High performance of a novel antigen detection test on nasopharyngeal specimens for SARS-CoV-2 infection diagnosis: a prospective study

Abstract

Introduction The SARS-CoV-2 pandemic has become a major public health issue worldwide. Developing and evaluating rapid and easy-to-perform diagnostic tests is an absolute priority. The current prospective study was designed to assess diagnostic performances of an antigen-based rapid detection test (COVID-VIRO) in a real-life setting. Methods Two nasopharyngeal specimens of symptomatic or asymptomatic adult patients hospitalized in the Infectious Diseases Department or voluntarily accessing the COVID-19 Screening Department of the Regional Hospital of Orleans, France, were concurrently collected. COVID VIRO diagnostic specificity and sensitivity were assessed in comparison to real-time reverse transcriptase quantitative polymerase chain reaction (RT-qPCR) results. A subgroup of patients underwent an additional oropharyngeal and/or a saliva swab for rapid testing. Results 121 patients already having a confirmed infection and 127 patients having no evidence of recent or ongoing infection were enrolled, for a total of 248 couple of nasopharyngeal swab specimens. Overall COVID-VIRO sensitivity was 96.7% (IC: 93.5%-99.9%). In asymptomatic patients, patients having symptoms for more than 4 days and those having a RT-qPCR Cycle threshold value >32, sensitivity was of 100%, 95.8% and 96.9% respectively. The concordance between RT-qPCR and COVID VIRO rapid test was 100% for the 127 patients with no SARS-CoV-2 infection. Conclusion COVID-VIRO test had 100% specificity and above 95% sensitivity, better than WHO recommendations (specificity ≥97-100%, sensitivity ≥80%). These rapid tests are particularly interesting for large-scale screening in Emergency Department, low resource settings and airports.

Analytical Performances of the Point-of-Care BIOSYNEX COVID-19 Ag BSS for the Detection of SARS‐CoV‐2 Nucleocapsid Protein in Nasopharyngeal Swabs: A Prospective Field Evaluation During the COVID-19 Third Wave in France

“…Furthermore, analytical performances of comparable order as those of our study Ag-RDT were previously reported for some Ag-RDTs in lateral ow immunoassay format [7,9,21,[25][26][27][28][29][30][31][32][33][34][35], while several studies have reported much lower sensitivity levels contrasting with always high speci city [3,[36][37][38][39][40][41]. For example, a comparable Ag-RDT such as the novel COVID-VIRO® from AAZ (Boulogne Billancourt, France) showed a sensitivity of 96.7% and a speci city of 100% in a real-life community setting [31]. In addition, the Ag-RDT RDT BIOSYNEX COVID-19 Ag BSS ful lled also the current recommendations of the French High Authority of Health (Haute Autorité de santé, Saint-Denis, France) for a screening Ag-RTD stating that, at minimum, Ag-RDTs would need to correctly identify signi cant proportions of symptomatic patients (sensitivity ≥ 80%) as well as asymptomatic individuals (sensitivity ≥ 50%) and would have very high speci city (≥ 90%) [42].…”

“…Finally, the Ag-RDT RDT BIOSYNEX COVID-19 Ag BSS ful lled the current WHO's recommendations for a screening Ag-RTD stating that, at minimum, Ag-RDTs would need to correctly identify signi cantly more cases than they would miss (sensitivity ≥ 80%) and would have very high speci city (≥ 97-100%) [20]. Furthermore, analytical performances of comparable order as those of our study Ag-RDT were previously reported for some Ag-RDTs in lateral ow immunoassay format [7,9,21,[25][26][27][28][29][30][31][32][33][34][35], while several studies have reported much lower sensitivity levels contrasting with always high speci city [3,[36][37][38][39][40][41]. For example, a comparable Ag-RDT such as the novel COVID-VIRO® from AAZ (Boulogne Billancourt, France) showed a sensitivity of 96.7% and a speci city of 100% in a real-life community setting [31].…”

The accuracy of novel antigen rapid diagnostics for SARS-CoV-2: a living systematic review and meta-analysis

“…After removing duplicates, 8,921 articles were screened, and 266 papers were considered eligible for full-text review. Of these, 148 were excluded because they did not present primary data [13,19–131] or the Ag-RDT was not commercially available [16,132–164], leaving 133 studies to be included in the systematic review (Fig 1) [4,165–296].…”

Field clinical performance of SARS-CoV-2 point-of-care diagnostic tests: a living systematic review of trials up to 17th of August, 2021

“…For instance, Cerutti et al conducted a trial with 330 patients and only a minority of frozen samples was included (n = 13); this trial was included in our criteria 26 . In the other hand, a prospective study by Courtellemont et al 27 was not included in analysis as known positive patients were pre-selected to enroll; therefore, operators knew the status of the patients beforehand. A similar situation happened in the study conducted by Ghofrani et al 28 , which conducted an comparison with known positive patients and selected eligible samples; the methodology of this study was not clear and the sensitivity, reported as 96.7%, is much higher than usually reported in literature for antigen assays 29 .…”