Multicenter Evaluation of a Fully Automated High-Throughput SARS-CoV-2 Antigen Immunoassay

Nörz, Dominik; Olearo, Flaminia; Perisic, Stojan; Bauer, Matthias F.; Riester, Elena; Schneider, Tanja; Schönfeld, Kathrin; Laengin, Tina; Lütgehetmann, Marc

INTRODUCTION: Molecular testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to suffer from delays and shortages. Antigen tests have recently emerged as a viable alternative to detect patients with high viral loads, associated with elevated risk of transmission. While rapid lateral flow tests greatly improved accessibility of SARS-CoV-2 detection in critical areas, their manual nature limits scalability and suitability for large-scale testing schemes. The Elecsys(®) SARS-CoV-2 Antigen assay allows antigen immunoassays to be carried out on fully automated high-throughput serology platforms. METHODS: A total of 3139 nasopharyngeal and oropharyngeal swabs were collected at 3 different testing sites in Germany. Swab samples were pre-characterized by reverse transcription real-time polymerase chain reaction (RT-qPCR) and consecutively subjected to the antigen immunoassay on either the cobas e 411 or cobas e 801 analyzer. RESULTS: Of the tested respiratory samples, 392 were PCR positive for SARS-CoV-2 RNA. Median concentration was 2.95 × 10(4) (interquartile range [IQR] 5.1 × 10(2)–3.5 × 10(6)) copies/ml. Overall sensitivity and specificity of the antigen immunoassay were 60.2% (95% confidence interval [CI] 55.2–65.1) and 99.9% (95% CI 99.6–100.0), respectively. A 93.7% (95% CI 89.7–96.5) sensitivity was achieved at a viral RNA concentration ≥ 10(4) copies/ml (~ cycle threshold [C(t)] value < 29.9). CONCLUSION: The Elecsys SARS-CoV-2 Antigen assay reliably detected patient samples with viral loads ≥ 10,000 copies/ml. It thus represents a viable high-throughput alternative for screening of patients or in situations where PCR testing is not readily available. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40121-021-00510-x.