Prosthetic Joint Infections Test Receives CE Marking
|
By LabMedica International staff writers Posted on 05 Feb 2015 |
|
Image: On the left are the typical radiographic findings of infection with irregular bone destruction and periosteal reaction. In many cases however the infection is really low grade and difficult to establish (Photo courtesy of Radiological Society of the Netherlands).
The first diagnostic test that can detect in patients' blood antibodies against several bacteria types frequently responsible for prosthetic infections, in particular Staphylococcus, the most often encountered type in such infections.
The new test has received Conformité Européenne (CE) marking, and provides qualitative information in a couple of hours for each targeted bacteria types, which enables caregivers, in association with the usual assessments, to accelerate and improve the care of patients who have prosthetic joint infections.
This BJI InoPlex test (Diaxonit; Paris France) requires 10 µl of serum taken by a simple blood draw and can be easily repeated. After adequate preparation, the test is carried out directly in the biology laboratory of the hospital with a standard Luminex instrument (Luminex; Austin, TX, USA). The test uses a combination of several recombinant protein antigens to test for anti-Staphylococcus immunoglobulin G (IgG for S. aureus and S. epidermidis). The BJI InoPlex kit contains various reagents necessary to perform the test, a 96-well filter plate, calibration CD-ROM containing specific calibration information for each batch and a user manual. The BJI InoPlex software is used to interpret the data and report a result per family of bacteria.
The performance of BJI InoPlex compared with microbiological results on intraoperative samples are respectively 82.2% for specificity and 75.9% for sensitivity, all types of targeted staphylococci included. Other bacteria targeted by BJI InoPlex are less frequent in the prevalence of prosthetic infections, and the incidence of proven intraoperative infections with these bacteria also ended up being limited in the study cohort. The high specificity of the test for two families of bacteria, Group B-Streptococcus and Propionibacterium acnes, preferentially orients towards the absence of an immune response against these types of bacteria, BJI InoPlex is being used in addition to other tests performed.
Related Links:
Diaxonit
Luminex
The new test has received Conformité Européenne (CE) marking, and provides qualitative information in a couple of hours for each targeted bacteria types, which enables caregivers, in association with the usual assessments, to accelerate and improve the care of patients who have prosthetic joint infections.
This BJI InoPlex test (Diaxonit; Paris France) requires 10 µl of serum taken by a simple blood draw and can be easily repeated. After adequate preparation, the test is carried out directly in the biology laboratory of the hospital with a standard Luminex instrument (Luminex; Austin, TX, USA). The test uses a combination of several recombinant protein antigens to test for anti-Staphylococcus immunoglobulin G (IgG for S. aureus and S. epidermidis). The BJI InoPlex kit contains various reagents necessary to perform the test, a 96-well filter plate, calibration CD-ROM containing specific calibration information for each batch and a user manual. The BJI InoPlex software is used to interpret the data and report a result per family of bacteria.
The performance of BJI InoPlex compared with microbiological results on intraoperative samples are respectively 82.2% for specificity and 75.9% for sensitivity, all types of targeted staphylococci included. Other bacteria targeted by BJI InoPlex are less frequent in the prevalence of prosthetic infections, and the incidence of proven intraoperative infections with these bacteria also ended up being limited in the study cohort. The high specificity of the test for two families of bacteria, Group B-Streptococcus and Propionibacterium acnes, preferentially orients towards the absence of an immune response against these types of bacteria, BJI InoPlex is being used in addition to other tests performed.
Related Links:
Diaxonit
Luminex
Platinum Member
COVID-19 Rapid Test
OSOM COVID-19 Antigen Rapid Test
POCT Fluorescent Immunoassay Analyzer
FIA Go
New
Gold Member
Magnetic Bead Separation Modules
MAG and HEATMAG
Latest Pathology News
- AI Integrated With Optical Imaging Technology Enables Rapid Intraoperative Diagnosis
- HPV Self-Collection Solution Improves Access to Cervical Cancer Testing
- Hyperspectral Dark-Field Microscopy Enables Rapid and Accurate Identification of Cancerous Tissues
- AI Advancements Enable Leap into 3D Pathology
- New Blood Test Device Modeled on Leeches to Help Diagnose Malaria
- Robotic Blood Drawing Device to Revolutionize Sample Collection for Diagnostic Testing
- Use of DICOM Images for Pathology Diagnostics Marks Significant Step towards Standardization
- First of Its Kind Universal Tool to Revolutionize Sample Collection for Diagnostic Tests
- AI-Powered Digital Imaging System to Revolutionize Cancer Diagnosis
- New Mycobacterium Tuberculosis Panel to Support Real-Time Surveillance and Combat Antimicrobial Resistance
- New Method Offers Sustainable Approach to Universal Metabolic Cancer Diagnosis
- Spatial Tissue Analysis Identifies Patterns Associated With Ovarian Cancer Relapse
- Unique Hand-Warming Technology Supports High-Quality Fingertip Blood Sample Collection
- Image-Based AI Shows Promise for Parasite Detection in Digitized Stool Samples
- Deep Learning Powered AI Algorithms Improve Skin Cancer Diagnostic Accuracy
- Microfluidic Device for Cancer Detection Precisely Separates Tumor Entities
Channels
Clinical Chemistry
view channel
3D Printed Point-Of-Care Mass Spectrometer Outperforms State-Of-The-Art Models
Mass spectrometry is a precise technique for identifying the chemical components of a sample and has significant potential for monitoring chronic illness health states, such as measuring hormone levels... Read more.jpg "Image: Reaching speeds up to 6,000 RPM, this centrifuge forms the basis for a new type of inexpensive, POC biomedical test (Photo courtesy of Duke University)")
POC Biomedical Test Spins Water Droplet Using Sound Waves for Cancer Detection
Exosomes, tiny cellular bioparticles carrying a specific set of proteins, lipids, and genetic materials, play a crucial role in cell communication and hold promise for non-invasive diagnostics.... Read more
Highly Reliable Cell-Based Assay Enables Accurate Diagnosis of Endocrine Diseases
The conventional methods for measuring free cortisol, the body's stress hormone, from blood or saliva are quite demanding and require sample processing. The most common method, therefore, involves collecting... Read more
Molecular Diagnostics
view channel
Blood Proteins Could Warn of Cancer Seven Years before Diagnosis
Two studies have identified proteins in the blood that could potentially alert individuals to the presence of cancer more than seven years before the disease is clinically diagnosed. Researchers found... Read more (1)_1.jpg "Image: Ultrasound image of micro-histotripsy liberation of biomarkers in a tumor (Photo courtesy of Joy Wang and Pradyumna Kedarisetti)"){kind=small}
Ultrasound-Aided Blood Testing Detects Cancer Biomarkers from Cells
Ultrasound imaging serves as a noninvasive method to locate and monitor cancerous tumors effectively. However, crucial details about the cancer, such as the specific types of cells and genetic mutations... Read more_1.jpg "Image: The innovative method to customize and strengthen DNA origami structure promises breakthroughs in medicine (Photo courtesy of Shutterstock)")
.jpg "Image: The QIAstat-Dx Respiratory Panel Plus has received U.S. FDA clearance (Photo courtesy of QIAGEN)")
Hematology
view channel
Next Generation Instrument Screens for Hemoglobin Disorders in Newborns
Hemoglobinopathies, the most widespread inherited conditions globally, affect about 7% of the population as carriers, with 2.7% of newborns being born with these conditions. The spectrum of clinical manifestations... Read more
First 4-in-1 Nucleic Acid Test for Arbovirus Screening to Reduce Risk of Transfusion-Transmitted Infections
Arboviruses represent an emerging global health threat, exacerbated by climate change and increased international travel that is facilitating their spread across new regions. Chikungunya, dengue, West... Read more
POC Finger-Prick Blood Test Determines Risk of Neutropenic Sepsis in Patients Undergoing Chemotherapy
Neutropenia, a decrease in neutrophils (a type of white blood cell crucial for fighting infections), is a frequent side effect of certain cancer treatments. This condition elevates the risk of infections,... Read more
First Affordable and Rapid Test for Beta Thalassemia Demonstrates 99% Diagnostic Accuracy
Hemoglobin disorders rank as some of the most prevalent monogenic diseases globally. Among various hemoglobin disorders, beta thalassemia, a hereditary blood disorder, affects about 1.5% of the world's... Read moreImmunology
view channel.jpg "Image: The AI predictive model identifies the most potent cancer killing immune cells for use in immunotherapies (Photo courtesy of Shutterstock)")
AI Predicts Tumor-Killing Cells with High Accuracy
Cellular immunotherapy involves extracting immune cells from a patient's tumor, potentially enhancing their cancer-fighting capabilities through engineering, and then expanding and reintroducing them into the body.... Read more
Diagnostic Blood Test for Cellular Rejection after Organ Transplant Could Replace Surgical Biopsies
Transplanted organs constantly face the risk of being rejected by the recipient's immune system which differentiates self from non-self using T cells and B cells. T cells are commonly associated with acute... Read more
AI Tool Precisely Matches Cancer Drugs to Patients Using Information from Each Tumor Cell
Current strategies for matching cancer patients with specific treatments often depend on bulk sequencing of tumor DNA and RNA, which provides an average profile from all cells within a tumor sample.... Read more
Genetic Testing Combined With Personalized Drug Screening On Tumor Samples to Revolutionize Cancer Treatment
Cancer treatment typically adheres to a standard of care—established, statistically validated regimens that are effective for the majority of patients. However, the disease’s inherent variability means... Read morePathology
view channel
AI Integrated With Optical Imaging Technology Enables Rapid Intraoperative Diagnosis
Rapid and accurate intraoperative diagnosis is essential for tumor surgery as it guides surgical decisions with precision. Traditional intraoperative assessments, such as frozen sections based on H&E... Read more
HPV Self-Collection Solution Improves Access to Cervical Cancer Testing
Annually, over 604,000 women across the world are diagnosed with cervical cancer, and about 342,000 die from this disease, which is preventable and primarily caused by the Human Papillomavirus (HPV).... Read more
Hyperspectral Dark-Field Microscopy Enables Rapid and Accurate Identification of Cancerous Tissues
Breast cancer remains a major cause of cancer-related mortality among women. Breast-conserving surgery (BCS), also known as lumpectomy, is the removal of the cancerous lump and a small margin of surrounding tissue.... Read more
Technology
view channel
New Diagnostic System Achieves PCR Testing Accuracy
While PCR tests are the gold standard of accuracy for virology testing, they come with limitations such as complexity, the need for skilled lab operators, and longer result times. They also require complex... Read more
DNA Biosensor Enables Early Diagnosis of Cervical Cancer
Molybdenum disulfide (MoS2), recognized for its potential to form two-dimensional nanosheets like graphene, is a material that's increasingly catching the eye of the scientific community.... Read more
Self-Heating Microfluidic Devices Can Detect Diseases in Tiny Blood or Fluid Samples
Microfluidics, which are miniature devices that control the flow of liquids and facilitate chemical reactions, play a key role in disease detection from small samples of blood or other fluids.... Read more
Breakthrough in Diagnostic Technology Could Make On-The-Spot Testing Widely Accessible
Home testing gained significant importance during the COVID-19 pandemic, yet the availability of rapid tests is limited, and most of them can only drive one liquid across the strip, leading to continued... Read moreIndustry
view channel
Danaher and Johns Hopkins University Collaborate to Improve Neurological Diagnosis
Unlike severe traumatic brain injury (TBI), mild TBI often does not show clear correlations with abnormalities detected through head computed tomography (CT) scans. Consequently, there is a pressing need... Read more
Beckman Coulter and MeMed Expand Host Immune Response Diagnostics Partnership
Beckman Coulter Diagnostics (Brea, CA, USA) and MeMed BV (Haifa, Israel) have expanded their host immune response diagnostics partnership. Beckman Coulter is now an authorized distributor of the MeMed... Read more_1.jpg "Image: Thermo Fisher will distribute Bio-Techne products across Europe (Photo courtesy of 123RF)")
