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      Method evaluation study of a new generation of vitamin D assays

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          Abstract

          Introduction

          Recently several diagnostic manufacturers have launched new 25-hydroxy-vitamin D (25[OH]D) assays, which are aligned to the National Institute of Standards and Technology (NIST) Standard Reference Materials (SRM) (NIST, Gaithersburg, Maryland). The aim of this study was to compare the performance of one liquid chromatography-tandem mass spectrometry (LC-MS/MS) method, one enzyme linked immunosorbent assay (ELISA), and one recalibrated and previous version of a chemiluminescence immunoassay (CLIA).

          Material and methods

          Serum-aliquots of 198 patient samples from routine 25(OH)D analysis were measured by the ClinMass® LC-MS/MS Complete Kit (RECIPE Chemicals + Instruments GmbH, Munich, Germany), the ORGENTEC 25(OH)D 3/D 2 ELISA (ORGENTEC Diagnostika GmbH, Mainz, Germany), the recalibrated Immunodiagnostic Systems (IDS)-iSYS 25(OH)D S and the previous used IDS-iSYS 25(OH)D CLIA (Immunodiagnostic Systems Ltd, Boldon, United Kingdom). Bland-Altman and Deming regression analyses were calculated for methods comparison of all tested 25(OH)D assays. The LC-MS/MS method was defined as the reference method. Within-run and between-run precision measurements were performed for all methods with three different concentration levels.

          Results

          Compared to the LC-MS/MS method, the new IDS-iSYS 25(OH)D S and ORGENTEC 25(OH)D 3/D 2 assay demonstrated mean relative biases of 16.3% and 17.8%. The IDS-iSYS 25(OH)D assay showed the lowest mean bias of 1.5%. Deming regression analyses of the recalibrated IDS-iSYS 25(OH)D S and the ORGENTEC 25(OH)D 3/D 2 assay showed proportional differences, when compared to the reference method. All assays showed a within-run and between-run imprecision of ≤ 20% at each of the evaluated concentration levels.

          Conclusions

          The evaluated standardized immunoassays and LC-MS/MS are useful methods for measuring 25(OH)D serum-levels in clinical laboratories.

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          Most cited references20

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          Assay variation confounds the diagnosis of hypovitaminosis D: a call for standardization.

          Stephanie H. DeLuca, Christopher Hansen, Marc Drezner … (2004)
          Endemic hypovitaminosis D contributes to osteoporosis development. However, variation in 25-hydroxyvitamin D (25OHD) measurement is reported and confounds the diagnosis of vitamin D insufficiency/deficiency. This report emphasizes the marked variability observed in serum 25OHD measurements between laboratories.Initially, postmenopausal women had serum 25OHD determinations: 42 in laboratory A, 20 in laboratory B. Their mean (sem) serum 25OHD concentrations were 46 (2.1) and 21 (2.3) ng/ml in laboratories A and B, respectively. Furthermore, there was little overlap in serum 25OHD among these clinically similar individuals. Specifically, 17% of those measured in laboratory A but 90% in laboratory B were below an arbitrary threshold value of 32 ng/ml.Subsequently, serum was obtained from 10 healthy adults. Two aliquots from each individual, one of which was spiked with 20 ng/ml 25OHD, were sent to six laboratories. Substantial variability was noted between these six laboratories. The mean serum 25OHD concentration ranged from 17.1-35.6 ng/ml. Similarly, the mean increase produced by spiking with 20 ng/ml ranged from 7.7-18.0 ng/ml.In conclusion, 25OHD assays yield markedly differing results; whether an individual is found to have low or normal vitamin D status is a function of the laboratory used. If the medical community is to make progress in correcting widespread hypovitaminosis D, 25OHD measurement must be standardized.
          Article 0 comments Cited 91 times – based on 0 reviews     Review now
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            Vitamin D status as an international issue: national surveys and the problem of standardization.

            Christopher T. Sempos, Hubert Vesper, Karen W Phinney … (2012)
            Wide spread variation in measurement results of total 25-hydroxyvitamin D (25(OH)D) confounds international efforts to develop evidence-based clinical guidelines. Accordingly, NIH Office of Dietary Supplements (ODS) in collaboration with CDC National Center for Environmental Health (NCEH), National Institute of Standards and Technology (NIST) and Ghent University established the Vitamin D Standardization Program (VDSP) in November 2010. VDSP objectives include: (1) standardize 25(OH)D concentration measurements in national health surveys around the world, (2) evaluate survey differences, (3) extend standardization efforts to assay manufacturers, and to clinical, commercial, and research laboratories, (4) promote standardization of emerging metabolites of vitamin D status, and (5) enable the use of standardized data in patient care and public health. An interlaboratory comparison study is being conducted to assess measurement variability among current assays. Participants include national health surveys from Australia, Canada, Germany, Ireland, Mexico, South Korea, UK and USA, 15 assay manufacturers, and two external quality assurance programs. CDC will implement a formal laboratory certification program. Standardization activities will use single-donor, fresh-frozen serum collected using the CLSI C37 protocol. Initial assay performance criteria, based on biological variability data, are ≤ 10 % imprecision and ≤ 5 % bias in relation to the reference values. An ancillary study on commutability of NIST SRM 972a, external quality assurance testing materials is included. To increase the comparability of existing data from different national surveys, master equations will be developed to facilitate the conversion of already existing national survey data to the NIST-Ghent University reference measurement procedures.
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              Accuracy of 25-hydroxyvitamin D assays: confronting the issues.

              Chris Carter (2010)
              Measurement of 25-hydroxyvitamin D (25-OHD) is widely used for assessing vitamin D status. There has been a dramatic increase in 25-OHD requests over recent years prompting many laboratories to consider the use of automated immunoassays. To achieve higher throughput, these methods have abandoned the traditional solvent extraction of samples and are therefore more prone to non-specific interference. The Vitamin D External Quality Assessment Scheme (DEQAS) has revealed method-related differences in 25-OHD results, raising concerns about the comparability and accuracy of different assays. This paper highlights some of the pre-analytical, analytical and post-analytical issues which may influence the accuracy of 25-OHD assays and interpretation of results. Recent attention has focused on reconciling the relatively high results given by liquid chromatography-tandem mass spectrometry (LC-MS/MS) to those of the DiaSorin radioimmunoassay (RIA) on which clinical decision points have previously been based. Data is presented on 20 DEQAS samples which were analysed by an LC-MS/MS assay developed as a candidate reference measurement procedure by the US National Institute of Standards and Technology (NIST). The NIST results were on average 11.2% lower than those given by routine LC-MS/MS methods. If confirmed, these results suggest that most routine LC-MS/MS assays are perhaps overestimating 25-OHD by failing to resolve a molecule having the same mass as 25-OHD(3) and a similar fragmentation pattern. All 25-OHD assays should be monitored by a proficiency testing scheme and the results made available to clinicians and editors of scientific journals.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Biochem Med (Zagreb)
                Journal ID (iso-abbrev): Biochem Med (Zagreb)
                Journal ID (publisher-id): BM
                Title: Biochemia Medica
                Publisher: Croatian Society of Medical Biochemistry and Laboratory Medicine
                ISSN (Print): 1330-0962
                ISSN (Electronic): 1846-7482
                Publication date (Electronic): 05 June 2015
                Publication date Collection: June 2015
                Volume: 25
                Issue: 2
                Pages: 203-212
                Affiliations
                [1]Institute of Laboratory Medicine, General Hospital Steyr, Steyr, Austria
                Author notes
                Corresponding author: Dietmar Enko, dietmar.enko@ 123456gespag.at
                Article
                Publisher ID: bm-25-203
                DOI: 10.11613/BM.2015.020
                PMC ID: 4470105
                PubMed ID: 26110032
                SO-VID: 1405a0df-469f-4d79-b2a0-77518d97d19e
                Copyright statement: Copyright @ 2015
                History
                Date received : 15 December 2014
                Date accepted : 30 April 2015
                Categories
                Subject: Research Article

                Keywords: vitamin d,immunoassays,liquid chromatography-tandem mass spectrometry,reference standards,quality improvement
                Data availability:
                Keywords: vitamin d, immunoassays, liquid chromatography-tandem mass spectrometry, reference standards, quality improvement

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