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30th June 2021  Author: Paul Carton

Automated Kit Tops Comparison of SARS-CoV-2 Antigen Tests' Detection on Range of Viral Loads

The European Commission has cited a new paper on its 'Scientific literature on COVID-19 Test Methods and Devices' database, which showed Ortho Clinical Diagnostics' VITROS Immunodiagnostic SARS-CoV-2 Antigen test to be 100% accurate when compared to gold-standard RT-PCR test results when Ct values were equal or less than 30.

The VITROS test was given Emergency Use Authorization by the US FDA and, according to Ortho Clinical Diagnostics, is suitable "for mass-scale testing" and provides "same-day results for labs." The automated system can run up to 130 tests per hour, targets the nucleocapsid. and returns results in 48 minutes.

The paper 'Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection'' (published in the Journal of Clinical Medicine) evaluated 5 antigen tests in total; the other 4 were the following point-of-care rapid immunochromatographic antigen tests: 

The study was carried out on 188 patients (118 symptomatic and 70 asymptomatic) at the Clinique Saint-Luc (Bouge, Namur, Belgium) using nasopharyngeal swab samples.

Ct values that correlate to contagiousness determined by the US CDC, ECDC, and Canada differ (<33, <35, and <24 respectively). So the study compared how each antigen test fared under the variety of viral loads, with the majority of rapid antigen tests performing perfectly on Ct values less than 15 and reasonably well on values less than 20.

Lead Author Mr. Julien Favresse says reasons for carrying out the evaluation were to fill the gap in head-to-head comparison studies done on antigen tests and the limited amount on automated antigen tests.



Date Published: 30th June 2021

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