Header

UZH-Logo

Maintenance Infos

Evaluation of two fully automated immunoassay based tests for the measurement of 1α,25-dihydroxyvitamin D in human serum and comparison with LC-MS/MS


Spanaus, Katharina; von Eckardstein, Arnold (2017). Evaluation of two fully automated immunoassay based tests for the measurement of 1α,25-dihydroxyvitamin D in human serum and comparison with LC-MS/MS. Clinical Chemistry and Laboratory Medicine, 55(9):1305-1314.

Abstract

BACKGROUND: 1α,25-Dihydroxyvitamin D [1,25(OH)2 vitD] is the bioactive form of vitamin D. Due to the very low concentrations of 1,25(OH)2 vitD in the blood and its lipophilic character, measurement of this parameter is analytically challenging. Requiring preceding manual extraction steps before analysis, previous assays have been laborious.
METHODS: In the presented study, we evaluated the performance of two immunoassays from DiaSorin and from Immunodiagnostic Systems (IDS) which combine fully automated extraction and measurement of 1,25(OH)2 vitD. Imprecision and linearity were verified according to Clinical and Laboratory Standards Institute EP15-A3 and EP6-A guidelines, respectively. Ninety-three patient serum samples sent to our institute for determination of 1,25(OH)2 vitD, as well as 20 Vitamin D External Quality Assessment Scheme (DEQAS) samples, were used to evaluate correlation and agreement of 1,25(OH)2 vitD measurements between the two immunoassays and with liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS).
RESULTS: Total imprecision was 5.2% or less for the DiaSorin test but reached 20.1% for the IDS iSYS test. 1,25(OH)2 vitD concentrations measured with the DiaSorin assay showed a strong correlation with 1,25(OH)2 vitD levels measured by LC-MS/MS and a good agreement with method specific means of DEQAS samples. By contrast, the IDS iSYS test overestimated 1,25(OH)2 vitD concentrations in human serum, particularly at higher concentrations.
CONCLUSIONS: Due to its high sensitivity, low imprecision, broad measurement range, and good agreement with 1,25(OH)2 vitD concentrations measured by LC-MS/MS, the DiaSorin test is a valuable analytical option for the determination of 1,25(OH)2 vitD.

Abstract

BACKGROUND: 1α,25-Dihydroxyvitamin D [1,25(OH)2 vitD] is the bioactive form of vitamin D. Due to the very low concentrations of 1,25(OH)2 vitD in the blood and its lipophilic character, measurement of this parameter is analytically challenging. Requiring preceding manual extraction steps before analysis, previous assays have been laborious.
METHODS: In the presented study, we evaluated the performance of two immunoassays from DiaSorin and from Immunodiagnostic Systems (IDS) which combine fully automated extraction and measurement of 1,25(OH)2 vitD. Imprecision and linearity were verified according to Clinical and Laboratory Standards Institute EP15-A3 and EP6-A guidelines, respectively. Ninety-three patient serum samples sent to our institute for determination of 1,25(OH)2 vitD, as well as 20 Vitamin D External Quality Assessment Scheme (DEQAS) samples, were used to evaluate correlation and agreement of 1,25(OH)2 vitD measurements between the two immunoassays and with liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS).
RESULTS: Total imprecision was 5.2% or less for the DiaSorin test but reached 20.1% for the IDS iSYS test. 1,25(OH)2 vitD concentrations measured with the DiaSorin assay showed a strong correlation with 1,25(OH)2 vitD levels measured by LC-MS/MS and a good agreement with method specific means of DEQAS samples. By contrast, the IDS iSYS test overestimated 1,25(OH)2 vitD concentrations in human serum, particularly at higher concentrations.
CONCLUSIONS: Due to its high sensitivity, low imprecision, broad measurement range, and good agreement with 1,25(OH)2 vitD concentrations measured by LC-MS/MS, the DiaSorin test is a valuable analytical option for the determination of 1,25(OH)2 vitD.

Statistics

Citations

Dimensions.ai Metrics
1 citation in Web of Science®
1 citation in Scopus®
Google Scholar™

Altmetrics

Downloads

33 downloads since deposited on 26 Jun 2017
33 downloads since 12 months
Detailed statistics

Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Institute of Clinical Chemistry
Dewey Decimal Classification:610 Medicine & health
540 Chemistry
Language:English
Date:2017
Deposited On:26 Jun 2017 07:36
Last Modified:14 Mar 2018 15:55
Publisher:De Gruyter
ISSN:1434-6621
OA Status:Green
Publisher DOI:https://doi.org/10.1515/cclm-2016-1074
PubMed ID:28245186

Download

Download PDF  'Evaluation of two fully automated immunoassay based tests for the measurement of 1α,25-dihydroxyvitamin D in human serum and comparison with LC-MS/MS'.
Preview
Content: Published Version
Filetype: PDF
Size: 2MB
View at publisher