LABiTec, Germany

CoaDATA 504

CoaDATA 504, Semi automated, Single channel coagulation analyser for clotting assays based on turbodensitometric measuring principle with auto start function.

CoaDATA 504, Semi automated, Single channel coagulation analyser for clotting assays based on turbodensitometric measuring principle with auto start function.

MEASURING PRINCIPLE

The analyser operates according to the opto-mechanical measuring principle. This measuring principle is especially suited for lipemic and/or icteric colored samples as well as reagents with kaolin.

A light beam passes through the cuvette containing the test plasma onto a photo detector. Any change in the intensity of the transmitted light, that is light increase or decrease, is converted into an electric signal. Hence, even the most unstable clot can be detected.

The period from adding the start reagent until clot formation is measured. It then can be converted into the appropriate units (%, ratio, INR, mg/dl, g/l). Once the start reagent has been added, the measuring channel is adjusted, that is the lamp intensity automatically adjusts up or down depending on the turbidity of the test sample. In this process the turbidity of the sample plasma and the reagent are adjusted.

A mixer is located in the cuvette. During the measuring process the mixer provides homogeneity of the reagent-plasma medium. At the same time a small whirl emerges through the mixer movement which assures that even the smallest fibrin clot is formed in front of the photo detector.

This stirring action combined with the optical measurement constitutes the basic features of the patented “turbodensitometric measuring principle

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

T1. Single channel semi automated device based on the well established measuring principle.

– Very compact instrument based on LED diode (CoaDATA 504) or LED
photometric/clotting, to handle all routine clotting assays with CoaDATA 504 and
additionally chromogenic and immunoturbidimetric tests with CoaDATA 504+.

2. The systems need only low end volumes for measurement.

– Saves a significant cost on the test reagents.

3. Though basic versions can be equipped with external printer, external barcode reader.

– Small or big workloads, the same level of accuracy and convenience for integrity of results.

4. The system (CoaDATA 504+) shares in its software two point calibration curve each with upto nine points.

– Offering great ease of operation and convenience for all routine and special tests.

5. The systems have facilities for 15 editable tests with provision for test order selectability and convenience of test input.

– In a small footprint the systems offer convenience normally found in much more expensive machines.

6. CoaDATA 504+ has a reference channel with ambient light rejection capability.

– System is not affected due to the interference from lipemic, hemolytic and turbid samples.

7. CoaDATA 504+ incorporates dual wavelength technology with two user selectable
wavelengths at 405nm and 750nm.

– The unique technology permits analysis of routine and chromogenic test and delivers precise and reliable results.

8. The systems despite the small size have extensive features – LIS capability, patient ID entry, LIS/Host (USB) and interfaces including RS 232, USB, SD-card for result management and software update in such a compact unit.

– Extensive capabilities with the hardware and software, comparable to high end high cost systems in a compact small device.

9. The test throughput is of the order of 30 PT, and 15 APTT per hour with an excellent sensitivity of 1gram /litre for fibrinogen.

– The ideal system for labs with growing needs with results, reliable and comparable to larger analysers.

10.The mixer speed in the cuvette is selectable between 200 and 1000 RPM depending on the test method.

Provides for easy methods development and adaptation to specific test conditions, for precise and repeatable results.

11.The software structure permits differentiated access for parameter set up, parameter printout and service password and task, with four level password.

– Ensures integrity of the data, including the programmes and the results features available with bigger systems.

TECHNICAL DATA

CoaLAB 4004

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

Application: CLotting tests

Operation: Manual

Measuring principle: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

Wavelength: Approx.875nm

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 504 (Model CD12-1-17) is a semi-automated 1-channel in-vitro diagnostic analyser for coagulation, based on the turbodensitometric measuring principle. The anlayser is capable to perform a wide range of tests such as prothombin time, activated and partial thromboplastin time, fibrinogen, and single factor assays. The diagnosis and control of coagulation parameter is performed in the combination with several reagents for coagulation diagnostics.

BUYER’S SPECIFICATION

1. Single channel coagulation analyser based on turbodensitometric and photometric principle of measurement for accurate results.

2. The machine shall have two line LCD display and key pad for easy operator guidance and navigation, and display of results and provision for external printer and or barcode scanner.

3. The optics shall be based on LED photometer with at least two wavelengths 405 and 750nm, for analysis.

4. The system shall have reference channel and ambient light rejection facility for enhanced sensitivity.

5. The analyser shall have capability to perform all the routine (i) clotting tests like PT, APTT, fibrinogen (ii) chromogenic assays like plasminogen, ATIII, protein C etc. and (iii) immunoturbidimetric tests like D-Dimer, on the same platform .

6. The test throughput shall be approximately PT ~ 30/hr and APTT ~ 15/hr.

7. The system sensitivity shall be ~ 1 g/l for fibrinogen.

8. Should have facility for programming and storing of at least 15 tests, and freely editable.

9. The software shall have facility for at least two nos. of nine point calibration curve, and editable, with automatic result calculation facility.

10. Should be insensitive to interference from hemolytic, icteric and lipemic samples, for reliable results.

11. The machine shall have provision for positive patient identification manually or with a barcode scanner, and data export to LIS.

12. The interface capabilities should include as standard, RS232, USB and memory for software update, and result management.

FAQs

1. What is the principle of measurement?

– Turbodensitometry is the principle of measurement, with a proven track record over several years with 504 and 504+ combines the proven turbidodensitometry with LED photometry.

2. What is the light source used?

– It is based on long life LED diode with 504, and in case of 504+, it is LED photometric, with two wavelengths.

3. What is the wavelength of measurement?

– It is in IR region for 504, and 405nm and 750nm in case of 504+.

4(a)Does the system have any reference channel?

– Yes, with 504+, and 504 does not have reference channel.

(b) Do the analysers have ambient light rejection facility?

– Yes, the 504+ has the feature, and not available with 504.

5(a) Do the systems support on board calibration curve ?

– Yes, in case of 504+ nine point calibration curve is supported, but not in 504.

(b) How many calibration curves can be stored on-board ?

– Two calibration curves can be stored on-board with 504+. It is not available in case of 504.

6. How many test protocols are on-board ?

– There are 15 tests which can be stored and recalled from memory.

7. Does the system support external printer?

– Yes, the system(s) can be connected to external printer Seiko Epson DU414 or equivalent.

8. Do systems permit barcode identification of sample?

– Yes, when equipped with optional barcode reader.

9. What are the interface facilities available as standard?

– (i) RS232 (ii) USB (iii) SD-card for result and software management (iv) external barcode reader.

10. Can results be exported to LIS?

– Yes, LIS/HOST (USB) and LIS protocol (unidirectional) facilities are available.

11. Do systems allow usage of third party cuvettes?

– No, the cuvettes come with “cuvette card” for tracking of cuvette usage and only cuvettes supplied by LABiTec can be used.

12. Are systems sensitive to interference from hemolytic, icteric and lipemic samples?

– No, the system 504+ is sensitive to and not affected and free from interferences from hemolytic, icteric and lipemic samples.

13. What are the major differences between 504 and 504+ functionally?

– 504+ shares majority of features with 504 except for the fact that 504+ can handle (i) Chromogenic substrate based assays (eg. protein C, ATIII etc.), (ii) Immunoturbidimetry tests (e.g. D-Dimer) (iii) 504+ is equipped with measuring technologies for turbodensitometric and photometric tests at 405 and 750nm, (iv) Employs unique dual- wavelength technology (v) Insensitive to lipemic, icteric and hemolysed samples (vi) Nine point calibration curve, two nos. are supported.

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