Author(s)

Lei Zhang ¹, Feng Yang ², Junzhe Zhu ³

Affiliation(s)

¹ Zhejiang Gongshang University, Hangzhou, Zhejiang, 310018, China
² Community Health Service Center, Hangzhou, Zhejiang, 310000, China
³ Wenzhou Medical University, Wenzhou, Zhejiang, 310000, China

Corresponding Author

Lei Zhang

ABSTRACT

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.

KEYWORDS

Vitamin D; Rapid Test Cassette; Chromatographic Immunoassay; 25-Hydroxyvitamin D; Point-Of-Care Testing; Self-Testing

CITE THIS PAPER

Lei Zhang, Feng Yang, Junzhe Zhu, 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. MEDS Clinical Medicine (2025) Vol. 6: 94-98. DOI: http://dx.doi.org/10.23977/medsc.2025.060315.

REFERENCES

[1] Holick MF. Vitamin D deficiency. N Engl J Med. 2007;357(3):266-281.
[2] Pilz S, März W, Wellnitz B, et al. Vitamin D and mortality in older men. J Clin Endocrinol Metab. 2008; 93(7): 2603-2608.
[3] Looker AC, Johnson CL, Lacher DA, et al. Vitamin D status: United States, 2001-2006. NCHS Data Brief. 2011; (59): 1-8.
[4] Jones G. Assays for vitamin D and its metabolites. Clin Biochem Rev. 2008;29(Suppl 1):S63-S71.
[5] Wang Y, Zhang M, Li X, et al. Evaluation of a lateral flow immunoassay for rapid detection of 25-hydroxyvitamin D in human serum. Clin Chim Acta. 2019;495:240-245.

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