Standardization of DiaSorin and Roche automated third generation PTH assays with an International Standard: impact on clinical populations
-
Etienne Cavalier
,
Pierre Delanaye
Abstract
Background: Standardization of parathyroid hormone (PTH) assays is a major issue, especially in hemodialyzed (HD) patients. Two automated third generation PTH assays (Roche Elecsys and DiaSorin Liaison) are now available. These assays are specific for the (1-84) PTH and do not cross-react with the (7-84) fragment, contrary to second generation (intact) assays. We aimed to calibrate the two methods against the WHO International PTH Standard (IS) 95/646 to see if the two assays could provide comparable results in a population of healthy subjects, HD patients and patients suffering from primary hyperparathyroidism (PHP).
Methods: We selected 79 healthy subjects and two populations of patients presenting PTH disorders: 56 HD and 27 PHP patients. We reconstituted the IS in a pool of human serum containing undetectable levels of 1-84 PTH and prepared 13 serum standards ranging from 0 to 2000 pg/mL. The standards were run on the two instruments to calibrate the assays on the IS. The different populations were run before and after restandardization.
Results: As these kits were differently calibrated, the results obtained after restandarization were significantly different. Restandardization process improved concordance between assays and, taking the analytical variability of the two kits into account, the results could be considered to be similar.
Conclusions: Restandardization of automated third generation PTH assays with the WHO 1-84 PTH Standard significantly reduces inter-method variability. Reference ranges and raw values are totally transposable from one method to the other in healthy subjects, but also in diseased patients, e.g., with HD or those suffering from PHP.
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©2014 by Walter de Gruyter Berlin/Boston
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Artikel in diesem Heft
- Frontmatter
- Editorial
- Colorectal cancer and screening programs: not only analytical issues
- Reviews
- Laboratory diagnostics of inherited platelet disorders
- Reticulated platelets: analytical aspects and clinical utility
- Genetics and Molecular Diagnostics
- Advanced tools for BRCA1/2 mutational screening: comparison between two methods for large genomic rearrangements (LGRs) detection
- General Clinical Chemistry and Laboratory Medicine
- Establishing, harmonizing and analyzing critical values in a large academic health center
- Standardization of DiaSorin and Roche automated third generation PTH assays with an International Standard: impact on clinical populations
- First fully automated immunoassay for anti-Müllerian hormone
- A multicenter evaluation of dysthyroxinemia in a defined patient cohort
- New biomarkers in diagnosis of early onset preeclampsia and imminent delivery prognosis
- Soluble Fms-like tyrosine kinase-1 to placental growth factor ratio in mid-pregnancy as a predictor of preterm preeclampsia in asymptomatic pregnant women
- Development of a new immunoassay for the detection of ethyl glucuronide (EtG) in meconium: validation with authentic specimens analyzed using LC-MS/MS. Preliminary results
- Optimizing centrifugation of coagulation samples in laboratory automation
- Evaluation of the automated coagulation analyzer CS-5100 and its utility in high throughput laboratories
- A new sampling device for faecal immunochemical testing: haemoglobin stability is still an open issue
- Reference Values
- Faecal haemoglobin concentrations vary with sex and age, but data are not transferable across geography for colorectal cancer screening
- Cancer Diagnostics
- Enhanced miR-182 transcription is a predictor of poor overall survival in colorectal adenocarcinoma patients
- Importance of promoter methylation of GATA4 and TP53 genes in endometrioid carcinoma of endometrium
- Frequent methylation of HOXA9 gene in tumor tissues and plasma samples from human hepatocellular carcinomas
- Letters to the Editor
- Further comments on “Critical review of laboratory investigations in clinical practice guidelines: proposals for the description of investigation”
- A questionnaire study among nurses: awareness of blood and urine sample collection procedures
- Measurement uncertainty and clinical interpretation of measurement results
- Laboratory automation: how will you select the boarding assays?
- Improvement and evaluation of a 1,2-dioleoylglycerol method for measuring pancreatic lipase catalytic activity in serum
- The novel variant p.Ser465Leu in the PCSK9 gene does not account for the decreased LDLR activity in members of a FH family
- 1,5 Anhydroglucitol serum concentration as a biomarker for screening gestational diabetes in early pregnancy
- A rare condition: IgE type monoclonal gammopathy of undetermined significance
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