IDS iSYS automated intact procollagen-1-N-terminus pro-peptide assay: method evaluation and reference intervals in adults and children

Abstract

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.

Age-related collagen turnover of the interstitial matrix and basement membrane: Implications of age- and sex-dependent remodeling of the extracellular matrix

“…The level of PINP was higher in young men and women compared to older subjects with a progressive decrease until the age around 50. This observation is in accordance with previous studies showing a decrease in women between age 30–35, stable level from age 35–45 followed by an increase until the age of 65 [ 35 , 37 ]. In men, a significant decrease with age has also been observed [ 37 ].…”

Bone turnover markers in serum and urine as diagnostic, prognostic and monitoring biomarkers of bone metastasis

“…Determinations of the intact, trimeric PINP and the total PINP in the sum of intact and monomeric PINP can, in the meantime, be performed on laboratory analyzers (Table 1). With a few exceptions, such as patients with kidney insufficiency due to a decreased clearance of the monomeric PINP form [39], the results of total PINP and intact PINP are well comparable [37,40]. However, differences under various clinical conditions have to be considered [35].…”

Effects of cholecalciferol supplementation and optimized calcium intakes on vitamin D status, muscle strength and bone health: A one-year pilot randomized controlled trial in adults with severe burns

“…CTX concentration <695 ng/l and b-ALP concentration <21 mg/l were considered normal. Normal range for P1NP was 7.5-95.4 ng/ml with changes according to age and sex [18]. Serum tartrateresistant acid phosphatase 5b (TRAP) was measured using ELISA (IDS, Boldon, UK): NR was 1.5-4.7 U/l.…”