FDA Cleared Blood Lead Testing System Displayed at AACC
|
By LabMedica International staff writers Posted on 27 Jul 2015 |
|
US Food and Drug Administration (FDA) 510(k) clearance has been given for a new compact, relatively low cost analyzer to quantify lead levels in blood.
The “LeadCare Plus” clinical lead analyzer from Magellan Diagnostics (Billerica, MA, USA) offers simple-to-perform lead analysis with a compact footprint that makes blood lead testing accessible and practical for labs of any size. With dimensions smaller than a laptop, single-use consumables, and electronic calibration, the system is easy to implement even in space- and resource-constrained labs. The LeadCare Plus system is based on technology developed by Magellan Diagnostics that has been in clinical use for nearly two decades.
Blood lead testing is a critical preventative service: symptoms of lead exposure are nonspecific and subclinical, so a routine blood test is often the only way to identify exposure. According to the Centers for Disease Control and Prevention (CDC), there are over half a million children just in the USA still affected with elevated blood lead levels. Without early detection, elevated blood lead levels can impair cognition, reduce IQ, and cause attention-deficit disorders.
Amy Winslow, president, Magellan Diagnostics, said, "We are pleased that the FDA has cleared the LeadCare Plus System. Our mission is to help expand access to blood lead testing by offering a solution for every setting. With our other products CLIA-waived LeadCare II for point-of-care testing and LeadCare Ultra for high throughput lab analysis, LeadCare Plus completes this offering by providing a low capital cost system that gives even small labs the opportunity to bring this test in-house."
All three products will be on display during AACC 2015 (July 26–30; Atlanta, GA, USA) Clinical Lab Expo, Booth 3254.
Related Links:
Magellan Diagnostics
American Association for Clinical Chemistry (AACC)
AACC 2015 Annual Meeting & Clinical Lab Expo
The “LeadCare Plus” clinical lead analyzer from Magellan Diagnostics (Billerica, MA, USA) offers simple-to-perform lead analysis with a compact footprint that makes blood lead testing accessible and practical for labs of any size. With dimensions smaller than a laptop, single-use consumables, and electronic calibration, the system is easy to implement even in space- and resource-constrained labs. The LeadCare Plus system is based on technology developed by Magellan Diagnostics that has been in clinical use for nearly two decades.
Blood lead testing is a critical preventative service: symptoms of lead exposure are nonspecific and subclinical, so a routine blood test is often the only way to identify exposure. According to the Centers for Disease Control and Prevention (CDC), there are over half a million children just in the USA still affected with elevated blood lead levels. Without early detection, elevated blood lead levels can impair cognition, reduce IQ, and cause attention-deficit disorders.
Amy Winslow, president, Magellan Diagnostics, said, "We are pleased that the FDA has cleared the LeadCare Plus System. Our mission is to help expand access to blood lead testing by offering a solution for every setting. With our other products CLIA-waived LeadCare II for point-of-care testing and LeadCare Ultra for high throughput lab analysis, LeadCare Plus completes this offering by providing a low capital cost system that gives even small labs the opportunity to bring this test in-house."
All three products will be on display during AACC 2015 (July 26–30; Atlanta, GA, USA) Clinical Lab Expo, Booth 3254.
Related Links:
Magellan Diagnostics
American Association for Clinical Chemistry (AACC)
AACC 2015 Annual Meeting & Clinical Lab Expo
New
Gold Member
Genetic Type 1 Diabetes Risk Test
T1D GRS Array
8-Channel Pipette
SAPPHIRE 20–300 µL
Capillary Blood Collection Tube
IMPROMINI M3
Latest AACC 2015 News
- Automated Molecular Diagnostics System Presented at AACC 2015
- Portable Molecular Diagnostics System Unveiled At 2015 AACC
- Expanded Steroid Control Launched at the 2015 AACC Annual Meeting
- Innovative New Technology to Provide Plastic-Exterior Components with Glass Interior, Presented at AACC 2015
- Eco-Friendly Immunoassay Reagents Featured at AACC 2015
- Low Cost Point-of-Care DNA Amplification Test for Chlamydia Infection Demonstrated at the 2015 AACC Annual Meeting
- Inexpensive Multipurpose Point-of-Care Analyzer Unveiled at 2015 AACC Annual Meeting
- State-of-the-Art Automated Laboratory Systems Highlighted at the 2015 AACC Annual Meeting
- Siemens Showcases Multiple New IVD Solutions at AACC 2015
- New HPLC Quadruples Clinical Throughput Capabilities, Displayed at AACC 2015
- Diagnostic Test that Measures Active Renin in Hypertension Displayed at the 2015 AACC Annual Meeting
- Hair Testing May Offer Insights into Asthma-Related Complications in Pregnancy
- Two Newly Developed Tests May Better Diabetes Diagnosis and Monitoring
- CE Marking of Theranostic Monitoring Test Announced at 2015 AACC Annual Meeting
- Ebola Rapid Lateral Flow Test Previewed at the 2015 AACC Annual Meeting
- AACC: Better Quality and Patient-Friendliness Needed in Direct Testing
Channels
Clinical Chemistry
view channel
Blood Test Could Predict and Identify Early Relapses in Myeloma Patients
Multiple myeloma is an incurable cancer of the bone marrow, and while many patients now live for more than a decade after diagnosis, a significant proportion relapse much earlier with poor outcomes.... Read more
Compact Raman Imaging System Detects Subtle Tumor Signals
Accurate cancer diagnosis often depends on labor-intensive tissue staining and expert pathological review, which can delay results and limit access to rapid screening. These conventional methods also make... Read more
Molecular Diagnostics
view channel
Blood Metabolite Signature Test Better Predicts Type 2 Diabetes Risk
Type 2 diabetes is rising worldwide and now accounts for more than 90% of all diabetes cases, driven by impaired insulin response and long-term metabolic dysfunction. The disease often develops silently... Read more
Genetic Test Could Detect Predisposition to Pancreatic Cancer
Pancreatic ductal adenocarcinoma is one of the deadliest cancers, largely because it is usually diagnosed at an advanced stage when treatment options are limited. The lack of effective population screening... Read more
Hematology
view channel
AI Algorithm Effectively Distinguishes Alpha Thalassemia Subtypes
Alpha thalassemia affects millions of people worldwide and is especially common in regions such as Southeast Asia, where carrier rates can reach extremely high levels. While the condition can have significant... Read more
MRD Tests Could Predict Survival in Leukemia Patients
Acute myeloid leukemia is an aggressive blood cancer that disrupts normal blood cell production and often relapses even after intensive treatment. Clinicians currently lack early, reliable markers to predict... Read more
Immunology
view channel
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
New Test Measures How Effectively Antibiotics Kill Bacteria
Antibiotics are typically evaluated by how well they inhibit bacterial growth in laboratory tests, but growth inhibition does not always mean the bacteria are actually killed. Some pathogens can survive... Read more
New Antimicrobial Stewardship Standards for TB Care to Optimize Diagnostics
Antibiotic resistance is rising worldwide, threatening the effectiveness of treatments for major infectious diseases, including tuberculosis (TB). Resistance to key TB drugs, such as bedaquiline, is of... Read more
Pathology
view channel
Intraoperative Tumor Histology to Improve Cancer Surgeries
Surgical removal of cancer remains the first-line treatment for many tumors, but ensuring that all cancerous tissue is removed while preserving healthy tissue is a major challenge. Surgeons currently rely... Read more
Rapid Stool Test Could Help Pinpoint IBD Diagnosis
Inflammatory bowel disease (IBD) is a chronic condition in which the immune system mistakenly attacks the digestive tract, causing persistent gut inflammation. Diagnosis and disease monitoring often depend... Read more
AI-Powered Label-Free Optical Imaging Accurately Identifies Thyroid Cancer During Surgery
Thyroid cancer is the most common endocrine cancer, and its rising detection rates have increased the number of patients undergoing surgery. During tumor removal, surgeons often face uncertainty in distinguishing... Read more
Technology
view channel
Aptamer Biosensor Technology to Transform Virus Detection
Rapid and reliable virus detection is essential for controlling outbreaks, from seasonal influenza to global pandemics such as COVID-19. Conventional diagnostic methods, including cell culture, antigen... Read more
AI Models Could Predict Pre-Eclampsia and Anemia Earlier Using Routine Blood Tests
Pre-eclampsia and anemia are major contributors to maternal and child mortality worldwide, together accounting for more than half a million deaths each year and leaving millions with long-term health complications.... Read more
Industry
view channel
WHX Labs Dubai to Gather Global Experts in Antimicrobial Resistance at Inaugural AMR Leaders’ Summit
World Health Expo (WHX) Labs in Dubai (formerly Medlab Middle East), which will be held at Dubai World Trade Centre from 10-13 February, will address the growing global threat of antimicrobial resistance... Read more
