(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
(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.
(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.
(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
– 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.
(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.