Korean J Lab Med.  2006 Jun;26(3):146-152. 10.3343/kjlm.2006.26.3.146.

Laboratory Evaluation of Bone Metabolism Index Using Elecsys 2010

• Suk JH
• Cho EH
• Lee SY
• Kim JW

• KMID: 2238879
• DOI: http://doi.org/10.3343/kjlm.2006.26.3.146

Abstract

BACKGROUND: Bone markers can provide a prognostic information about the risk of osteoporotic fracture and are useful tools for monitoring the efficacy of antiresorptive therapy. We evaluated the analytical performance of the bone markers of Elecsys 2010 (Roche Diagnostics Corp., Indianapolis, USA).
METHODS
We evaluated the analytical performance of the Elecsys 2010 for serum parathyroid hormone (PTH), osteocalcin, and serum bone-derived degradation products of type I collagen C-telopeptide (S-CTX) using control material and patients' specimens. For the comparison studies, an immunoradiometric assay was used for PTH and an ELISA for serum osteocalcin and serum bone-derived degradation products of type I collagen N-telopeptide (S-NTX). We established the reference intervals of S-CTX and serum osteocalcin by analyzing 4569 Korean healthy subjects according to sex and age.
RESULTS
Within-run and total CV of most items were below 5% except S-CTX low level (5.42%). Elecsys 2010 showed a good linearity (r> or =0.99, P<0.01). Good correlations with other methods were found in osteolcalcin (r=0.95, P<0.01) and PTH (r=0.96, P<0.01). S-CTX showed a good correlation with S-NTX (r=0.76, P<0.01). Reference intervals of serum osteocalcin (ng/mL) and S-CTX (ng/mL) were 9.58-33.62 and 0.18-0.89, respectively, in adult male, 8.00-31.46 and 0.11-0.81 in 31-50 years old female, and 8.30-43.50 and 0.11-1.00 in 51-80 years old female.
CONCLUSIONS
Elecsys 2010 bone markers showed a satisfactory precision, linearity, and a good correlation with other methods. With its 'one system-many capabilities' features, Elecsys 2010 would be a useful tool for measuring bone metabolism indices.

Keyword

Elecsys 2010; Automated chemistry analyzer; Evaluation; Bone markers

MeSH Terms

Adult
Collagen Type I
Enzyme-Linked Immunosorbent Assay
Female
Humans
Immunoradiometric Assay
Male
Metabolism*
Osteocalcin
Osteoporotic Fractures
Parathyroid Hormone
Collagen Type I
Osteocalcin
Parathyroid Hormone

Figure

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  Fig. 1. Linearity of osteocalcin, S-CTX, and PTH analysed by elecsys 2010.

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  Fig. 2. The correlation of N-MID osteocalcin by elecsys 2010 and metra osteocalcin by ELISA (n=40).

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  Fig. 3. The correlation of PTH by elecsys 2010 and PTH-IRMA by immunoradiometric assay (n=40).

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  Fig. 4. The correlation of S-NTX by ELISA and S-CTX by elecsys 2010 (n=58). *Nanomoles bone collagen equivalents.

Reference

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