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https://hdl.handle.net/2440/73027
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dc.contributor.author | Cluse, Z. | - |
dc.contributor.author | Fudge, A. | - |
dc.contributor.author | Whiting, M. | - |
dc.contributor.author | Parkinson, I. | - |
dc.contributor.author | O'Loughlin, P. | - |
dc.date.issued | 2012 | - |
dc.identifier.citation | Annals of Clinical Biochemistry, 2012; 49(2):159-165 | - |
dc.identifier.issn | 0004-5632 | - |
dc.identifier.issn | 1758-1001 | - |
dc.identifier.uri | http://hdl.handle.net/2440/73027 | - |
dc.description.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. | - |
dc.description.statementofresponsibility | Zee N Cluse, Andrew N Fudge, Malcolm J Whiting, Brett McWhinney, Ian Parkinson, and Peter D O’Loughlin | - |
dc.language.iso | en | - |
dc.publisher | Royal Soc Medicine Press Ltd | - |
dc.rights | © 2012 The Association for Clinical Biochemistry | - |
dc.source.uri | http://dx.doi.org/10.1258/acb.2011.011018 | - |
dc.subject | Humans | - |
dc.subject | Vitamin D | - |
dc.subject | Chromatography, Liquid | - |
dc.subject | Reproducibility of Results | - |
dc.subject | Tandem Mass Spectrometry | - |
dc.subject | Limit of Detection | - |
dc.title | Evaluation of 25-hydroxy vitamin D assay on the immunodiagnostic systems iSYS analyser | - |
dc.type | Journal article | - |
dc.identifier.doi | 10.1258/acb.2011.011018 | - |
pubs.publication-status | Published | - |
Appears in Collections: | Aurora harvest 5 Pathology publications |
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