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

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.