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Despite international standardization efforts, significant analytical differences remain among automated 25-hydroxyvitamin D immunoassays, with the DiaSorin Liaison XL demonstrating the closest agreement to the LC-MS/MS reference method compared to Beckman Coulter and Roche assays. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

September 14, 2026NutrientsOpen Access

Comprehensive Comparison of Three Automated 25-Hydroxyvitamin D Immunoassays with a VDSCP Traceable LC-MS/MS Method Across Clinically Relevant Decision Thresholds

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To compare the analytical performance and diagnostic concordance of three automated 25-hydroxyvitamin D immunoassays against a reference LC-MS/MS method across clinical decision thresholds.
Analyzed 400 prospectively collected adult outpatient serum samples evenly distributed across four concentration tiers (<25, 25–49, 50–74, and ≥75 nmol/L).
Conducted simultaneous testing on DiaSorin Liaison XL, Beckman Coulter DxI 9000, and Roche cobas e602 alongside a VDSCP-traceable LC-MS/MS platform.
Evaluated diagnostic accuracy at cutoffs of <25, <50, and <75 nmol/L using Deming regression, Bland–Altman analysis, and assessments of interference from vitamin D metabolites.
Roche cobas e602 consistently overestimated 25-hydroxyvitamin D levels, reducing diagnostic sensitivity while providing high specificity across all thresholds, with positive bias correlated with higher concentrations of C3-epi-25OHD3 and 24,25-dihydroxyvitamin D3.
Beckman Coulter DxI 9000 exhibited the highest sensitivity for detecting vitamin D deficiency but yielded higher false-positive rates, particularly at the <75 nmol/L threshold.
DiaSorin Liaison XL demonstrated the closest overall agreement with LC-MS/MS across all decision cutoffs, achieving Cohen's κ values ranging from 0.818 to 0.895.

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Implication

Method comparison study reveals substantial analytical variation among automated vitamin D immunoassays in adult outpatient samples, highlighting the need for method-aware clinical interpretation.

Cite This Study

Rácz et al. (2026) studied this question.

synapsesocial.com/papers/6aa7b26d0926e14a848b0dfd https://doi.org/10.3390/nu18182986

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Implication

Method comparison study reveals substantial analytical variation among automated vitamin D immunoassays in adult outpatient samples, highlighting the need for method-aware clinical interpretation.

Comprehensive Comparison of Three Automated 25-Hydroxyvitamin D Immunoassays with a VDSCP Traceable LC-MS/MS Method Across Clinically Relevant Decision Thresholds

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Discussion

Implication

Cite This Study

Comprehensive Comparison of Three Automated 25-Hydroxyvitamin D Immunoassays with a VDSCP Traceable LC-MS/MS Method Across Clinically Relevant Decision Thresholds

Key Points

Discussion

Implication

Cite This Study

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