children; immunoassay; immunodiagnostic systems (ids); procollagen-I N-terminus propeptide (pinp); reference interval; reference range
Abstract :
[en] 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.
Disciplines :
Laboratory medicine & medical technology
Author, co-author :
Morovat, Alireza
Catchpole, Anthony
MEURISSE, Angélique ; Centre Hospitalier Universitaire de Liège - CHU > Chimie médicale
CARLISI, Ignazia ; Centre Hospitalier Universitaire de Liège - CHU > Chimie médicale
Funck-Brentano T, Biver E, Chopin F, Bouvard B, Coiffier G, Souberbielle JC, et al. Clinical utility of serum bone turnover markers in postmenopausal osteoporosis therapy monitoring: a systematic review. Semin Arthritis Rheum 2011;41: 157-69.
Vasikaran S, Cooper C, Eastell R, Griesmacher A, Morris HA, Trenti T, et al. International Osteoporosis Foundation and International Federation of Clinical Chemistry and Laboratory Medicine position on bone marker standards in osteoporosis. Clin Chem Lab Med 2011;49: 1271-4.
Risteli J, Risteli I. Products of bone collagen metabolism. In: Seibel MJ, Robes SP, Bilizikian RJ, editors. Dynamics of bone and cartilage metabolism: principles and clinical applications, 2nd ed., chapter 23. San Diego, USA: Academic Press, 2006: 391-405.
Koivula MK, Ruotsalainen V, Bjorkman M, Nurmenniemi S, Ikaheimo R, Savolainen K, et al. Difference between total and intact assays for N-terminal propetide of type 1 procollagen reflects degradation of pN-collagen rather than denaturation of intact propeptide. Ann Clin Biochem 2010;47: 67-71.
Garnero P, Vergnaud P, Hoyle N. Evaluation of a fully automated serum assay for total N-terminal propeptide of type 1 collagen in post menopausal osteoporosis. Clin Chem 2008;54: 188-96. (Pubitemid 351182613)
Koivula M-K, Richardson J, Leino A, Valleala H, Griffiths K, Barnes A, et al. Validation of an automated intact N-terminal propeptide of type I procollagen (PINP) assay. Clin Biochem 2010;18: 1453-7.
Cluse ZN, Fudge AN, Whiting MJ, McWhinney B, Parkinson I, O'Loughlin PD. Evaluation of 25-hydroxy vitamin D assay on immunodiagnostic systems iSYS analyser. Ann Clin Biochem 2012;49: 159-65.
Passing H, Bablok W. A new biometrical procedure for testing the equality of measurements from two different analytical methods. Application of linear regression procedures for method comparison studies in clinical chemistry, Part I. J Clin Chem Clin Biochem 1983;21: 709-20. (Pubitemid 14208512)
Lomeo A, Bolner A. Stability of several biochemical markers of bone metabolism. Clin Chem 2000;46: 1200-2. (Pubitemid 30643330)
Brandt J, Krogh TN, Jensen CH, Frederiksen JK, Teisner B. Thermal instability of the trimeric structure of the N-terminal propeptide of human procollagen type I in relation to assay technology. Clin Chem 1999;45: 47-53. (Pubitemid 29036384)
Melkko J, Kauppila S, Niema S, Risteli L, Haukipuro K, Jukkola A, et al. Immunoassay of intact amino-terminal propeptide of human type 1 procollagen. Clin Chem 1996;42: 947-54.
Marin L, Koivula M-K, Jukkola-Vuorinen A, Leino A, Risteli J. Comparison of total and intact aminoterminal propeptide of type I procollagen assays in patients with breast cancer with or without bone metastases. Ann Clin Biochem 2011;48: 447-51.
Jukkola A, Tähtelä, R, Thölix E, Vuorinen K, Blanco G, Risteli L, et al. Aggressive breast cancer leads to discrepant serum levels of the type I procollagen propeptides PINP and PICP. Cancer Res 1997;57: 5517-20. (Pubitemid 28006758)
Pollmann D, Siepmann S, Geppert R, Wernecke K-D, Possinger K, Lüftner D. The amino-terminal propeptide (PINP) of type I collagen is a clinically valid indicator of bone turnover and extent of metastatic spread in osseous metastatic breast cancer. Anticancer Res 2007;27: 1853-62. (Pubitemid 46954687)
Martínez J, Olmos JM, Hernández JL, Pinedo G, Llorca J, Obregón E, et al. Bone turnover markers in Spanish postmenopausal women. The Camargo cohort study. Clin Chim Acta 2009;409: 70-4.
Olmos JM, Hernández JL, Martínez J, Pariente E, Llorca J, González-Macías J. Bone turnover markers in Spanish adult men. The Camargo Cohort Study. Clin Chim Acta 2010;411: 1511-5.
Adami S, Bianchi G, Brandi ML, Giannini S, Ortolani S, DiMunno O, et al. Determinants of bone turnover markers in healthy premenopausal women. Calcif Tissue Int 2008;82: 341-7.
Glover SJ, Garneo P, Naylor K, Rogers A, Eastell R. Establishing a reference range for bone turnover markers in young, healthy women. Bone 2008;42: 623-30.
Pi YZ, Wu XP, Liu SP, Luo XH, Cao XZ, Xie H, et al. Age-related changes in bone biochemical markers and their relationship with bone mineral density in normal Chinese women. J Bone Miner Metab 2006;24: 380-5. (Pubitemid 44306174)
Glover S, Gall M, Schoenborn-Kellenberger O, Wagener M, Garnero P, Boonen S, et al. Establishing a reference interval for bone turnover markers in 637 healthy, young, premenopausal women from the United Kingdom, France, Belgium, and the United States. J Bone Min Res 2009;24: 389-97.
Sharp CA, Evans SF, Risteli L, Risteli J, Worsfold M, Davie MW. Effects of low- and conventional-dose transcutaneous HRT over 2 years on bone metabolism in younger and older postmenopausal women. Eur J Clin Invest 1996;26: 763-71. (Pubitemid 26308648)
Peris P, Alvarez L, Monegal A, Guañabens N, Durán M, Pons F, et al. Biochemical markers of bone turnover after surgical menopause and hormone replacement therapy. Bone 1999;25: 349-53. (Pubitemid 29406061)
de Papp AE, Bone HG, Caulfield MP, Kagan R, Buinewicz A, Chen E, et al. A cross-sectional study of bone turnover markers in healthy premenopausal women. Bone 2007;40: 1222-30. (Pubitemid 46550988)
Recker R, Lappe J, Davies KM, Heaney R. Bone remodeling increases substantially in the years after menopause and remains increased in older osteoporosis patients. J Bone Miner Res 2004;19: 1628-33. (Pubitemid 41094325)
Leder BZ, LeBlanc KM, Schoenfeld DA, Eastell R, Finkelstein JS. Differential effects of androgens and estrogens on bone turnover in normal men. J Clin Endocrinol Metab 2003;88: 204-10. (Pubitemid 36115166)
Szulc P, Claustrat B, Marchand F, Delmas PD. Increased risk of falls and increased bone resorption in elderly men with partial androgen deficiency: the MINOS study. J Clin Endocrinol Metab 2003;88: 5240-7. (Pubitemid 37452722)
Välimäki VV, Alfthan H, Ivaska KK, Löyttyniemi E, Pettersson K, Stenman UH, et al. Serum estradiol, testosterone, and sex hormone-binding globulin as regulators of peak bone mass and bone turnover rate in young Finnish men. J Clin Endocrinol Metab 2004;89: 3785-9. (Pubitemid 39071472)
Crofton PM, Evans M, Taylo MR, Holland CV. Procollagen type I amino-terminal propeptide: pediatric reference data and relationship with procollagen type I carboxy-terminal propeptide. Clin Chem 2004;50: 2173-6. (Pubitemid 39425865)
Rauchenzauner M, Schmid A, Heinz-Erian P, Kapelari K, Falkensammer G, Griesmacher A, et al. Sex- and age-specific reference curves for serum markers of bone turnover in healthy children from 2 months to 18 years. J Clin Endocrinol Metab 2007;92:443-9.