Immunodiagnostic Systems Hldgs PLC Automated IgM assay to detect SARS-CoV-2 (9784V)
August 13 2020 - 2:00AM
UK Regulatory
TIDMIDH
RNS Number : 9784V
Immunodiagnostic Systems Hldgs PLC
13 August 2020
Immunodiagnostic Systems Holdings plc.
13 August 2020
Automated assay to detect SARS-CoV-2 IgM antibodies
Immunodiagnostic Systems Holdings plc (IDS), a specialty
solution provider to the clinical laboratory diagnostic market,
announces a new automated SARS-CoV-2 IgM assay (The Test) has
achieved CE marking and is expected to be available for sale in the
UK, European Union and other countries which accept the CE mark as
the basis of regulatory approval in September.
The Test, which arises from the partnership between IDS and
Technogenetics, is designed to run on the automated IDS-iSYS
analyser. For territories which do not accept CE marked products,
the requisite regulatory approvals will be required.
The presence of IgM antibodies to a virus is generally more
short-lived than that of IgG antibodies. Thus, testing both
antibody classes often helps the laboratory and clinician
differentiate between a recent and an historic infection. During
the outbreak of 2003-SARS and 2016-Zika, IgM / IgG antibody
detection was used as one of the recommended diagnostic
methods.
Test Overview
-- Detects specific IgM antibodies indicating recent exposure to
the COVID-19 virus and that the immune system has started
responding to the virus;
-- When used in conjunction with IDS' automated SARS-CoV-2 IgG
assay, will help laboratories to differentiate between the IgG and
IgM antibody isotypes present in a sample;
-- Test results available within 30 minutes.
These tests can play a critical role in the fight against
COVID-19 by helping healthcare professionals identify individuals
who may have been exposed to the SARS-CoV-2 virus and may have
developed an immune response. Healthcare authorities have generally
requested separate detection of IgM and IgG antibodies, as this can
cover a wider period of antibody production, and each isotype may
contribute complementary information as to the infection
status.
Jaap Stuut, CEO of IDS commented:
"The ability to test IgG and IgM antibodies simultaneously from
the same sample tube, on the same automated analyzer, will provide
a valuable diagnostic complement to RT-PCR tests used to detect the
COVID-19 virus."
For further information:
Immunodiagnostic Systems Holdings plc Tel: +44 (0) 191 519 6111
Jaap Stuut, Chief Executive Officer
Paul Martin, Group Finance Director
Peel Hunt LLP Tel: +44 (0) 20 7418 8900
James Steel
Oliver Jackson
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END
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