To support countries in their efforts to strengthen detection of TB disease and infection, the World Health Organization (WHO) has published an updated version of the WHO operational handbook on tuberculosis: module 3:diagnosis,to accompany the WHO consolidated guidelines on tuberculosis published earlier this year. The document provides laboratory personnel, clinicians and other clinical staff, as well as ministries of health and technical partners, with detailed guidance on implementing WHO evidence-based recommendations. Furthermore, it describes operational considerations for the use of WHO-recommended tests, providing an overview of all testing classes, presenting revised model algorithms, and outlining the steps and processes required to implement and scale up new tests and testing strategies.
A new study conducted by Quest Diagnostics in collaboration with the University of Alabama has revealed significant gaps in the testing and treatment of sexually transmitted infections (STIs) among pregnant women in the United States.
With the application of the latex-enhanced immunoturbidimetry and the enzyme immunoassay amplification, the sensitivity of biochemical test items is greatly improved. Representative products applied in the biochemical technology platform in 2019-2020 are as follows:
Devyser’s novel test for detecting donor-derived cell-free DNA in blood samples from kidney-transplant patients and its product for screening and follow-up of stem cell transplant patients fulfill IVDR requirements in Europe.
Roche announced that the cobas® HPV test for use on the cobas® 6800/8800 Systems has been awarded World Health Organization (WHO) prequalification. WHO prequalification expands the availability of this critical HPV screening tool in countries that rely on the global organisation’s list in making purchasing and implementation decisions.
Enzo Biochem said after the close of markets on Thursday that it has entered an agreement to sell the assets of its clinical laboratory division to Laboratory Corporation of America.
Becton Dickinson announced that it received 510(k) clearance from the US Food and Drug Administration for a high-throughput assay to detect vaginitis.
On March 14, 2023, Agilent Technologies announced the establishment of an innovation collaboration lab with Alta Scientific Co., Ltd.
Visby Medical said that it has received 510(k) clearance and a CLIA waiver from the US Food and Drug Administration for its second-generation point-of-care sexual health test.
Virax Biolabs Group has reached an agreement for the supply of an Avian Influenza A Virus (AIV) real-time PCR test kit in the European Union (EU) region, or CE mark-accepting markets.
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