Analytical and clinical validation of the new Abbot Architect 25(OH)D assay: fit for purpose?
-
Etienne Cavalier
,
Pierre Lukas
Abstract
Background:
We provide a clinical and analytical evaluation of the reformulated version of the Abbott Architect 25-hydroxyvitamin D assay. We compared this assay with three commercial automated immunoassays and against a VDSP-traceable liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) in six different populations. We also supplemented 40 healthy volunteers with either 600,000 IU of vitamin D2 or 100,000 of vitamin D3 to evaluate the performance of the immunoassays vs. the LC-MS/MS.
Methods:
Precision and limit of quantification were assessed, 25(OH)D2 and C3-epimer recovery were calculated. Two hundred and forty samples obtained in healthy Caucasians and Africans, osteoporotic, hemodialyzed and intensive care patients and 3rd trimester pregnant women were analyzed by all methods. Correlation was studied using Passing-Bablok and Bland-Altman analysis. Concordance correlation coefficient (CCC) was calculated to evaluate agreement between immunoassays and LC-MS/MS. We verified if patients were homogeneously classified with the immunoassays when they took vitamin D2 or vitamin D3 after 1, 7 and 28 days.
Results:
We observed excellent analytical features and showed a very good correlation to the LC-MS/MS results in the overall population. Compared to the other immunoassays, concordance of the new Abbott assay with the LC-MS/MS was at least similar, and often better in diseased populations. Althought the cross-reactivity with 25(OH)D2 was not of 100%, there was no significant difference in the classifications of the patients, either supplemented with D2 or D3 or after 7 or 28 days.
Conclusions:
This modified version of the Abbott Architect assay is clearly improved compared to the previous one and presents a better agreement with the LC-MS/MS.
References
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©2017 Walter de Gruyter GmbH, Berlin/Boston
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Articles in the same Issue
- Frontmatter
- Editorials
- Targeting errors in microbiology: the case of the Gram stain
- Time for a holistic approach and standardization education in laboratory medicine
- Reviews
- Serum uric acid levels and risk of prehypertension: a meta-analysis
- Lactic acidosis: an update
- Mini Review
- Progress and impact of enzyme measurement standardization
- Opinion Paper
- Critical comments to a recent EFLM recommendation for the review of reference intervals
- IFCC Paper
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- Genetics and Molecular Diagnostics
- Evaluation and comparison of three assays for molecular detection of spinal muscular atrophy
- General Clinical Chemistry and Laboratory Medicine
- Risk analysis of the preanalytical process based on quality indicators data
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- Looking beyond linear regression and Bland-Altman plots: a comparison of the clinical performance of 25-hydroxyvitamin D tests
- Next-generation osmotic gradient ektacytometry for the diagnosis of hereditary spherocytosis: interlaboratory method validation and experience
- Diagnosis of sphingolipidoses: a new simultaneous measurement of lysosphingolipids by LC-MS/MS
- Monitoring nicotine intake from e-cigarettes: measurement of parent drug and metabolites in oral fluid and plasma
- Development of a rapid and quantitative lateral flow assay for the simultaneous measurement of serum κ and λ immunoglobulin free light chains (FLC): inception of a new near-patient FLC screening tool
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- Cancer Diagnostics
- Utility of proGRP as a tumor marker in the medullary thyroid carcinoma
- Cardiovascular Diseases
- Can non-cholesterol sterols and lipoprotein subclasses distribution predict different patterns of cholesterol metabolism and statin therapy response?
- Infectious Diseases
- Improving Gram stain proficiency in hospital and satellite laboratories that do not have microbiology
- Diabetes
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- Corrigendum
- EFLM Recommendation
- Corrigendum to: Recommendation for the review of biological reference intervals in medical laboratories
- Letters to the Editor
- Evaluation of the trueness of serum alkaline phosphatase measurement in a group of Italian laboratories
- Innovative software for recording preanalytical errors in accord with the IFCC quality indicators
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- Identification of 5-fluorocytosine as a new interfering compound in serum capillary zone electrophoresis
- How to define reference intervals to rule in healthy individuals for clinical trials?
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