NEW YORK – PerkinElmer on Tuesday said it has received the CE mark for a COVID-19 antigen test.
The PerkinElmer COVID-19 Antigen Test can be used to screen or help diagnose symptomatic and asymptomatic patients suspected of having the disease. It qualitatively detects SARS-CoV-2 nucleocapsid protein antigen in nasal or nasopharyngeal swab specimens and provides results in as little as 15 minutes, the Waltham, Massachusetts-based company said, adding it has launched the test in more than 30 countries that accept CE marking.
PerkinElmer said the test is "ideally suited" for use in professional clinical and non-clinical settings at the point of care, including in healthcare centers, travel hubs, businesses, and educational institutions.
In clinical studies, the test has demonstrated sensitivity of more than 97 percent in all nasal and nasopharyngeal samples. Specificity across 202 negative samples was 100 percent, the company added.