ELISA Instruments Receive European IVD Use Certification
|
By LabMedica International staff writers Posted on 27 Nov 2013 |
|
Image: The Multiskan FC Microplate Photometer (Photo courtesy of Thermo Scientific).
Image: The Wellwash Microplate Washer (Photo courtesy of Thermo Scientific).
Two instruments designed for routine enzyme-linked immunosorbent assay (ELISA) diagnostic applications have been approved in Europe for use in clinical laboratories as in vitro diagnostic (IVD) tools.
The Thermo Scientific (Milford, MA, USA) Multiskan FC (IVD model) microplate photometer and the Wellwash (IVD model) microplate washer now conform to the European Directive 98/79/EC and are available throughout Europe.
The Multiskan FC instrument is a reliable and robust filter-based microplate photometer, measuring absorbance in the wavelength range of 340–850 nm. The instrument rapidly reads both 96- and 384-well plates with the option of shaking and of incubation up to 50 °C. The Multiskan's large color monitor is powered by a logical and intuitive graphical user interface that is able to display eight different languages (English, French, German, Spanish, Portuguese, Russian, Japanese, and Chinese). The instrument has USB ports for transferring data and protocols.
The Wellwash microplate washer was designed for washing 96-well plates in routine ELISA applications. It is equipped with one wash bottle and a 1 x 8 wash-head with a 1 x 12 wash-head available as an option. The instrument boasts a large keypad and color display with an intuitive user interface that requires minimal training and allows for quick protocol development. Liquid level sensors present in wash and waste bottles as well as an automatic prime feature assure safe performance, while an aerosol cover prevents spread of droplets containing infectious disease agents.
“Researchers working in ELISA applications need simplified solutions that will help maximize their efforts and results,” said Hanna Granö-Fabritius, business director in the sample preparation and analysis division of Thermo Scientific. “Our instruments are critically important for [in] vitro diagnostics use, and lab managers can be assured that these products are compliant with the IVD Directive requirements. Our instruments are designed to offer convenience and reliability in clinical diagnostics and quality control laboratories to improve ease of use and accelerate results.”
Related Links:
Thermo Scientific
 Analyzer.jpg)
The Thermo Scientific (Milford, MA, USA) Multiskan FC (IVD model) microplate photometer and the Wellwash (IVD model) microplate washer now conform to the European Directive 98/79/EC and are available throughout Europe.
The Multiskan FC instrument is a reliable and robust filter-based microplate photometer, measuring absorbance in the wavelength range of 340–850 nm. The instrument rapidly reads both 96- and 384-well plates with the option of shaking and of incubation up to 50 °C. The Multiskan's large color monitor is powered by a logical and intuitive graphical user interface that is able to display eight different languages (English, French, German, Spanish, Portuguese, Russian, Japanese, and Chinese). The instrument has USB ports for transferring data and protocols.
The Wellwash microplate washer was designed for washing 96-well plates in routine ELISA applications. It is equipped with one wash bottle and a 1 x 8 wash-head with a 1 x 12 wash-head available as an option. The instrument boasts a large keypad and color display with an intuitive user interface that requires minimal training and allows for quick protocol development. Liquid level sensors present in wash and waste bottles as well as an automatic prime feature assure safe performance, while an aerosol cover prevents spread of droplets containing infectious disease agents.
“Researchers working in ELISA applications need simplified solutions that will help maximize their efforts and results,” said Hanna Granö-Fabritius, business director in the sample preparation and analysis division of Thermo Scientific. “Our instruments are critically important for [in] vitro diagnostics use, and lab managers can be assured that these products are compliant with the IVD Directive requirements. Our instruments are designed to offer convenience and reliability in clinical diagnostics and quality control laboratories to improve ease of use and accelerate results.”
Related Links:
Thermo Scientific
Gold Member
Collection and Transport System
PurSafe Plus®
CBM Analyzer
Complete Blood Morphology (CBM) Analyzer
Automatic Hematology Analyzer
DH-800 Series
Latest Technology News
- Robotic Technology Unveiled for Automated Diagnostic Blood Draws
- ADLM Launches First-of-Its-Kind Data Science Program for Laboratory Medicine Professionals
- Aptamer Biosensor Technology to Transform Virus Detection
- AI Models Could Predict Pre-Eclampsia and Anemia Earlier Using Routine Blood Tests
- AI-Generated Sensors Open New Paths for Early Cancer Detection
- Pioneering Blood Test Detects Lung Cancer Using Infrared Imaging
- AI Predicts Colorectal Cancer Survival Using Clinical and Molecular Features
- Diagnostic Chip Monitors Chemotherapy Effectiveness for Brain Cancer
- Machine Learning Models Diagnose ALS Earlier Through Blood Biomarkers
- Artificial Intelligence Model Could Accelerate Rare Disease Diagnosis
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
Industry
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