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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)

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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

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