批准快速链球菌聚合酶链反应用于传统临床实验室以外的检查
|
By LabMedica International staff writers Posted on 27 Jul 2015 |
|
图片：Cobas Liat系统设计为一个快速、易用、紧凑的PCR系统（照片由Roche提供）。
Cobas Liat系统是一种耗时15分钟的诊断检查，用于检测咽喉培养物中的甲型链球菌（Strep A），此检查在一种已获得美国食品和药品管理局临床检验改进修正计划（CLIA）豁免的用户友好自动PCR平台上运行。
CLIA豁免允许在非传统实验室地点进行Roche（Basel，Switzerland）cobas Liat系统Strep A检验，包括医师办公室、急诊室、保健诊所、药学临床和其他医疗机构。
Cobs Liat系统是一种快速、易用、紧凑的PCR平台，设计用于床旁按需检查，如医师办公室、药房、以及医院和卫星实验室。此系统配备全自动触摸屏导引操作，操作者需要接受的培训量最少，随时可以使用。该系统包括cobas Liat分析仪——一种小巧的台式分析仪，由一组广泛的仪器保护，并组合了越来越多的检测方法，包括cobas甲型/乙型流感、cobas甲型/乙型流感和RSV，以及Cobas Strep A。
“今天的决定允许在此前依赖快速抗原技术的临床环境中使用cobas Strep A检验，原本使用的技术灵敏度较低，常需要进行确证检验，”Roche Diagnostics的首席运营官，Roland Diggelmann说明。“Cobas Strep A检查大约需要15分钟的时间出具报告，相对于需要使用培养物进行检查要经过数天才能得出结果的情况而言，新的方法改善了患者和专业医疗人员的临床经验。”
Related Links:
Roche
CLIA豁免允许在非传统实验室地点进行Roche（Basel，Switzerland）cobas Liat系统Strep A检验，包括医师办公室、急诊室、保健诊所、药学临床和其他医疗机构。
Cobs Liat系统是一种快速、易用、紧凑的PCR平台，设计用于床旁按需检查，如医师办公室、药房、以及医院和卫星实验室。此系统配备全自动触摸屏导引操作，操作者需要接受的培训量最少，随时可以使用。该系统包括cobas Liat分析仪——一种小巧的台式分析仪，由一组广泛的仪器保护，并组合了越来越多的检测方法，包括cobas甲型/乙型流感、cobas甲型/乙型流感和RSV，以及Cobas Strep A。
“今天的决定允许在此前依赖快速抗原技术的临床环境中使用cobas Strep A检验，原本使用的技术灵敏度较低，常需要进行确证检验，”Roche Diagnostics的首席运营官，Roland Diggelmann说明。“Cobas Strep A检查大约需要15分钟的时间出具报告，相对于需要使用培养物进行检查要经过数天才能得出结果的情况而言，新的方法改善了患者和专业医疗人员的临床经验。”
Related Links:
Roche
Gold Member
Respiratory Syncytial Virus Test
OSOM® RSV Test
Automated MALDI-TOF MS System
EXS 3000
ESR Analyzer
TEST1 2.0
Latest 微生物学 News
Channels
Clinical Chemistry
view channel
New PSA-Based Prognostic Model Improves Prostate Cancer Risk Assessment
Prostate cancer is the second-leading cause of cancer death among American men, and about one in eight will be diagnosed in their lifetime. Screening relies on blood levels of prostate-specific antigen... Read more
Extracellular Vesicles Linked to Heart Failure Risk in CKD Patients
Chronic kidney disease (CKD) affects more than 1 in 7 Americans and is strongly associated with cardiovascular complications, which account for more than half of deaths among people with CKD.... Read more
Molecular Diagnostics
view channel
Diagnostic Device Predicts Treatment Response for Brain Tumors Via Blood Test
Glioblastoma is one of the deadliest forms of brain cancer, largely because doctors have no reliable way to determine whether treatments are working in real time. Assessing therapeutic response currently... Read more
Blood Test Detects Early-Stage Cancers by Measuring Epigenetic Instability
Early-stage cancers are notoriously difficult to detect because molecular changes are subtle and often missed by existing screening tools. Many liquid biopsies rely on measuring absolute DNA methylation... Read more
“Lab-On-A-Disc” Device Paves Way for More Automated Liquid Biopsies
Extracellular vesicles (EVs) are tiny particles released by cells into the bloodstream that carry molecular information about a cell’s condition, including whether it is cancerous. However, EVs are highly... Read more
Blood Test Identifies Inflammatory Breast Cancer Patients at Increased Risk of Brain Metastasis
Brain metastasis is a frequent and devastating complication in patients with inflammatory breast cancer, an aggressive subtype with limited treatment options. Despite its high incidence, the biological... Read moreHematology
view channel
New Guidelines Aim to Improve AL Amyloidosis Diagnosis
Light chain (AL) amyloidosis is a rare, life-threatening bone marrow disorder in which abnormal amyloid proteins accumulate in organs. Approximately 3,260 people in the United States are diagnosed... Read more
Fast and Easy Test Could Revolutionize Blood Transfusions
Blood transfusions are a cornerstone of modern medicine, yet red blood cells can deteriorate quietly while sitting in cold storage for weeks. Although blood units have a fixed expiration date, cells from... Read more
Automated Hemostasis System Helps Labs of All Sizes Optimize Workflow
High-volume hemostasis sections must sustain rapid turnaround while managing reruns and reflex testing. Manual tube handling and preanalytical checks can strain staff time and increase opportunities for error.... Read more
High-Sensitivity Blood Test Improves Assessment of Clotting Risk in Heart Disease Patients
Blood clotting is essential for preventing bleeding, but even small imbalances can lead to serious conditions such as thrombosis or dangerous hemorrhage. In cardiovascular disease, clinicians often struggle... Read moreImmunology
view channel
Blood Test Identifies Lung Cancer Patients Who Can Benefit from Immunotherapy Drug
Small cell lung cancer (SCLC) is an aggressive disease with limited treatment options, and even newly approved immunotherapies do not benefit all patients. While immunotherapy can extend survival for some,... Read more
Whole-Genome Sequencing Approach Identifies Cancer Patients Benefitting From PARP-Inhibitor Treatment
Targeted cancer therapies such as PARP inhibitors can be highly effective, but only for patients whose tumors carry specific DNA repair defects. Identifying these patients accurately remains challenging,... Read more
Ultrasensitive Liquid Biopsy Demonstrates Efficacy in Predicting Immunotherapy Response
Immunotherapy has transformed cancer treatment, but only a small proportion of patients experience lasting benefit, with response rates often remaining between 10% and 20%. Clinicians currently lack reliable... Read more
Microbiology
view channel
Comprehensive Review Identifies Gut Microbiome Signatures Associated With Alzheimer’s Disease
Alzheimer’s disease affects approximately 6.7 million people in the United States and nearly 50 million worldwide, yet early cognitive decline remains difficult to characterize. Increasing evidence suggests... Read more
AI-Powered Platform Enables Rapid Detection of Drug-Resistant C. Auris Pathogens
Infections caused by the pathogenic yeast Candida auris pose a significant threat to hospitalized patients, particularly those with weakened immune systems or those who have invasive medical devices.... Read more
Pathology
view channel
Engineered Yeast Cells Enable Rapid Testing of Cancer Immunotherapy
Developing new cancer immunotherapies is a slow, costly, and high-risk process, particularly for CAR T cell treatments that must precisely recognize cancer-specific antigens. Small differences in tumor... Read more
First-Of-Its-Kind Test Identifies Autism Risk at Birth
Autism spectrum disorder is treatable, and extensive research shows that early intervention can significantly improve cognitive, social, and behavioral outcomes. Yet in the United States, the average age... Read more
Technology
view channel
Robotic Technology Unveiled for Automated Diagnostic Blood Draws
Routine diagnostic blood collection is a high‑volume task that can strain staffing and introduce human‑dependent variability, with downstream implications for sample quality and patient experience.... Read more
ADLM Launches First-of-Its-Kind Data Science Program for Laboratory Medicine Professionals
Clinical laboratories generate billions of test results each year, creating a treasure trove of data with the potential to support more personalized testing, improve operational efficiency, and enhance patient care.... Read more
Aptamer Biosensor Technology to Transform Virus Detection
Rapid and reliable virus detection is essential for controlling outbreaks, from seasonal influenza to global pandemics such as COVID-19. Conventional diagnostic methods, including cell culture, antigen... Read more
AI Models Could Predict Pre-Eclampsia and Anemia Earlier Using Routine Blood Tests
Pre-eclampsia and anemia are major contributors to maternal and child mortality worldwide, together accounting for more than half a million deaths each year and leaving millions with long-term health complications.... Read moreIndustry
view channel
New Collaboration Brings Automated Mass Spectrometry to Routine Laboratory Testing
Mass spectrometry is a powerful analytical technique that identifies and quantifies molecules based on their mass and electrical charge. Its high selectivity, sensitivity, and accuracy make it indispensable... Read more
AI-Powered Cervical Cancer Test Set for Major Rollout in Latin America
Noul Co., a Korean company specializing in AI-based blood and cancer diagnostics, announced it will supply its intelligence (AI)-based miLab CER cervical cancer diagnostic solution to Mexico under a multi‑year... Read more
Diasorin and Fisher Scientific Enter into US Distribution Agreement for Molecular POC Platform
Diasorin (Saluggia, Italy) has entered into an exclusive distribution agreement with Fisher Scientific, part of Thermo Fisher Scientific (Waltham, MA, USA), for the LIAISON NES molecular point-of-care... Read more