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DCA Vantage™ Analyser (Starter Pack)

DCA Vantage™ Analyser (Starter Pack)

$3,000.00 (excl. GST)

Provide the clinical confidence your patients deserve. The DCA VantageTM Analyser helps you monitor glycaemic 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 analyser that speeds and simplifies diabetes tests and delivers accurate1, clinically relevant results shown to improve decision-making2,3,patient compliance, and outcomes4.

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

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.

ARTG #175890

Intended Use

The DCA VantageTM Analyser is a semi-automated, bench top system. It is designed to quantitatively measure the percent of Haemoglobin A1c in blood and low concentrations of albumin in urine (microalbuminuria), creatinine in urine, and the albumin/creatinine ratio in urine. The DCA VantageTM Analyser is intended for professional use in a physician’s office or hospital laboratory. Tests performed using the DCA VantageTM Analyser are intended for professional in vitro diagnostic use at the point of care.

 Every DCA Vantage™ Analyser purchased includes the following items:

1 X 10282970 DCA Vantage™ Analyser

1 X 10336648 Installation Kit

1 X 10328736 Printer Paper 5X20m/pkt

1 X 10698915 HbA1c Reagent Cartridges 10/pkt

 Online Training

Monitor glycemic control and diabetes complications using an analyser 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 units with % (NGSP) and mmol/mol (IFCC)
  • HbA1c patient trending graphs can be viewed or printed
  • Optional Bar-code scanner for safer and faster patient/operator ID entry

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 Customisable security office
  • Convenient local storage of up to 4,000 onboard records with powerful sorting capabilities
  • Capability to 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 decentralised settings

  • Access modes support up to 1,000 operators, protect patient information, and prevent operation by unauthorised 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

 

ARTG #175890

Intended Use

The DCA VantageTM Analyser is a semi-automated, bench top system. It is designed to quantitatively measure the percent of Haemoglobin A1c in blood and low concentrations of albumin in urine (microalbuminuria), creatinine in urine, and the albumin/creatinine ratio in urine. The DCA VantageTM Analyser is intended for professional use in a physician’s office or hospital laboratory. Tests performed using the DCA VantageTM Analyser are intended for professional in vitro diagnostic use at the point of care.

Overview

 

System Description

Point of care immunoassay analyser

Quantitative Tests

Haemoglobin 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 and Albumin: monoclonal antibody agglutination reaction
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 pre-treatment; 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

 On board Computer

 

Storage Capacity/Memory

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

Display

Colour 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 unauthorised 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 analyser

USB-Port

Standard USB 2.0

External Bar Code Reader (optional)

Serial (9 pin)

On board Printer

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

External Printer

Supports standard PCL printer interface via USB port

 General

 

Dimensions

25.4 (h) x 28.7 (w) x 27.7 (d) cm

Weight

3.88 kg

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 (Albumin)
15°C to 32°C (HbA1c)

Operating Temperature

5°C to 40°C;
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)

 

STORAGE

Product requires ambient storage of temperatures between 15-25°C.

 

Analyser

Q. What warranty is provided with the DCA Vantage™ Analyser?
A.
The DCA Vantage™ Analyser has a 12 month warranty. For full details refer to “Conditions of Supply of Product for Professional Use (Healthcare)”

Q. Are there any circumstances where the DCA VantageTM Analyser should not be used to diagnose diabetes?
A. The Siemens Healthcare Diagnostic DCA VantageTM HbA1c Reagent Cartridges can be an aid to diagnose diabetes and identify patients at risk for developing diabetes.

Do not use this test to diagnose:

  • Patients with a haemoglobinopathy, but normal red cell turnover. For example, a sickle cell trait.
  • Patients with abnormal red cell turnover. For example, anaemias from haemolysis and iron deficiency.
  • Patients with  iron  deficiency  and  haemolytic  anaemia,  various haemoglobinopathies,  thalassemias,  hereditary  spherocytosis, malignancies, and severe chronic hepatic and renal disease.

This test should not replace glucose testing for Type 1 diabetes, paediatrics, and pregnant women.

Do not use Haemoglobin A1c to diagnose diabetes during pregnancy.

 

Q. What is the sample collection procedure and sample size required to complete a test?
A. HbA1c – requires 1uL of whole blood to complete the HbA1c test. The sample may be obtained by finger prick or venepuncture. 

Urine Microalbumin/Creatinine Ratio - requires 40uL of urine sample from either a random, overnight or 24-hour collection.  Use no preservative.  Urine specimens may be stored at 2°C–8°C for up to two weeks.  Do not freeze.  Allow urine specimens to reach room temperature naturally.  Mix urine specimen thoroughly before use.

 

Q. How do I clean my DCA VantageTM Analyser?
A. Please refer to the DCA VantageTM Operators Guide – Section 6 Maintenance – Cleaning the Exterior for more detailed instructions.

The exterior of the instrument can be cleaned with a lint-free cloth dampened with water or ethanol.

NOTE: Turn the power off and disconnect the power cord before cleaning the exterior of the system.  DO NOT allow liquid to drip into the system as this can damage the optics.

 

Q. Can the DCA VantageTM Analyser report both % and mmol/mol units?
A. Yes, the DCA VantageTM Analyser can report either % or mmol/mol or both units can be reported together on the same printout. Please call the Technical Information Number for assistance in customising the units you require.

 

Reagents and Consumables

Q. What reagents and consumables do I need to operate the DCA VantageTM Analyser?
A. To complete a HbA1c test you need the following:
  • 10282970 DCA VantageTM Analyser
  • 10698915 HbA1c Reagent Cartridges
  • 10311161 HbA1c Normal & Abnormal Control Kit (Optional but recommended)
  • 10328736 Printer Labels (if hard copy is required)
  • 10328736 Printer Paper (if hard copy is required)

To complete a Microalbumin/Creatinine test you need the following:

  • 10282970 DCA VantageTM Analyser
  • 10311480 Microalbumin/Creatinine Reagent Cartridges
  • 10325406 Microalbumin/Creatinine Low & High Control Kit (Optional but recommended)
  • 10334754 Multistix® 10SG (refer below Q&A)
  • 10328736 Printer Labels (if hard copy is required)
  • 10328736 Printer Paper (if hard copy is required)

 

Q. Why do I need to order Multistix 10SG when ordering Microalbumin/Creatinine (ACR) Reagent Kit?
A. Urine specimens containing in excess of 2000 mg/L of albumin may give assay results within the range of the DCA System because of the antigen excess effect for direct agglutination assays.

Screening the urine sample first with Multistix® 10SG will detect gross proteinuria. 

Urine samples with a Protein test pad colour change of greater than ++ (1 g/L or 100 mg/dL) should not be analysed using the Microalbumin/Creatinine (ACR) Reagent Kit.  These samples should be sent to a laboratory to be analysed using another method.

 

Q. How should I store my DCA VantageTM Reagents?
A. Please refer to the DCA VantageTM HbA1c and Microalbumin/Creatinine Reagent Cartridges “TECH SPEC S” tab.

 

Q. How many results can be printed per roll of printer paper or labels?
A. For paper each unit size contains 5 x 20m rolls (100m total) before the pink strip appears. For labels each unit size contains 5 x 10.7m rolls (53.5m total). The number of result printouts depends on whether the full (long) or short (partial) report is selected in the setup as well as required data entry fields.

 A full (long) report with 7 data entry fields is 17 cm in length.  This works out to approximately 117 printouts per paper roll (585 total), and approximately 58 printouts per label roll (294 total).

There is an option to purchase either printer paper or printer labels. Both are thermal paper however the difference is the printer label has an adhesive backing which provides for direct attachment to patient notes without the need to use tape. Printer paper requires tape to be used if attaching to patient notes.

 

Q. Why is the printer not working?
A. Check the instrument is set up to automatically print the results. Instructions can be found in the DCA Vantage™ Operators Manual – Section 9, Customising the System.

Ensure you are using the Siemens DCA Vantage™ Printer Paper or Labels and check to see if it has been loaded the correct way. The DCA Vantage™ Printer Paper and Labels are thermal so will only print on one side.

If the printer paper or labels have recently been changed, check that the printer’s paper holding arm/lever is down and engaged in the closed position. See manual for directions.

If the results will still not print please call Technical Assistance on 1800 310 300.

 

Quality Control

Q. Why do I need to run Quality Control?
A. Quality Control (QC) is used to ensure patient results being reported by the DCA VantageTM Analyser are true and accurate. QC does this by testing the reagent cartridges are reacting and being read correctly prior to the running of patient samples. Quality control testing also detects errors resulting from incorrect user technique.

 

Q. How often do I need to run Quality Control?
A. It is recommended to run quality control specimens under the following conditions:
  • At regular intervals in accordance with your local guidelines.
  • With each new shipment of reagents
  • With each new lot of reagents
  • Each time a calibration card is scanned
  • To train and confirm performance acceptability for new users
  • When results do not match the patient’s clinical condition or symptoms

As per the requirements documented in ISO 15189 Medical Testing Field Application Document:

The Australasian Association of Clinical Biochemists‟ position statement on PoCT is applied in relation to cartridge-based instruments and is also considered to be relevant to the disciplines of haematology, microbiology and immunology. QC testing must be performed on all PoCT devices and for every analyte/test for which the PoCT device is being used.  This is additional to the statement in the AACB guidelines.

Devices using cartridge-based technology (e.g. blood gas analysers, glycohaemaglobin meters) shall have a minimum of two liquid QC samples tested per month unless a higher frequency is suggested by the manufacturer (once made up, the DCA VantageTM HbA1c and Microalbumin/Creatinine controls are liquid QC).  These two QC samples should contain both normal and abnormal levels. In addition to the above QC program, QC testing should also be undertaken when:

  • The lot number of the consumables changes;
  • There is a new delivery of consumables;
  • An operator lacks confidence in a patient result;
  • The health care professional does not believe that the PoCT result fits the patients clinical picture;
  • Substantial maintenance procedures have been carried out on the device;
  • The device has suffered a physical insult (e.g. dropped, temperature extremes – hot or cold, etc.).

 

Q. How should I store my DCA VantageTM Quality Control?
A. Please refer to the DCA VantageTM HbA1c Normal & Abnormal Control Kit and DCA Vantage TM Microalbumin/Creatinine Low & High Control Kit “TECH SPECS” tab.

 

All education and training for the DCA VantageTM Analyser is available exclusively online. Please refer to the following tools:

    1. Complimentary diabetes and kidney disease app for iPhone or iPad

      Download Diabetes and Kidney Disease AppDownload Diabetes Clinical Care from App Store

       

       

       

      2. PEPconnect : Online, virtual competency-based education training for Siemens products.

        Go to PEP Connect training www.siemens.com/PEP

         

         

         

        PEPconnect is a technologically advanced, virtual, competency-based education and training solution that focuses on increasing the knowledge, skills, and abilities of each individual user - ultimately reducing the time to achieve job competency.  Through this customisable approach, individual learners can plan, achieve, and maintain proficiency standards directly from any device at their convenience.
        • Access education and real-time performance support, anytime, anywhere, on any device.
        • Construct your personalised learning experience.
        • Share and connect your learning experience with others.
        • Utilise an intuitive interface.

           

            Product is typically delivered within 7 days

            Delivery is free of charge


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