LumiraDx HbA1c Assay Screens and Identifies Patients at Risk for Developing Diabetes
|
By LabMedica International staff writers Posted on 30 May 2022 |
|
Rising global rates of diabetes presents growing need for broader access and an easier, more connected solution for HbA1c testing in community-based healthcare settings such as primary care and retail pharmacy. The increase in global health expenditure due to diabetes has been considerable in recent years, growing from USD 232 billion in 2007 to USD 966 billion in 2021 for adults aged 20-79 years – an increase of 316% over the last 15 years. By offering both broader access and an easier, more connected solution for HbA1c testing, patients who might be at risk of developing diabetes can manage their condition sooner, potentially leading to less strain on healthcare systems. Now, a new rapid microfluidic immunofluorescence assay is designed to address the growing clinical need for accessible and reliable HbA1c testing in the community healthcare setting.
LumiraDx’s (London, UK) HbA1c test is an automated, quantitative fingerstick assay that is run on its highly portable LumiraDx Platform. It is intended for the monitoring of individuals with diabetes, and as an aid in screening and identifying patients who may be at risk for developing diabetes. Used with the LumiraDx Platform, the test provides results in less than seven minutes from sample application for the monitoring of individuals with diabetes, and as an aid in screening and identifying patients who may be at risk for developing diabetes, all at the point of care.
The addition of HbA1c to the LumiraDx test menu, enables the consolidation of multiple instruments to a single, next generation POC Platform with a common workflow. The LumiraDx HbA1c test has a reportable range of 20 - 130 mmol/mol HbA1c (4.0 - 14.0% HbA1c). In an external, multi-site clinical study, the test achieved precision, expressed as mean paired replicate % CV, of ≤2.50% in both capillary and venous whole blood.
"With our growing test menu, the LumiraDx Platform is able to quickly and accurately support clinicians with a variety of diagnostic and treatment decisions at the point of care," said Ron Zwanziger, LumiraDx's Chief Executive Officer commented. "HbA1c is an important addition to our Platform not only for our existing pharmacy and primary care customers, but for new customers looking to consolidate their current testing needs into one centralized and streamlined, connected Platform that delivers lab comparable performance."
Related Links:
LumiraDx
Latest Molecular Diagnostics News
- Genetic-Based Tool Predicts Survival Outcomes of Pancreatic Cancer Patients
- Urine Test Diagnoses Early-Stage Prostate Cancer
- New Genetic Tool Analyzes Umbilical Cord Blood to Predict Future Disease
- Spinal Fluid Biomarker for Parkinson’s Disease Offers Early and Accurate Diagnosis
- Revolutionary Blood Test Detects 30 Different Types of Cancers with 98% Accuracy
- Simple Blood Test Better Predicts Heart Disease Risk
- New Blood Test Detects 12 Common Cancers Before Symptoms Appear
- Blood Test Could Predict Relapse of Autoimmune Blood Vessel Disease
- First-of-its-Kind Blood Test Detects Trauma-Related Diseases
- Key Gene Identified in Common Heart Disease Unlocks Life-Saving Diagnostic Potential
- Cheap Cell-Free DNA Based Test Accurately Predicts Preterm Birth
- RNA Blood Test Detects Cancers and Resistance to Treatment
- IL-6 Outperforms Traditional Tests for Early Sepsis Detection
- Simple Blood Test Improves Heart Attack and Stroke Risk Prediction
- Blood Biomarker Test Could Detect Genetic Predisposition to Alzheimer’s
- Novel Autoantibody Against DAGLA Discovered in Cerebellitis
Channels
Clinical Chemistry
view channel
Mass Spectrometry-Based Monitoring Technique to Predict and Identify Early Myeloma Relapse
Myeloma, a type of cancer that affects the bone marrow, is currently incurable, though many patients can live for over 10 years after diagnosis. However, around 1 in 5 individuals with myeloma have a high-risk... Read more
‘Brilliantly Luminous’ Nanoscale Chemical Tool to Improve Disease Detection
Thousands of commercially available glowing molecules known as fluorophores are commonly used in medical imaging, disease detection, biomarker tagging, and chemical analysis. They are also integral in... Read more
Low-Cost Portable Screening Test to Transform Kidney Disease Detection
Millions of individuals suffer from kidney disease, which often remains undiagnosed until it has reached a critical stage. This silent epidemic not only diminishes the quality of life for those affected... Read more
New Method Uses Pulsed Infrared Light to Find Cancer's 'Fingerprints' In Blood Plasma
Cancer diagnoses have traditionally relied on invasive or time-consuming procedures like tissue biopsies. Now, new research published in ACS Central Science introduces a method that utilizes pulsed infrared... Read moreHematology
view channel
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
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
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
Machine Learning-Enabled Blood Test Predicts Immunotherapy Response in Lymphoma Patients
Chimeric antigen receptor (CAR) T-cell therapy has emerged as one of the most promising recent developments in the treatment of blood cancers. However, over half of non-Hodgkin lymphoma (NHL) patients... Read more
Microbiology
view channel
New Test Diagnoses Bacterial Meningitis Quickly and Accurately
Bacterial meningitis is a potentially fatal condition, with one in six patients dying and half of the survivors experiencing lasting symptoms. Therefore, rapid diagnosis and treatment are critical.... Read more
Handheld Device Delivers Low-Cost TB Results in Less Than One Hour
Tuberculosis (TB) remains the deadliest infectious disease globally, affecting an estimated 10 million people annually. In 2021, about 4.2 million TB cases went undiagnosed or unreported, mainly due to... Read more
New AI-Based Method Improves Diagnosis of Drug-Resistant Infections
Drug-resistant infections, particularly those caused by deadly bacteria like tuberculosis and staphylococcus, are rapidly emerging as a global health emergency. These infections are more difficult to treat,... Read more
Breakthrough Diagnostic Technology Identifies Bacterial Infections with Almost 100% Accuracy within Three Hours
Rapid and precise identification of pathogenic microbes in patient samples is essential for the effective treatment of acute infectious diseases, such as sepsis. The fluorescence in situ hybridization... Read morePathology
view channel
AI-Based Model Predicts Kidney Cancer Therapy Response
Each year, nearly 435,000 individuals are diagnosed with clear cell renal cell carcinoma (ccRCC), making it the most prevalent subtype of kidney cancer. When the disease spreads, anti-angiogenic therapies... Read more
Sensitive and Specific DUB Enzyme Assay Kits Require Minimal Setup Without Substrate Preparation
Ubiquitination and deubiquitination are two important physiological processes in the ubiquitin-proteasome system, responsible for protein degradation in cells. Deubiquitinating (DUB) enzymes contain around... Read more
Technology
view channel
Light Signature Algorithm to Enable Faster and More Precise Medical Diagnoses
Every material or molecule interacts with light in a unique way, creating a distinct pattern, much like a fingerprint. Optical spectroscopy, which involves shining a laser on a material and observing how... Read more
Disposable Microchip Technology Could Selectively Detect HIV in Whole Blood Samples
As of the end of 2023, approximately 40 million people globally were living with HIV, and around 630,000 individuals died from AIDS-related illnesses that same year. Despite a substantial decline in deaths... Read more
Pain-On-A-Chip Microfluidic Device Determines Types of Chronic Pain from Blood Samples
Chronic pain is a widespread condition that remains difficult to manage, and existing clinical methods for its treatment rely largely on self-reporting, which can be subjective and especially problematic... Read more
Innovative, Label-Free Ratiometric Fluorosensor Enables More Sensitive Viral RNA Detection
Viruses present a major global health risk, as demonstrated by recent pandemics, making early detection and identification essential for preventing new outbreaks. While traditional detection methods are... Read moreIndustry
view channel
Cepheid and Oxford Nanopore Technologies Partner on Advancing Automated Sequencing-Based Solutions
Cepheid (Sunnyvale, CA, USA), a leading molecular diagnostics company, and Oxford Nanopore Technologies (Oxford, UK), the company behind a new generation of sequencing-based molecular analysis technologies,... Read more
Grifols and Tecan’s IBL Collaborate on Advanced Biomarker Panels
Grifols (Barcelona, Spain), one of the world’s leading producers of plasma-derived medicines and innovative diagnostic solutions, is expanding its offer in clinical diagnostics through a strategic partnership... Read more
