|
COVID-19 Crisis Puts Spotlight on Use of Immunoassay Tests
Friday, June 26, 2020
Healthcare publisher, Kalorama Information, highlights immunoassay products receiving clearance or being developed for COVID-19.
ARLINGTON, Va., June 18, 2020 /PRNewswire-PRWeb/ -- The COVID-19 crisis has focused attention on immunoassays. Immunoassays have been used in clinical laboratory medicine since the 1960s and are indispensable tools in clinical diagnostics. Immunoassays are tests that are based on the binding of antibodies to antigens to identify the presence of a substance (an analyte). There has been a great opportunity for immunoassay companies to produce serology-based tests for COVID-19. Serology tests are important to better quantify the number of cases of COVID-19. Kalorama covers the market for immunoassays in its The Worldwide Market for In Vitro Diagnostic Tests, 12th Edtion: https://kaloramainformation.com/product/the-world-market-for-in-vitro-diagnostic-tests-12th-edition.
A wide range of types of immunoassays is used to measure proteins (including antibodies), hormones, drugs, and other analytes. Fully automated immunoassay systems are now found in clinical laboratories. COVID-19 tests that can be used to identify whether individuals have been exposed to the virus by looking at the immune response have been developed. In order to meet an increased demand for clinical testing, the FDA opened the emergency use authorization (EUA) process to high-complexity CLIA labs on February 28, 2020 creating a new pathway for regulated assay development in the COVID-19 emergency.
A number of companies worldwide have received clearance or are developing tests including:
-- Epitope Diagnostics offers the EDI Novel COVID-19 IgG ELISA Kit. The EDI
Novel Coronavirus COVID-19 IgG and IgM assays utilize a microplate-based
enzyme linked immunoassay (ELISA) technique, an established technology
and industry standard in diagnostics. The assay procedure is simple to
perform with a two-step plate wash with a total incubation time of less
than 2 hours for up to 91 samples per plate. Both IgG and IgM kits have
already been used for clinical testing at multiple sites in China. The
test is CE marked.
-- Medakit offers a COVID-19 IgM/IgG Rapid Test POC lateral flow
immunoassay. It can be used for rapid screening of carriers of the virus
that are symptomatic or asymptomatic. The test is CE marked.
-- Eagle Biosciences offers the Coronavirus COVID-19 IgM ELISA Assay Kit.
It is used for the qualitative detection of novel coronavirus infected
pneumonia cases, suspected clustering cases, and other new coronaviruses
in serum samples (COVID-19) through measurement of the COVID-19 IgM
antibody. It is a serological plate-based assay technique designed for
detecting and quantifying substances such as peptides, proteins,
antibodies and hormones. It is CE marked.
-- BD and BioMedomics launched a rapid serology test to detect exposure to
COVID-19 in March 2020. This is a rapid test provided at the point of
care providing results in just 15 minutes. The test analyzes blood,
serum or plasma samples for the presence of immunoglobulin M (IgM) and
Immunoglobulin G (IgG) antibodies associated with the coronavirus
(SARS-CoV-2). IgM provides the first line of defense during viral
infections, followed by the generation of adaptive, high-affinity IgG
responses for long-term immunity and immunological memory. The detection
of COVID-19 IgM antibodies tends to indicate a recent exposure to
COVID-19, and detection of COVID-19 IgG antibodies indicates a later
stage of infection. The test is completed in four, simple steps. First,
blood is collected through normal blood collection devices such as the
BD Microtainer Contact-Activated Lancet. A few drops of blood are then
transferred to the test cartridge, followed by two to three drops of a
buffer. The results can be read in 15 minutes, similar to how
over-the-counter pregnancy tests show multiple lines for positive
results and a single line for negative results. As of May 21, 2020, the
test was removed from the FDA EUA list.
-- Gold Standard Diagnostics Group participants have developed COVID-19
ELISA assays including COVID-19 IgG, IgM and IGA tests.
-- Ortho-Clinical Diagnostics offers its ELISAQ test that detects IGG and
is designed to be used with VITROS Immunodiagnostic Products and the
VITROS 3600 system. It was approved for EUA by FDA.
-- Roche launched its Elecsys Anti-SARS-CoV-2 serology test to detect
antibodies in people that have been exposed to COVID-19. The Elecsys
Anti-SARS-CoV-2 immunoassay is an in vitro test, using human serum and
plasma drawn from a blood sample, to detect antibodies and determine the
body's immune reaction to SARS-CoV-2.
These are among scores of immunoassay products released that can detect COVID-19 immune response.
About Kalorama Information
For more than 30 years, Kalorama Information has been a leading publisher of market research in healthcare areas, including in vitro diagnostics (IVD), biotechnology, healthcare, medical devices, and pharmaceuticals.
SOURCE Kalorama Information
|
|
|
|
|
|
 |
The New Identity Theft Crisis: AI Scams, Child Victims, and Credit Damage Are All Spiking | Jan 22, 2026
|
|
PayDo Launches Unified Payment Infrastructure Suite for Digital Businesses | Jan 22, 2026
|
|
AllSci Launches Hypothesis Publishing: A Seamless Way to Share, Connect, and Advance Scientific Ideas | Jan 22, 2026
|
|
Darwin CX Caps a Banner Year with AI Launch, Sold-Out Events, and Industry Book Launch | Jan 22, 2026
|
|
Canadian Fintech Tuhk Inc., Founded by Ethoca and NuData Security Veterans, Raises US$6 Million Seed Round Led by FINTOP, with Lloyds Banking Group and Capital One Ventures | Jan 22, 2026
|
|
Fintech Startup BON Credit Secures $3.5 Million In Funding | Jan 22, 2026
|
|
IoTeX Publishes MiCA-Compliant Whitepaper for IOTX, Enabling EU-Wide Alignment Under the New Regulatory Framework | Jan 22, 2026
|
|
Nudge Security Unveils Industry's Most Comprehensive AI Security Governance Platform | Jan 22, 2026
|
|
Gametime Launches "12 Days of Gametime" Holiday Giveaway in Partnership with Barstool Sports | Jan 22, 2026
|
|
TSX Venture Exchange Market Data Now Available Across Over 40 Blockchains via Chainlink | Jan 22, 2026
|
|
|
|
