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Coagulation analyzers offer variety of tests, designs. (Product Roundup).

As with many other kinds of laboratory equipment, coagulation analyzers run the gamut of options, from automated instruments to manual devices, from high-volume processing to low-volume analysis, and from a wide selection of assays to a small, core group of tests. Other factors such as turnaround times, size, and expanded capabilities play important roles, as well.

This month's roundup will take a look at several coagulation analyzers currently available.

Manual testing

The FibroSystem by BD Diagnostics Systems features the Fibrometer Precision Coagulation Timer, which measures coagulation properties of plasma for diagnostic use and anticoagulant therapy control. The Fibrometer operates manually by pressing a timer bar or automatically with the Automatic Electric Pipette, which dispenses 0.1 [+ or -] 0.005 mL or 0.2 [+ or -] 0.01 mL of plasma or reagent into a FibroTube cup and immediately starts the Fibrometer. Utilizing the Pipette Automator with two Fibrometers permits use of an Electric Pipette with either Fibrometer unit without having to disconnect the pipette. FibroTube disposable plastic cups are designed to eliminate hot and cold spots that might cause erratic test results, and FibroTip disposable plastic pipette tips help prevent specimen cross-contamination. Incubating reagents and test specimens at a temperature of 37.2 [+ or -] 0.5 degrees Celsius, the FibroSystem uses 20 warming wells for cups and 20 warming wells for 12 x 75 mm tubes. The FibroSystem Organizer is a storage unit for one pipette, 100 tips, and 200 cups.


BD Diagnostic Systems

Circle 170 or visit

Multisample analysis

Using turbidimetric and absorbance technologies, Beckman Coulter's ACL Advance coagulation analyzer offers random access to run clotting, chromogenic, and immunological assays simultaneously. The automated benchtop system holds up to 1.20 patient samples (12 universal racks of 10 cups or primary tubes), allowing operators to load the samples, walk away, and return after testing is finished. Additional samples can be loaded continuously, without interrupting work in prowess. It performs autodilution of samples and calibrators, as well as eliminates the manual steps of pipetting and dilution, by using two pipettors and a precision dispensing system. The ACL Advance offers an extensive test menu, including D-dimer, free protein S, APCR-V Leiden, and vWF (von Willebrand factor). Additional features include: measurement of fibrin strand formations; clot curve analysis; a barcode scanner for tube identification; a throughput of up to 240 PT (prothrombin time) and up to 180 aPTT (activated partial thromboplastin tim e) tests per hour; 42 onboard reagents (34 positions, including six stirred positions, cooled to 1.5 degrees Celsius); a capacity of 264 reaction cuvettes grouped in strips of eight; stat, capability in any rack; and a transparent cover, allowing complete visibility of instrument operations.

ACL Advance

Beckman Coulter Inc.

Circle 171 or visit

Microfiltration technology

The Microsample Coagulation Analyzer Model MCA 310 by Bio/Data Corp. is intended for coagulation tests based on fibrin endpoint detection by optical measurement of the initial rate of change in absorption when performing chromogenic assays. It is a fully automated, random-access coagulation analyzer capable of performing plasma-based PT, aPTT, and kinetic fibrinogen assays simultaneously and directly on a single, disposable cuvette without additional setup or reagents. Coagulation-quality plasma is produced in less than 20 seconds directly from a primary specimen tube without centrifugation. Autopipetting of controls performs factor assays, prepares dilutions, plots curves, and reports in percent activity. The system signals when it detects hemolyzed, grossly lipemic, or clotted samples. The MCA 310 has an estimated throughput of 240 reportable results per hour, the first results being available in less than 10 minutes. It offers continuous testing of any test at any time and in any order, and stat. tests can be performed without interrupting routine operations. A fully enclosed test processing area protects operators from exposure to biohazardous materials.

MCA 310

Bio/Data Corp.

Circle 172 or visit

Medium-volume system

bioMerieux's Coag-A-Mate MTX II is a medium-volume, automated analyzer with many of the features of high-volume systems. Using photo-optical detection with a 405 nm halogen light source, the compact, benchtop analyzer performs many tests, including: PT, aPTT, TT, FIB (fibrinogen), factor assays, INR, ATIII, plasminogen, [alpha]-2 antiplasmin, heparin anti-Xa, protein C, APCR (activated protein C resistance), lupus screen and confirmatory, PNP, P+P, and mixing studies, as well as user-programmable tests such as clottable protein C and S. It conducts 70 to 80 tests per hour, with up to eight assays per sample, and permits random-access, batch, and stat. tube loading up to 32 tubes. Fast stat. loading occurs within 20 seconds, and stat. results are provided within two to five minutes. PT and aPTT results are normalized for use with other bioMerieux analyzers. Menu-driven software displays reference curves, clot waveforms, and reaction curves. The system also offers dedicated reagents, a reagent block cooled to 1 5 degrees Celsius, and an optional barcode scanner for tube identification. MTX III, an upgrade of the MTX II that provides D-dimer testing and waveform analysis, will be available in 2003, according to the manufacturer.

Coag-A-Mate MTX II

BioMerieux Inc.

Circle 173 or visit

High-volume processing

Designed for large-scale laboratories, Dade Behring's Sysmex CA-7000 Automated Coagulation Analyzer uses clotting, chromogenic, and immunological methodologies to process routine and specialty assays by using complete, 20-parameter random-access capabilities. When screening tests are abnormal, it can automatically perform another test according to preset criteria to provide further information on abnormal samples. The analyzer processes up to 100 samples in 10 racks at the same time, and more racks can be added as it completes processing. The CA-7000 has a throughput of 300 samples per hour, or 550 results per hour when testing PT and aPTT simultaneously. Operators also can load reagents and reaction cuvettes without interrupting workflow. Its automated reagent management system allows operators to confirm reagent lots and type, and dual integrated barcode readers confirm patients' samples. Besides permitting automatic repeat, redilution, and reflex testing, it offers a second-generation optional cap-piercing feature to improve preanalytical processing time. The analyzer also has the ability to calibrate assays while running routine specimens.


Dade Behiring Inc.

Circle 174 or visit

Automated, benchtop device

The STA Compact by Diagnostica Stago Inc. is a fully automated, benchtop coagulation workstation offering a selection of 80 user-definable tests for performing clotting, chromogenic, and immunological assays in a random-access manner. Tests include PT, aPTT, TT, FIB, heparin, LMWH, intrinsic and extrinsic pathway factors, ATIII, protein C and S, vWF, and D-dimer, as well as calibration and quality control. It has the flexibility to rerun tests, perform additional tests, and process stat. samples at any time. The STA Compact has an onboard capacity of 96 primary sample tubes (5 mL and 2.5 mL) and provides sample and reagent level detection, automatic dilutions, a barcode readout system for samples and reagents, and optional cap piercing. There are 45 positions for different-sized vials of reagents, which are kept at a temperature of 17.5 [+ or -] 2.5 degrees Celsius. Specimens are measured at a temperature of 37 [+ or -] 0.5 degrees Celsius.

STA Compact Diagnostica Stago Inc.

Semiautomated operation

Circle 175 or visit

The ThromboScreen 400C by Fisher Diagnostics is a four-channel, photo-optical benchtop instrument that offers clotting and chromogenic capabilities for manual coagulation testing. A standard 405 nm light filter permits various coagulation and fibrinolysis tests such as PT, aPIT, TT, FIB, heparm, protein C and S, ATIII, venom time, APCR, and factor assays. It is programmable up to a 5-point calibration curve, and it operates in single, duplicate, or quadruplicate testing modes. It does not require stir bars for clot detection. The 400C features autopipetting with an electronic triggered start, a 24-well prewarming station with independent photo-optics, and storage positions for stirred and unstirred reagents. Test results are displayed on a liquid crystal display and can be printed on a fully integrated thermal printer.

ThromboScreen 400c Fisher Diagnostics

Clot tracking

Circle 176 or visit

Haemoscope's Thrombelastograph (TEG) Coagulation Analyzer monitors the thrombodynamic properties of blood as it is induced to clot under a low-shear environment resembling sluggish venous flow. Using a sample of whole blood, the benchtop system documents the interaction of platelets with protein coagulation cascade from the time of loading until initial fibrin formation, clot rate strengthening, and fi- brin-platelet binding via GpIIb-IIIa, to eventual clot lysis. It determines whether the patient has normal, hypo-, or hypercoagulable hemostasis by the time, rate, strength, and stability of the formed clot, and provides an indication of treatment necessary to normalize it. The system, which uses disposable cups and pins, can process eight samples simultaneously on four analyzers with two independent channels each. Temperature is regulated at 37 [+ or -] 0.5 degrees Celsius.

TEG Haemoscope Corp.

Circle 177 or visit

Testing flexibility

The Thor Hemostasis Analyzer by Helena Laboratories performs several coagulation tests, including PT, aPTT, TT, FIB, and factor deficiency, as well as eight user-defined assays, on single, duplicate, or half-volume samples. Able to read four samples simultaneously, it has throughputs per hour of 240 for PTs, 144 for aPTTs, 276 for TTs, and 320 for FIBs, and it offers easy access for stat. tests. The analyzer features primary tube sampling with cap piercing to eliminate open tops, barcode reading for sample identification, automatic dilutions and retests as needed, and a closed waste disposal system. It has five reagent-dispensing stations with programmed delivery volumes, so there is no need to replace reagents for multitest profiles. The Thor provides clotting times, calculates ILNR values, and stores FIB and factor assay reference curves, and it can record each patients cumulative hemostasis history.

Thor Helena Laboratories

Circle 178 or visit

Portable analyzer

Weighing less than 1 pound, the GEM PCL is a portable, handheld, battery-operated coagulation analyzer that performs a variety of tests at the patient's bedside using 50 [mu]L of fresh whole blood, automatically mixing and measuring samples. Its test menu includes PT, aPTT, ACT, ACT-LR, and citrated PT and aPTT, and results are provided in less than five minutes. The PT test, which has an 151 (International Sensitivity Index) of 1, also gives INR and plasma-equivalent results. The ACT test uses silica as an activator, so it is unaffected by aprotinin. Its PT and aPTT reagents are correlated to the manufacturer's benchtop ACL coagulation analyzer. Electronic quality control is performed once a day, and liquid quality control is performed once with each box of 45 test cartridges. The GEM PCL can also be used in conjunction with the GEM Premier 3000 Blood Gas Analyzer to provide coagulation, blood gas, electrolyte, and metabolite results in one patient report.

GEM PCL Instrumentation Laboratory Co.

Circle 180 or visit

Phil Reynolds is assistant editor of MLO. Henry O. Ogedegbe, Ph.D., Florida Gulf Coast University Dept. of Environmental Health, Molecular and Clinical Services, assisted in preparing this article.
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Author:Reynolds, Phil
Publication:Medical Laboratory Observer
Date:Nov 1, 2002
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