Clinical Performance Evaluation Of The Vitamin D Rapid Test Cassette (OVD-402H): Comparative Analysis With HPLC And A Predicate Quantitative Assay

Abstract

This study evaluates the diagnostic accuracy of the Vitamin D Rapid Test Cassette (OVD-402H) using two independent data sets: a 2025 comparison with high-performance liquid chromatography (HPLC) (n = 10) and a 2017 in-house clinical study benchmarked against a predicate quantitative assay (n = 90). The cassette correctly classified vitamin D status (deficient, insufficient, sufficient) in all ten HPLC-verified samples and achieved 94.4 % overall agreement in the larger in-house cohort. These findings confirm that OVD-402H delivers laboratory-comparable performance while retaining the speed and simplicity required for point-of-care testing.