Product Focus on Diabetes

Oct. 19, 2012
Management of POC diabetes testing

DCA Vantage® Analyzer is a point-of-care (POC) diabetes testing instrument that can provide accurate, clinically relevant results to improve decision-making, patient compliance, and outcomes.   It is a POC HbA1c analyzer that meets NGSP’s tightened performance criteria.

Features to improve workflow for POC clinicians include self-contained cartridges for walk-away operation; no sample or reagent preparation; barcode scanner; and minimal maintenance requirements.

Management for POC coordinators can be simplified through features that include the support up to 1,000 operators; operator lock-out to prevent operation by unauthorized users; and POCT1-A2 protocol to streamline data transfer to LIS/HIS, RAPIDComm® system, or third-party POC data management systems.

The device provides an HbA1c report in 6 minutes with patient trending graphs and albumin, creatinine and A:C ratio in 7 minutes; includes an onboard GFR calculator; supports dual reporting for HbA1c results; and expresses results as HbA1c%, IFCC mmol/mol, or both.

Siemens Healthcare Diagnostics

Linearity product

The A1c-Cellular® Linearity product is commercially-available Hemoglobin A1c  (HbA1c) linearity/calibration verification material with intact red blood cells. It is a five-level assayed linearity material used to assess instrument accuracy and verify patient reportable range of the HbA1c parameter.

The product’s unique formulation does not require reconstitution. The material tests the entire reportable range of the instrument system, including the lyse step. Instrument-specific target values and expected ranges are provided for immediate instrument accuracy verification.

A1c-Cellular Linearity features 7-day open-vial stability and 105-day closed-vial stability. Cap-pierceable vials offer convenience of auto sampling for analyzers with those capabilities, and barcodes for instruments capable of barcode scanning.

Streck, Inc.

Survey reports 97% to 100% accuracy

The G8 HPLC Analyzer provides fast and accurate HbA1c monitoring. Customers have achieved a pass rate of 97% to 100% in accuracy-based proficiency testing surveys. The system utilizes the Gold Standard Ion-Exchange method of HbA1c measurement with less than 2% CVs and an analysis time of only 1.6 minutes.

The analyzer provides direct determination of stable HbA1c. It is used for in vitro diagnostic measurement of HbA1c in blood specimens. The G8 uses a non-porous column and microcomputer technology to quickly and accurately measure the stable portion of HbA1c as a percentage of the total amount of hemoglobin present in the sample. It provides accurate and precise separation of HbA1c from other hemoglobin fractions. Off-line pretreatment is not required, and there is no interference from the labile portion of HbA1c.

Along with a compact footprint of 21″ x 19″ x 20″, the analyzer has simple touch-screen operation, automatic start-up, and daily maintenance.

Tosoh Bioscience. Inc.

HbA1c measurement in 4 minutes

Quo-Test is used for easy and reliable measurement of glycated hemoglobin (HbA1c) in the detection and management of diabetes.  Fast and accurate results can be obtained from the machine in just 4 minutes from 4 μl of blood from a finger prick or venous sample. The user-friendly device has a multi-lingual menu and allows for efficient data handling, with a barcode reader and storage of up to 7,000 results, which can be downloaded to a computer via a USB port.

The device is awaiting FDA clearance with a launch expected early in 2013, will be sold in North, Central, and South America by Stanbio Laboratory.

EKF Diagnostics

Meter measures glucose and blood ketones

The Nova Max Plus Blood Glucose/Ketone meter measures both glucose and blood ketones on a single meter. This test provides the opportunity for early recognition of DKA symptoms, a potentially life threatening yet preventable complication of diabetes. Once detected, treatment can be initiated to help prevent DKA.

Blood ketone and glucose tests are performed using the same procedure. Simply insert a glucose or ketone test strip into Nova Max Plus and apply a tiny, 0.3 microliter, fingerstick blood sample. Glucose and ketone testing can often be performed using the same fingerstick.  Glucose results are available in 6 seconds and blood ketone results in 10 seconds using a separate ketone test strip.

Nova Diabetes Care, Inc.

Assay eliminates manual pretreatment steps

The Hemoglobin A1c assay for ACE®, ACE Alera®, and ACE Axcel™ Clinical Chemistry Systems eliminates manual pretreatment steps, saving time and improving precision, as well as providing 30-day on-board stability. The new A1c assay is certified by the National Glycohemoglobin Standardization Program (NGSP) and is traceable to the Diabetes Control and Complications Trial (DCCT).

The American Diabetes Association now recommends the A1c assay to diagnose and screen for diabetes and prediabetes, giving the test a prominent role in its Standards of Medical Care in Diabetes—2012. Hemoglobin A1c has several advantages over traditional fasting plasma glucose and glucose tolerance tests: greater patient convenience, since fasting is not required; improved preanalytical stability; and  fewer day-to-day variations caused by illness and stress.

Alfa Wassermann Diagnostic Technologies

Ready-to-use liquid control with extended stability

Dropper A1c Diabetes Control, a ready-to-use liquid control with extended stability, is now available.

Features include three years frozen shelf life from date of manufacture and six months of refrigerated open vial stability to reduce waste, plus dropper bottles for simple dispensing. Twenty-one days of open vial room temperature stability eliminates storage problems and provides maximum portability, which is ideal for sites without refrigeration. Dropper A1c is designed for use with most major immunoassay and boronate affinity laboratory and POCT analyzers.

Quantimetrix also provides Quantrol®, a comparative data management quality control program for all Dropper A1c Diabetes Control users. Free monthly reports are provided for participants allowing each lab to monitor test performance and trend analysis.


Automated capillary electrophoreses system

CAPILLARYS 2 Flex Piercing instrument for hemoglobin, protein, and CDT testing is now available. This system is the latest addition to the automated capillary electrophoresis portfolio offering the addition of high-throughput, cap-piercing capabilities for whole-blood, primary sample tube specimens.

The company has also developed a next generation separation method for HbA1c testing (CE marked and pending FDA clearance). This HbA1c assay brings a significant performance improvement over other methods due to the simple, direct analysis of HbA1c delivering clear-cut and precise separation without interference of Hb variants and an accurate quantification of HbA2. Analytic performance includes excellent accuracy, precision, and linearity over a broad range. Sebia provides expertise and innovation in the field of electrophoresis with automated and scalable solutions to fit into any size laboratory.

Sebia, Inc.