PerkinElmer Secures FDA Emergency Use Authorization for EUROIMMUN’s Anti-SARS-CoV-2 ELISA Serology Test
By LabMedica International staff writers Posted on 06 May 2020 |
Image: EUROIMMUN’s Anti-SARS-CoV-2 ELISA (IgG) serology test (Photo courtesy of PerkinElmer, Inc.)
PerkinElmer, Inc. (Waltham, MA; USA) has secured Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for EUROIMMUN’s (a PerkinElmer company) Anti-SARS-CoV-2 ELISA (IgG) serology test.
The EUROIMMUN Anti-SARS-CoV-2 ELISA (IgG) is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. It has 99% specificity and 100% sensitivity after 21 days following the onset of symptoms. Clinical laboratories certified to perform high complexity tests under Clinical Laboratory Improvement Amendments (CLIA) can immediately begin using this ELISA for the detection of antibodies of the immunoglobulin class G.
EUROIMMUN has the capacity to manufacture millions of assays per month. Since March, it has already started shipping its Anti-SARS-CoV-2 ELISA (IgG) to leading laboratories across the globe. EUROIMMUN intends to further build production capacity to meet heightened demand.
“Leading with science is a fundamental part of our DNA at PerkinElmer, and the EUROIMMUN team recognized early on that understanding the pathogenesis of COVID-19 from a cellular biology level is paramount to developing a highly accurate and reliable antibody test,” said Prahlad Singh, president and chief executive officer, PerkinElmer. “As a result, the antigen used in the EUROIMMUN Anti-SARS-CoV-2 ELISA (IgG), the spike protein S1 domain, is more likely to reflect virus neutralizing antibodies than antibodies to N capsid nucleoprotein. This is also supported by the fact that most of the COVID-19 vaccine development programs in the US and worldwide have chosen the spike protein as their target.”
“It is possible that 50% or more of people who have been infected with COVID-19 might not display symptoms, making it difficult to identify those who have previously contracted COVID-19,” added Prahlad Singh. “That’s why serological testing that utilizes an antigen highly specific to SARS-CoV-2 is such an important tool in understanding how pervasive this virus is.”
The EUROIMMUN Anti-SARS-CoV-2 ELISA (IgG) is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. It has 99% specificity and 100% sensitivity after 21 days following the onset of symptoms. Clinical laboratories certified to perform high complexity tests under Clinical Laboratory Improvement Amendments (CLIA) can immediately begin using this ELISA for the detection of antibodies of the immunoglobulin class G.
EUROIMMUN has the capacity to manufacture millions of assays per month. Since March, it has already started shipping its Anti-SARS-CoV-2 ELISA (IgG) to leading laboratories across the globe. EUROIMMUN intends to further build production capacity to meet heightened demand.
“Leading with science is a fundamental part of our DNA at PerkinElmer, and the EUROIMMUN team recognized early on that understanding the pathogenesis of COVID-19 from a cellular biology level is paramount to developing a highly accurate and reliable antibody test,” said Prahlad Singh, president and chief executive officer, PerkinElmer. “As a result, the antigen used in the EUROIMMUN Anti-SARS-CoV-2 ELISA (IgG), the spike protein S1 domain, is more likely to reflect virus neutralizing antibodies than antibodies to N capsid nucleoprotein. This is also supported by the fact that most of the COVID-19 vaccine development programs in the US and worldwide have chosen the spike protein as their target.”
“It is possible that 50% or more of people who have been infected with COVID-19 might not display symptoms, making it difficult to identify those who have previously contracted COVID-19,” added Prahlad Singh. “That’s why serological testing that utilizes an antigen highly specific to SARS-CoV-2 is such an important tool in understanding how pervasive this virus is.”
Latest COVID-19 News
- New Immunosensor Paves Way to Rapid POC Testing for COVID-19 and Emerging Infectious Diseases
- Long COVID Etiologies Found in Acute Infection Blood Samples
- Novel Device Detects COVID-19 Antibodies in Five Minutes
- CRISPR-Powered COVID-19 Test Detects SARS-CoV-2 in 30 Minutes Using Gene Scissors
- Gut Microbiome Dysbiosis Linked to COVID-19
- Novel SARS CoV-2 Rapid Antigen Test Validated for Diagnostic Accuracy
- New COVID + Flu + R.S.V. Test to Help Prepare for `Tripledemic`
- AI Takes Guesswork Out Of Lateral Flow Testing
- Fastest Ever SARS-CoV-2 Antigen Test Designed for Non-Invasive COVID-19 Testing in Any Setting
- Rapid Antigen Tests Detect Omicron, Delta SARS-CoV-2 Variants
- Health Care Professionals Showed Increased Interest in POC Technologies During Pandemic, Finds Study
- Set Up Reserve Lab Capacity Now for Faster Response to Next Pandemic, Say Researchers
- Blood Test Performed During Initial Infection Predicts Long COVID Risk
- Low-Cost COVID-19 Testing Platform Combines Sensitivity of PCR and Speed of Antigen Tests
- Finger-Prick Blood Test Identifies Immunity to COVID-19
- Quick Test Kit Determines Immunity Against COVID-19 and Its Variants