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Parathormone stability in hemodialyzed patients and healthy subjects: comparison on non-centrifuged EDTA and serum samples with second- and third-generation assays

Parathormone stability in hemodialyzed patients and healthy subjects: comparison on... AbstractBackground:Parathyroid hormone (PTH) stability is important. Many studies have shown divergent results between EDTA and serum, which are mainly linked to differences in protocols or cut-offs used to determine whether or not PTH remained stable. No studies have yet compared PTH stability as measured by second- and third-generation assays on the same samples in hemodialyzed patients and healthy subjects.Methods:Five pairs of samples (EDTA and gel tubes) were obtained in 10 hemodialyzed patients before a dialysis session and in 10 healthy subjects. One pair was centrifuged and run directly to define the “T0”. Two pairs were kept at +4°C and two pairs were kept at +25°C. They were centrifuged after 4 and 18 h. Supernatant was kept at –80°C for 1 week. All samples were measured in a single batch, on Roche Cobas and DiaSorin XL second- and third-generation PTH assays. We used three different approaches to evaluate PTH stability: Wilcoxon test, an Acceptable Change Limit (ACL) according to ISO Guide 5725-6 and a Total Change Limit (TCL) derived from the sum of biological and technical variability according to WHO.Results:PTH decreased in all samples. Stability of PTH was mainly dependent on the way it was evaluated. Percentages of decrease were systematically lower in EDTA vs. serum. Wilcoxon and ACL showed that PTH was no more stable after 4 h at +4°C in EDTA or serum gel tubes. None of the subjects presented a PTH decrease higher than the TCL with EDTA plasma. In serum gel tubes, PTH was unstable only when kept at 25°C for 18 h.Conclusions:PTH seems more stable in EDTA than in serum gel tubes but only when samples have to stay unprocessed for a long period (18 h) at room temperature (25°C), which can happen when samples are delivered from external care centers. For all the other conditions, using serum gel tubes is recommended since calcium measurement, which is necessary for a good PTH results interpretation, can be achieved on the same tube. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Clinical Chemistry and Laboratory Medicine (CCLM) de Gruyter

Parathormone stability in hemodialyzed patients and healthy subjects: comparison on non-centrifuged EDTA and serum samples with second- and third-generation assays

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Publisher
de Gruyter
Copyright
©2017 Walter de Gruyter GmbH, Berlin/Boston
ISSN
1437-4331
eISSN
1437-4331
DOI
10.1515/cclm-2016-0914
pmid
28099122
Publisher site
See Article on Publisher Site

Abstract

AbstractBackground:Parathyroid hormone (PTH) stability is important. Many studies have shown divergent results between EDTA and serum, which are mainly linked to differences in protocols or cut-offs used to determine whether or not PTH remained stable. No studies have yet compared PTH stability as measured by second- and third-generation assays on the same samples in hemodialyzed patients and healthy subjects.Methods:Five pairs of samples (EDTA and gel tubes) were obtained in 10 hemodialyzed patients before a dialysis session and in 10 healthy subjects. One pair was centrifuged and run directly to define the “T0”. Two pairs were kept at +4°C and two pairs were kept at +25°C. They were centrifuged after 4 and 18 h. Supernatant was kept at –80°C for 1 week. All samples were measured in a single batch, on Roche Cobas and DiaSorin XL second- and third-generation PTH assays. We used three different approaches to evaluate PTH stability: Wilcoxon test, an Acceptable Change Limit (ACL) according to ISO Guide 5725-6 and a Total Change Limit (TCL) derived from the sum of biological and technical variability according to WHO.Results:PTH decreased in all samples. Stability of PTH was mainly dependent on the way it was evaluated. Percentages of decrease were systematically lower in EDTA vs. serum. Wilcoxon and ACL showed that PTH was no more stable after 4 h at +4°C in EDTA or serum gel tubes. None of the subjects presented a PTH decrease higher than the TCL with EDTA plasma. In serum gel tubes, PTH was unstable only when kept at 25°C for 18 h.Conclusions:PTH seems more stable in EDTA than in serum gel tubes but only when samples have to stay unprocessed for a long period (18 h) at room temperature (25°C), which can happen when samples are delivered from external care centers. For all the other conditions, using serum gel tubes is recommended since calcium measurement, which is necessary for a good PTH results interpretation, can be achieved on the same tube.

Journal

Clinical Chemistry and Laboratory Medicine (CCLM) – de Gruyter

Published: Jul 26, 2017

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  • Delayed measurement of PTH in patients with CKD: storage of the primary tube in the dialysis unit, which temperature? Which kind of tube?
  • Considerations in parathyroid hormone testing
  • Thrombin-mediated degradation of parathyroid hormone in serum tubes
  • Variability of parathyroid hormone and other markers of bone mineral metabolism in patients receiving hemodialysis
  • Effect of anticoagulants and storage temperatures on stability of plasma and serum hormones
  • Stability of analytes related to clinical chemistry and bone metabolism in blood specimens after delayed processing
  • Performance and diagnostic application of a two-site immunoradiometric assay for parathyrin in serum