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Evaluating the role of a fully automated SARS-CoV-2 antigen ECLIA immunoassay in the management of the SARS COV 2 pandemic on general population.

Mariarosa CartaMichela PascarellaAnna CappellettiMario RassuDavide Giavarina
Published in: Diagnosis (Berlin, Germany) (2022)
Our study confirms the reliability of the fourth-generation antigen assay in recognizing negative samples. Conversely, sensitivity appears to be less reliable (68.0%) than reported in the literature. This could be due to a non-randomized study group: many swab samples were taken from patients with expected low viral load (hospitalized for COVID for more than 10-12 days or asymptomatic patients for epidemiological surveillance). The strong correlation of sensitivity and viral load could prove significant to track the infectiousness of infected people, as previous studies reported that a viral load of at least 10E6 copies of RNA/mL, corresponding to 25 CT, is the threshold of transmission of the disease.
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