Multicenter evaluation of a fully automated high-throughput SARS-CoV-2 antigen immunoassay (preprint)

ABSTRACT

Background: Molecular testing for 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(R) 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 RT-qPCR and consecutively subjected to the antigen immunoassay on either the cobas e411 or cobas e801 analyzers. Results: Of the tested respiratory samples, 392 were PCR positive for SARS-CoV-2 RNA. Median concentration was 2.95x104 (interquartile range [IQR] 5.1x102-3.5x106) copies/mL. Overall sensitivity and specificity of the antigen immunoassay were 60.5% (95% confidence interval [CI] 55.5-65.4) and 99.9% (95% CI 99.6-100), respectively. A 93.7% (95% CI 89.7-96.5) sensitivity was achieved at a viral RNA concentration [≥]104 copies/mL (cycle threshold (Ct) value <29.9). Conclusion: The Elecsys SARS-CoV-2 Antigen assay reliably detected patient samples with viral loads of 10,000 copies/mL and higher. It thus represents a viable high-throughput alternative for pre-screening of patients, or in situations where PCR testing is not readily available.