No abstract

Using the same vitamin-D-replete population to establish the reference range for 10 commercial PTH kits significantly improved the classification of haemodialysis patients according to the KDIGO target range.

Our results show that, whatever the assay, the "true" 25(OH)D of a patient will be >80 nmol/L if its measured concentration is >100 nmol/L. In other words, if a physician considers that a normal VTD status is defined by a 25(OH)D level>or=80 nmol/L, he should ensure that the patients present a 25(OH)D >or=100 nmol/L.

Background: We carried out a technical evaluation of the Immunodiagnostic Systems (IDS) automated intact procollagen-I N-terminus propeptide (PINP) assay on the iSYS platform, and established reference intervals for PINP in both adults and children. Methods: Assay imprecision, recovery and interference were studied. Serum and plasma values were compared, and PINP stability was assessed. Using 828 specimens, IDS iSYS intact PINP and Roche E170 total PINP values were compared. Specimens from 597 adults and 485 children and adolescents were used to establish reference intervals for intact PINP. Results: The method demonstrated good recovery and acceptable imprecision. The assay was unaffected by icterus and lipaemia, but haemolysis decreased measured PINP. Serum and plasma values were comparable. There was a non-linear relation between IDS intact and Roche total PINP values. Pre-and post-menopausal women had comparable PINP values, but there was a difference between women of different age groups. Serum PINP in men showed a decline in young age up to 45 years, but remained steady thereafter. Separate reference intervals were established for four age groups in women and for two age groups in men. Data for children were partitioned into four-year age groups, and these showed PINP to be high with no major gender differences until 12 years of age. Thereafter, values in females decreased in 13-16 years age groups and further in 17-20 years age groups, whereas PINP increased in boys of 13-16 years of age with a subsequent decline at 17-20 years. Conclusions: The IDS iSYS PINP intact assay appears to be reliable. We have established gender-and age-related reference intervals for children and adults based on a relatively large healthy North European population.

The determination of intact parathyroid hormone levels is used for diagnosis and in the management of renal osteodystrophy. Pre-analytical and analytical conditions are important in the overall confidence of the assay. Unfortunately, there are no clear recommendations for the use of serum samples or samples anticoagulated with ethylenediaminotetraacetic acid (EDTA) for the best preservation of intact parathyroid hormone. In our study, the Roche Elecsys assay was used to measure intact hormone in both serum and EDTA plasmas from 16 hemodialysis patients over the span of a month. Parathyroid hormone stability was determined in samples kept frozen for 1-5 days or after 8-24 h at room temperature. There was no difference in hormone stability between serum and EDTA samples after 1 day in frozen storage. After 5 days frozen, hormone degradation was significantly greater after EDTA anticoagulation than in serum aliquots. When samples were stored at room temperature, intact parathyroid hormone was significantly more stable in EDTA-treated samples than in clotted serum samples, especially after 24 h. We conclude that optimum results are achieved in the measurement of intact parathyroid hormone levels depending on the workflow of the lab. If the lab works with intermittent batches of samples, frozen serum is the best. If the lab services general practitioners and/or several hospitals and has a continuous flow of samples, EDTA-treated samples stored at room temperature are the best.