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

Abstract

The Ferritin Rapid Test Cassette is a chromatographic immunoassay designed for qualitative self-testing of ferritin in human whole blood to screen for potential iron deficiency. This study evaluated its diagnostic performance—sensitivity, specificity, accuracy, and precision—using Chemiluminescent Immunoassay (CLIA) as the reference standard. A total of 102 specimens (23 ferritin-abnormal and 79 ferritin-normal) were tested. The assay showed 91.3% sensitivity (95% CI: 72.0–98.9), 96.2% specificity (95% CI: 89.3–99.2), and 95.1% overall accuracy (95% CI: 88.9–98.4). No cross-reactivity was observed with HAMA, RF, or human hemoglobin. Both intra- and inter-assay precision exceeded 99% across clinically relevant ferritin levels (0, 30, 100 ng/mL). These results demonstrate that the Ferritin Rapid Test Cassette is a rapid, accurate, and user-friendly tool for self-assessment of ferritin levels, aiding in early detection of iron deficiency and anemia.