Immunologic tests

Qorvo Biotechnologies Omnia™ SARS-CoV-2 Antigen Test Platform Validated in National Institutes of Health (NIH) Funded Study

Retrieved on: 
星期三, 七月 28, 2021
Medicine, Medical tests, Branches of biology, Medical terminology, Academic disciplines, Immunologic tests, Biotechnology, Molecular biology, Point-of-care testing, Rapid antigen test, Sensitivity and specificity

Atlantas Center for Microsystems Engineered Point-of-Care Technologies (ACME-POCT) completed two independent studies, an adult study and a pediatric study, verifying the low SARS-CoV-2 limit of detection (LOD) and high specificity/sensitivity of the Qorvo Omnia Antigen Test.

Key Points: 
  • Atlantas Center for Microsystems Engineered Point-of-Care Technologies (ACME-POCT) completed two independent studies, an adult study and a pediatric study, verifying the low SARS-CoV-2 limit of detection (LOD) and high specificity/sensitivity of the Qorvo Omnia Antigen Test.
  • Three pediatric samples that tested negative on the Qorvo Omnia Antigen Test had Cycle threshold (Ct) values greater than 38 on the Hologic system, indicating very low viral loads in those samples.
  • Overall, the investigators found the Qorvo Omnia platform design intuitive and easy to use while producing rapid test results compared to high-sensitivity molecular testing systems, with test results within 20 minutes from sample collection.
  • This project has been funded in part by the NIH Rapid Acceleration of Diagnostics (RADxSM) initiative with federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health.

Bio-Techne and PROGEN Introduce New Simple Plex AAV2 Immunoassay

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星期三, 七月 28, 2021
Natural sciences, Chemistry, Physical sciences, Laboratory techniques, Immunologic tests, Titration, Immunology, Biochemistry methods, Multiplex, Assay, Titer, Immunoassay

Bio-Techne, owner of the leading ProteinSimple branded protein analysis portfolio of products, and PROGEN will offer the Simple Plex AAV2 viral titer assay on Ella instruments, its multiplexing immunoassay system.

Key Points: 
  • Bio-Techne, owner of the leading ProteinSimple branded protein analysis portfolio of products, and PROGEN will offer the Simple Plex AAV2 viral titer assay on Ella instruments, its multiplexing immunoassay system.
  • Featuring antibodies from PROGEN, the Simple Plex AAV2 viral titer assay detects assembled viral capsids as well as the comprehensively characterized AAV2 standard to deliver industry leading specificity.
  • Available on the Ella platform, the Simple Plex AAV2 assay utilizes the recombinant AAV2 antibody (A20R) from industry leader PROGEN to quantify assembled AAV2 capsids.
  • "Working with ProteinSimple to develop the Simple Plex AAV2 assay was a great experience," said Katja Betts, CEO of PROGEN.

Global WholeHealth Partners Corp.'s (OTC: GWHP) Antibody IgG/IgM and Antigen Tests That They Offer Are Capable of Detecting the DELTA B.1.617.2, United Kingdom (B.1.1.7), South Africa (B.1.351), and Brazil (P.1) of COVID 19 SARS 2

Retrieved on: 
星期一, 七月 26, 2021
Medicine, Branches of biology, Medical specialties, Medical tests, Glycoproteins, Zoonoses, Immunologic tests, Chromatography, Rapid antigen test, Antibody, COVID-19, Immunoglobulin G

Global WholeHealth Partners Corp (OTC: GWHP) states that the Antibody IgG/IgM and Antigen tests that they offer are capable of detecting all the current identified SARS-CoV-2 viruses.

Key Points: 
  • Global WholeHealth Partners Corp (OTC: GWHP) states that the Antibody IgG/IgM and Antigen tests that they offer are capable of detecting all the current identified SARS-CoV-2 viruses.
  • The government is working with the diagnostics industry to ensure the gains in domestic manufacturing are not lost over time.
  • To conquer COVID and win this war, Global must keep up the research and development of tests.
  • Global WholeHealth Partners recognizes that there is a crucial need for faster testing and faster results when it comes to fighting the COVID.

CityHealth Launches RapidReturn COVID-19 Travel Kit

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星期一, 七月 26, 2021
Medicine, Medical tests, Branches of biology, Clinical medicine, Medical terminology, Immunologic tests, COVID-19 testing, Rapid antigen test

The RapidReturn Kit allows US-bound travelers to take a supervised Rapid Antigen test and receive travel-approved results from anywhere in the world.

Key Points: 
  • The RapidReturn Kit allows US-bound travelers to take a supervised Rapid Antigen test and receive travel-approved results from anywhere in the world.
  • Priced at just $75 per kit, each kit contains 2 tests.
  • One kit per traveler is recommended, so travelers are prepared for flight delays or inconclusive results that require a second test.
  • CityHealth's RapidReturn Kit is one of the most affordable and user-friendly pre-travel COVID test kits on the market.

Ortho Clinical Diagnostics Announces Launch of the Interleukin-6 (IL-6) Reagent Pack, Latest Addition to Ortho's Critical Care Blood Testing Menu

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星期四, 七月 22, 2021
Clinical medicine, Medicine, Branches of biology, Blood tests, Acute-phase proteins, Chemical pathology, Ortho Clinical Diagnostics, Immunologic tests, Ortho, C-reactive protein, Troponin, IVD

IL-6 is gaining utility in the evaluation of the most severe forms of respiratory distress, one of the causes of poor outcomes for patients suffering inflammatory diseases.

Key Points: 
  • IL-6 is gaining utility in the evaluation of the most severe forms of respiratory distress, one of the causes of poor outcomes for patients suffering inflammatory diseases.
  • Ortho's comprehensive critical care menu also includes tests for hs Troponin, NT-pro BNP, Ferritin, CRP, D-dimer, Lactate, and PCT.
  • Ortho Clinical Diagnostics (Nasdaq: OCDX) is one of the world's largest pure-play in vitro diagnostics (IVD) companies dedicated to transforming patient care.
  • Ortho helps its customers enhance clinical outcomes, improve efficiency, overcome staffing challenges and reduce costs.

Ortho Clinical Diagnostics Announces Launch of the Interleukin-6 (IL-6) Reagent Pack, Latest Addition to Ortho's Critical Care Blood Testing Menu

Retrieved on: 
星期四, 七月 22, 2021
Clinical medicine, Medicine, Branches of biology, Blood tests, Acute-phase proteins, Chemical pathology, Ortho Clinical Diagnostics, Immunologic tests, Ortho, C-reactive protein, Troponin, IVD

IL-6 is gaining utility in the evaluation of the most severe forms of respiratory distress, one of the causes of poor outcomes for patients suffering inflammatory diseases.

Key Points: 
  • IL-6 is gaining utility in the evaluation of the most severe forms of respiratory distress, one of the causes of poor outcomes for patients suffering inflammatory diseases.
  • Ortho's comprehensive critical care menu also includes tests for hs Troponin, NT-pro BNP, Ferritin, CRP, D-dimer, Lactate, and PCT.
  • Ortho Clinical Diagnostics (Nasdaq: OCDX) is one of the world's largest pure-play in vitro diagnostics (IVD) companies dedicated to transforming patient care.
  • Ortho helps its customers enhance clinical outcomes, improve efficiency, overcome staffing challenges and reduce costs.

Chembio Diagnostics Receives $28.3 Million Purchase Order from Bio-Manguinhos for DPP SARS-CoV-2 Antigen Tests in Brazil

Retrieved on: 
星期三, 七月 21, 2021
Medicine, Medical tests, Branches of biology, Clinical medicine, Medical terminology, Immunologic tests, Chromatography, Molecular biology, Rapid antigen test, COVID-19, Point-of-care testing

HAUPPAUGE, N.Y., July 20, 2021 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading point-of-care diagnostic company focused on infectious diseases, announced its receipt today of a $28.3 million purchase order from Bio-Manguinhos for the purchase of Chembio’s DPP SARS-CoV-2 Antigen tests for delivery during 2021 to support the urgent needs of Brazil’s Ministry of Health in addressing the COVID-19 pandemic. The DPP SARS-CoV-2 Antigen test is designed to detect the SARS-CoV-2 antigen, which indicates an active COVID-19 infection, in only 20 minutes using a minimally invasive nasal swab. Chembio’s delivery of the full number of tests covered by the purchase order may be affected by limitations of Chembio’s supply chain, staffing, and liquidity, and other matters outside Chembio’s control.

Key Points: 
  • The DPP SARS-CoV-2 Antigen test is designed to detect the SARS-CoV-2 antigen, which indicates an active COVID-19 infection, in only 20 minutes using a minimally invasive nasal swab.
  • Chembio has a long-standing relationship with Bio-Manguinhos, having supplied multiple products for point-of-care detection of COVID-19 antibodies, HIV, and other infectious diseases.
  • We believe the purchase order validates the investments we made earlier this year in inventory for the DPP SARS-CoV-2 Antigen test and look forward to ramping up production.
  • Chembios portfolio of DPP-based point-of-care tests with FDA regulatory approvals include the DPP HIV-Syphilis System (PMA approved), DPP HIV 1/2 Assay (PMA approved and CLIA waived), DPP Zika IgM System (510(k)), and DPP Ebola Antigen System (EUA).

Trinity Biotech Provides A Business Development Update For Q2 2021

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星期五, 七月 16, 2021
Medicine, Branches of biology, Natural sciences, Immunologic tests, Medical tests, Biotechnology, Chromatography, Molecular biology, Rapid antigen test

DUBLIN, Ireland, July 16, 2021 (GLOBE NEWSWIRE) -- Trinity Biotech plc (Nasdaq: TRIB) provides a business development update for Q2 2021.

Key Points: 
  • DUBLIN, Ireland, July 16, 2021 (GLOBE NEWSWIRE) -- Trinity Biotech plc (Nasdaq: TRIB) provides a business development update for Q2 2021.
  • Trinity Biotech has been the main confirmatory test provider for the detection of the HIV virus on the African continent over many years.
  • In June 2021, the Company received an update from the WHO on the approval process.
  • Trinity Biotech is at an advanced stage in the development of a SARS-CoV-2 antigen test.

Ninonasal® Antigen Self-Tests Made in France

Retrieved on: 
星期五, 七月 16, 2021
Other Consumer, Medical devices, Infectious diseases, Hospitals, Other Health, Biotechnology, Managed care, Pharmaceutical, Consumer, Health, Medicine, Branches of biology, Medical tests, Natural sciences, Immunologic tests, Medical terminology, Chromatography, Molecular biology, Rapid antigen test

NG Biotech presents Ninonasal, the COVID-19 antigen self-test thats detecting Delta and Epsilon variants.

Key Points: 
  • NG Biotech presents Ninonasal, the COVID-19 antigen self-test thats detecting Delta and Epsilon variants.
  • View the full release here: https://www.businesswire.com/news/home/20210716005156/en/
    NG Biotech presents Ninonasal, the COVID-19 antigen self-test thats detecting Delta and Epsilon variants.
  • In France, Ninonasal is assembled into kits and distributed by Boiron Laboratories in order to strengthen its fully made in France character.
  • With Ninonasal, we did not just launch another rapid antigen test.

Curebase, InBios Announce Results of Virtual Clinical Trial of InBios COVID-19 Rapid Detection Test Using Curebase Platform

Retrieved on: 
星期三, 七月 14, 2021
Medicine, Natural sciences, Branches of biology, Immunologic tests, Medical tests, Medical terminology, Biochemistry methods, COVID-19 testing, Laboratory techniques, Immunoassay, COVID-19, Swab

For this study, Curebase converted drive-through COVID-19 testing centers in southern California into clinical research sites with its unique decentralized clinical trial software platform and virtual site support model.

Key Points: 
  • For this study, Curebase converted drive-through COVID-19 testing centers in southern California into clinical research sites with its unique decentralized clinical trial software platform and virtual site support model.
  • This process required no physical interaction with patients and enabled hundreds of people to be screened in a few weeks.
  • The SCoV-2 Ag Detect Rapid Test is a patent-pending lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleoprotein antigen in direct nasal swab specimens.
  • The point-of-care test r equires no instrumentation or transport media step and can be performed on-site with results delivered in about 20 minutes.