EUROIMMUN Anti-SARS-CoV-2 S1 Curve ELISA Receives FDA Emergency Use Authorization
October 05 2021 - 4:30PM
Business Wire
Assay enabling the measurement of IgG
antibodies could yield future discoveries and insights on immune
responses to SARS-CoV-2
EUROIMMUN, a PerkinElmer, Inc. company (NYSE: PKI), announced
today that the U.S. Food and Drug Administration has provided
Emergency Use Authorization (EUA) for its Anti-SARS-CoV-2 S1
CurveTM ELISA (IgG). This assay allows for the qualitative and
semi-quantitative detection of IgG antibodies formed against the
SARS-CoV-2 S1 antigen, in human serum and plasma. Clinical
laboratories certified under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA) can immediately begin using this ELISA
for the detection of antibodies of the immunoglobulin class G.
The Anti-SARS-CoV-2 S1 Curve ELISA (IgG) – based on EUROIMMUN’s
Anti-SARS-CoV-2 QuantiVacTM ELISA (IgG) that received CE mark in
November 2020 – measures the concentration of antibodies against
the S1 domain of the spike protein including the receptor binding
domain (RBD), which represents an important target antigen for
virus neutralizing antibodies. Due to the low protein homologies
within the coronavirus family, the existence of IgG antibodies
specifically indicates recent or prior infection and is to be used
as an aid in identifying individuals with an adaptive immune
response to SARS-CoV-2. For this reason, S1 based tests play a
critical role in ongoing vaccine development programs and in
research efforts to examine the immunity of individuals previously
infected by SARS-CoV-2.
“Assays that enable the detection of IgG antibodies are an
important tool in the arsenals of scientists and researchers
working to understand the nature of SARS-CoV-2 and prevent the
spread of other highly infectious viruses like it in the future,”
said Dr. Wolfgang Schlumberger, CEO of EUROIMMUN. “With this latest
EUA of our semi-quantitative antibody test, more laboratories will
have the ability to generate in-depth insights on immunity that
advance future antibody therapies and vaccines for COVID-19.”
The assay can run manually or using the EUROLabTM Workstation
ELISA, Sprinter XLTM and other third party ELISA platforms.
The Anti-SARS-CoV-2 S1 Curve ELISA (IgG) is one of many
solutions in EUROIMMUN’s SARS-CoV-2 specific portfolio, which also
includes real-time PCR tests, an antigen detection assay and
multiple antibody tests, a dried blood spot solution, as well as
automation systems for small, medium and high sample
throughput.
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 15,000 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 $3.8 billion in 2020,
serves customers in 190 countries, and is a component of the
S&P 500 index. Additional information is available at
www.perkinelmer.com.
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Media Relations: Chet Murray (781) 663-5728
chet.murray@perkinelmer.com Investor Relations: Steve Willoughby
(781) 663-5677 steve.willoughby@perkinelmer.com
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