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https://hdl.handle.net/2440/73027
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Type: | Journal article |
Title: | Evaluation of 25-hydroxy vitamin D assay on the immunodiagnostic systems iSYS analyser |
Author: | Cluse, Z. Fudge, A. Whiting, M. Parkinson, I. O'Loughlin, P. |
Citation: | Annals of Clinical Biochemistry, 2012; 49(2):159-165 |
Publisher: | Royal Soc Medicine Press Ltd |
Issue Date: | 2012 |
ISSN: | 0004-5632 1758-1001 |
Statement of Responsibility: | Zee N Cluse, Andrew N Fudge, Malcolm J Whiting, Brett McWhinney, Ian Parkinson, and Peter D O’Loughlin |
Abstract: | <h4>Background</h4>We evaluated the recently released chemiluminescence assay for 25-hydroxy vitamin D (25-OHD) on the Immunodiagnostic Systems iSYS (IDS-iSYS) automated analyser.<h4>Methods</h4>The IDS-iSYS comparison was performed using patient samples previously measured for 25-OHD by a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method (n = 119) and an IDS enzyme immunoassy (IDS-EIA) method (n = 64). Limit of detection and limit of quantification were determined from a precision profile. Imprecision was assessed using quality control material and pooled serum. External QAP material (Vitamin D External Quality Assessment Scheme, UK) was analysed to establish inaccuracy. Linearity was assessed by two dilution studies. Cross-reactivity was determined by three serial dilution studies of patient samples with known 25-OHD(2) concentrations.<h4>Results</h4>The IDS-iSYS correlated well with both established methods (iSYS = 1.03LC-MS/MS - 6.53, R(2) = 0.82 and iSYS = 1.07IDS-EIA - 1.61, R(2) = 0.86). Imprecision of the iSYS assay for IDS control material was 13.4% at 32 nmol/L, 10% at 78 nmol/L, 9.4% at 161 nmol/L, and for the pooled material 9.3% at 72 nmol/L and 5.6% at 158 nmol/L. The evaluation found the assay to be highly accurate (IDS-iSYS = 0.93ALTM + 3.79, R(2) = 0.94) and linear (obs(1) = 0.93exp(1) - 5.05, R(2) = 0.99 (P = 0.256); and obs(2) = 0.97exp(2) + 6.07, R(2) = 0.97 (P = 0.654); ALTM, all-laboratory trimmed mean). Cross-reactivity studies demonstrated no significant difference to the calculated total 25-OHD as measured by LC-MS/MS.<h4>Conclusions</h4>Even though the imprecision of the iSYS was found to be greater than that of the LC-MS/MS and EIA methods, the performance characteristics of the IDS-iSYS 25-OHD assay are suitable for routine diagnostic purposes on a high throughput automated analyser. |
Keywords: | Humans Vitamin D Chromatography, Liquid Reproducibility of Results Tandem Mass Spectrometry Limit of Detection |
Rights: | © 2012 The Association for Clinical Biochemistry |
DOI: | 10.1258/acb.2011.011018 |
Published version: | http://dx.doi.org/10.1258/acb.2011.011018 |
Appears in Collections: | Aurora harvest 5 Pathology publications |
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