LABiTec, Germany

CoaDATA 4004

CoaDATA 4004, Semi automated, Four channel coagulation

analyser for fast and accurate measurement of coagulation, chromogenic and turbidimetric assays.

CoaDATA 4004, Semi automated, Four channel coagulation
analyser for fast and accurate measurement of coagulation, chromogenic and turbidimetric assays.

MEASURING PRINCIPLE

The CoaDATA 4004 uses the photometric measuring principle (transmission) as shown below:

The light source is an LED (1) with narrow-band emission spectrum. The emitted light from LED1 (405nm) and LED2 (750nm) is divided into a measuring beam 1 and a measuring beam 2 by use of a beamsplitter. Each of these beams is focused by means of the collimator lens and aperture to a parallel beam of light. The light beam passes through the cuvette (2) to the photosensitive receiver (3). The generated current and the resulting voltage (4) at the photosensitive receiver is proportional to the received light as long as the component is operated within the optimal range. If a photo transistor is used, the voltage conversion is already integrated, by use of a photodiode the conversion must be done by a operational amplifier (5) circuit. The resulting voltage must be increased in order to adapt the input voltage range of the AD converter(6). The absorbance value (Extinktion) of the light is calculated from the transmission value. The Beer-Lambert law is used.

The reaction curve consists of periodically collected measuring values. The curve can be calculated by use of specific algorithms to detect the reaction time or to determine the reactivity of a substance in the sample.

Due to the fact that the mixer motor underneath the measuring channel can be configured for continuous or temporarily stirring traditional clotting tests according the turbodensitometric principle or chromogenic tests can be performed.

MAJOR MERITS

The machine incorporates multi-wavelength analysis for handling advanced coagulation tests.

– Offers user selectable wavelengths 405/750nm for each channel for interference free accurate results.

2. Semi automated two/four channel coagulation analyser for accurate determination of (i) coagulation (ii) chromogenic (iii) immunoturbidimetric assays.

– Ability to handle in a small foot-print, routine, PT, APTT, fibrinogen, TT, batroxobin, or chromogenic assays, AT3, plasminogen, protein C etc. or immunotests like D-dimer and CRP and including special tests like APC resistance, Factor V Leiden, lupus anticoagulant etc. on the same machine, with comparable results to automated systems costing several times higher.

3. Single system with several modes of testing as standard covering a broad spectrum of coagulation tests in a small analyser!

– Best suited as prime system for mid size labs for routine and special tests, and an ideal back-up for referral centres or larger labs, including for special coagulation tests.

4. Positive patient identification numeric, and alphanumeric with barcode and uni-directional HOST communication.

– Offers majority of features found with automated and bigger systems and the benefits within the reach of smaller labs.

5. Large measuring range with higher accuracy and precision, thanks to unique measuring system.

– Performance exceeds, compared to systems based on “optical only” principle, by combining best of both, LED photometer with photo mechanics.

6. Automatic calculation of results for PT and fibrinogen, and choice of several units (eg. seconds, mg/dl, mE, ratio etc.) and with 15 programmable test positions, freely editable, reagent parameters.

– Extend a higher level of user convenience, flexibility and easy adaptability to suit varying lab needs.

7. A myriad of features which are practical and offered as standard at no extra cost, in a semi automated device – external thermal printer, RS 232, USB device, SD-card.

– No add-on or hidden cost and possibilities include (i) external printer in case of problem with internal standard printer (ii) Data transmission to SD-card or external PC. (iii) Reagent setting loaded /stored via chip card. (iv) patient id numeric and alphanumeric with barcode. (v) Uni-direction host communication.

Semi automated analyser, sharing most features found in automated device!

8. Two or four independent channels of measurement as available with CoaData 2004 offer possibilities of single or double determination, as preferred.

– Saves time, improves throughput and when run in duplicate, increases the test precision.

9. The system automatically starts the measuring process, with the sudden change in absorbance, with the addition of start reagent to the sample cuvette.

– The above approach avoids possible time delay, between addition and measurement as is possible with mechanical devices, guaranteeing absolutely reproducible results.

10. The system employs micro cuvettes with the end volume of the order of 150 to 300uls, for measurement.

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– There is a substantial saving in the reagent usage permitting the minimum end volume of sample and reagent at 150uls rather than 300uls for quite a few critical tests.

11. The machine incubates and mixes sample and reagent automatically and also guides the exact time to add start-reagent and the auto-start function automatically clocks the exact time of addition of reagent though pipetting is manual, and initiate reagent mixing and subsequent clot detection in a seamless sequence.

– All critical functions except for sample and reagent pipetting are virtually automated with this semi-automated system, to ensure that final results are comparable to those from automated analysers!

To sum up, CoaData 2004 and 4004 systems employing turbodensitometry principle, integrate the best of the features with the mechanical and optical devices, with robust optics and flexible software. All areas which can compromise with the accuracy and precision of results, have been addressed for ensuring very precise and reproducible results. The above advantages with flexibility to use micro or macro volumes, offer easy adaptation to suit the lab needs with.

TECHNICAL DATA

CoaLAB 4004

Type of analyzer: Semi-automated 1-channel in-vitro-
diagnostic analyzer for coagulation

Application: Measurement of chromogenic assays and clotting tests (turbodensitometric)

Operation: Manual

Measuring principle:Photometric (transmission), turbodensitometric

Sensitivity: ~ 1 g/l Fibrinogen; PT 10% of norm

Test throughput: ~30/h PT, ~15/h aPTT

Cuvette volume: min. 150 μl, max. 200 μl (test suspension)

Calibration: Manual input of calibration points, method dependent

Software: Stored in Memory

Pre-programmed methods:PT, in sec, %, Ratio, INR (combinations)

aPTT, in sec, and Ratio

Fibrinogen, in sec, [g/l] and [mg/dl]

Thrombin Time (TT), in sec

D-Dimer 405/750nm

AT 405nm

Intr. Factor, in %

Extr. Factor, in %

Light Source: LED photometer

Wavelength1: 1405nm

Wavelength2: 750nm

Display: Liquid crystal display, 2 lines with 20
characters each

Thermal Block: Temperature controlled at 37.4°C +/ -0.4°C

Measuring channel(s): 1

Light protection caps: 1 (designed for yellow pipette tips by
Eppendorf)

Reagent vial positions: 1 á 22.0 mm diameter

Cuvette positions: 4 for pre-heating/incubation

Measuring time: Max. 420 sec

Mixer: 200 – 1000 rpm, depending on test method

APPLICATIONS

CoaLAB 4004

The CoaDATA 2004 / 4004 (Model CD12-2-17 / CD12-4-17) are a semi-automated 2 / 4-channel in-vitro diagnostic analyzer for coagulation, chromogenic and
immunturbodensitometric assays of blood plasma. The analyzer is capable to perform a wide range of tests such as Prothrombin time, activated and partial Thromboplastin time, Fibrinogen, and special tests such as single factor assays, Anti-Thrombin III, Protein C, Protein S, D-Dimer. The diagnosis and control of coagulation parameter is performed in the combination with several reagents for coagulation diagnostics.

BUYER’S SPECIFICATION

1. Semi automated two/four channel coagulation analyser for reliable determination of coagulation, chromogenic and immunoturbidimetric assays on the same platform with built-in printer.

2. The system shall provide operator guidance through two line LCD and key pad, with provision for optional external thermal printer, if preferred.

3. Shall offer high resolution photometer unit with mechanical stirring for reliable results over the entire spectrum of coagulation testing.

4. Shall permit user to select 405 or 750nm wavelength for each channel for interference free accurate run.

5. Facility should be available for multi wavelength analysis for advanced coagulation testing and diagnosis and insensitive to interferences from hemolytic, icteric, and lipemic samples.

6. The analyser shall have compensation for ambient light and with large measuring range for accurate and precise results.

7. Shall have provision for positive patient id, numeric and alpha numeric with barcode scan.

8. The machine shall have at least four reagent positions and 15 incubation positions for handling convenience, for one-off or batch processing.

9. It should be an open system to reagents with facility for storing at least 15 programmes on board and freely editable.

10. The machine shall have facility to incubate, mix sample and reagent automatically and guide the exact time to add start reagent, and with auto start function to automatically clock exact time of addition of reagent, without the need for electronic pipette or manual start, for precise results.

11. Shall have capability for storage and recall of at least two calibration curves, with up to nine calibration points with editing possibility.

12. The interface capabilities shall include RS232, USB device for host, SD-card for storage of results and programmes.

FAQs

1. What is the principle of measurement?

-The system combines turbodensitometric (opto mechanical) and photometric
(photomechanical) with high resolution LED photometer with the mechanical stirring to ensure precise and reliable results./

2. How many measuring channels are offered?

– CoaDATA 2004 offer two channels and CoaDATA 4004 offers four channels for
measurement.

3. How many samples can the system handle simultaneously?

– The analyser can run two samples in duplicate, or four different samples in CoaDATA 4004 system and one sample in duplicate or two different samples at the same time.

4. Is it possible to upgrade the two or four channel models into higher versions?

– No, the systems cannot be upgraded.

5. What are the different platforms in which the assays are covered?/

– Both 2004 and 4004 are suited for determination of coagulation (clotting), chromogenic and immunoturbidimetric based assays.

6(a)What is the type of photometer employed?

– High resolution LED photometer with multiwavelength analysis with user selectable wavelengths 405nm/750nm, and with reference channel to compensate for ambient light to ensure accurate results.

(b)What is the lamp source of the photometer?

– Long life LED.

(c) What are the wavelengths available with the LED photometer?

– (i) LED, one wavelength for reference channel to compensate ambient light.

– (ii) LED second wavelengths, for 405 and 750nm.

7. How does the system handle routine clotting or chromogenic tests?

– Since the mixer motor is underneath the measuring channel it can be configured for continuous or temporary stirring for traditional clotting tests (eg. PT/APTT/TT….) employing well established/turbodenistometric principle, or chromogenic tests.(eg. AT III, protein C, plasmingen etc.) can be performed based on 405nm or 750nm.

8. What are the evaluation methods employed?

– It is elaborate and includes (i) fixed extinction, (ii) difference, and (iii) kinetics with linearity control to ensure consistently accurate and reproducible results, with results comparable to automated devices.

9. Is it an open or a closed system?

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– Both 2004 and 4004 are open to reagents from standard sources reagents, and test parameters are freely editable by user for total flexibility.

10. Is it possible to connect the system to an external printer?

– Yes, the machines are complete with internal thermal printer, and can be equipped with external (optional) printer, if preferred.

11.What are the relative merits of the new design?

– More insensitive to interference from hemolysis, icteric and lipemic samples and ambient light compensation ensures provides more reliable results over the spectrum of coagulation tests.

12. What is the brief description of measuring unit?

– CoaDATA 2004 – Two Four (one stirred) 18 cuvettes

– CoaDATA 4004 – Four Four (one stirred) 16 cuvettes

13. What is the speed of stir bar employed for turbodenistometry method of analysis?

– It is adjustable in the range 200 to 1000 rpm providing for easy and exact adaptation and optimisation of various tests and reagents and in addition providing reliable measurement of even fragile clots.

14. How many test parameters maximum can be stored for recall?

– 15 programmable test positions are available.

15. How many calibration curves are on board?

– Two editable calibration /reference curves with nine points each are available, with facility for manual input of calibration points depending on methods.

16. Does system have provision for selection of units and conversion capabilities?

– Yes, automatic calculation of results in sec, INR, %, g/l, mg/dl, Ratio, mE, and ng/dl, and selection of three conversions for each test are available for enhanced user convenience.

17. What is the routine test volume involved?

– Only micro volume of 150 µl as test volume is involved.

18.Does the systems have facility for patient-ID?

– Yes, (i) manual numeric entry of patient I.D. and (ii) alphanumeric entry with bar code scanner are available for ensuring integrity of sample results.

19. Do the systems have password protection?

– Yes software structure in the systems allows differentiated access for parameter set-up, parameter print-out, and service task via password at four levels covering lab staff, lab manager , service and factory, features not always available even in bigger systems.

To know more about CoaDATA 2004:

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