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.
Subject(s)
Adult , Female , Humans , Male , Collagen Type I , Enzyme-Linked Immunosorbent Assay , Immunoradiometric Assay , Metabolism , Osteocalcin , Osteoporotic Fractures , Parathyroid HormoneABSTRACT
BACKGROUND: These days the Hepatitis B virus (HBV) DNA quantitation is the common tool for defining the viral replication state and antiviral therapeutic effect. However, it has a slow turn around time due to a labour intensive complex procedure. The HBeAg assay is a simple, rapid test, but it gives only qualitative information. However, Elecsys 2010 immunoanalyzer (Roche Diag-nostics GmbH, Germany) gives not only qualitative information but also semiquantitative information. So, we want to know about the clinical utility of HBeAg semiquantitation on Elecsys 2010. METHODS: HBeAg and HBV DNA were measured serially for 18 months by Elecsys 2010 and the Hybrid Capture System (HCS; Digene Corporation, Gaithersburg, USA) respectively to evaluate their general correlations (n=287) and serial-changing patterns after lamivudine treatment (n=30, 12-18 months) in 41 patients positive for HBeAg and HBV DNA. RESULTS: Positive correlation was found between the semiquantitative results of HBeAg and the quantitative results of HBV DNA (R=0.56, P<0.05). At two and five months after lamivudine treatment, significant differences (P<0.05) between HBV DNA disappearance groups (group 2, 3) and the HBV DNA remnant group (group 4) were found in the HBeAg level and a decreasing rate. The serial HBeAg and HBV DNA level and the decreasing rate showed a similar pattern in the HBV DNA disappearance groups (group 2, 3). However, a markedly delayed decreasing pattern in the HBeAg level was observed in the HBV DNA remnant group, when compared with HBV DNA. CONCLUSIONS: HBeAg semiquantitation using Elecsys 2010 would provide a cost effective, fast and valuable, and supplementary monitoring tool when the result might be reported in quantity in a dynamic range, because HBeAg semiquantitation could provide an outline of the HBV replication state HBeAg positive patients and a therapeutic predictive value in HBeAg positive, lamivudine treated patients.