Clinical assessment of Ortho VITROS SARS-CoV-2 antigen chemiluminescence immunoassay

Given the clear awareness that COVID-19 has not disappeared but is here to stay, fast, high-throughput and relatively low-cost diagnostic techniques are likely to drive the market in the foreseeable future. The results of our clinical evaluation of the Ortho VITROS SARS-CoV-2 antigen chemiluminescence immunoassay during the time of circulating highly mutated SARS-CoV-2 variants such as BA.2.86 and JN.1 confirms the good performance of this technique in the diagnosis of acute SARS-CoV-2 infection, with cumulative accuracy and diagnostic sensitivity at the manufacturer’s cut-off value being 77 % and 72 %, respectively, which is in line with values reported in a previous meta-analysis when earlier SARS-CoV-2 variants were actively circulating. The accuracy and sensitivity in samples from patients with high viral load, who are thought to be the main carriers of SARS-CoV-2 transmission, was even better, showing a near perfect agreement with the molecular biology reference technique and a sensitivity of 95.6 %, which would allow fast, efficient and relatively inexpensive identification of super-spreaders.