalcic disorders especially in patients with renal failure. At present, second or third generation PTH assays are available on the market from Roche Diagnostics as well as from others companies but the lack of standardization has complicated the interpretation.
Methods
We wanted to assess the clinical impact by measuring the PTH levels with the two generations concomitantly on different groups of populations including 46 healthy, 103 pre-dialyzed and 73 hemodialyzed (HD) patients.
Results
In healthy subjects, the PTH concentrations were not different whatever the generation used, whereas beyond 200 pg/mL, we reported an overestimation of the second generation PTH. In patients with chronic kidney disease (CKD) stage 3–5 the observed differences between the two generations increase with increasing PTH levels and decreasing glomerular filtration rate (GFR). Classification according to the kidney disease: improving global outcomes (KDIGO) revealed a high percentage of discordant results between the two generations (κ coefficient <0.20). These discrepancies are clinically relevant as PTH levels remain the cornerstone for diagnosis and treatment of the CKD-mineral and bone disorder (CKD-MBD).
Conclusions
The introduction of a new PTH assay generation in clinical practice should be carried out with caution.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: None declared.
Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
References
1. Sturgeon CM, Sprague S, Almond A, Cavalier E, Fraser WD, Algeciras-Schimnich A, et al. IFCC Working Group for PTH. Perspective and priorities for improvement of parathyroid hormone (PTH) measurement – a view from the IFCC Working Group for PTH. Clin Chim Acta 2017;467:42–7.10.1016/j.cca.2016.10.016Search in Google Scholar PubMed PubMed Central
2. Hecking M, Kainz A, Bielesz B, Plischke M, Beilhack G, Hörl WH, et al. Clinical evaluation of two novel biointact PTH(1-84) assays in hemodialysis patients. Clin Biochem 2012;45:1645–51.10.1016/j.clinbiochem.2012.08.006Search in Google Scholar PubMed
3. Gannagé-Yared MH, Farès C, Ibrahim T, Rahal ZA, Elias M, Chelala D. Comparison between a second and a third generation parathyroid hormone assay in hemodialysis patients. Metabolism 2013;62:1416–22.10.1016/j.metabol.2013.05.007Search in Google Scholar PubMed
4. O’Flaherty D, Sankaralingam A, Scully P, Manghat P, Goldsmith D, Hampson G. The relationship between intact PTH and biointact PTH (1-84) with bone and mineral metabolism in pre-dialysis chronic kidney disease (CKD). Clin Biochem 2013;46:1405–9.10.1016/j.clinbiochem.2013.06.023Search in Google Scholar PubMed
5. Tan K, Ong L, Sethi SK, Saw S. Comparison of the Elecsys PTH(1-84) assay with four contemporary second generation intact PTH assays and association with other biomarkers in chronic kidney disease patients. Clin Biochem 2013;46:781–6.10.1016/j.clinbiochem.2013.01.016Search in Google Scholar PubMed
6. Cavalier E, Betea D, Schleck ML, Gadisseur R, Vroonen L, Delanaye P, et al. The third/second generation PTH assay ratio as a marker for parathyroid carcinoma: evaluation using an automated platform. J Clin Endocrinol Metab 2014;99:E453–7.10.1210/jc.2013-3730Search in Google Scholar PubMed
7. Cavalier E, Delanaye P, Lukas P, Carlisi A, Gadisseur R, Souberbielle JC. Standardization of DiaSorin and Roche automated third generation PTH assays with an International Standard: impact on clinical populations. Clin Chem Lab Med 2014;52:1137–41.10.1515/cclm-2013-1027Search in Google Scholar PubMed
8. Bonanséa TC, Ohe MN, Brandão C, Ferrer CF, Santos LM, Lazaretti-Castro M, et al. Experience with a third-generation parathyroid hormone assay (BIO-PTH) in the diagnosis of primary hyperparathyroidism in a Brazilian population. Arch Endocrinol Metab 2016;60:420–5.10.1590/2359-3997000000183Search in Google Scholar PubMed
9. Einbinder Y, Benchetrit S, Golan E, Zitman-Gal T. Comparison of intact PTH and bio-intact PTH assays among non-dialysis dependent chronic kidney disease patients. Ann Lab Med 2017;37:381–7.10.3343/alm.2017.37.5.381Search in Google Scholar PubMed PubMed Central
10. Cavalier E, Salsé M, Dupuy AM, Bargnoux AS, Watar F, Souberbielle JC, et al. Establishment of reference values in a healthy population and interpretation of serum PTH concentrations in hemodialyzed patients according to the KDIGO Guidelines using the Lumipulse® G whole PTH (3rd generation) assay. Clin Biochem 2018;54:119–22.10.1016/j.clinbiochem.2018.02.019Search in Google Scholar PubMed
11. Bland JM, Altman DG. Measuring agreement in method comparison studies. Stat Methods Med Res 1999;8:135–60.10.1177/096228029900800204Search in Google Scholar
12. London G, Coyne D, Hruska K, Malluche HH, Martin KJ. The new kidney disease: improving global outcomes (KDIGO) guidelines – expert clinical focus on bone and vascular calcification. Clin Nephrol 2010;74:423–32.Search in Google Scholar
13. Moe SM, Drüeke TB, Block GA, Cannata-Andía JB, Elder GJ, Fukagawa M, et al. KDIGO clinical practice guideline for the diagnosis, evaluation, prevention and treatment of chronic kidney disease mineral and bone disorder (CKD-MBD). Kidney Int 2009;76:S1–28.Search in Google Scholar
14. Guggenmoos-Holzman I. The meaning of kappa: probabilistic concepts of reliability and validity revisited. J Clin Epidemiol 1996;49:775–82.10.1016/0895-4356(96)00011-XSearch in Google Scholar
15. KDIGO 2017 Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD). Kidney International Supplements 2017;7:1–59.10.1016/j.kisu.2017.04.001Search in Google Scholar PubMed PubMed Central
16. Gardham C, Stevens PE, Delaney MP, LeRoux M, Coleman A, Lamb EJ. Variability of parathyroid hormone and other markers of bone mineral metabolism in patients receiving hemodialysis. Clin J Am Soc Nephrol 2010;5:1261–7.10.2215/CJN.09471209Search in Google Scholar PubMed PubMed Central
©2019 Walter de Gruyter GmbH, Berlin/Boston
Articles in the same Issue
- Frontmatter
- Obituary
- Jillian Russyll (AKA Jill) Tate
- Editorial
- The long way to standardization of practices: HbA1c as archetypal example
- Reviews
- Secretory tumors of the pituitary gland: a clinical biochemistry perspective
- Thalassemia in the laboratory: pearls, pitfalls, and promises
- Opinion Paper
- Diagnostic biomarkers of muscle injury and exertional rhabdomyolysis
- General Clinical Chemistry and Laboratory Medicine
- Patient’s knowledge and awareness about the effect of the over-the-counter (OTC) drugs and dietary supplements on laboratory test results: a survey in 18 European countries
- National surveys on 15 quality indicators for the total testing process in clinical laboratories of China from 2015 to 2017
- Urinary albumin strip assay as a screening test to replace quantitative technology in certain conditions
- Cerebrospinal fluid free kappa light chains and kappa index perform equal to oligoclonal bands in the diagnosis of multiple sclerosis
- Different immunoreactivity of monomers and dimers makes automated free light chains assays not equivalent
- The utility of saliva testing in the estimation of uremic toxin levels in serum
- Determination of cannabinoids in oral fluid and urine of “light cannabis” consumers: a pilot study
- Moving from the second to the third generation Roche PTH assays: what are the consequences for clinical practice?
- Baseline hepcidin measurement in the differential diagnosis of anaemia for elderly patients and its correlation with the increment of transferrin saturation following an oral iron absorption test
- Reference Values and Biological Variations
- A multicenter study for the evaluation of the reference interval for TSH in Italy (ELAS TSH Italian Study)
- Cancer Diagnostics
- Urinary measurement of circulating tumor DNA for treatment monitoring and prognosis of metastatic colorectal cancer patients
- BCL2L12: a multiply spliced gene with independent prognostic significance in breast cancer
- Diabetes
- The global impact of the International Federation of Clinical Chemistry and Laboratory Medicine, Education and Management Division: engaging stakeholders and assessing HbA1c quality in a multicentre study across China
- The frequency of testing for glycated haemoglobin, HbA1c, is linked to the probability of achieving target levels in patients with suboptimally controlled diabetes mellitus
- Letters to the Editor
- Response to article by Caponi et al. about serum free light chains
- Response to Letter to the Editor about immunochemical measurement of urine free light chains
- Estimated GFR-specific 99th percentiles for high-sensitive cardiac troponin T based on the adjusted analytical change limit (adjACL) in hospitalized patients
- Perioperative heart-type fatty acid binding protein concentration cutoffs for the identification of severe acute kidney injury in patients undergoing cardiac surgery
- A peculiar reaction curve with dual spikes in absorbance during a total bilirubin assay in spite of accurate results induced by high M-protein concentration
- Extremely low high-density-lipoprotein cholesterol due to an unusual non-inherited cause: a case report
- A single-center performance evaluation of the fully automated iFlash anti-Müllerian hormone immunoassay
- Genetic polymorphisms and variants in the LDL receptor associated with familial hypercholesterolemia: cascade screening and identification of the variants 666C>A, 862G>A, 901G>A, and 919G>A of a Brazilian family
- Undetected paraganglioma by functional imaging techniques: case report
- A particular case of AML patient with the polymorphism G105G (rs11554137) and the missense mutation R132C in IDH1 gene
- Atypical “hairy cell-like” presentation of leukemic mantle cell lymphoma
- Evaluation of a rapid centrifugation step (4500 g for 2 min) in coagulation assays to monitor direct oral anticoagulants
Articles in the same Issue
- Frontmatter
- Obituary
- Jillian Russyll (AKA Jill) Tate
- Editorial
- The long way to standardization of practices: HbA1c as archetypal example
- Reviews
- Secretory tumors of the pituitary gland: a clinical biochemistry perspective
- Thalassemia in the laboratory: pearls, pitfalls, and promises
- Opinion Paper
- Diagnostic biomarkers of muscle injury and exertional rhabdomyolysis
- General Clinical Chemistry and Laboratory Medicine
- Patient’s knowledge and awareness about the effect of the over-the-counter (OTC) drugs and dietary supplements on laboratory test results: a survey in 18 European countries
- National surveys on 15 quality indicators for the total testing process in clinical laboratories of China from 2015 to 2017
- Urinary albumin strip assay as a screening test to replace quantitative technology in certain conditions
- Cerebrospinal fluid free kappa light chains and kappa index perform equal to oligoclonal bands in the diagnosis of multiple sclerosis
- Different immunoreactivity of monomers and dimers makes automated free light chains assays not equivalent
- The utility of saliva testing in the estimation of uremic toxin levels in serum
- Determination of cannabinoids in oral fluid and urine of “light cannabis” consumers: a pilot study
- Moving from the second to the third generation Roche PTH assays: what are the consequences for clinical practice?
- Baseline hepcidin measurement in the differential diagnosis of anaemia for elderly patients and its correlation with the increment of transferrin saturation following an oral iron absorption test
- Reference Values and Biological Variations
- A multicenter study for the evaluation of the reference interval for TSH in Italy (ELAS TSH Italian Study)
- Cancer Diagnostics
- Urinary measurement of circulating tumor DNA for treatment monitoring and prognosis of metastatic colorectal cancer patients
- BCL2L12: a multiply spliced gene with independent prognostic significance in breast cancer
- Diabetes
- The global impact of the International Federation of Clinical Chemistry and Laboratory Medicine, Education and Management Division: engaging stakeholders and assessing HbA1c quality in a multicentre study across China
- The frequency of testing for glycated haemoglobin, HbA1c, is linked to the probability of achieving target levels in patients with suboptimally controlled diabetes mellitus
- Letters to the Editor
- Response to article by Caponi et al. about serum free light chains
- Response to Letter to the Editor about immunochemical measurement of urine free light chains
- Estimated GFR-specific 99th percentiles for high-sensitive cardiac troponin T based on the adjusted analytical change limit (adjACL) in hospitalized patients
- Perioperative heart-type fatty acid binding protein concentration cutoffs for the identification of severe acute kidney injury in patients undergoing cardiac surgery
- A peculiar reaction curve with dual spikes in absorbance during a total bilirubin assay in spite of accurate results induced by high M-protein concentration
- Extremely low high-density-lipoprotein cholesterol due to an unusual non-inherited cause: a case report
- A single-center performance evaluation of the fully automated iFlash anti-Müllerian hormone immunoassay
- Genetic polymorphisms and variants in the LDL receptor associated with familial hypercholesterolemia: cascade screening and identification of the variants 666C>A, 862G>A, 901G>A, and 919G>A of a Brazilian family
- Undetected paraganglioma by functional imaging techniques: case report
- A particular case of AML patient with the polymorphism G105G (rs11554137) and the missense mutation R132C in IDH1 gene
- Atypical “hairy cell-like” presentation of leukemic mantle cell lymphoma
- Evaluation of a rapid centrifugation step (4500 g for 2 min) in coagulation assays to monitor direct oral anticoagulants
