title: New automated multiplex assay for bone turnover markers in osteoporosis.
abstract: BACKGROUND
  Serum C-terminal cross-linked telopeptide of type I collagen (CTX-I), N-terminal propeptide of type I collagen (PINP), and osteocalcin (OC) are among the most sensitive bone turnover markers for evaluating osteoporosis. Each marker is currently measured individually by manual or automated immunoassays that are time consuming and require substantial sample volume. We evaluated the performance characteristics of a novel, fully automated, protein-array chip system that allows the simultaneous measurement of CTX-I, PINP, OC, and intact parathyroid hormone (PTH) in 20 microL of serum.
  
  
  METHODS
  We measured CTX-I, PINP, OC, and PTH using multiplex and corresponding automated single assays in 157 healthy premenopausal women, 74 healthy men, and 56 postmenopausal osteoporotic women before and 6 months after treatment with oral ibandronate (150 mg/month).
  
  
  RESULTS
  Within- and between-run CVs of the multiplex assay were similar to those of single measurement assays (<10% for all markers), whereas the limit of quantification was lower, except for OC. Multiplex values highly correlated (r > 0.93, P < 0.0001 for all markers) with the corresponding single assays, and measured concentrations were comparable. After 6 months of ibandronate, CTX-I, PINP, and OC decreased by a median of 48%, 63%, and 52%, respectively (P < 0.0001 for all 3 markers), magnitudes similar to those of the corresponding single assays.
  
  
  CONCLUSIONS
  The automated protein-array chip demonstrated similar analytical precision, improved analytical sensitivity, and comparable measured concentrations to those of single assays. The multiplex assay should be useful for assessing bone metabolism in large clinical studies, particularly when sample volume is limited.
authors.affiliation: CCBR-SYNARC, Biochemical Markers, Lyon, France.
authors.forename: Aurélie
authors.initials: A
authors.lastname: Claudon
authors.forename: Philippe
authors.initials: P
authors.lastname: Vergnaud
authors.forename: Cécile
authors.initials: C
authors.lastname: Valverde
authors.forename: Anita
authors.initials: A
authors.lastname: Mayr
authors.forename: Ursula
authors.initials: U
authors.lastname: Klause
authors.forename: Patrick
authors.initials: P
authors.lastname: Garnero
mesh_terms: D000328:Adult; D015415:Biomarkers / Q000097:blood; D004164:Diphosphonates / Q000097:blood; D005260:Female; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D008297:Male; D008593:Menopause / Q000097:blood; D008875:Middle Aged; D010024:Osteoporosis / Q000378:metabolism*; D012680:Sensitivity and Specificity
chemical_list: D015415:Biomarkers; D004164:Diphosphonates