A Prospective Study to Evaluate the Clinical Performance of A Novel MultitargetBased Antigen Test on the Detection of SARS-CoV-2 in Symptomatic PopulationComparison to Nuclear Acid-Based Tests

Abstract

The study was designed to evaluate the clinical performance characteristics of the First Sign® SARS-CoV-2 Antigen Test, a visual read lateral flow immunoassay (W.H.P.M., Inc.). Individuals presenting at the study sites were evaluated by health care providers for COVID-19 symptoms and sequentially enrolled. The standard of care nasopharyngeal swab sample was first collected for RT-PCR testing. Participant self-collection nasal swab sample was then obtained for the Antigen Test. The clinical performance characteristics of the study device were calculated by comparing participant study device test result recorded at the point of care with the participant matched RT-PCR results provided by qualified CLIA high complexity laboratories. A total of 128 symptomatic adult participants were included in the study, of which 46.8% (60/128) were determined to be RT-PCR positive for SARS-CoV-2. The mean comparator cycle threshold value (Ct) for RT-PCR positive participants included in the study was Ct 25 (range Ct 18-Ct 39). The First Sign® SARS-CoV-2 Antigen Test demonstrated an overall clinical sensitivity of 96.7% (58/60) and a clinical specificity of 98.5% (67/68) when compared with EUA RT-PCR comparator results for the detection of SARS-CoV-2 in symptomatic individuals within 5 days of symptom onset. The clinical sensitivity for samples with RT-PCR Ct<30 was 100% (48/48), 90% (10/12) for samples with RT-PCR Ct ≥ 30, and 98.2% (55/56) for samples with RT-PCR Ct ≤ 34. Study results indicate that during the initial phase of infection, when upper respiratory viral loads and viral shedding levels are typically highest, an observed anterior nasal swab self-collected by the patient and applied to the First Sign® SARS-CoV-2 Antigen Test may be as effective in detecting the presence of SARS-CoV-2 in symptomatic individuals as a EUA RT-PCR assay. Additionally, the ability to obtain a low-cost qualitative result within 15 minutes, combined with the simplicity of the anterior nasal self-sampling procedure, may dramatically increase testing efficiency while significantly reducing risk to health care providers by minimizing or eliminating the need for close contact with the patient.