Siemens Healthineers announced 7 January that the U.S. FDA has issued an Emergency Use Authorization (EUA) for their laboratory-based IL-6 assay to measure the presence of Interleukin-6 (IL-6) in human serum or plasma. IL-6 is an indicator of potential severe inflammatory response in patients with confirmed SARS-CoV-2 infection. Emergency use of this test is limited […]
ZTA Biotech, a Budapest-based biotech start-up, announced 6 January the breakthrough development of a COVID-19 antibody (IgG) test using the ELISA protocol – and is offering the intellectual property rights to licensees or a sole-rights purchaser.
DiaSys has introduced cartridge-based rapid tests for the detection of COVID-19 antigens and IgM and IgG antibodies, Influenza A&B as well as SGTi-flex COVID-19 & Flu A/B Ag DUO. These rapid tests are easy and reliable to use and provide accurate results within a short time. Besides providing quick access to test results, rapid tests […]
Hologic’s new Genius Digital Diagnostics System is now CE marked in Europe. Genius Digital Diagnostics is the first digital cytology platform to combine a new artificial intelligence (AI) algorithm with advanced digital imaging to help cytotechnologists and pathologists identify precancerous lesions and cancer cells in women.
NUVIO has released the first completely reusable 3D cell culture microplate on the market. Scientific research currently consumes highvolumes of single-use plastics – from serological pipettes and pipette tips to vials and culture microplates – these are just a few of the many plastic items thrown in the garbage in labs every day. eNUVIO’s completely […]
Three types of assays are used to monitor COVID-19 infection: detection of the virus by a molecular test (PCR), by an antigen test, and serological assays that detect antibodies produced upon infection.
Beckman Coulter has launched its Access SARS-CoV-2 Immunoglobulin M (IgM) assay in countries accepting the CE Mark. The new IgM antibody test demonstrated 99.9% specificity with 1,400 negative samples and 100% sensitivity at >18 days post symptom onset and post positive PCR. Beckman Coulter’s IgM assay is part of a full suite of testing solutions […]
Mologic’s professional-use COVID-19 Rapid Antigen Test has been certified with a CE mark. The test provides health professionals an accurate detection of the nucleoprotein of the SARS-CoV-2 virus in respiratory swabs, within 10 minutes. Development and validation were supported by the Wellcome Trust and the Foreign, Commonwealth and Development Office (FCDO) Joint Initiative on Research […]
Associates of Cape Cod, Inc. (ACC), an East Falmouth, Massachusetts-based IVD company, recently launched Fungitell STAT. Fungitell STAT is the first and only single sample format FDA-cleared and CE-marked rapid in vitro diagnostic screening test for invasive fungal infection (IFI) that detects (13)-ß-D-glucan in serum within 60 minutes. This near POC test offers the convenience […]
Nova Biomedical has released Nova Primary, a rapid, accurate, easy to use, blood glucose laboratory analyser. Nova Primary fills the need for a new glucose reference analyzer to replace the YSI STAT PLUS 2300 Glucose and L-Lactate analyser.
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