Performance evaluation of the densitometry analyzer “QuickNavi Reader^TM2”

Abstract

We evaluated the performance of the densitometer “QuickNavi Reader^TM2”. The concordance rate between reader judgment and visual judgment was 100% for SARS-CoV-2 antigen-positive specimens, influenza virus antigen-positive specimens, and negative control specimens. Using automatic read mode, the time from sample addition to positive line detection in SARS-CoV-2 antigen-positive specimens was investigated and averaged 1.28 minutes. Individual differences in visual positivity were observed in the comparison of the determination thresholds of the SARS-CoV-2 recombinant antigen dilution series samples, SARS-CoV-2 antigen-positive pool samples, and influenza virus A antigen-positive pool samples and Negative decision threshold. On the other hand, the reader’s judgment threshold and the visual judgment threshold were almost the same in all three series. QuickNavi Reader^TM2 guarantees judgment accuracy and reproducibility equivalent to visual observation, saves labor in time management, and shortens the time to report results, contributing to the provision of higher quality immunochromatographic methods.