The European Commission has proposed updating common specifications for certain class D in vitro diagnostic devices to consider tests for certain parasites and viruses that are of public health concern. Stakeholders have four weeks to comment on the proposed amendments. Ferdous Al-Faruque has the details in Regulatory Focus: https://bit.ly/4fXUysL
RAPS Europe’s Post
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The recent de novo FDA approval of the Prenosis Sepsis Immunoscore is getting headlines for being an “AI-driven” test but what really excites me is that it’s raising broad awareness of sepsis. Sepsis is the immune system becoming dysregulated following infection or injury, including from COVID-19. It can happen to anyone. And it kills over 350,000 Americans each year. We can’t effectively fight outbreaks and pandemics until we have better solutions for sepsis. Why? Because often it’s the host response to an infection that causes the damage, not the virus itself. And so solving for sepsis is useful against *any* virus, fungus, or bacterium. We need to be better able to diagnosis, predict, prevent, and treat sepsis. We can’t really do any of those all that well now at scale. Better tests made by Cytovale and Prenosis will greatly help. But we also need treatments and home-based solutions. I’m proud of BARDA DRIVe especially Kim Sciarretta for being such a pioneer in helping solve sepsis.
In a first, FDA authorizes AI-driven test to predict sepsis in hospitals
washingtonpost.com
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𝘊𝘩𝘭𝘢𝘮𝘺𝘥𝘪𝘢 𝘵𝘳𝘢𝘤𝘩𝘰𝘮𝘢𝘵𝘪𝘴 (CT) and 𝘕𝘦𝘪𝘴𝘴𝘦𝘳𝘪𝘢 𝘨𝘰𝘯𝘰𝘳𝘳𝘩𝘰𝘦𝘢𝘦 (NG) are the most common bacteria causing sexually transmitted infections (STIs). As we discussed previously, rapid access to molecular testing plays a vital role in early STI diagnosis, helping to prevent serious complications. Our STI portfolio is designed to support diagnostic and laboratory services. FluoroType® STI provides dual target detection, ensuring reliable reporting of the challenging-to-detect pathogen NG, as well as CT. This offering is a syndromic panel, powered by the innovative LiquidArray® technology. It covers seven pathogens using nine targets in a single well. This next-generation multiplexing capability allows for the detection and differentiation of the most prevalent bacterial and parasitic pathogens responsible for major STIs. For more information, click the following link: https://lnkd.in/dvzPHmXq. #PublicHealth #STI #Healthcare #BrukerMID #moleculardiagnostics
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Polymerase Chain Reaction (PCR) tests have become crucial in modern healthcare, particularly for diagnosing viral infections such as COVID-19. This comprehensive guide will explore the RT PCR test. Read More: https://lnkd.in/dbq6hUPw
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I’m very proud to share the special issue planned for @toxins on the role bacterial porins and clotting induced abnormalities in vivo and in vitro in collaboration with other journal @medicina mdpi and @immuno mdpi and @antibiotics . A new chance to better understand the link among thrombotic microangiopathies and infections #specialissue #toxins #mdpi #aslnapoli2nord #ospedalesantamariadellegrazie
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The Role of PCR Testing in Transplant Infections Management - check out this white paper from Thermo Fisher Scientific https://lnkd.in/eApGpzCX #medtech #PCRtesting #infectionmanagement
The Role of PCR Testing in Transplant Infections Management
med-technews.com
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🎊 Tongzhou Biotech New Product Release! #HumanParainfluenzaVirus (HPIV) are an important cause of #Respiratoryillness in children and adults with a wide range of clinical manifestations including colds, croup, bronchiolitis, and #pneumonia. #HPIV is an important pathogen of acute #RespiratoryTractInfection in children, and human parainfluenzae virus often exists in respiratory secretions and spreads through person-to-person direct contact and respiratory droplets. The #HPIVRapidTest (Nasopharyngeal Swab) is a rapid test to qualitatively detect the presence of Human #parainfluenza virus antigens in nasopharyngeal swab. The test uses antibodies specific for Human #parainfluenza virus to selectively detect #HumanParainfluenza virus antigens in nasopharyngeal swab specimens. 🔎 More information: https://lnkd.in/g5Ygb5bu #GlobalHealthChallenge #RapidTest #Medical #healthy #medicaltreatment #IVD
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SMALLPOX READINESS Modern Strategies Against an Ancient Disease -Lawrence O. Gostin, JD1; Shalini Singaravelu, MSc2; Noreen Hynes, MD, MPH3 Even the best medical countermeasures may prove ineffective without whole-of-society and systems readiness, including implementation, acceptance, and equitable distribution. Reliable and equitable access to smallpox medical countermeasures will depend on the ability of the countermeasures enterprise to surge, meet demand, and protect high-risk populations. The threat level is high and increasing. The nation’s preparedness must be equal to that threat. https://lnkd.in/gTNFfekv
Modern Strategies for Smallpox Readiness
jamanetwork.com
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Clinical Biochemist | Dual Master's in Digital Health and Public Health Management | COVID-19 Expert | Leader in Clinical Diagnostics | Published Scientist.
🦠💉 **Drawing Parallels: Leveraging Common Cold Trials for COVID-19 Challenge Studies** 🧪🔬 Exploring the potential of challenge trials in addressing the COVID-19 pandemic, researchers are drawing insights from trials involving infections with common cold viruses. By leveraging lessons learned from past trials, particularly those involving respiratory viruses like the common cold, scientists aim to optimize the design and implementation of COVID-19 challenge studies. These trials, which intentionally expose participants to the virus, offer a controlled environment for studying vaccine efficacy and advancing therapeutic interventions. Stay tuned as the medical community navigates the ethical and scientific considerations surrounding COVID-19 challenge trials, guided by insights from previous research endeavors. #COVID19Research #ChallengeTrials #MedicalEthics #RespiratoryViruses #ScientificInnovation 🦠💉🧪🔬
Trials that infected people with common colds can inform today’s COVID-19 challenge trials
nature.com
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SIRT1 modulates the immune response in pneumonia. Decreased SIRT1 expression is associated with a more immature neutrophil response, suggesting impaired bacterial clearance. Increasing SIRT1 may improve clinical outcomes in pneumonia https://lnkd.in/gaBGsyPe
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H.Pylori (Helicobacter Pylori) Did you know that H.Pylori is a bacteria that can cause stomach problems like nausea, vomiting and bloating and can actually progress to cancer . It is spread through contaminated food, water and mouth-mouth contact . Early diagnosis is the key for managing H.Pylori infections which comes hand in hand with rapid laboratory tests like stool antigen test and blood antibody test. For more information about H.Pylori kindly click the link below https://buff.ly/4cZzkZG
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