We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress hp
Sign In
Advertise with Us

Download Mobile App




基于PCR的肠胃炎诊断测定获得欧洲上市批文

By LabMedica International staff writers
Posted on 13 Nov 2014
一项基于PCR的检验直接用大便样本筛查引起肠胃炎的细菌,它作为符合有关体外诊断医疗设备的98/79/EC指令的CE-IVD产品,通过了欧洲的上市认证。

芬兰埃斯波市Mobidiag有限公司的Amplidiag细菌性肠胃炎检验利用成熟的qPCR(定量聚合酶链反应)技术直接用大便样本快速定性检测八种肠胃炎致病菌,无需预先培养样本。

Amplidiag细菌性肠胃炎检验产品对从同一份大便样本提取的DNA进行一次测定,快速检测八种最常见、最重要的肠道病原菌,当天报送结果。它不仅检测弯曲菌、沙门氏菌、志贺氏菌/EIEC和耶尔森菌,还检测四种致泻大肠杆菌菌株:肠致病性大肠杆菌(EPEC)、肠集聚型大肠杆菌(EAEC)、溶血素大肠杆菌(EHEC)和肠毒性大肠杆菌(ETEC)。

瑞典和芬兰开展了一项双中心性能评估研究,通过测定1,235份病人样本和125份掺杂样本确证Amplidiag细菌性肠胃炎检验。结果显示,与常规的粪便培养法和独立核酸方法相比,其总体灵敏度为99.0%,特异性为99.9%。以粪便培养法为标准Amplidiag细菌性肠胃炎检验没有给出任何假阴性结果。

Related Links:
Mobidiag有限公司 

Gold Member
Fibrinolysis Assay
HemosIL Fibrinolysis Assay Panel
POC Helicobacter Pylori Test Kit
Hepy Urease Test
CBM Analyzer
Complete Blood Morphology (CBM) Analyzer
Automated Chemiluminescence Immunoassay Analyzer
MS-i3080
Read the full article by registering today, it's FREE! It's Free!
Register now for FREE to LabMedica.com and get access to news and events that shape the world of Clinical Laboratory Medicine.
  • Free digital version edition of LabMedica International sent by email on regular basis
  • Free print version of LabMedica International magazine (available only outside USA and Canada).
  • Free and unlimited access to back issues of LabMedica International in digital format
  • Free LabMedica International Newsletter sent every week containing the latest news
  • Free breaking news sent via email
  • Free access to Events Calendar
  • Free access to LinkXpress new product services
  • REGISTRATION IS FREE AND EASY!
Click here to Register








Channels

Molecular Diagnostics

view channel
Image: The diagnostic device can tell how deadly brain tumors respond to treatment from a simple blood test (Photo courtesy of UQ)

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

Immunology

view channel
Image: Circulating tumor cells isolated from blood samples could help guide immunotherapy decisions (Photo courtesy of Shutterstock)

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

Microbiology

view channel
Image: New evidence suggests that imbalances in the gut microbiome may contribute to the onset and progression of MCI and Alzheimer’s disease (Photo courtesy of Adobe Stock)

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

Technology

view channel
Image: Vitestro has shared a detailed visual explanation of its Autonomous Robotic Phlebotomy Device (photo courtesy of Vitestro)

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

Industry

view channel
Image: Roche’s cobas® Mass Spec solution enables fully automated mass spectrometry in routine clinical laboratories (Photo courtesy of Roche)

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
Copyright © 2000-2026 Globetech Media. All rights reserved.