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.

Newly CE-Marked Automated Respiratory Disease Assay Now Available

By LabMedica International staff writers
Posted on 09 Sep 2014

Image: The GeneXpert IV fully integrated and automated on-demand molecular diagnostic system (Photo courtesy of Cepheid).

Image: The GeneXpert IV fully integrated and automated on-demand molecular diagnostic system (Photo courtesy of Cepheid).

A dedicated “laboratory in a cartridge” that enables the simultaneous diagnosis of influenza A and B and RSV (respiratory syncytial virus) is now available for use on one of the world's leading diagnostic platforms.

The patented, single use Xpert Flu/RSV XC assay runs on Cepheid's (Sunnyvale, CA, USA) GeneXpert System, one of the world's leading molecular diagnostic platforms with more than 7,000 systems installed to date.

A dedicated GeneXpert cartridge, which centralizes sample extraction, amplification, and detection, is now available for 18 different pathogens. The cartridge is the heart of the GeneXpert system, which includes instruments in 1, 2, 4, 16, 48, or 80-module configurations.

"We employed a novel in silico approach to identify multiple complementary target segments to avoid the effects of seasonal genetic drift and to anticipate emerging novel influenza strains. Though simple to perform, Xpert Flu/RSV XC is a highly multiplexed, state-of-the-art test for rapid and accurate detection and differentiation of Flu A, Flu B, and RSV infection," said Dr. David Persing, Chief Medical and Technology Officer at Cepheid. "This test may also become a valuable asset in efforts toward pandemic preparedness because it was designed from its inception to provide unprecedented coverage of avian influenza strains."

The Xpert Flu/RSV XC assay will begin shipping in September 2014 as a CE-IVD Marked product.

Related Links:
Cepheid

Visit expo >

Gold Member

Immunochromatographic Assay

CRYPTO Cassette

POC Helicobacter Pylori Test Kit
Hepy Urease Test

Homocysteine Quality Control

Liquichek Homocysteine Control

Gel Cards

DG Gel Cards

Latest Microbiology News

Channels

Clinical Chemistry

view channel

New Blood Test Index Offers Earlier Detection of Liver Scarring

Metabolic fatty liver disease is highly prevalent and often silent, yet it can progress to fibrosis, cirrhosis, and liver failure. Current first-line blood test scores frequently return indeterminate results,... Read more

Image: One of 32 sensors in the electronic nose (Photo courtesy of Linköping University)

Electronic Nose Smells Early Signs of Ovarian Cancer in Blood

Ovarian cancer is often diagnosed at a late stage because its symptoms are vague and resemble those of more common conditions. Unlike breast cancer, there is currently no reliable screening method, and... Read more

Simple Blood Test Offers New Path to Alzheimer’s Assessment in Primary Care

Timely evaluation of cognitive symptoms in primary care is often limited by restricted access to specialized diagnostics and invasive confirmatory procedures. Clinicians need accessible tools to determine... Read more

Existing Hospital Analyzers Can Identify Fake Liquid Medical Products

Counterfeit and substandard medicines remain a serious global health threat, with World Health Organization estimates suggesting that 10.5% of medicines in low- and middle-income countries are either fake... Read more

Molecular Diagnostics

view channel

Blood Test Could Spot Common Post-Surgery Condition Early

Heterotopic ossification (HO), the abnormal formation of bone in soft tissue, is a common complication following hip replacement surgery. The condition affects nearly one in three patients and can lead... Read more

New Blood Test Can Help Predict Testicular Cancer Recurrence

Stage 1 testicular germ cell tumor is typically treated with surgery followed by active surveillance. Although most patients experience strong long-term outcomes, about one in four will see their cancer... Read more

New Test Detects Alzheimer’s by Analyzing Altered Protein Shapes in Blood

Alzheimer’s disease begins developing years before memory loss or other symptoms become visible. Misfolded proteins gradually accumulate in the brain, disrupting normal cellular processes.... Read more

Image: Proteomic analysis of cerebrospinal fluid revealed a set of markers that better distinguishes MS from related inflammatory diseases (Photo courtesy of TUM, adapted by MPI of Biochemistry)

New Diagnostic Markers for Multiple Sclerosis Discovered in Cerebrospinal Fluid

Multiple sclerosis (MS) affects nearly three million people worldwide and can cause symptoms such as numbness, visual disturbances, fatigue, and neurological disability. Diagnosing the disease can be challenging... Read more

Hematology

view channel

$Image: Hemex Health’s Gazelle platform is designed to rapidly separate and detect hemoglobin fractions and variants using miniaturized electrophoresis technology (photo courtesy of Hemex Health)$

Rapid Cartridge-Based Test Aims to Expand Access to Hemoglobin Disorder Diagnosis

Sickle cell disease and beta thalassemia are hemoglobin disorders that often require referral to specialized laboratories for definitive diagnosis, delaying results for patients and clinicians.... Read more

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

Image: The new device can fit in the palm and is capable of measuring the quality of red blood cells (Photo courtesy of Xiaoyun Ding)

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

Immunology

view channel

Cancer Mutation ‘Fingerprints’ to Improve Prediction of Immunotherapy Response

Cancer cells accumulate thousands of genetic mutations, but not all mutations affect tumors in the same way. Some make cancer cells more visible to the immune system, while others allow tumors to evade... Read more

Image: The study identified a distinct immune signature associated with treatment-resistant myasthenia gravis (Dodd, Katherine C. et al., Med (2026). DOI: 10.1016/j.medj.2025.100987)

Immune Signature Identified in Treatment-Resistant Myasthenia Gravis

Myasthenia gravis is a rare autoimmune disorder in which immune attack at the neuromuscular junction causes fluctuating weakness that can impair vision, movement, speech, swallowing, and breathing.... Read more

New Biomarker Predicts Chemotherapy Response in Triple-Negative Breast Cancer

Triple-negative breast cancer is an aggressive form of breast cancer in which patients often show widely varying responses to chemotherapy. Predicting who will benefit from treatment remains challenging,... Read more

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:The technique enables sequencing of the M. tuberculosis genome directly from patient samples without culturing the bacteria first (Photo courtesy of Adobe Stock)

Rapid Sequencing Could Transform Tuberculosis Care

Tuberculosis remains the world’s leading cause of death from a single infectious agent, responsible for more than one million deaths each year. Diagnosing and monitoring the disease can be slow because... Read more

Blood-Based Viral Signature Identified in Crohn’s Disease

Crohn’s disease is a chronic inflammatory intestinal disorder affecting approximately 0.4% of the European population, with symptoms and progression that vary widely. Although viral components of the microbiome... Read more

Image: The findings suggest that interactions between gut bacteria and the viruses they harbor may contribute to colorectal cancer development (photo courtesy of Adobe Stock)

Hidden Gut Viruses Linked to Colorectal Cancer Risk

Colorectal cancer (CRC) remains a leading cause of cancer mortality in many Western countries, and existing risk-stratification approaches leave substantial room for improvement. Although age, diet, and... Read more

Three-Test Panel Launched for Detection of Liver Fluke Infections

Parasitic liver fluke infections remain endemic in parts of Asia, where transmission commonly occurs through consumption of raw freshwater fish or aquatic plants. Chronic infection is a well-established... Read more

Pathology

view channel

World’s First Optical Microneedle Device to Enable Blood-Sampling-Free Clinical Testing

Blood sampling is one of the most common clinical procedures, but it can be difficult or uncomfortable for many patients, especially older adults or individuals with certain medical conditions.... Read more

Pathogen-Agnostic Testing Reveals Hidden Respiratory Threats in Negative Samples

Polymerase Chain Reaction (PCR) testing became widely recognized during the COVID-19 pandemic as a powerful method for detecting viruses such as SARS-CoV-2. PCR belongs to a group of diagnostic methods... Read more

Molecular Imaging to Reduce Need for Melanoma Biopsies

Melanoma is the deadliest form of skin cancer and accounts for the vast majority of skin cancer-related deaths. Because early melanomas can closely resemble benign moles, clinicians often rely on visual... Read more

Urine Specimen Collection System Improves Diagnostic Accuracy and Efficiency

Urine testing is a critical, non-invasive diagnostic tool used to detect conditions such as pregnancy, urinary tract infections, metabolic disorders, cancer, and kidney disease. However, contaminated or... Read more

Industry

view channel

Cepheid Joins CDC Initiative to Strengthen U.S. Pandemic Testing Preparednesss

Cepheid (Sunnyvale, CA, USA) has been selected by the U.S. Centers for Disease Control and Prevention (CDC) as one of four national collaborators in a federal initiative to speed rapid diagnostic technologies... Read more

QuidelOrtho Collaborates with Lifotronic to Expand Global Immunoassay Portfolio

QuidelOrtho (San Diego, CA, USA) has entered a long-term strategic supply agreement with Lifotronic Technology (Shenzhen, China) to expand its global immunoassay portfolio and accelerate customer access... Read more

WHX Labs in Dubai spotlights leadership skills shaping next-generation laboratories

WHX Labs in Dubai (formerly Medlab Middle East), held at Dubai World Trade Centre (DWTC) from 10–13 February, brings together international experts to discuss the factors redefining laboratory leadership,... Read more

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