PerkinElmer Changes COVID-19 Rapid Testing Landscape with Highly Sensitive Point of Care Antigen Test for Mass Screening
PerkinElmer (NYSE: PKI) has launched its COVID-19 Antigen Test for the qualitative detection of SARS-CoV-2 antigen, yielding results in 15 minutes. This test, suitable for professional use in various settings, is already available in over 30 countries. Clinical studies show a sensitivity rate exceeding 97% and 100% specificity, indicating no false positives. The company emphasizes the need for reliable antigen testing to support reopening strategies globally. The test complements PerkinElmer's existing portfolio, which includes high throughput RNA extraction and RT-PCR solutions.
- Sensitivity rate exceeding 97% in clinical studies.
- 100% specificity showing no false positives.
- Available in over 30 countries that accept CE mark.
- Rapid results in just 15 minutes facilitate quick decision-making.
- None.
PerkinElmer, Inc. (NYSE: PKI) today 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 centers, travel hubs, businesses and educational institutions. Clinical studies in symptomatic and asymptomatic populations, including individuals with low viral load, have shown sensitivity of greater than
“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 organizations worldwide,” said Masoud Toloue, Ph.D., Senior Vice President, Diagnostics, PerkinElmer. “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.”
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.
About PerkinElmer
PerkinElmer enables scientists, researchers, and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food, and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 14,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately
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