November 2019 Product Focus – Hematology

Oct. 24, 2019
Clinical labs challenged by increased diabetes diagnoses New products respond to industry demands and updated test guidelines.

In 2018, statistics showed there were 425 million people worldwide with diabetes. According to the International Diabetes Federation (IDF), this number is forecasted to increase to 642 million by 2040, proving that diabetes remains one of the fastest-growing diseases. These increasing numbers are forcing the clinical laboratory industry to keep pace with the test products and treatment options that are being introduced. In addition to new products that claim to offer more accurate results and greater reliability are updated testing guidelines, which are influenced by the ever-changing nature of the everyday disease itself.

Among the many factors the IDF lists as responsible for diabetes are “higher levels of urbanization, aging populations and the growing adoption of more sedentary lifestyles, which leads to insufficient physical activity, greater rates of obesity and a higher intake of unhealthy foods.” However, another factor currently receiving more attention is genetics, and how genes play a role in the increased risk for pre-diabetes among family members. As such, many clinicians suggest that early detection of diabetes could be key in the treatment and management of the disease, and in some cases, could potentially reverse diabetes entirely.

In an effort to stay current with diabetes awareness and detection, new products and test options are being tailored to provide more specific, individualized results. While current demands for disease screening and monitoring are expected to grow as long as the world’s diagnosed population grows, there remains a general belief that there is more work to be done in diagnosing diabetes. For today’s clinicians, it’s no longer a determination between Type 1 and Type 2 with treatments assigned accordingly. Now, clinicians are asking for change by way of more category and subtype options—noting that every patient doesn’t respond the same way to the same treatment, asserting that personalized medicine needs to do more for all diabetic patients.

Should changes or additions in diabetes classifications occur, this might allow physicians to improve customized patient treatment options for more effective disease monitoring and management. Also looking at change is the American Diabetes Association (ADA), who revised its own criteria in the 2019 Standards of Medical Care in Diabetes, which is updated annually. The 2019 updated information, “supports a diagnosis of diabetes when it’s possible to obtain two abnormal tests from a single sample.” The ADA pointed out, “This approach may allow for a faster diagnosis and implementation of an appropriate treatment plan when such laboratory values are available.”

With the increase in diabetes detection, clinical labs continue to compete among themselves to be the first to introduce and market the next greatest new product or assay that will answer the demands of the industry. Companies such as Beckman (Coulter) and Bio-Rad (Laboratories), Siemens (Healthineers) and Sebia know all-too-well the importance of having a cost-effective new product or test that provides the highest accuracy and reliability for every patient diagnosis. With  many clinicians looking to embrace new products, here are some of the most recent industry launches and introductions for your consideration.

HbA1c Advanced assay

Beckman Coulter’s fully automated hemoglobin A1c (HbA1c) Advanced assay enables laboratories to provide physicians with a National Glycohemoglobin Standardization Program (NGSP) certified assay for diagnosing diabetes, monitoring long-term glucose control in individuals with diabetes and identifying patients who may be at risk of developing diabetes. Available on the DxC 700 AU, the HbA1c Advanced assay enables laboratories to integrate whole blood analysis with their existing routine and STAT samples to deliver optimized turnaround time. Beckman Coulter’s HbA1c Advanced assay is unaffected by common hemoglobin variants and offers a total precision of less than 2 percent CV and demonstrates world-class Six-Sigma performance. Beckman Coulter

Glucose hospital meter system

Nova’s StatStrip glucose hospital meter system is the first and only glucose meter to receive clearance by the FDA for use with capillary sampling in critically ill patients. This comes after extensive studies at Mayo Clinic and Johns Hopkins of patients receiving intensive medical intervention/therapy. StatStrip is now the only glucose meter system that is FDA-cleared for the detection and management of dysglycemia with all patients, in all departments including with critically ill patients, on all sample types. Use of any other strip-based glucose meter with critically ill patients is considered “off-label” by the FDA and CMS. Nova Biomedical

 A1c-Cellular control

Streck’s A1c-Cellular is the only A1c control on the market with intact red blood cells. A1c-Cellular tests the entire HbA1c procedure, including the lysing of the red blood cell—a step omitted with other controls. This important step ensures the entire system, instrument and reagents, is working properly and providing accurate patient results. A1c-Cellular is convenient and easy to use. It does not need to be reconstituted, which reduces the potential for human error. A1c-Cellular is available in two clinically significant levels, and is provided in cap-pierceable plastic vials, which allow autosampling on HbA1c analyzers with such capabilities. Streck

Specific GA test

The Lucica method for Glycated Albumin (GA), manufactured by Asahi Kasei Pharma Corporation, is a specific test for GA that is now FDA cleared for sale in the U.S. The test is distributed exclusively by EKF USA and is one of the most widely used and published GA methods worldwide for intermediate term monitoring of glycemic control in diabetes patients. The test quantitatively measures GA in human serum on compatible clinical chemistry analyzers with open channel capability. Both GA (enzymatic) and total albumin (BCP) are specifically measured in separate reactions and results are expressed as a ratio (%), minimizing differences in protein concentrations between patients. EKF Diagnostics

HPLC technology

The D-100 uses ion-exchange HPLC for HbA1c testing. Results are generated every 45 seconds (80 results/hour). Smart technology utilizing Onboard Advisor Software provides a consistent and thorough review of every result. In addition, RFID-tagged reagents and cartridges track usage in real time. No interference is present from the most common heterozygous hemoglobin variants: HbAS, HbAC, HbAD and HbAE, Carbamylated Hb & Labile A1c, HbF ≤ 30% and Lipemia ≤ 6,000mg/dL (60g/L).* *Interferences from common hemoglobin variants: HbAS, HbAC, HbAD, and HbAE were tested. Based on net performance criteria the results were acceptable. Bio-Rad Laboratories

 3-Screen islet cell antibody

The KRONUS 3-Screen islet cell autoantibody ELISA assay kit is for the simultaneous and non-differential detection of GAD and/or IA-2 and/or ZnT8 autoantibodies in human serum. The kit depends upon the ability of the autoantibodies to act divalently and form a bridge between the antigens coated on the ELISA plate wells and the 3-screen biotin. Once this bridge is formed, streptavidin peroxidase attached to the colorogenic substrate (TMB) is bound. The 3-screen biotin and absorbance of each well is directly proportional to the amount of autoantibody present. For research use only. Not for use in diagnostic procedures. Manufactured under assigned patents and licenses. KRONUS

Special diabetes linearity

The Linearity FLQ Special Diabetes for Roche Systems, item #K929M-5, is a frozen liquid product, consisting of five levels that demonstrate a linear relationship to each other when assayed for C-peptide and insulin. This product is stored at -15°C with an open vial stability of five days when stored at 2-8°C. Audit MicroControl

 High resolution capillary separation

Sebia’s CAPILLARYS 3 TERA provides high -resolution capillary separation for HbA1c, hemoglobins, serum proteins, serum Iimunofixation by capillary (immunotyping) and CDT. The fully automated CAPILLARYS 3 TERA offers proven technology, enhanced throughput, increased walk-away capabilities and more flexibility for large-volume laboratories. Sebia

 Fructosamine assay

Fructosamine (glycated protein) is an earlier indicator of diabetic control compared to HbA1c. The enzymatic method for fructosamine testing offers improved specificity and reliability compared to conventional methods.The Randox fructosamine assay is standardized to the highest level,  as the calibrator and control are assigned relative to human serum glycated with 14C-glucose, directly reflecting the nature of the patient sample. Automated applications are available detailing instrument-specific settings for the convenient use of the Randox fructosamine assay on a wide range of clinical chemistry analyzers. Randox Laboratories