LABiTec, Germany

CoaLAB 1000

CoaLAB 1000, compact bench top fully automated clotting, chromogenic and immunoturbidimetric coagulation analyser for precise and reliable results over the entire coagulation spectrum.

CoaLAB 1000, Compact bench top fully automated clotting, chromogenic and immunoturbidimetric coagulation analyser for precise and reliable results over the entire coagulation spectrum.

MEASURING PRINCIPLE

The analyser uses a photo-optical detection principle. Clotting, chromogenic and immunologic assays can be run simultaneously in random access, depending on the available wavelength installed in the analyser.

The measuring module consists of the measuring rotor having two measuring channels each equipped with LED photometer. Depending on the analyser there are either

– 2 LED photometers with a filter 405nm only or

– 2 LED photometers with filters at 405nm/570nm/740nm

A light beam passes through the cuvette and is received by the photodiode. As soon as the starting reagent is added to the plasma, the measuring time starts.

Any change in the light transmittance is detected and converted into an electrical signal by the photodiode.

When the assay is complete, the raw data (seconds for coagulation assays and mE/sec (Extinction) for chromogenic assays) are processed and reported.

MAJOR MERITS

Totally automated two channel coagulation analyser for clotting, chromogenic and immunological assays.

Capable of performing routine clotting assays like PT, APTT, fibrinogen, thrombin time, ecarin time, batroxobin, factor assays and latex assays like D-Dimer, CRP and chromogenic assays like AT3, protein C, plasminogen, α 2 antiplasmin, as well as tests like Factor V Leiden, LA, PiCT, TDT, and TAFI etc.

– The system offers comprehensive testing capabilities covering most coagulation tests including routine, special and emerging tests, addressing future needs as well.

Touch sensitive LCD display with on board graphic user interface, and no need for external computer.

– Provides easy guidance for operator and intuitive software for easy operation and usage and minimum space requirement.

The system is based on the photometry with magnetic stir bars to homogenise the approach and to increase the sensitivity.

– Based on the well proven and unique principle combining the best of photometry and continuous mechanical stirring, for precise results even in the case of tests involving fragile clots.

Two channel LED photometer with two reference channels.

– Relatively impressive throughput of 120 PTs, 60 APTTs and 80 fibrinogen tests per hour, in a compact foot print and precise results, thanks to referencing.

Has 32 cuvette ring rotor, 22 sample positions for the primary and or secondary tubes, and 15 regent positions and three stat positions.

– Provides for carrying out a number of tests without the need for exchange, or intervention with total automation, adequate and practical in most laboratory conditions.

The test volume is 150μl typically and 300μls maximum, providing for easy
adaptation to different tests and methodologies.

– Offers economy of scale for the expensive tests, with flexibility for easy adaptation of specific and appropriate reagents, to suit the lab requirement.

Provides for automation with result calculation in percentage, INR, ratio, mg/dl, g/l, μg/ml etc. automatic predilution of the samples, automatic repeat function, automatic calibration and so on.

– Total automation, in every practical aspect providing greater level of convenience and accuracy.

Memory of 10,000 results and curve data on internal SD-card.

– Helps in tracking the activity curve, and helps in easy diagnosis of certain abnormalities, providing the function what is known as “wave-form analysis” and first adapted by LABiTec!

Large data storage capacity without PC and associated hardware.

Patient ID can be entered manually, or, with the optional barcode scanner, in addition to on-board barcode scanning facility.

– Fail proof back-up for sample i.d. with entry of patient identification to avoid sample mix up even in the unlikely event of barcode scanner failure.

Internal USB interface for easy adaptation of other assays and field software updates.

– Ensures easy system upgradation in the field and protects against obsolescence.

Offers positive barcode identification and with the bi-directional host query/LIS communication as standard.

– Hassel free data transfer with host query for great convenience and data handling.

The CoaLab 1000 automated open system to reagents, quite compact in its design and big in performance, occupies very little bench space, offering great ease of use while incorporating all the features normally seen with larger and much more expensive analysers, with the ideal throughput which in most situations is adequate for medium and high end facilities without huge initial investment, but a system that meets your needs today and well into the future under Indian conditions.

TECHNICAL DATA

CoaLAB 1000

Type of instrument: Fully automated coagulation analyzer

Application: Coagulation, Chromogenic, Immunologic tests

Working methods: Sample oriented, Test selective, STAT (emergency)

Measuring principle:Photometric; with magnetic stirrers to homogenize the test mixture and increase the sensitivity

Light Source: LED, light emitting diode

Cuvette: Volume 150μl – max. 300μl

Test throughput: PT 120/h, aPTT 60/h, +/- 20 tests/h

Cuvette volume: min. 150 μl, max. 300 μl (test suspension)

Measuring channels: Two measuring channels at

– one wavelength 405nm or

– three wavelength 405/570/740nm

Calibration: – Manual input of calibration points (max. 7 points), two calibration curves for each test or

– Automatic calibration

STATS:STAT loading is possible at any time in up to three
assigned positions. Routine testing can be interrupted for STAT loading and then automatically giving priority to the STAT sample

Analyzer data

Reagent positions: 15 positions at room temperature

– (R1-R3) for 15ml reagent vials (left/right pos. stirred)

– (R4-R15) for 5ml reagent vials.

Reagent block can be removed from working area for external cooling.

Washer positions: 2 positions at room temperature

– (W1-W2) for Washer & Cleaner

Calibration/Dilution: 8 positions at room temperature

– (C1-C8) for Controls, Calibrators & Dilutions

Sample positions: 2×11 positions for primary & secondary tubes/cups

1×3 positions for STAT

Measuring rotor: One heated measuring rotor at 37°C +/-0.4°C with two measuring channels, designed for cuvette rings.

Cuvette rings: Cuvette ring with 32 cuvettes

Wash Station: One wash station for pipettor cleaning

Pipettor: Capacitive, movable in three directions (x, y, z),
heated at 37°C

Dilutor 250μl syringe

– minimal dosing 2μl

– maximal dosing 250μl

– Resolution: 12 half steps for 1 μl (for 250 μl syringe)

– Level sensors for distilled and waste water container

Rinsing: Two modes

– Regular with distilled water

– 4 intensive with washing solution for probe cleaning(Thrombin inactivator)

Cleaning: Cleaning of pumps and tubing with Cleaner

Display: Touch sensitive colour display

Visible area: 11.5×8.7cm

Display resolution: 320 x 240 pixels, ¼ VGA).

Software: Linux based operating system with Graphic User Interface (GUI)

Programmable Methods: 50 reagents/tests can be freely programmed

Interfaces: 1x USB for external printer device

1x USB for USB Memory device

1x LAN for external PC connection

2x RS 232C serial interfaces

1x external Barcode Scanner connection

APPLICATIONS

CoaLAB 1000

The CoaLAB 1000 named hereafter as analyser, is a fully automated photo-optical
blood plasma hemostasis instrument capable of performing clotting, chromogenic* and immunoassays* simultaneously in random access or batch mode from primary and secondary tubes.

For in-vitro diagnostic use only!

* Depending on the analyser model the system is capable to perform a wide range of coagulometric, chromogenic and immunologic coagulation tests such as Prothrombin time, activated and partial Thromboplastin time, Fibrinogen, derived Fibrinogen and special tests such as single factor assays, Anti-Thrombin III, Protein C, Protein S, C-Reactive Protein, D-Dimer and others based on the wavelength available in different analyser types.

Automated Coagulation Analyser

Totally automated bench top coagulation analyser which (i) shall be a stand alone device, with no external PC and monitor to control and run software, and save space. (ii) can permits flexible add-on field upgradable software, to protect against obsolescence. (iii) can offer various wavelengths to cover all major coagulation tests existing and emerging.

1. Instrument type – Fully automated coagulation analyser for the clotting, chromogenic and immunologic testing with cover for safety.

2. Display – Touch sensitive colour display with on-board graphic user interface.

3(a) Measuring principle – Photometric, LED photometer (405nm, 570nm, 740nm) with two reference channels.

(b) No. of measuring channels – Two, simultaneously.

4. Measuring unit – Controlled at 37ºC ± 0.4 ºC. 32 cuvette ring rotor.

5. Sample/reagent platform – 2×11 Sample positions for various primary and secondary tubes, between 1.7 and 4 ml.

3 x Stat positions.

15 x Reagent positions (3x15ml) stirred, (12x5ml) non-stirred.

Removable reagent tray for overnight cooling/ storage.

8 x Positions for controls and dilutions.

2 x Wash/cleaner positions with variable wash cycles.

6. Sampling – Dilutor, 2 to 250µl, volume freely programmable. Capacitive sensor for pipetting, that moves in three directions. Pipettor heated to 37ºC to preheat sample/reagent,

7. Test volume – 150 µl typically. Maximum – 300 µl

8. Maximum tests during same run – Ten tests per run depending on reagents/
buffers used.<h/2>

9. Assays to be covered – The following and not limited to Routine clotting: PT, APTT, Fibrinogen, Thrombin time, Ecarin, Batroxobin etc.

Factors: Extrinsic (II, V, VII ), Intrinsic (VIII, IX,XI, and XII ) etc.

Thrombosis risk: Protein C, Protein S, Lupus anticoagulant, Factor V Leiden, APC-resistance, PiCT, TDT, TAFI and so on.

Chromogenic: Protein C, Protein S, Anti-Thrombin III, Plasminogen, α2-Antiplasmin etc.

Immunoturbidimetric : D-Dimer, CRP etc.

10. Data management – On-board QC package with Levy-Jennings plot, and Westguard multi rules.

11. Software/hardware features – 50 programmable memory for reagents and test
locations individually editable.

Optimised cuvette consumption./

12. Additional functions – Interface 2x RS232 barcode scanner

2xUSB device (printer)

LAN (Host ) for bidirectional host communication.

SD card, chip card loading unit.

13. Power supply – 100v-240v 50-60 Hz.

FAQs

1. General:

(a) What type of analyser is CoaLAB 1000?

– CoaLAB 1000 is a compact fully automated coagulation analyser.

(b) What are the major attributes of the CoaLAB 1000 analyser?

– CoaLAB 1000 is the most compact analyser in its category and well suited as

(i) main system in medium to high workload centres under Indian conditions

(ii) reliable back-up system in referral labs and bigger analysers

(iii) dedicated analyser for consolidation of special tests.

(c) What are the different modes of measurement available?

– CoaLAB 1000 analyser can handle tests in clotting, chromogenic and
immunoturbodensitometric modes.

(d) How many channels does the system have?

– The CoaLAB 1000 has two high-resolution photometric measuring channels, each equipped with upto three wavelengths.

(e) Does the system have provision for continuous loading?

– Yes the analyser can be continuously loaded for optimum throughput but without sample rack.

(f) What is the measurement principle?

– The measurement with CoaLAB 1000 is based on photometry, with magnetic stir bars to homogenise the test approach and to increase the sensitivity.

(i) CoaLAB 1000 can perform the measurement by the use of stir bar inside the cuvette to have a better clot formation and hence better sensitivity for clot detection.

(ii) The system can perform without stir bars those coagulation tests, where clotting is not involved.

(g) What is the throughput of the system?

– Depending on the test approach, the throughput is 120 PT, 60 APTT and 80 fibrinogen tests per hour.

(h) Does the system need an external PC?

– No, the system is self contained and external PC is not required to operate.

(i) What is the walk away capability of the system in terms of (i) specimen (ii) number of tests?

(i) 25 maximum (ii) greater than 10.

(j) Does system calculate MNPT (Mean Normal Prothrombin Time) automatically?

Yes, automatic calculation of MNPT is initiated if standard is lower than 100%.

(k) How many calibration /reference curves can be stored on-board?

– Two calibration/reference curves can be assigned to each test and stored for recall.

(l) What is the maximum number of points available for each calibration?

Seven, and calibration curves are editable.

(m) Is it possible to prepare the work list in advance with reference to the samples/tests say for five rings or say 160 or say 250 patient samples before start of run?

– It is not possible to prepare a worklist > 22 patient sample in one batch. The preparation of the worklist is limited by the number of sample positions on board and during run following, patient samples can be loaded continuously.

(n) What is the calibration frequency in case of tests employing calibration, especially due to absence of on-board cooling?

– Independent from the reagent cooling the test calibration is necessary after change of the lot number and it is recommended to perform a weekly calibration.

2. Analyser:

(a) What are the test capabilities of the system?

– Analyser ensures precise and reliable result determination over the entire coagulation spectrum including

(i) PT (Seconds, % INR) , aPTT (Seconds, RATIO) , Fibrinogen according to Clauss (mg/dl, g/l), Thrombin Time (Seconds), Batroxobin Time (Seconds), Ecarin Test

(ii) Factor deficient: Extrinsic Factors II, V, VII and X (PT based), Intrinsic Factors VIII, IX, XI, and XII (aPTT based).

(iii)Thrombosis risk: Protein C (clotting test), Protein S (clotting test) , Lupus Anticoagulant, Factor V Leiden, APC-Resistance, PiCT (Prothrombinase induced clotting Time), TDT (Thrombin Dynamik Test), TAFI (Thrombin Activatable Fibrinolysis Inhibitor)

(iv)Chromogenic: Protein C (Chromogenic), Protein S (Chromogenic), Anti-Thrombin III, Plasminogen, α2-Antiplasmin

(v) Immunoturbodensitometric: D-Dimer, C-Reactive Protein.

(b) Is the system open to reagents from other sources?

– Yes, it is an open reagent system and reagents are reconstituted manually. But the reagents supplied through Wheecon are of high quality and optimised for use with the system and performance validated.

(c) What is the maximum no. of different measured assays on board simultaneously?

– A maximum of 15 assays can be handled simultaneously.

(d) What is the maximum number of different assays that can be programmed and calibrated at one time and stores on-board for recall?

– A maximum of 50 different assays, and locations are individually editable.

(e) Do factor assays involve manual manipulations or dilution or automatically carried out?

– No manual steps are not needed even in the case of factor assays.

(f) What is the type of light source?

– The system incorporates long life LED photometer including reference channels.

(g) What are the wavelengths employed?

– The wavelengths applicable are 405nm or 405, 570 and 750nm, depending on the analyser.

(h) What is the maximum number of cuvettes in the ring that can be loaded at a time?

– The ring can hold a maximum 32 cuvettes, single use.

(i) Is it possible to use part of the analysis cuvettes (say 26 used and 6 unused) not used during the current run, but use for analysis remaining (unused) cups, during subsequent run, or only new 32 ring cuvettes is to be loaded?

– The software optimizes the use of cuvettes from the cuvette ring. The cuvettes not used in the ring are stored and will be used during the next run. There is a deviation from the approach during automatic calibration. A calibration will be done within one cuvette ring and not over two cuvette rings. In this case not used cuvettes will get lost and cannot be used anymore.

(j) What is the minimum test volume?

– The volume is 150 µl test in micro volume.

(k) What is the temperature of measuring rotor, pipetting device?

– The measuring rotor and pipetting device are controlled at 38.4°C ± 0.4°C (measuring rotor) and 37.4°C ± 0.4°C (pipetting device).

(l) Does system have stat position ?

Yes there are three dedicated stat positions available.

(m) Does system provide for automatic washing?

– Yes, it is provided with two washer/cleaner positions for minimising carry over.

(n) What is the quality control facility available?

– QC program offered includes both Levy-Jennings chart and Westguard rules

(o) Does the system have facility for auto rerun function?

– Yes, auto test repeat function is available.

3. Sample:

(a) How many samples maximum can be handled at a time?

– Two fixed racks of 11 samples each and three stat positions, totalling to 25 samples maximum can be handled at a time.

(b) What is the minimum sample volume that can be used?

– The minimum sample volume is 2µl.

(c) Can the analyser handle primary tube sampling?

– Yes it can handle primary tube with the volume range 1.70 to 4.0ml.

(d) Is it possible to use a mix of primary and secondary sample tubes during the same run, either with manual i.d. entry or with on-board scanner?

– The CoaLAB 1000 can handle several sample cups and tubes. Standard settings on board to select a LABiTec specific 4ml cup, Hitachi cup, short sample tubes (like Sarstedt, B&D, Venoject etc.) and long sample tubes.

(e) Is sample capacitive sensing functional and relevant when secondary tubes
used?

– Capacitive sensing is active in any case when a liquid has to be aspirated, that is, it is active for sample, reagent, QC plasma aspiration and independent from the vial, cup or tube type.

(f) Does the system have facility for clot detection?

– No, the pipetting device is not equipped with clot detection capability, at this point.

(g) Does system have ability for on-board sample dilution?

– Yes, it handles on-board sample dilution.

(h) What is the maximum number of samples that can be on-board at a time?

– The system can accommodate a maximum of 2×11 samples, adaptable for different sizes of primary tubes.

(i) Does the machine have positive sample barcode scanning?

– Yes, positive sample barcode scanning is available with internal or external barcode scanner.

(j) How is the positive sample identification ensured?

– The system offers the flexibility of positive sample bar code identification by internal barcode reader as standard or optional external bar code reader, if preferred.

(k) How many positions are available on-board, for standards?

– There are eight standard/control positions available.

4. Reagent:

(a) What is the maximum number of reagent containers that can be loaded at a time?

– A maximum of fifteen different reagent containers can be put on-board.

(b) Does the system support multiple reagent configurations?

– Yes, it does.

(c) How many positions are available for reagents?

– Can hold a maximum of 15 reagents with 3x15ml stirred, and 12x5ml non-stirred positions.

(d) What is the range of reagent volume?

– Reagent volume can be programmed between 2.0 and 250 µl.

(e) Does the system have on-board reagent cooling?

– No, there is no reagent cooling unit on board.

5. Sample /Reagent

(a) What is the temperature maintained at measuring unit ?

– Temperature is controlled at 38 .4ºC ± 0.4 ºC

(b) What is the sample/reagent pipettor range?

– Dilutor range is 2-250µl in steps of 1µl

(c) Is the sample/reagent pre-heated?

– Yes, pipettor is heated to 37.4ºC± 0.4ºC before dispensing.

(d) What is the type of reagent /sample sensing employed?

– Capacitive pipetting device which moves in three directions.

6. Software /Hardware:

(a) What is the type of operator interface?

– System incorporates graphic colour touch display.

(b) How many test locations and reagents can be programmed for recall?

– 50 tests and 50 reagents are programmable and individually editable.

(c) How many test results and curve data can be held in memory?

– On board memory of upto 10,000 results and curve data on internal SD-card.

(d) What are the various interfacing capabilities offered as standard?

– (i) Chipcard reading unit (ii) 2 x RS232 (1 x barcode scanner, 1x for service purposes ) (iii) 2x USB device (printer, USB stick) (iv) SD-card (only internal) (vi) LAN (Host)

(e) Can the software be field upgraded?

– Yes, software/parameters can be field upgraded via USB-stick, defying obsolescence of the analyser.

(f) What major features are standard in software?

– Auto repeat function, automatic calibration, and QC program are all standard. Build in service and maintenance software.

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