25-Hydroxyvitamin D testing: challenging the performance of current automated immunoassays
-
Chris Farrell
Abstract
Background: Clinical laboratories require accurate and precise 25-hydroxyvitamin D (25-OHD) immunoassays to allow comparison of patient results with published decision limits. However, some variation in performance has been found with the previous generation of automated 25-OHD immunoassays. This study assessed the performance of four recently released automated 25-OHD immunoassays against a liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay.
Methods: A total of 983 samples from apparently healthy adults, plus 253 samples chosen to challenge the performance of the assays, were analyzed by the latest generation of immunoassays from Abbott, DiaSorin, Roche and Siemens. LC-MS/MS analysis was performed on a random subset of 264 samples. The precision of the immunoassays was assessed over 5 days with samples ranging between 3.0 and 370 nmol/L in concentration.
Results: Immunoassays showed significant differences in precision at 25-OHD concentrations of 3.0–86.5 nmol/L but all showed acceptable precision at higher concentrations. The DiaSorin assay agreed with LC-MS/MS across the measuring range of samples tested (7.7–425 nmol/L). The other assays showed generally good performance, but had some limitations when their performance was challenged with samples with low and high 25-OHD concentrations, heterophilic antibodies or high 25-OHD2 concentrations. The C3-epimer of 25-OHD was identified in 40.4% of healthy adults tested and was a source of analytical variance in immunoassays.
Conclusions: The latest generation of 25-OHD immunoassays has improved performance compared to previous assays. However, some immunoassays can still give discrepant results and this is most apparent when immunoassays are evaluated with a range of samples that challenge their analytical performance.
©2012 by Walter de Gruyter Berlin Boston
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- Masthead
- Masthead
- Editorials
- Tumor biomarkers: PSA and beyond
- Error reporting in transfusion medicine: an important tool to improve patient safety
- The measurement of 25-hydroxy vitamin D – an analytical challenge
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- Exhaled breath analysis for early cancer detection: principle and progress in direct mass spectrometry techniques
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- Mini Review
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- Genetics and Molecular Diagnostics
- Association of PBEF gene polymorphisms with acute lung injury, sepsis, and pneumonia in a northeastern Chinese population
- General Clinical Chemistry and Laboratory Medicine
- Brazilian laboratory indicators program
- Error reporting in transfusion medicine at a tertiary care centre: a patient safety initiative
- Application of mathematical models of system uncertainty to evaluate the utility of assay calibration protocols
- 25-Hydroxyvitamin D testing: challenging the performance of current automated immunoassays
- Analytical validation of the Roche 25-OH Vitamin D Total assay
- The new Roche Vitamin D Total assay: fit for its purpose?
- Improvement of a prenatal screening program for trisomy 18 in the first trimester of gestation
- Stability of osteopontin in plasma and serum
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- Letters to the Editor
- Evaluation of the cross-reactivity of 25-hydroxyvitamin D2 on seven commercial immunoassays on native samples
- Measurement of 25-hydroxyvitamin vitamin D by liquid chromatography tandem-mass spectrometry with comparison to automated immunoassays
- Analytical evaluation of a new automated protein binding assay to determine 25-hydroxyvitamin D concentrations
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Articles in the same Issue
- Congress Abstracts
- 44th National Congress of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology
- Masthead
- Masthead
- Editorials
- Tumor biomarkers: PSA and beyond
- Error reporting in transfusion medicine: an important tool to improve patient safety
- The measurement of 25-hydroxy vitamin D – an analytical challenge
- Reviews
- Kallikrein-related peptidases (KLKs): a gene family of novel cancer biomarkers
- Exhaled breath analysis for early cancer detection: principle and progress in direct mass spectrometry techniques
- γ′ Fibrinogen as a novel marker of thrombotic disease
- Mini Review
- Revaluating serum ferritin as a marker of body iron stores in the traceability era
- Genetics and Molecular Diagnostics
- Association of PBEF gene polymorphisms with acute lung injury, sepsis, and pneumonia in a northeastern Chinese population
- General Clinical Chemistry and Laboratory Medicine
- Brazilian laboratory indicators program
- Error reporting in transfusion medicine at a tertiary care centre: a patient safety initiative
- Application of mathematical models of system uncertainty to evaluate the utility of assay calibration protocols
- 25-Hydroxyvitamin D testing: challenging the performance of current automated immunoassays
- Analytical validation of the Roche 25-OH Vitamin D Total assay
- The new Roche Vitamin D Total assay: fit for its purpose?
- Improvement of a prenatal screening program for trisomy 18 in the first trimester of gestation
- Stability of osteopontin in plasma and serum
- Is there a suitable point-of-care glucose meter for tight glycemic control? Evaluation of one home-use and four hospital-use meters in an intensive care unit
- Cancer Diagnostics
- Rapid elimination kinetics of free PSA or human kallikrein-related peptidase 2 after initiation of gonadotropin-releasing hormone-antagonist treatment of prostate cancer: potential for rapid monitoring of treatment responses
- Detection of frequent ABCB1 polymorphisms by high-resolution melting curve analysis and their effect on breast carcinoma prognosis
- Cardiovascular Diseases
- The combined use of neutrophil gelatinase-associated lipocalin and brain natriuretic peptide improves risk stratification in pediatric cardiac surgery
- Association of the atherogenic index of plasma and oxidative stress status with weight gain during non-complicated pregnancy
- The high-sensitivity cardiac troponin T assay is superior to its previous assay generation for prediction of 90-day clinical outcome in ischemic stroke
- Letters to the Editor
- Evaluation of the cross-reactivity of 25-hydroxyvitamin D2 on seven commercial immunoassays on native samples
- Measurement of 25-hydroxyvitamin vitamin D by liquid chromatography tandem-mass spectrometry with comparison to automated immunoassays
- Analytical evaluation of a new automated protein binding assay to determine 25-hydroxyvitamin D concentrations
- Mindray BS-800M1: a new clinical chemistry system with a flexible technology meeting quality performances
- Association of urinary albumin and serum high molecular weight-adiponectin with metabolic syndrome in patients with essential hypertension
- Measurement of nitrite in plasma and serum: still a challenging analytical task
- Association between serum γ-glutamyltransferase and pulmonary dysfunction
- Serum ferritin concentrations predict incidence of metabolic syndrome in rural Korean adults
- Homocysteine, folic acid and vitamin B12 levels in females with severe acne vulgaris
