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  4. Vol 6, Issue 3, 2025

Evaluation of the Diagnostic Performance of Ferritin Rapid Test Cassette for Qualitative of Ferritin in Whole Blood (For Self-Testing)

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DOI: 10.23977/medsc.2025.060316 | Downloads: 6 | Views: 152

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 Ferritin Rapid Test Cassette is a chromatographic immunoassay specifically designed for the qualitative self-testing of ferritin levels in human whole blood obtained via fingerstick, aimed at identifying potential iron deficiency. This study systematically evaluates the performance characteristics of the test, including relative sensitivity, specificity, accuracy, and precision, using chemiluminescent immunoassay (CLIA) as the reference standard. A total of 102 specimens were analyzed, comprising 23 with abnormal ferritin levels and 79 with normal levels, all confirmed by CLIA from both symptomatic and asymptomatic individuals. Results demonstrated high relative sensitivity at 91.3% (95%CI: 72.0%-98.9%) and specificity at 96.2% (95% CI: 89.3%-99.2%), resulting in an overall accuracy of 95.1% (95% CI: 88.9%-98.4%). Importantly, the test showed no cross-reactivity with common interfering substances such as human anti-mouse antibodies (HAMA), rheumatoid factor (RF), or human hemoglobin, thereby affirming its specificity. Furthermore, both intra-assay and inter-assay precision were exceptional, achieving over 99% correct identification of specimens at concentrations of 0 ng/mL, 30 ng/mL, and 100 ng/mL. The limit of detection was established at 30 ng/mL. Collectively, these findings substantiate that the Ferritin Rapid Test Cassette is a reliable, rapid, and user-friendly tool for the qualitative self-assessment of ferritin levels, thereby facilitating the early detection of iron deficiency in various populations.

KEYWORDS

Ferritin; Iron Deficiency Anemia; Rapid Self-Test Cassette; Chromatographic Immunoassay; CLIA; Whole Blood; Self-Testing

CITE THIS PAPER

Lei Zhang, Feng Yang, Junzhe Zhu, Evaluation of the Diagnostic Performance of Ferritin Rapid Test Cassette for Qualitative of Ferritin in Whole Blood (For Self-Testing). MEDS Clinical Medicine (2025) Vol. 6: 99-103. DOI: http://dx.doi.org/10.23977/medsc.2025.060316.

REFERENCES

[1] World Health Organization. Iron deficiency anaemia: Assessment, prevention, and control. Geneva: WHO Press, 2011.
[2] Andrews NC. Iron homeostasis: New tales from the crypt. Cell, 2010, 142(1): 24-38.
[3] Ganz T. Hepcidin and iron homeostasis. Annual Review of Nutrition, 2013, 33: 73-85.
[4] Kryger MH, Otake K, Foerster J. Low body stores of iron and restless legs syndrome: A correctable cause of insomnia in adolescents and teenagers. Sleep Medicine, 2002, 3(2): 127-132.
[5] Mizuno S, Mihara T, Miyaoka T, et al. CSF iron, ferritin and transferrin levels in restless legs syndrome. Journal of Sleep Research, 2005, 14(1): 43-47.
[6] O'Farrell N, Holmes E, Cummins E. Lateral flow immunoassays for infectious diseases: A review. Analytical and Bioanalytical Chemistry, 2009, 393(3): 669-682.

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