25th February 2021 Product update: Rapidvirology staff writer
New CE-IVD COVID-19 Antigen Test Benchmarked Against Most Sensitive Gold-Standard Kit on Market
PerkinElmer has announced the launch of the PerkinElmer® COVID-19 Antigen Test for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in nasal (NS) or nasopharyngeal (NP) swab specimens.
The lateral flow immunoassay test can be used to screen or to aid in diagnoses of COVID-19 in asymptomatic or symptomatic individuals. A positive or negative result can be obtained in as little as 15 minutes to facilitate immediate isolation or treatment decisions.
This latest addition to the Company’s portfolio of SARS-CoV-2 testing solutions is available in more than 30 countries that accept the CE mark. The in vitro diagnostic device is ideally suited for professional use point-of-care (POC) clinical and non-clinical settings such as healthcare centres, travel hubs, businesses and educational institutions.
Clinical studies in symptomatic and asymptomatic populations, including individuals with low viral load, have shown a sensitivity of greater than 97% amongst all NS and NP samples. Specificity of the test across 202 negative samples was 100%, which means no false positives were identified.
PerkinElmer continues to work on the frontlines of improving COVID-19 testing. The Company’s comprehensive SARS-CoV-2 offerings span high throughput RNA extraction, RT-PCR, automation, ELISA, chemiluminescence, time-resolved fluorescence and lateral flow-based serology testing.
Based on comparative data released by the U.S. Food and Drug Administration, the PerkinElmer® New Coronavirus Nucleic Acid Detection Kit has the lowest limit of detection among authorized COVID-19 molecular diagnostic tests reported, deeming it the most sensitive assay.
This RT-PCR assay originally obtained FDA EUA in the spring of 2020 and recently received EUA to test individuals without symptoms or other reasons to suspect COVID-19 infection.
Date Published: 25th February 2021
Source article link: View
Note: This content has been edited by a rapidvirology.com staff writer for style and content.