Typhidot

Chembio Submits EUA Application for New DPP SARS-CoV-2 IgM/IgG Test System

Retrieved on: 
Tuesday, September 8, 2020
Branches of biology, Medical specialties, Glycoproteins, Antibodies, Medicine, Immunology, Immune system disorders, Immunoglobulin M, Immunoglobulin G, Severe acute respiratory syndrome coronavirus 2, Antibody-dependent enhancement, Typhidot

We are pleased to have accomplished all of our objectives in the development and validation of the new DPP SARS-CoV-2 IgM/IgG test system, stated Richard Eberly, Chembios President and Chief Executive Officer.

Key Points: 
  • We are pleased to have accomplished all of our objectives in the development and validation of the new DPP SARS-CoV-2 IgM/IgG test system, stated Richard Eberly, Chembios President and Chief Executive Officer.
  • We are excited to offer a solution to patients and clinicians across the healthcare system that addresses these needs.
  • The DPPSARS-CoV-2 IgM/IgG test system detects antibodies to the Spike Receptor Binding Domain in the blood that the body produces in response to a COVID-19 infection.
  • Forward-looking statements include statements regarding the intent, belief or current expectations of Chembio and its management with respect to obtaining an EUA for a COVID-19 antibody system.

Siemens Healthineers Obtains First FDA EUA for Semi-Quantitative Antibody Test

Retrieved on: 
Tuesday, August 4, 2020
Biotechnology, Medical Supplies, Health, FDA, Medical devices, Infectious diseases, Hospitals, Other Health, Medical specialties, Branches of biology, Medicine, Glycoproteins, Immunology, Antibody, Immunoglobulin G, Blood tests, Serology, COVID-19 testing, Typhidot

Siemens Healthineers announced today that it received FDA Emergency Use Authorization (EUA) for the SARS-CoV-2 IgG (COV2G) antibody test.2 This is the first antibody test authorized with a semi-quantitative detection claim and the fifth antibody test from the company to receive EUA that offers sensitivity and specificity of greater than 99 percent.

Key Points: 
  • Siemens Healthineers announced today that it received FDA Emergency Use Authorization (EUA) for the SARS-CoV-2 IgG (COV2G) antibody test.2 This is the first antibody test authorized with a semi-quantitative detection claim and the fifth antibody test from the company to receive EUA that offers sensitivity and specificity of greater than 99 percent.
  • Whereas the Siemens Healthineers SARS-CoV-2 Total antibody test detects antibodies to IgM and IgG that are present both early and later during the immune response, the COV2G antibody test specifically detects IgG antibodies that persist, and are the basis for an individuals longer term immune response.
  • The COV2G antibody test, and all SARS-CoV-2 antibody tests from Siemens Healthineers, detect antibodies to S1RBD.
  • For example, in a recent head-to-head evaluation of four commercial antibody tests conducted by Public Health England, in partnership with the University of Oxford, Siemens Healthineers COV2T assay was the only test that met both sensitivity and specificity targets.9
    To learn more about antibody test offerings from Siemens Healthineers, visit https://www.siemens-healthineers.com/laboratory-diagnostics/assays-by-di... .

MP Biomedicals and A*STAR Co-Develop Rapid Antibody Point-of-Care Test Kit for SARS-CoV-2

Retrieved on: 
Friday, July 24, 2020
Branches of biology, Medical specialties, Glycoproteins, Medicine, Antibodies, Immunology, Immunoglobulin M, Coronavirus disease, Immunoglobulin G, Typhidot, COVID-19 testing

Named as the ASSURE(R) SARS-CoV-2 IgG/IgM rapid test, or ASSURE(R) in short, the test kit detects antibodies produced by the human immune system in response to exposure to SARS-CoV-2.

Key Points: 
  • Named as the ASSURE(R) SARS-CoV-2 IgG/IgM rapid test, or ASSURE(R) in short, the test kit detects antibodies produced by the human immune system in response to exposure to SARS-CoV-2.
  • ASSURE(R) SARS-CoV-2 IgG/IgM Rapid Test Kit (Photo credit: MP Biomedicals)
    MP Biomedicals Diagnostics division's Research and Development team with their ASSURE(R) SARS-CoV-2 IgG/IgM Rapid Test kits.
  • The ASSURE(R) rapid antibody test kit has been granted Provisional Authorisation by the Health Sciences Authority (HSA) for its intended use in Singapore.
  • With this rapid antibody test kit, we are proud to contribute to the global fight against COVID-19."

Megna Health Announces FDA EUA Approval of COVID-19 Antibody Combo Test Kit

Retrieved on: 
Wednesday, July 22, 2020
Medical specialties, Branches of biology, Glycoproteins, Clinical medicine, Antibodies, Immunology, Immune system disorders, Immunoglobulin M, Immunoglobulin G, Immunologic tests, Typhidot, Seroconversion

Antibody tests could be even more important to the reopening decision-making process since antibody tests indicate a certain degree of immunity for future infection.

Key Points: 
  • Antibody tests could be even more important to the reopening decision-making process since antibody tests indicate a certain degree of immunity for future infection.
  • In addition to studies in 411 patients, Megna's Rapid Antibody Test Kit has also been validated independently by NIH/NCI (National Cancer Institute).
  • "Our antibody kit is a first among combo (IgM and IgG) antibody test kits approved and manufactured in U.S. with such sensitivity," said Eric Hill, Head of Marketing at Megna Health.
  • The company is headquartered in Exton, PA and the antibody combo test kits are manufactured in facilities in Pennsylvania as well.

Rapid Antibody Test Kits for COVID-19 Now Available Through South Carolina Medical Supply Firm, Vessel Medical

Retrieved on: 
Wednesday, June 10, 2020
Other Health, Research, Managed care, General Health, Infectious diseases, Hospitals, Science, Biotechnology, Medical Supplies, FDA, Other Science, Health, Branches of biology, Glycoproteins, Antibodies, Immunology, Immunoglobulin M, Immunoglobulin G, Immunoglobulin heavy chain, Typhidot

Thats why Vessel Medical , a provider of medical workflow solutions, supplies, and equipment, dedicated to providing testing kits and medical supplies needed for battling COVID-19, is now increasing access to quality SARS-CoV-2 rapid antibody test kits throughout the US.

Key Points: 
  • Thats why Vessel Medical , a provider of medical workflow solutions, supplies, and equipment, dedicated to providing testing kits and medical supplies needed for battling COVID-19, is now increasing access to quality SARS-CoV-2 rapid antibody test kits throughout the US.
  • Granted emergency use authorization (EUA) by the Food and Drug Administration (FDA), Vessel Medicals antibody test kits are available to be shipped nationwide for detection of COVID-19 Immunoglobulin G and Immunoglobulin M (IgG/IgM) antibodies.
  • Along with the introduction of this program to provide safety solutions, Vessel Medical donated thousands of N95 masks to hospital systems, fire departments, and police departments throughout South Carolina, where they are headquartered.
  • Vessel Medical, since its inception in 1991, has been committed to providing physicians offices, hospitals, laboratories and their employees with the right workflow solutions, medical supplies, and medical equipment for their needs.

Menarini Silicon Biosystems Begins Distribution of Rapid COVID-19 Antibody Test in North America

Retrieved on: 
Wednesday, June 10, 2020
Medical specialties, Branches of biology, Medicine, Glycoproteins, Antibodies, Immunology, Immunoglobulin M, Blood tests, Immunologic tests, Immunoglobulin G, Typhidot, Coombs test

The test is also available in Europe through A. Menarini Diagnostics, the European diagnostics division of The Menarini Group.

Key Points: 
  • The test is also available in Europe through A. Menarini Diagnostics, the European diagnostics division of The Menarini Group.
  • Healgen's COVID-19 IgG/IgM Rapid Test Cassette detects two types of antibodies, immunoglobulin G (IgG) and immunoglobulin M (IgM), in just 10 minutes.
  • To use the test, healthcare workers place a small sample of serum or plasma or one drop of blood on a test cassette.
  • Antibody tests that have EUA are preferred for public health and clinical use since their test performance data have been reviewed by FDA.

Validation and Reliability of COVID-19 Rapid Test BIOZEK

Retrieved on: 
Thursday, May 7, 2020
Branches of biology, Medical specialties, Glycoproteins, Medicine, Antibodies, Immunology, Immunologic tests, Immunoglobulin M, Immunoglobulin G, Blood tests, Typhidot

APELDOORN, Netherlands, May 7, 2020 /PRNewswire/ -- The validation and overall specificity of the Biozek rapid test has 98% for IgG and 96%, for IgM, which is a bench mark for antibody rapid tests.

Key Points: 
  • APELDOORN, Netherlands, May 7, 2020 /PRNewswire/ -- The validation and overall specificity of the Biozek rapid test has 98% for IgG and 96%, for IgM, which is a bench mark for antibody rapid tests.
  • Inzek has therefore taken initiative and supported the additional study, of which the initial test results are positive.
  • We would also like to highlight the two studies mentioned in the article are not about the Biozek test.
  • The BIOZEK rapid test has been certified by various authorities, led by the CE certification.

Salimetrics' New Salivary Infectious Disease Research Tools: Total Immunoglobulin M (IgM) ELISA Kit

Retrieved on: 
Tuesday, May 5, 2020
Branches of biology, Glycoproteins, Biology, Medical specialties, Antibodies, Immunoglobulin M, Salivary gland, Saliva, Saliva testing, Typhidot

In an effort to advance the science, Salimetrics introduces a new ELISA Kit to measure human total Immunoglobulin M (IgM) in saliva and oral fluids.

Key Points: 
  • In an effort to advance the science, Salimetrics introduces a new ELISA Kit to measure human total Immunoglobulin M (IgM) in saliva and oral fluids.
  • For salivary measures of pathogen specific IgM, total IgM should be used to qualify the salivary sample to ensure there are adequate levels of total IgM to detect the disease specific IgM of interest.
  • The new salivary IgM assay takes its place alongside the recently released Salimetrics Salivary Total Human IgG Assay Kit .
  • To learn more about the new Salivary IgM Assay Kit, researchers can visit the Salimetrics Website , or contact expert researcher support to integrate salivary IgM into their current or future research study.

Beroni Group’s SARS-CoV-2 IgG/IgM Antibody Detection Kit Received CE Certification

Retrieved on: 
Friday, April 3, 2020
Branches of biology, Glycoproteins, Medical specialties, Medicine, Antibodies, Immunology, Zoonoses, Severe acute respiratory syndrome-related coronavirus, Immunoglobulin G, Severe acute respiratory syndrome, Immunoglobulin M, Typhidot

Beronis SARS-CoV-2 IgG/IgM Antibody Detection Kit based on colloidal gold is a rapid single-use immunochromatographic test intended for the qualitative detection of IgG and IgM protein from the SARS-CoV-2 virus in capillary fingerstick whole blood, plasma, and serum samples.

Key Points: 
  • Beronis SARS-CoV-2 IgG/IgM Antibody Detection Kit based on colloidal gold is a rapid single-use immunochromatographic test intended for the qualitative detection of IgG and IgM protein from the SARS-CoV-2 virus in capillary fingerstick whole blood, plasma, and serum samples.
  • The point-of-care test kit is intended for professional use and delivers clinical results within 10 minutes.
  • Jacky Zhang, Chairman and CEO of Beroni Group, said, With the rapid increase in the number of coronavirus cases globally, the availability of fast and effective test kits is of utmost urgency.
  • Beroni will immediately commence discussions with potential distributors to distribute the test kit product to European Countries and other markets.

Predictive Technology Group Announces Distribution Agreement with Wellgistics, LLC for Its Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test for Use by Laboratories and Healthcare Workers at the Point-of-Care

Retrieved on: 
Friday, April 3, 2020
Branches of biology, Glycoproteins, Medical specialties, Medicine, Antibodies, Immunology, Immunoglobulin G, Severe acute respiratory syndrome-related coronavirus, Immunoglobulin M, Typhidot

From the onset of this global crisis, the Wellgistics leadership team has placed its sole focus on finding solutions for America.

Key Points: 
  • From the onset of this global crisis, the Wellgistics leadership team has placed its sole focus on finding solutions for America.
  • Our newly established alliance with Predictive Laboratories allows us to leverage our complex distribution network in delivering the life-saving Assurance AB COVID-19 IgM/IgG Rapid Antibody Test to healthcare professionals all across the country.
  • We will support Wellgistics, their team and customers with Predictive Laboratories full scientific, operational and service team members, added Robinson.
  • About the Assurance AB COVID-19 IgM/IgG Rapid Antibody Test:
    The Assurance AB COVID-19 IgM/IgG Rapid Antibody Test is a rapid test for the qualitative detection of IgM and IgG antibodies associated with the SARS-CoV-2 virus.