FM November2020 Digital P
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LabCor launches<br />
IgG test to assess<br />
effectiveness of<br />
COVID-19 vaccines<br />
LabCorp announced the launch of<br />
a test that provides a quantitative<br />
measurement of an individual’s SARS-<br />
CoV-2 IgG antibodies.<br />
Cov2Quant IgG test, which is<br />
available only for use in clinical trials and<br />
research, was developed to specifically<br />
detect and quantify antibodies to SARS-<br />
CoV-2, the virus that causes COVID-19.<br />
Other COVID-19 antibody tests available<br />
in the market are qualitative and detect<br />
the presence of antibodies, but do not<br />
provide information on the individual’s<br />
antibody levels, LabCorp said.<br />
The test is also currently being<br />
utilized by the Centers for Disease<br />
Control and Prevention (CDC) for<br />
SARS-CoV-2 seroprevalence studies<br />
to understand the level of antibodies<br />
produced through natural exposure and<br />
infection with the virus.<br />
Eurofins’ home<br />
COVID-19 nasal PCR<br />
test receives EUA<br />
An Emergency Use Authorization<br />
(EUA) from the US FDA has been<br />
granted to their at-home COVID-19 nasal<br />
PCR test, Eurofins US Clinical Diagnostics<br />
said.<br />
The EUA authorized self-collection<br />
kit gives consumers a minimally invasive,<br />
convenient and quick option to test from<br />
the comfort of their home.<br />
Results are provided<br />
via email within 24<br />
hours of sample<br />
receipt.<br />
Eurofins’<br />
infectious<br />
disease centre<br />
for excellence,<br />
Viracor,<br />
developed the test<br />
based on its highly<br />
sensitive, FDA EUAauthorized<br />
SARS-<br />
CoV-2 RT-PCR<br />
assay.<br />
ROCHE INTRODUCES<br />
LABORATORY SARS-COV-2<br />
ANTIGEN TEST<br />
Roche will launch a high-volume<br />
SARS-CoV-2 antigen test as an<br />
aid in the diagnosis of SARS-<br />
CoV-2 infection. The test is planned<br />
to be made available at the end of<br />
2020 for markets accepting the CE<br />
mark. The Swiss drug major also<br />
intends to file for Emergency Use<br />
Authorisation (EUA) from the US FDA.<br />
The Elecsys SARS-CoV-2 Antigen<br />
test is a laboratory immunoassay for<br />
the in vitro qualitative detection of<br />
the nucleocapsid antigen of SARS-<br />
CoV-2. The test is performed by<br />
healthcare professionals and uses<br />
nasopharyngeal or oropharyngeal<br />
swab samples from patients with<br />
signs and symptoms suggestive<br />
of COVID-19 or people with either<br />
known or suspected exposure to<br />
SARS-CoV-2.<br />
The Elecsys SARS-CoV-2 Antigen<br />
immunoassay runs on all cobas e<br />
immunochemistry analyzers. These<br />
fully automated systems can provide<br />
test results in 18 minutes for a single<br />
test, with a throughput of up to 300<br />
tests per hour from a single analyzer.<br />
A laboratory-based automated<br />
antigen assay allows for cost and<br />
error reduction due to the removal<br />
of manual handling as well as fast<br />
turn-around times and high-test<br />
throughput.<br />
300<br />
anitgen tests can be<br />
done per hour in<br />
a single analyser<br />
22 / FUTURE<br />
MEDICINE / November 2020