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

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DCA Vantage Analyzer

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DCA Vantage Analyzer
DCA Vantage Analyzer
Robust technology delivers proven performance
Manage diabetes testing in decentralized settings
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Provide the clinical confidence your patients deserve. The DCA Vantage® Analyzer helps you monitor glycemic control and detect early kidney disease in environments ranging from the physician’s office to remote, point-of-care coordinated sites in hospitals and multisite practices. Meet lab-quality testing standards with an analyzer that speeds and simplifies diabetes tests and delivers accurate,1 clinically relevant results shown to improve decision-making,2,3 patient compliance, and outcomes.4

  • Manage diabetes patients more effectively
  • Improve workflow in office or clinic
  • Simplify management of diabetes testing in decentralized settings
  • One of just two HbA1c analyzers that meet NGSP performance criteria1
  • Used by three out of four physicians who perform HbA1c testing in their office5

Features & Benefits

Monitor glycemic control and diabetes complications using an analyzer designed to make consultations easier. Fast, actionable test results enable you to determine the effectiveness of a treatment plan, make therapeutic adjustments with confidence, and be more certain whether patients are complying with your recommendations.

Monitor glycemic control

  • HbA1c from a small (1 µL) whole blood sample in 6 minutes
  • Flexible reporting of HbA1c% (NGSP, JDS, and Mono-S units) and IFCC (mmol/mol)
  • Reporting of HbA1c results as Estimated Average Glucose values* in the same units (mg/dL) that patients’ home glucose meters display
  • HbA1c patient trending graphs can be viewed or printed

Detect early kidney disease

  • Albumin, Creatinine, and Albumin-to-Creatinine (A:C) ratio from a urine specimen in 7 minutes to report a quantitative protein status with automatic creatinine adjustment
  • Onboard GFR calculator indexes kidney function

Improve workflow in the office or clinic

  • Self-contained cartridges facilitate easy, walkaway operation after sample loading
  • No sample or reagent preparation required
  • Bar-code scanner for safer and faster patient/operator ID entry
  • Review results on-screen or generate a hard copy report to minimize transcription errors in the office
  • Convenient local storage of up to 4,000 onboard records with powerful sorting capabilities
  • Automatically upload results to a PC via a USB flash drive to reduce manual logging and save time
  • Minimal maintenance requirements with automatic reminders to alert you when maintenance is due

Simplify management of diabetes testing in decentralized settings

  • Customizable security access modes support up to 1,000 operators, protect patient information, and prevent operation by unauthorized users
  • POCT1-A2 communication protocol streamlines data transfer for easy connectivity and fast, two-way communication to LIS/HIS, RAPIDComm® System, or other third-party POC data management systems
  • Automatically upload results and QC information to LIS/HIS to reduce manual logging and save time

Assays

Hemoglobin A1c (HbA1c)
Estimated Average Glucose (eAG) Result*
Albumin
Creatinine
Albumin-to-Creatinine (A:C) Ratio Results

Formulas for Calculated Results
% HbA1c = (HbA1c/Total Hemoglobin) x 100

eAG* mg/dL = (28.7 x HbA1C) – 46.7
eAG* mmol/L = (1.59 x HbA1C) – 2.59
GFR = 186 x (plasma creatinine mg/dL)-1.154 x (patient age years)-0.203 x (0.742 if female patient) x (1.210 if African American patient)

Formulas for Dual Reporting From IFCC to % HbA1c
NGSP = (0.09148 x IFCC) + 2.152
JDS = (0.09274 x IFCC) +1.724
Mono-S = (0.09890 x IFCC) + 0.884

Formulas for Dual Reporting From % HbA1c to IFCC mmol/mol
IFCC = (10.93 x NGSP) – 23.50
IFCC = (10.78 x JDS) – 18.59
IFCC = (10.11 x Mono-S) – 8.94

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. Lenters-Westra E, Slingerland RJ. Clin Chem 2010;56(1):44.

2. Thaler LM, et al. Diabetes Care 1999;22:1415-21.

3. Miller CD, et al. Diabetes Care 2003;26:1158-63.

4. Cagliero E, et al. Diabetes Care 1999;22:1785-9.

5. GHX Market Intelligence, market data report. 4Q 2012 Report.

*Not available in the U.S.
Some of the medical devices/features/applications listed may not yet be licensed for sale in Canada, in accordance with Canadian Law. Due to regulatory reasons, their future availability cannot be guaranteed. Please contact your local Siemens Healthineers organization for further details.

The products/features (mentioned herein) are not commercially available in all countries. Due to regulatory reasons their future availability cannot be guaranteed. Please contact your local Siemens organization for further details.