Poster Presentation Australian Society for Microbiology Annual Scientific Meeting 2022

Clinical performance of GeneFinder COVID-19 Ag Plus Rapid Test for detection of SARS-CoV-2 (#159)

Hyunjae Lee 1 2 , Taek Soo Kim 2 3 , Hyunwoong Park 1 3
  1. Department of Laboratory Medicine, Seoul National University Boramae Medical Center, Seoul, South Korea
  2. Department of Laboratory Medicine, Seoul National University Hospital, Seoul, South Korea
  3. Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul, South Korea

We evaluated GeneFinder COVID-19 Ag Plus Rapid Test for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and its performance was compared to the real-time reverse transcription-polymerase chain reaction (RT-PCR) test. Samples were obtained once from 310 suspected patients of coronavirus diseases 2019 (COVID-19) and transported in universal transport medium (UTM). The samples were tested with STANDARD M nCoV Real-Time Detection kit or Allplex 2019-nCoV Assay which are real-time RT-PCR tests approved by Emergency-Use-Authorization in South Korea. Clinical information including symptom onset and test results including cycle threshold (Ct) values were obtained at the day of RT-PCR test. The remaining stored samples were tested with GeneFinder COVID-19 Ag Plus Rapid Test. Out of 310 patients recruited, RT-PCR was positive in 140 patients and GeneFinder COVID-19 Ag Plus Rapid Test was positive in 118 patients. The overall sensitivity and specificity of GeneFinder COVID-19 Ag Plus Rapid Test in detection of SARS-CoV-2 compared to RT-PCR tests were 84.3% (95% confidence interval [CI], 77.0% - 89.7%) and 100% (95% CI, 97.2% - 100.0%), respectively. In patients with Ct values under 20, the sensitivity was 100% (95% CI, 92.8% - 100.0%). The sensitivity was 94.2% (95% CI, 83.1% - 98.5%) in patients with Ct values from 20 to 25 and 54.5% (95% CI, 24.6% - 81.9%) in patients with Ct values from 25 to 30. Patients with positive RT-PCR were classified into three groups according to symptom onset for further analysis. The sensitivity was 92.7% (95% CI, 79.0% - 98.1%) in patients whose symptoms appeared less than 3 days prior to RT-PCR. The sensitivity decreased to 71.1% (95% CI, 55.5% - 83.2%) in patients whose symptoms appeared more than 6 days prior to RT-PCR. The results indicate that the GeneFinder COVID-19 Ag Plus Rapid Test may be a convenient tool in quickly identifying and preventing COVID-19 transmission.