ArticleInternational journal of general medicine2026
Reliability of Point-of-Care Vitamin D Testing for Use in Primary Health Care: A Comparative Evaluation with Established CLIA Platforms.
Article in International journal of general medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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17 authors.
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Abstract
Background: Accurate measurement of serum 25-hydroxyvitamin D [25(OH)D] is essential for diagnosing deficiency and guiding treatment. While automated chemiluminescent immunoassays (CLIAs) are widely used in centralized laboratories, growing demand for rapid decisions has increased interest in reliable point-of-care (POC) testing. However, comparative data between modern POC systems and established laboratory analyzers remain limited. Aim: To assess the analytical agreement and diagnostic performance of a fluorescence-based POC vitamin D immunoassay and a contemporary automated CLIA platform against a benchmark automated CLIA system. Methods: A total of 311 human serum samples covering deficient, insufficient, sufficient, and high 25(OH)D concentrations were analyzed using one fluorescence-based POC assay and two automated CLIA platforms. Agreement was evaluated using Spearman correlation, Bland-Altman analysis, and receiver operating characteristic (ROC) curves. Diagnostic performance for vitamin D insufficiency (<30 ng/mL) was assessed by sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), overall percent agreement (OPA), and Cohen's κ. Results: All three assays showed excellent concordance, with strong correlations (r = 0.86-0.92) and similar median 25(OH)D concentrations. Bland-Altman analysis demonstrated modest, clinically acceptable biases (-14.3% to +10.0%) without proportional error. Diagnostic agreement was high, with AUC values of 0.96-0.98 and Cohen's κ values of 0.84-0.85, indicating high agreement in classifying vitamin D insufficiency. The fluorescence-based POC assay showed performance comparable to both automated CLIAs, with specificity of 91-96% and NPV of 91-97%. Conclusion: Both the fluorescence-based POC immunoassay and the contemporary automated CLIA platform demonstrated high diagnostic agreement with the benchmark automated CLIA system. These findings support the potential utility of both laboratory-based and decentralized assays for routine vitamin D screening in appropriate clinical settings.
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