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  5. DCA Vantage® Analyzer

DCA Vantage AnalyzerDrive diabetic patient compliance with trusted, clinically proven results

The DCA Vantage® Analyzer is a multi-parameter, point-of-care analyzer for monitoring glycemic control in patients with diabetes and detecting early kidney disease.

  • CLIA-waived HbA1c test that is IFCC and NGSP-certified
  • 1µl finger stick without fasting – HbA1c results in 6 minutes
  • Random urine sample provides A:C ratio in 7 minutes
  • Requires no sample or reagent preparation prior to testing
  • New 2-D bar-code scanner — for the DCA Vantage® Analyzer and CLINIITEK Status® Connect System

    Features & Benefits

    Easy to use and implement

    • Plug and play installation
    • Simple, one-step calibration scan with every new lot
    • Guided user-interface with step-by-step testing instructions
    • Hassle-free maintenance

    Improve patient outcomes and operational costs

    • Increase patient satisfaction when testing during office visit1
    • Aid in lowering HbA1c levels over time2,3
    • Reduce costs associated with post-visit testing1
    • Satisfy HbA1c and kidney check HEDIS quality measures

    Failsafe measures for audit risk mitigation

    • QC lockout prevents patient testing if QC not tested or fails
    • Prevent unauthorized users from testing and accessing confidential patient information
    • Eliminate transcription errors with bar-code data entry and automatic transmission of results
    • Link patient results to operators and material lot information (audit-ready)
    • Customizable operator-specific system access mode

    Results you can trust

    • Robust reagent cartridges designed to minimize pre-analytical errors associated with sample and reagent handling
    • Consistently meet NGSP and IFCC annual certifications for HbA1c
    • Clinically proven to correlate with lab methods4,5

    Assays

    Hemoglobin A1c (HbA1c)
    Albumin
    Creatinine
    Albumin-to-Creatinine (A:C) Ratio Results

    Technical Specifications

    Overview

     

    System Description

    Point-of-care immunoassay analyzer

    Quantitative Tests

    Hemoglobin A1c (whole blood): Range: 2.5% to 14% (4mmol/mol to 130 mmol/mol) Microalbumin/Creatinine (urine): Single test reports all three results for: Albumin: 5 to 300 mg/L; Creatinine: 15 to 500 mg/dL (1.3 to 44.2 mmol/L); Albumin-to Creatinine Ratio: 1 to 2000 mg/g (0.11 to 226 mg/mmol)

    Test Format

    Self-contained immunoassay cartridges

    Test Measurement

    Automatic, optional transmission

    Test Method

    HbA1c: monoclonal antibody agglutination reaction
    Albumin: polyclonal goat anti-human albumin antiserum
    Creatinine: Benedict Behre chemical reaction

    Time to Test Results

    HbA1c - 6 minutes

    A:C Ratio - 7 minutes

    Test Handling

    Sample Volume

    HbA1c - 1µL whole blood
    Microalbumin/Creatinine - 40µL urine

    Sample Preparation

    No pretreatment; no pipetting required

    Sample ID/Operator ID Entry

    Optional; via touch screen or bar code reader

    Calibration

    Calibration

    Lot-specific calibration card provides automatic calibration with every cartridge

    Traceable to International Federation of Clinical Chemistry (IFCC) reference materials and test methods for measurement of HbA1c

    Onboard Computer

    Storage Capacity/Memory

    4000 patient and/or control records
    Up to 1,000 operator IDs

    Display

    Color touch screen with 1/4 VGA resolution

    Data Export

    Via USB flash drive to PC or direct to LIS/HIS or data manager, if interfaced

    Quality Control/Compliance

     

    Flexible QC Scheduling

    None, Automatic Reminders or Required

    QC Testing

    Optional lockout if schedule not followed or QC fails

    User/Operator Access

    Restricted, if desired, to protect patient and QC data and prevent unauthorized use

    Matching Lab Results/
    Reference Method


    Adjustable correlation to reference methods

    Reference Ranges

    User-definable reference ranges available for HbA1c

    Computer/Peripheral Interfaces

     

    Serial Port

    RS232, ASTM

    Ethernet Connection

    ASTM or POCT1-A2

    Bi-Directional Capabilities

    ASTM: Remote computer can be set up to lock out patient tests
    POCT1-A2: Remote computer can be set up to lock out patient tests, and send operator list to analyzer

    USB-Port

    Standard USB 2.0

    External Bar Code Reader (optional)

    Serial (9 pin)

    Onboard Printer

    54 mm (2 in) width, thermal/label stock

    External Printer

    Supports standard PCL printer interface via USB port

    General

    Dimensions

    9.0 (h) x 11.5 (w) x 10.5 (d) inches 25.4 (h) x 28.7 (w) x 27.7 (d) cm

    Weight

    3.88 kg (9.0 lb)

    Power Requirements

    100 to 240 VAC; 50/60 Hz

    Line Leakage Current

    <0.3 mA in normal condition
    <0.5 mA in single fault condition

    Maximum Power Input

    70 VA; 30 watts

    Ambient Operating Temperature

    18°C to 30°C (64°F to 86°F) (Albumin)
    15°C to 32°C (61°F to 88°F) (HbA1c)

    Operating Temperature

    5°C to 40°C (41°F to 104°F);
    15% to 90% relative humidity

    Safety

    TUV SUD with CB Scheme, CSA-C22.2,
    EN60601, IEC 60601, UL60601

    EMC Emissions/Immunity

    FCC 47: Part 15 (Class B),
    EN60601-1-2 (Class B)

    References

    1

    Crocker, et al. Patient satisfaction with point-of-care laboratory testing: report of a quality improvement program in an ambulatory practice of an academic medical center.

    Clinica Chimica Acta. 2013;424:8-11.

    2

    Schnell, et al. Impact of HbA1c testing at point of care on diabetes management. Journal of Diabetes Science and Technology. 2017;11(3):611-17.

    3

    Petersen J, et al. Effect of point-of-care on maintenance of glycemic control as measured by A1C. Diabetes Care. 2007 Mar;30(3).

    4

    Felix O. Omoruyi, Gul M. Mustafa, Anthony O. Okorodudu, John R. Petersen. Clinica Chimica Acta 413 (2012) 625–629; evaluation of the performance of urine albumin, creatinine and albumin–creatinine ratio assay on two POCT analyzers relative to a central laboratory method.

    5

    Weykamp et al. Clin Chemisty 61:5; 752-759