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.

hp

Advertise with Us

Latest Issue

Expo Clinical Chem.Molecular DiagnosticsHematologyImmunologyMicrobiologyPathologyTechnologyIndustry Events

Expo Clinical Chem.Molecular DiagnosticsHematologyImmunologyMicrobiologyPathologyTechnologyIndustry Events Advertise with Us

GLOBE SCIENTIFIC, LLC

EUROIMMUN AG

Merck Life Science KGaA

GC Medical Science corp.

Featured Whitepaper

Boule Diagnostics AG:
Slide preparation for WBC differential by manual microscopy

Download Mobile App

Featured Video

ADLM:
ADLM 2025 – Bring the wonder to the premier global laboratory medicine conference

Trending Articles

Rapid Bedside Test Predicts Sepsis with Over 90% Accuracy

First-Of-Its-Kind Device Profiles Newborns' Immune Function Using Single Blood Drop

First Ever Technology Recognizes Disease Biomarkers Directly in Menstrual Blood in Sanitary Towels

Portable Diagnostic Tool Uses Bioluminescence to Detect Viruses at POC

Molecular Fingerprint for Insulin Sensitivity Could Diagnose Diabetes Before Disease Develops

Virtual Staining Technology Paves Way for Non-Invasive Pathological Diagnosis

Crucial Biomarker Discovery to Enable Early Diagnosis of Chronic Renal Failure

DIASYS DIAGNOSTIC SYSTEMS

Partner Sites

HospiMedica

Surgical Ablation During CABG Improves Survival in Patients with Preexisting Atrial Fibrillation

New Battery Technology Delivers Additional Power to Implantable Medical Devices

New Model Reveals Optimal Positioning of Orthopedic Screws in Fractures

Non-Invasive Tool for Removing Lung Cancer Tumors Reduces Surgical Trauma

Optimized Gold Nanoparticles to Improve Drug Delivery, Cancer Therapy and Imaging

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

Visit expo >

Gold Member

Flocked Fiber Swabs

Puritan® Patented HydraFlock®

3-Part Differential Hematology Analyzer
Swelab Alfa Plus Sampler

New

Multilevel Whole Blood Calibrator Set

6PLUS1

New

Urine Drug Test

Instant-view® Phencyclidine Urine Drug Test

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!

Sign in: Registered website members

Sign in: Registered magazine subscribers

Latest 实验室技术 News

Channels

Clinical Chemistry

view channel

Image: A new diagnostic tool shines a powerful new light into the viral darkness (Photo courtesy of Adobe Stock)

Portable Diagnostic Tool Uses Bioluminescence to Detect Viruses at POC

Point-of-care diagnostics have become crucial tools in many households, enabling individuals to measure blood sugar, conduct pregnancy tests, and even perform their own COVID-19 assays. These diagnostics... Read more

Image: The POC device rapidly predicts neonatal respiratory disease at birth in the NICU (Photo courtesy of SIME Diagnostics)

AI-Powered Lung Maturity Test Identifies Newborns at Higher Risk of Respiratory Distress

Each year, approximately 300,000 babies in the United States are born between 32 and 36 weeks' gestation, according to national health data. This group is at an elevated risk for respiratory distress,... Read more

Image: The GlycoLocate platform uses multi-omics and advanced computational biology algorithms to diagnose early-stage cancers (Photo courtesy of AOA Dx)

AI-Powered Blood Test Accurately Detects Ovarian Cancer

Ovarian cancer ranks as the fifth leading cause of cancer-related deaths in women, largely due to late-stage diagnoses. Although over 90% of women exhibit symptoms in Stage I, only 20% are diagnosed in... Read more

Image: The researchers detected genomic alterations from plasma cfDNA (Photo courtesy of 123RF)

Automated Decentralized cfDNA NGS Assay Identifies Alterations in Advanced Solid Tumors

Current circulating cell-free DNA (cfDNA) assays are typically centralized, requiring specialized handling and transportation of samples. Introducing a flexible, decentralized sequencing system at the... Read more

Molecular Diagnostics

view channel

Image: Cancers can be detected in the bloodstream prior to clinical signs or symptoms (Photo courtesy of 123RF)

MCED Tests Detect Cancers in Bloodstream Three Years Prior To Diagnosis

Detecting cancer before symptoms emerge remains a major challenge in oncology. Now, a new study reveals that tumor-derived genetic material can be found in the bloodstream as early as three years before... Read more

Image: NHS is the first in the world to roll out a revolutionary blood test for cancer patients (Photo courtesy of Adobe Stock)

Revolutionary Blood Test Aims to Fast-Track Lung Cancer Patients for Targeted Therapy

Delays in diagnosing and treating lung and breast cancer can significantly affect patient survival, especially when access to targeted therapies hinges on time-consuming tissue biopsies.... Read more

Image: The new diagnostic based on analysis of urine samples could also be designed to reveal whether a tumor has metastasized (Photo courtesy of MIT)

Simple Paper Test Offers Early Cancer Diagnosis

Diagnosing cancer at an early stage remains a significant clinical challenge, particularly in resource-limited settings where access to advanced testing equipment is scarce. Conventional detection methods... Read more

Image: The precision oncology test identifies patients most at risk of undergoing severe toxicity from treatment with 5FU/capecitabine (Photo courtesy of 123RF)

Precision Oncology Test Predicts Patient Toxicity Before Beginning Chemotherapy

5-fluorouracil (5FU) and capecitabine have been cornerstone chemotherapeutic agents for over four decades, effectively treating a variety of cancers. However, 5FU/capecitabine can cause varying degrees... Read more

Hematology

view channel

Image: CitoCBC is the world first cartridge-based CBC to be granted CLIA Waived status by FDA (Photo courtesy of CytoChip)

Disposable Cartridge-Based Test Delivers Rapid and Accurate CBC Results

Complete Blood Count (CBC) is one of the most commonly ordered lab tests, crucial for diagnosing diseases, monitoring therapies, and conducting routine health screenings. However, more than 90% of physician... Read more

Image: The FINDER multifunctional testing platform can run multiple types of tests and deliver rapid results for near-patient use (Photo courtesy of Baebies)

First Point-of-Care Heparin Monitoring Test Provides Results in Under 15 Minutes

Heparin dosing requires careful management to avoid both bleeding and clotting complications. In high-risk situations like extracorporeal membrane oxygenation (ECMO), mortality rates can reach about 50%,... Read more

Image: The 3-parameter CCRS model was devised specifically for patients diagnosed with clonal cytopenia (Photo courtesy of 123RF)

New Scoring System Predicts Risk of Developing Cancer from Common Blood Disorder

Clonal cytopenia of undetermined significance (CCUS) is a blood disorder commonly found in older adults, characterized by mutations in blood cells and a low blood count, but without any obvious cause or... Read more

Image: The technology has the unique ability to detect challenging RhD variants that are typically excluded by other commercial tests (Photo courtesy of BillionToOne)

Non-Invasive Prenatal Test for Fetal RhD Status Demonstrates 100% Accuracy

In the United States, approximately 15% of pregnant individuals are RhD-negative. However, in about 40% of these cases, the fetus is also RhD-negative, making the administration of RhoGAM unnecessary.... Read more

Immunology

view channel

Image: The tip optofluidic immunoassay platform enables rapid, multiplexed antibody profiling using only 1 μL of fingertip blood (Photo courtesy of hLife, DOI:10.1016/j.hlife.2025.04.005)

POC Diagnostic Platform Performs Immune Analysis Using One Drop of Fingertip Blood

As new COVID-19 variants continue to emerge and individuals accumulate complex histories of vaccination and infection, there is an urgent need for diagnostic tools that can quickly and accurately assess... Read more

Image: Switching to an experimental drug after liquid biopsy detection of breast cancer recurrence can improve outcomes (Photo courtesy of Shutterstock)

Treatment Switching Guided by Liquid Biopsy Blood Tests Improves Outcomes for Breast Cancer Patients

Standard treatment for patients with advanced estrogen receptor (ER)-positive, HER2-negative breast cancer, a subtype driven by estrogen receptors that fuel tumor growth, often involves aromatase inhibitors,... Read more

Image: Custom hardware and software for the real-time detection of immune cell biophysical signatures in NICU (Photo courtesy of Pediatric Research, DOI:10.1038/s41390-025-03952-y)

First-Of-Its-Kind Device Profiles Newborns' Immune Function Using Single Blood Drop

Premature infants are highly susceptible to severe and life-threatening conditions, such as sepsis and necrotizing enterocolitis (NEC). Newborn sepsis, which is a bloodstream infection occurring in the... Read more

Image: The cancer stem cell test can accurately choose more effective treatments (Photo courtesy of University of Cincinnati)

Stem Cell Test Predicts Treatment Outcome for Patients with Platinum-Resistant Ovarian Cancer

Epithelial ovarian cancer frequently responds to chemotherapy initially, but eventually, the tumor develops resistance to the therapy, leading to regrowth. This resistance is partially due to the activation... Read more

Microbiology

view channel

Image: Cutting-edge hospital genomics initiative takes on dangerous superbug (Photo courtesy of 123RF)

Real-Time Genome Sequencing Detects Dangerous Superbug Causing Hospital Infections

Superbug infections caused by Staphylococcus aureus, or ‘golden staph’, are notoriously difficult to treat and claim over one million lives globally each year. These bacteria can rapidly develop resistance... Read more

Diagnostic Test Accurately Detects Colorectal Cancer by Identifying Microbial Signature in Gut Bacteria

Colorectal cancer remains one of the deadliest and most common forms of cancer worldwide, with only 40% of cases diagnosed before metastasis. Current screening methods, like colonoscopy, are invasive and... Read more

Image: PowerBlade is a portable device that uses a drop of blood and an automated sequence of steps to efficiently detect sepsis (Photo courtesy of NRC)

Rapid Bedside Test Predicts Sepsis with Over 90% Accuracy

Sepsis is a severe response to an infection that causes the immune system to attack the body's own organs and tissues, potentially leading to organ failure and death if not addressed promptly.... Read more

Image: The new prototype blood test for infectious diseases is designed to be delivered and analyzed at the POC (Photo courtesy of Abertay University)

New Blood Test Detects Up to Five Infectious Diseases at POC

Researchers have developed a prototype flow-through assay capable of detecting up to five different infections, with results that can be quickly analyzed and transmitted via a specialized smartphone app.... Read more

Pathology

view channel

Image: Microscopy image of invasive breast cancer cells degrading their underlying extracellular matrix (Photo courtesy of University of Turku)

Visualization Tool Illuminates Breast Cancer Cell Migration to Suggest New Treatment Avenues

Patients with breast cancer who progress from ductal carcinoma in situ (DCIS) to invasive ductal carcinoma (IDC) face a significantly worse prognosis, as metastatic disease remains incurable.... Read more

Image: A new at-home self-collection device aims to reduce the screening gap for cervical cancer (Photo courtesy of CU School of Medicine)

New At-Home Cervical Cancer Screening Device to Increase Accessibility for Patients

Cervical cancer is typically linked to certain types of human papillomavirus (HPV), which is passed through sexual contact. While many people are infected with HPV, only a small percentage will develop... Read more

Image: Mimix Reference Standards are cell-line derived to maintain genomic complexity and mimic patient material across molecular diagnostics workflows (Photo courtesy of Revvity)

New Cancer Testing Standards to Improve Diagnostic Accuracy for Oncology Labs

Accurate diagnosis, including the identification of genomic markers, is essential for determining the most effective cancer treatments for patients. To ensure this, laboratories require reliable reference... Read more

Image: An algorithm within the Check4 platform interprets data from the cartridge and sends test results to users by text or email (Photo courtesy of IdentifySensors)

Digital Diagnostic Platform Uses Electronic Technology for Rapid Disease Detection

Traditional diagnostic methods often fall short in providing rapid, accurate detection of infectious diseases, leading to delays in treatment and increased transmission. Now, a groundbreaking digital diagnostics... Read more

Technology

view channel

Image: The machine learning-based method delivers near-perfect survival estimates for PAC patients (Photo courtesy of Shutterstock)

AI Method Predicts Overall Survival Rate of Prostate Cancer Patients

Prostate adenocarcinoma (PAC) accounts for 99% of prostate cancer diagnoses and is the second most common cancer in men globally after skin cancer. With more than 3.3 million men in the United States diagnosed... Read more

Image: The second-generation sampler currently under development (Photo courtesy of Breathe BioMedical)

Breath Test to Enable Early Detection of Breast Cancer

Mammograms often fail to detect breast cancer in women with dense breast tissue, missing up to 60% of cases due to reduced image clarity. Breath analytics has the potential to allow for timely detection... Read more

Image: Concept of biosensor integrated into hygiene pads enabling direct semi-quantitative analysis of biomarkers in unprocessed menstruation blood (Photo courtesy of Dosnon, L et al. DOI: 10.1002/advs.202505170)

First Ever Technology Recognizes Disease Biomarkers Directly in Menstrual Blood in Sanitary Towels

Over 1.8 billion people menstruate worldwide, yet menstrual blood has been largely overlooked in medical practice. This blood contains hundreds of proteins, many of which correlate with their concentration... Read more

Image: Scanning electron microscopy images showing 3D micro-printed Limacon-shaped whispering-gallery-mode microcavities with different amounts of deformation (Photo courtesy of A. Ping Zhang/PolyU)

Tiny Microlaser Sensors with Supercharged Biosensing Ability to Enable Early Disease Diagnosis

Optical whispering-gallery-mode microlaser sensors function by trapping light within tiny microcavities. When target molecules bind to the cavity, they induce subtle changes in the laser’s frequency, allowing... Read more

Industry

view channel

Image: The collaboration aims to speed up the adoption of ultrasensitive immunoassays incorporating single-molecule counting technology (Photo courtesy of Fujirebio)

Fujirebio Collaborates with Stanford Medicine to Advance Infectious Disease Research

Fujirebio (Tokyo, Japan) has entered into a collaboration with Stanford Medicine (Palo Alto, CA, USA) to accelerate the adoption of ultrasensitive immunoassays that incorporate single-molecule counting... Read more

Image: The LEX system brings together high speed and high sensitivity in a PCR molecular system to redefine POC diagnostics (Photo courtesy of LEX Diagnostics)

QuidelOrtho to Acquire MDx Company LEX Diagnostics

QuidelOrtho Corporation (San Diego, CA, USA) has announced a refocusing of its molecular diagnostics strategy which now includes acquiring LEX Diagnostics (Cambridgeshire, UK) and discontinuing development... Read more

Image: The new partnerships enhance QIAGEN’s capabilities to support pharma partner clinical trials using QIAcuity digital PCR (Photo courtesy of QIAGEN)

QIAGEN Enters into New Strategic Partnerships for Expanding MRD Testing Portfolio in Oncology

Minimal residual disease (MRD) testing offers a highly sensitive way to monitor treatment response, identify patients at risk of relapse before symptoms appear and inform decisions on therapy usage.... Read more

Danaher and AstraZeneca Partner on Next Generation AI-Powered Diagnostics

Danaher Corporation (Washington, D.C., USA) has entered into a partnership with AstraZeneca (Cambridge, UK to develop and commercialize novel diagnostic tools and tests intended to help clinicians... Read more

LabMedica

About Us
Advertising Info
Subscription
Client Login
Privacy Policy
Terms of Service
Cookie Policy
Journal Info
Contact Us

Channels

Clinical Chem.
Molecular Diagnostics
Hematology
Immunology
Microbiology
Pathology
Technology
BioResearch
Industry
Events
Focus
Webinars

Features

Events Product Showcase LinkXpress Whitepapers archive Video Library

Partner Sites

LabMedica Expo HospiMedica.com Globetech.net

Archive:

BioResearch
COVID-19

2025
MEDLAB 2024
Medica ADLM Medlab 2023
Medica AACC

EUROMEDLAB Medlab 2022
MEDICA AACC ECCMID EUROMEDLAB Medlab 2021
Medica

Copyright © 2000-2025 Globetech Media. All rights reserved.

MOBILE | FULL SITE