Mycoplasma genitalium infection

Providers in the United States may now order the FDA-cleared HPV self-collection solution for their patients to use in their offices or other healthcare settings, with goal to reduce barriers to screening by enabling discreet self-collection Quest also plans to make self-collection option available at its 2,000 patient service centers in the United States early next month, expanding access to screening New solution follows company's launch of GTI self-collection option for several STIs and related conditions last fall SECAUCUS, N.J., April 2, 2025 /PRNewswire/ -- Quest Diagnostics (NYSE: DGX), a leader in diagnostic information services, today announced a new solution aimed at broadening access to human papillomavirus (HPV) screening to help identify women who are at risk of developing cervical cancer. Physicians can now offer patients the option to collect their own specimen for HPV screening in a physician's office or other healthcare setting. The company also plans to introduce the self-collection option for patients, with a physician's order, at its 2,000 Quest patient service centers nationwide early next month. The new option builds on Quest's experience in providing patients with discrete self-collection options. The company introduced a self-collection service option for vaginitis and other genital tract infections, such as chlamydia, gonorrhea, trichomoniasis and Mycoplasma genitalium, at its patient service centers in October 2024, and has experienced strong demand for the solution since the launch. The new offering utilizes the FDA-cleared HPV self-collection solution from Roche (SIX: RO, ROG; OTCQX: RHHBY), approved for use with Roche's cobas® HPV test in May 2024. Interested patients can opt for self-collection in clinical settings, such as a doctor's office, or other healthcare settings. "We are seeing more demand for solutions that empower patients to take an active role in their health care," said Kathleen Valentine, Vice President and General Manager of Women's and Reproductive Health Services at Quest Diagnostics. "Cervical cancer is highly preventable when detected early, and yet, over 4,000 American women will die this year of cervical cancer primarily due to inadequate screening. Our goal is to make HPV screening more accessible and discreet for women who may otherwise skip or delay this vital preventive care test and therefore increase their risk of developing cervical cancer." The solution is not FDA approved for at-home collection, and self-collection is not intended to replace a pelvic examination provided by a clinician. Patients should inform their healthcare provider if they suspect they are pregnant or if they have recently had symptoms of pelvic inflammatory disease (such as pelvic pain, pain with sexual intercourse, unusual vaginal discharge or bad odor). If the patient cannot self-collect a specimen, then collection should be performed in another healthcare setting, like a physician's office, where greater support can be provided. The self-collection option is available at no extra charge for the patient or health plan. Improving access to reduce cervical cancer incidence When testing for HPV in conventional practice, a healthcare provider collects a specimen from a patient in their office or clinic and forwards it to a laboratory for testing. With the new self-collection service, patients may self-collect from their vagina in a private room at a physician's office using a simple step-by-step guide.1 The provider will send the specimen to a nearby Quest Diagnostics testing laboratory. After testing, results will be provided to the physician and patient electronically. The physician may review the results during a separate patient visit and provide further evaluation as needed. "The most reliable cervical cancer method is co-testing, which combines HPV and Pap testing, on a specimen collected by a skilled physician," said board-certified obstetrician and gynecologist Damian P. Alagia, MD, Senior Medical Director, Women's Health, Quest Diagnostics. "Yet, the reality is that some patients, whether due to stigma, trauma or some other factor, are not comfortable undergoing specimen collection by their OBGYN or other doctor. Giving providers and patients options is important for caring for the needs and interests of the individual patient." Historically, ensuring routine cervical cancer screening has been challenging, with 4.4 million fewer American women receiving screenings in 2021 when compared to 2019.2 Incidence of cervical cancer in women aged 30-44 increased 1.7% over the same time.3 Recent draft guidelines from the United States Preventive Services Task Force (USPSTF) on cervical cancer screening states self-collection for HPV screening "has similar accuracy to clinician-collected tests and is associated with increased screening in underscreened individuals and in historically underscreened populations."4 Quest Diagnostics is a leader in women's and reproductive health, which includes a complete menu of solutions for screening for and diagnosing cervical cancer. For more information, visit . About Quest Diagnostics Quest Diagnostics works across the healthcare ecosystem to create a healthier world, one life at a time. We provide diagnostic insights from the results of our laboratory testing to empower people, physicians and organizations to take action to improve health outcomes. Derived from one of the world's largest databases of de-identifiable clinical lab results, Quest's diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve healthcare management. Quest Diagnostics annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our nearly 55,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives and create a healthier world. . SOURCE Quest Diagnostics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

研究背景与意义 解脲支原体（Ureaplasma urealyticum, UU）作为泌尿生殖道常见的机会性病原体，因其缺乏细胞壁而对β-内酰胺类抗生素天然耐药，临床治疗依赖大环内酯类、四环素类及氟喹诺酮类药物。既往研究多聚焦于UU与生殖道炎症、不孕症及妊娠并发症的关联，但针对区域性流行病学特征及耐药性动态变化的系统性数据仍较匮乏。 本研究由四川大学华西第二医院团队开展，首次基于SAT（Simultaneous Amplification and Testing，实时荧光恒温扩增技术）RNA检测技术，对中国西南地区8,934例女性和儿童样本进行UU感染分析，并整合药敏数据，为临床精准干预提供循证依据。 研究方法与创新点 研究设计 人群与样本：纳入2019-2023年就诊的8,934例受试者，包括育龄女性（泌尿生殖道拭子）和新生儿（咽拭子），覆盖门诊与住院患者。 检测技术：采用SAT技术检测UU RNA，灵敏度显著高于传统培养法，同时相比于DNA检测，可区分死菌活菌。 药敏分析：对阳性样本进行体外培养，测试对四环素类（如多西环素）、大环内酯类（阿奇霉素、红霉素）及氟喹诺酮类（氧氟沙星）的敏感性。 创新性 技术优势：SAT技术规避了DNA检测可能存在的死菌干扰，更精准反映感染状态。 人群细分：首次同时纳入育龄女性与新生儿，揭示母婴传播的临床影响。 核心发现与临床启示 流行病学特征 感染率：总体阳性率达47.92%，育龄女性（20-40岁）门诊患者感染率最高（88.03%），新生儿住院患者感染率达93.99%。 母婴风险：新生儿UU感染与早产（UU阳性组早产发生率52.75% vs. UU阴性组早产发生率44.64%），尤其是在极早产（28-32周）和超早产（24-28周）新生儿中，及支气管肺发育不良（BPD, 6.89% vs. 4.18%）显著相关，提示垂直传播的临床危害。 耐药模式  敏感药物：四环素类（如多西环素）和大环内酯类（阿奇霉素、红霉素）敏感性最高（>90%），与既往药敏研究一致。 耐药趋势：氟喹诺酮类（氧氟沙星）耐药率较高（约60%），需警惕区域耐药差异。 科室差异：新生儿科样本对大环内酯类敏感性（阿奇霉素93.8%）显著高于妇科样本，可能与新生儿抗生素暴露较少有关。 讨论与建议 筛查及治疗策略优化 为了有效预防不良妊娠结局和新生儿并发症，育龄女性（尤其孕前）及早产儿应纳入常规UU筛查，SAT技术可作为优选方法。 基于药物敏感性数据，不同患者群体的经验性治疗应选择不同的抗菌药物。我们的药物敏感性结果表明，对于女性，推荐的一线选择是多西环素、四环素、普利斯特霉素和交沙霉素；对于孕妇，推荐交沙霉素和克拉霉素；对于新生儿，推荐红霉素和阿奇霉素。 耐药性管理 动态监测：建立区域耐药数据库，避免经验性用药导致的治疗失败。 联合用药：对混合感染或耐药株，可探索四环素类联合大环内酯类的序贯疗法。 结  语 本研究通过高精度检测技术与大样本临床分析，明确了中国西南地区UU感染的流行病学特征及耐药现状，为制定针对UU感染的预防和治疗策略提供了重要依据，特别是在高危人群中（如育龄女性和新生儿）的干预措施。同时，研究结果也提示需要进一步探索UU感染对妊娠结局的影响机制，并建立标准化的抗生素治疗方案。 仁度生物生殖道致病病原体产品包括沙眼衣原体(CT)、淋病奈瑟菌(NG)、解脲脲原体(UU)、生殖支原体(MG)感染4项核酸检测试剂盒，可以实现尿液样本RNA活菌检测，全面覆盖生殖道致病病原体检测，只需少量尿液样本，即可高灵敏获取准确结果，并较PCR法提前1-2周辅助判愈。无创采样，一个样本四个结果，高灵敏测活菌，为临床筛查优选。 文献原文 Epidemiological characteristics and clinical antibiotic resistance analysis of Ureaplasma urealyticum infection among women and children in southwest China. Huang et al. BMC Infectious Diseases (2024) 24:849 https://doi.org/10.1186/s12879-024-09760-9 往期回顾 文献速递 | 中国女性生殖道感染门诊患者的沙眼衣原体及生殖支原体患病率及其危险因素的多中心流行病学调查 关于仁度 上海仁度生物科技股份有限公司（股票代码：688193）成立于2007年，是国内最早一批专注于RNA分子诊断技术和产品的生命科学企业之一，致力于开发临床需求尚未满足的创新诊断技术和产品。公司拥有RNA实时荧光恒温扩增（SAT）的独家专利技术平台，以该技术平台为基础自主研发了一系列分子诊断试剂和设备一体化产品，专注于为生殖、呼吸、消化、血液、食品、环境安全等领域病原体的精准诊断、有效防控和个性化诊疗提供解决方案。 仁爱生命 度衡健康 专注病原体RNA临床检测

FLOQSwab-formatted QAPs Supporting Fourplex PCR Tests for Bacterial STIsMISSISSAUGA, Ontario, July 24, 2023 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces that it is presenting results of its Quality Assessment Products (“QAPs™”) for supporting the clinical use and accuracy of multiplex tests for four of the most prevalent sexually-transmitted infections (“STIs”) at the American Association of Clinical Chemistry (“AACC”) conference taking place in Anaheim, California July 23 to 27, 2023. At AACC, Microbix will exhibit alongside leading firms that provide tests to diagnose and direct treatment of STIs and other infectious diseases. Microbix will thereby showcase its ever-growing portfolio of QAPs that help ensure the accuracy of antigen and molecular (i.e., “PCR”) tests and their workflows. Also at AACC, Microbix will present a poster titled “Evaluating the Performance of Emerging STI Point of Care Assays Using Novel, Room Temperature Stable CT/NG/TV/MG Positive Swab Quality Control Materials.” The poster reviews the performance of novel PROCEED®FLOQ® (RUO) QAPs to support the clinical use and accuracy of multiplex PCR tests for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG) – four of the most prevalent STIs. The poster can be read at https://microbix.com and a REDx®FLOQ® (IVD) product format is also available. Point of Care Tests (“PoCTs”) that can distinguish between STI-causing pathogens promise improved access to care and faster turnaround time from patient-sampling to test-result. However, users of such PoCTs must have accurate and robust test-control materials for quality management purposes. Microbix therefore developed a whole-workflow multiplex STI QAP desiccated on a Copan FLOQSwab® that is stable at 2-30°C and contains inactive whole-genome target pathogens. The poster evaluated its performance with multiple diagnostic platforms in current use and in development, namely the Abbott Alinity™ m STI assay, Aprimeo/Bosch Vivalytic™ STI Assay, BD MAX™ CT/GC/TV assay, Cepheid Xpert® CT/NG and TV assays, Seegene Novaplex™ CT/NG/TV/MG assay, an IVD assay in late-stage development, and a lab-developed assay. Dr. Amer Alagic, an author of the poster and Director of R&D at Microbix, commented prior to his presentation of the poster at AACC “Microbix’s whole-genome and room-temperature stable FLOQSwab-formatted QAPs continue to demonstrate their ability to support quality management on a wide range of molecular assays and instrument platforms. We’re pleased to be offering Microbix QAPs to support clinically-important STI testing – as tools for validation, verification, and training, as external quality assessment samples, and as in-kit controls.” Purchase enquires for these and all Microbix QAPs can be e-mailed to customer.service@microbix.com. About Microbix Biosystems Inc.Microbix Biosystems Inc. creates proprietary biological products for human health, with over 100 skilled employees and annualized sales targeting C$ 2.0 million per month. It makes a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens drive the antibody tests of approximately 100 diagnostics makers, while QAPs are sold to clinical lab accreditation organizations, diagnostics companies, and clinical labs. Microbix QAPs are now available in over 30 countries, supported by a network of 10 international distributors. Microbix is ISO 9001 & 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products. Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably viral transport medium (DxTM™) to stabilize patient samples for lab-based molecular diagnostic testing and Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots. Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada. Forward-Looking InformationThis news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of AACC, the Poster, the STI QAPs, or their relevance, Microbix’s or others’ products or services, business and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced in its presentations, regulatory compliance and approvals, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity or timeliness of delivery), currency exchange rates, maintaining adequate working capital or raising new capital on acceptable terms or at all, and other similar statements about anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions, and expectations; they are not guarantees of future performance. Microbix cautions that all forward-looking information is inherently uncertain and actual performance may be affected by a number of material factors, many of which are beyond its control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions, and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent Microbix’s judgement as of the date of this new release, and it is under no obligation to update or alter any forward-looking information. Please visit https://microbix.com or www.sedar.com for recent Microbix news and filings. For further information, please contact Microbix at: Cameron Groome, CEO(905) 361-8910Jim Currie, CFO(905) 361-8910Deborah Honig, Investor RelationsAdelaide Capital Markets(647) 203-8793 ir@microbix.com Copyright © 2023 Microbix Biosystems Inc. Microbix®, DxTM™, Kinlytic®, PROCEEDx®, QAPs™, and REDx® are trademarks of Microbix Biosystems Inc.PROCEEDx®FLOQ® and REDx®FLOQ® are trademarks of Microbix Biosystems Inc. in collaboration with Copan Italia S.p.A.Copan®, FLOQ®, and FLOQSwab® are trademarks of Copan Italia S.p.A.Other companies’ names and products are protected by their respective trademarks.