Evaluation of two rapid antigen tests to detect SARS-CoV-2 in a hospital setting

Abstract

Successful containment strategies for the SARS-CoV-2 pandemic will depend on reliable diagnostic assays. Point-of-care antigen tests (POCT) may provide an alternative to time-consuming PCR tests to rapidly screen for acute infections on site. Here, we evaluated two SARS-CoV-2 antigen tests: the STANDARD™ F COVID-19 Ag FIA (FIA) and the SARS-CoV-2 Rapid Antigen Test (RAT). For diagnostic assessment, we used a large set of PCR-positive and PCR-negative respiratory swabs from asymptomatic and symptomatic patients and health care workers in the setting of two University Hospitals in Munich, Germany, i.e. emergency rooms, patient care units or employee test centers. For FIA, overall clinical sensitivity and specificity were 45.4% (n = 381) and 97.8% (n = 360), respectively, and for RAT, 50.3% (n = 445) and 97.7% (n = 386), respectively. For primary diagnosis of asymptomatic and symptomatic individuals, diagnostic sensitivities were 60.9% (FIA) (n = 189) and 64.5% (RAT) (n = 256). This questions these tests’ utility for the reliable detection of acute SARS-CoV-2-infected individuals, in particular in high-risk settings. We support the proposal that convincing high-quality outcome data on the impact of false-negative and false-positive antigen test results need to be obtained in a POCT setting. Moreover, the efficacy of alternative testing strategies to complement PCR assays must be evaluated by independent laboratories, prior to widespread implementation in national and international test strategies.

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

“…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].…”

Analytical performances of the point-of-care SIENNA™ COVID-19 Antigen Rapid Test for the detection of SARS-CoV-2 nucleocapsid protein in nasopharyngeal swabs: A prospective evaluation during the COVID-19 second wave in France

“…The study Ag-RDT fulfilled the current World Health Organization (WHO)'s recommendations for a screening Ag-RTD stating that, at minimum, Ag-RDTs would need to correctly identify significantly more cases than they would miss (sensitivity !80%) and would have very high specificity (!97-100%) (World Health Organization, 2020a). Furthermore, analytical performances of comparable order as those of our study Ag-RDT were previously reported for some Ag-RDTs in lateral flow immunoassay format (Cerutti et al, 2020;Chaimayo et al, 2020;Diao et al, 2021;Favresse et al, 2021;Linares et al, 2020;Schildgen et al, 2021;Toptan et al, 2020;Weitzel et al, 2020), while several studies have reported much lower sensitivity levels contrasting with always high specificity (Albert et al, 2020;Dinnes et al, 2020;Scohy et al, 2020;Yamayoshi et al, 2020;Osterman et al, 2021;Torres et al, 2021).…”

Head-to-head performance comparison of self-collected nasal versus professional-collected nasopharyngeal swab for a WHO-listed SARS-CoV-2 antigen-detecting rapid diagnostic test

“…Studies that show lower sensitivity on either of the two tests (e.g. 64.5% by Osterman et al [ 14 ] for Roche SARS-CoV-2 Ag-RDT or Olearo et al [ 15 ] with 44.6% for Panbio in symptomatic patients), most commonly perform the test not according to manufacturer’s recommendations (most often either not using the sample type or swab recommended, or prediluting the sample in transport media). This possible reason for the difference in performance between studies was also highlighted in the recent systematic reviews.…”