PerkinElmer has launched its 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 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 suited for professional use point-of-care (POC) clinical and non-clinical settings. Clinical studies in symptomatic and asymptomatic populations, including individuals with low viral load, have shown 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.
Masoud Toloue, senior vice president, diagnostics, PerkinElmer, said: “While RT-PCR tests remain the gold standard in COVID-19 diagnostics, there is an unmet need in the market for a highly reliable antigen test that can support the reopening strategies of organisations worldwide. Sensitivity and reliability matters, especially in this challenging environment. Just like with our RT-PCR test, significant talent and effort was put behind developing a lateral flow antigen test that sets the benchmark for rapid testing, and may help facilitate the safe return of in-person education, commerce and everyday life.”
