Comparative Diagnostic Accuracy of Self-Administered and Professional Antigen-detecting Rapid Diagnostics Tests for SARS-CoV-2 Infection in Individuals with or without Symptoms.

Abstract Limited data exist comparing the diagnostic performance of antigen-detecting rapid diagnostic tests (Ag-RDTs) when collected by healthcare personnel versus self-collection. This single-center study, conducted from October 2021 to January 2022, involved 245 symptomatic and 203 high-risk participants aged above 18. Randomization determined the utilization of two Ag-RDT types: 5T for self-testing and 25T administered by medical professionals. Of the participants, 78 individuals tested positive via RT-PCR, with 67 in the symptomatic group and 11 in the high-risk group. Notably, Ag-RDT displayed excellent performance, achieving an AuROC of 0.93 (95%CI, 0.90–0.97). No significant difference in accuracy between the two Ag-RDT types was found, with AuROC values of 0.92 for self-test and 0.94 for professional test Ag-RDT (p-value = 0.564). Within the symptomatic group, there was a sensitivity of 88.1% (95%CI, 77.8–94.7) and a specificity of 99.3% (95%CI, 96.3–100). In the high-risk group, Ag-RDT showed a sensitivity of 81.8% (95%CI, 48.2–97.7) and a specificity of 100% (95%CI, 98.0–100). This study highlights the equal accuracy of self-administered and professionally conducted Ag-RDT tests for SARS-CoV-2 detection.