Evaluation of the Performance Characteristics of the Vitamin D Rapid Test Cassette for Semi-Quantitative Self-Testing of 25-Hydroxyvitamin D in Human Fingerstick Whole Blood

The Vitamin D Rapid Test Cassette is a rapid chromatographic immunoassay designed for semi-quantitative detection of 25-hydroxyvitamin D (25(OH)D) in human fingerstick whole blood, with potential for self-testing by individuals. This study aimed to comprehensively evaluate its performance characteristics, including sensitivity, specificity and accuracy, through in-house clinical studies. A total of 90 specimens [4 vitamin D-deficient (1-10ng/ml), 56 insufficient (10-30ng/ml), and 30 sufficient (30-100ng/ml)] from individuals with suspected deficiency or insufficiency were tested. Results showed a relative sensitivity of 95%, specificity of 93.3% and accuracy of 94.4%. The limit of detection covered the three critical ranges (10ng/mL, 10-30ng/ml, 30-100ng/ml), and intra-assay/inter-assay precision was satisfactory (>95% correct identification). These findings indicate the cassette is a reliable, rapid, and practical tool for initial vitamin D status screening, including self-testing scenarios, aiding timely decisions on supplementation and health management.