PerkinElmer has expanded its testing solutions portfolio with the launch of its new Covid-19 antigen test for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in nasal (NS) or nasopharyngeal (NP) swab specimens.
The PerkinElmer COVID-19 Antigen Test is a lateral flow immunoassay test for screening or diagnosing Covid-19 in asymptomatic or symptomatic people. It can deliver a positive or negative result in 15 minutes.
It is well suited for professional use point-of-care (POC) clinical and non-clinical settings such as healthcare facilities, travel hubs, businesses, and educational institutes.
According to clinical studies in symptomatic and asymptomatic individuals, including those with low viral load, the in vitro diagnostic device demonstrated more than 97% sensitivity in all NS and NP samples.
A specificity of 100% was observed across 202 negative samples, indicating that no false positives were detected.
PerkinElmer Diagnostics senior vice-president Masoud Toloue 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.
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“Just like with our RT-PCR test, significant talent and effort were 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.”
The antigen test is available in more than 30 countries that accept the CE mark.
The company’s portfolio of SARS-CoV-2 testing solutions includes high- throughput RNA extraction, RT-PCR, automation, ELISA, chemiluminescence, time-resolved fluorescence, and lateral flow-based serology testing.
According to the US Food and Drug Administration’s (FDA) comparative data, PerkinElmer New Coronavirus Nucleic Acid Detection Kit has the lowest detection limit among other authorised Covid-19 molecular diagnostic tests.
Last March, this RT-PCR assay received FDA emergency use authorisation (EUA). It received EUA to test individuals without symptoms last month.