The ACL TOPTM

Hemostasis Testing System: Features and TechnicalDescription

COAGULATION 15

The ACL TOPTM

Hemostasis Testing System: Features and Technical Description

Table of Contents

I. Overview Page 5

II. Technical Description Page 8

III. Main System Features Page 16

IV. Specification Table Page 22

V. Hemostasis Assays Page 23

VI. IL Monographs Page 24

The new ACL TOP hemostasis system from Instrumentation Laboratory is a fully automated, benchtop, random-access analyzer, designed specificallyfor in vitro coagulation and fibrinolysis diagnostic testing in the assessmentof thrombosis and hemostasis. As the new standard in hemostasis, the ACLTOP works harder and smarter to meet the increasing demands of the high-volume test lab, offering more capabilities while reducing time-consumingQC and maintenance tasks.

The ACL TOP combines flexibility, intelligence, ease-of-use and speed todeliver complete “Testing Process Automation” for the demanding hemostasislaboratory.

The ACL TOP system:

• Consolidates testing capabilities into one system• Provides a complete solution for both routine and specialty assays

(clotting, chromogenic and immunoassays)• Offers high throughput with up to 360 PT results per hour,

24 hours a day, 7 days a week• Operates quickly and easily, with an expandable and versatile platform

that can be tailored to the needs of each laboratory• Automates QC and maintenance, increasing productivity while

reducing workload

Developed by the leaders in intelligent automation, the ACL TOP offers highperformance for the high-volume lab.

The ACL TOP system provides results for both direct hemostasis measurements and calculated parameters. The ACL TOP performs the following types of tests:

Coagulometric (Turbidimetric) TestsChromogenic (Absorbance) TestsImmunological Tests

The following describes the operating principles for each of the three types of tests. (For additional detail, please see the “ACL TOP Operator’sManual”.)

Coagulometric (Turbimetric) MeasurementsThe principle of coagulometric clot detection is used to measure and recordthe amount of time required for a plasma specimen to clot. The techniqueassesses coagulation endpoints by measuring change in optical density.

Chromogenic (Absorbance) MeasurementsChromogenic tests use the colorimetric principle of measuring absorbanceof light by the solution in a cuvette. The amount of light that reaches thephotodector is converted into an electrical signal that is proportional toenzyme activity.

5I. Overview

What It Is

What It Does

How It Works

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Immunological MeasurementsThe principle of immunological measurement is used to directly measureand record the concentration of an analyte in a sample (and not its activity) by measuring change in optical density. Although similar to the turbimetricmethod, the immunological method relies on the formation of antigen-antibodycomplexes to affect light transmission.

The ACL TOP testing process is fully automated, with on-board QC andmaintenance, enhancing performance and productivity. Please see belowfor more on system features and benefits.

The ACL TOP was developed based on feedback from the people who usethe instruments. Created by Instrumentation Laboratory (IL), who has beenat the forefront of diagnostic innovation for over 40 years, the ACL TOP delivers what users asked for and more. Highly automated for high-throughput screening, the ACL TOP works harder and does more, offering the followingfeatures for a total solution:

Optimal Sample Management• Parallel loading of racks; no sample queuing• Continuous loading• 120 samples on-board• Simultaneous loading of different sample containers• Closed-Tube Sampling (CTS) with cap-piercing module• Barcode identification• Sample presence detection• Automatic sample predilution• Factor parallelism testing with automatic multiple solutions

Automatic Checks and Validation• Sample liquid level sensing• Automatic rerun testing with possibility of extra sample predilution

for enhanced test linearity• Automatic reflex testing• Automatic results validation

Optimal Reagent Management• Parallel loading of racks for reagents, calibrators, controls,

deficient plasma, and any required material• Continuous loading• Up to 60 materials on-board• Barcoded vials for random loading and automatic identification,

including vial size, expiration date and lot• Vial presence detection for non-barcoded materials• Handling of multiple vials of the same material

Automatic Sensing and Tracking• Reagent liquid level sensing• Volume tracking• Expiration date tracking• Calibration stability tracking

Real-Time STAT Capability• STAT samples loaded on any rack, in any position, at any time• System ready to run 24 hours a day• Expiration date tracking• PT result in less than three minutes when processing one sample

from idle system status

Why It Works (Better, Faster, and Easier)

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ACL TOP Benefits

In addition to automation of the testing process, the ACL TOP takes care of itself so users can minimize time performing QC and maintenance. QCsoftware allows for set-up of automatic QC analysis utilizing Westgard Rules.Minimal maintenance is needed (less than five minutes daily), ordered bythe user, but performed by the system. Fully automatic maintenance is provided for all other daily activities.

Last, the system’s user-friendly interface and intuitive controls make operationfast and easy. The result is more capabilities, greater assurance of highperformance, with less effort.

Here’s why the ACL TOP is the optimal choice for high throughput testing:

Complete• Broad test menu and large capacity of materials on-board• Consolidated workstation for routine and specialty assays: clotting,

chromogenic and immunoassays• Specialty assays as easy as routine

Fast• Continuous operation• High throughput (up to 360 PT results per hour)• Optical units capable of simultaneous reading of clotting and

chromogenic assays allows optimal throughput, independent of test mix• Real-time processing of STAT samples

Friendly• Powerful and intuitive Windows® 2000 software and touch-screen• Automated reagent management, automated QC and automated

maintenance• On-line help

Safe • Transparent, locked covers for samples and reagents• CTS-configuration option minimizes exposure to biohazards• Barcoded vials for all materials• Password-controlled user access and automatic logging of significant

events

Reliable• 24 hours/7 days continuous operation• State-of-the-art technology• Extensive company history in instrument and reagent development

and manufacturing

Versatile• Base configuration (Open-Tube Sampling)• CTS configuration with cap-piercing module• Laboratory Automation System (LAS) configuration offering direct

off-board sampling without mechanical interfaces

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The ACL TOP hardware was designed for efficiency and effectiveness inthe high-throughput hemostasis laboratory. IL’s innovative developmentteam limited the number of moving components without compromising the throughput of the system. The end result is a reliable system, requiringminimal maintenance, which meets the needs of the high-volume laboratory.

The hardware on the ACL TOP is divided into two modules:

1. Control module (CM) Pentium-based processor used by the operator to interact with the system.

2. Analytical module (AM) This module is composed of seven areas: cuvette loading, sample area, cuvette shuttle, reagent area, optical reading units, cuvette waste and the external clean solutions.

These components are highlighted below.

Control Module Sample Area Reagent Area

Analytical Module

Cuvette Loading Area

Cuvette Waste Drawer

External Rinse and Clean

Hardware

II. Technical Description

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Cuvette Loading

The cuvette loading area is on the left side of the analyzer. The cuvette,composed of polystyrene, is uniquely designed. Four individual cuvettes aremolded together to form a cuvette strip. Ten strips are linked together toform a cuvette clip. Ten clips are packaged together as a cuvette block.The block is packaged to facilitate ease of entry into the cuvette loadingarea. The area will accommodate two blocks at one time for a total of 800on-board cuvettes.

The cuvette clips are loaded vertically. When the clip advances to the front, itis moved to a horizontal position. The cuvette shuttle then grips one strip fromthe clip and transports it for use. The cuvettes are used for either sample predilutions or analysis.

The cuvette loading area is accessible at all times to the operator. Thisallows for cuvette loading at any time while the system is idle or operating.The system will alert the user when the cuvettes are running low and whenthe loader is empty.

Cuvette Strip Cuvette Block

Cuvette Clip

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Sample Area

The sample area is located to the right of the cuvette loading area. This area contains the heated sample probe with a dedicated rinse bath, rackpositions for samples and diluents, and cuvette strip holders for dilutionsand incubation. It is visible through the tinted-glass safety panel on the frontof the analyzer and is maintained at ambient temperature. The safety panelis monitored and locked for safety during sample processing, yet it providesvisible access to the area. This area accommodates the sample racks andtwo diluent racks.

The samples are loaded in racks on-board the system. Each rack will hold ten samples. The sample area will accommodate 12 racks, for a total of120 samples. The racks contain barcode identification. The system alerts theuser if a specimen in a rack position cannot be identified. The racks also containspring clips that allow usage of sample tubes of varying sizes. In addition todirect tubes, samples may be processed in cups or pour-off tubes. To processin pour-off tubes, adapters are available for use. The diluent racks in this areaare located to the right of the 12 samples racks. Each rack can hold: samplediluent, control, calibrator, quality control or clean material. This area canaccommodate two racks for a total of 16 materials.

Sample Rack Area Diluent Rack Area

Sample Area (ACL TOP Base Model)

Cuvette Load Area

Cuvette Hold Area(room temperature)

Sample Probe

CuvetteIncubator Area

Clean / RinseWells

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Any of the sample or diluent positions can be accessed by pressing a buttonbelow the desired location on the analyzer. This activates the barcode readerto position itself respectively. The barcode reader traverses the front of thesystem along with a rigid curtain. The curtain ensures safety and maintainsthe area at the optimal temperature during analysis. When the reader ispositioned, a rack can be inserted while the sample barcodes are read.Positioning the reader beside the rack minimizes stray light from impactingthe barcode reading.

Once a rack is latched into position, the LED for the location turns green.During analysis, it turns orange and the rack is locked and non-removable.Upon completion of the analysis for all samples on the rack, the LED returnsto green. The rack can then be removed and replaced with a new rack ofsamples to be processed.

Samples and materials in the sample area are aspirated using the sampleprobe. The probe incorporates a sensor that recognizes the presence ofliquids and stops at the optimized liquid level. During aspiration and transport,the probe heats the liquid to 37° C +/- 1° C. A Teflon® tube connects theprobe to a syringe pump that is capable of delivering 4 to 250 µL.

The samples and materials are aspirated and dispensed into a cuvette. Thecuvette strips are held in the sample area in two regions; one at ambient airtemperature and the other heated to 37° C. The ambient temperature areacan hold 14 cuvette strips and the incubated area can hold eight strips. Inthese areas, dilutions and incubations of sample occur.

Cuvette Shuttle

The cuvette shuttle has a unique, highly efficient design for moving cuvettestrips throughout the system. The shuttle runs along the back of the analyzerbehind the sample and reagent areas. The shuttle grips the desired cuvettestrip, retracts it into its 37° C heated chamber, moves to the next desiredposition and places the cuvette strip. The shuttle has access to all cuvetteareas at all times and can, therefore, move cuvettes to any position. Thesystem utilizes one shuttle for all cuvette transportation needs.

Sample Rack

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Reagent Area

The reagent area is located to the right of the sample area. This area has twoheated reagent probes, along with a corresponding rinse bath, rack positionsfor reagents and diluents, eight cuvette strip incubators and four OpticalRead Units (ORU). It is visible through the tinted-glass safety panel on thefront. The reagent cooling area is maintained at approximately 15° C. The safetypanel is monitored and locked for safety during reagent aspiration, yet it providesvisible access to the area. This area accommodates the reagent racks and adiluent rack.

The reagents are loaded in racks on-board the system. Each rack can hold six reagent vials and the reagent area can accommodate six racks for a totalof 36 reagents. The racks contain barcode identification. The system alerts the user if a specimen cannot be identified. The first two positions within each rack have stirring capability; therefore, the system can accommodate12 vials requiring reagent stirring. These positions can also be utilized for non-stirred reagents.

The reagent rack area is divided into two regions. One region is for “intermediate”reagents and the other is for “starter” reagents. The intermediate reagentsare those that are added first to the sample in the cuvette. They can then be mixed and incubated with the sample. The reagent area contains eightincubator positions to hold cuvette strips for dispensation and incubation ofintermediate reagents. The starter reagents are those that initiate the final reaction. The starter reagents are dispensed when the cuvette strip is loadedinto one of the four ORUs. Incubators and ORUs are maintained at 37° C.

As an example, in the APTT test, the intermediate reagent is cephalin and thestarter reagent is calcium chloride. Reagent rack positions 1-4 are utilized forthe intermediate reagents and 3-6 for the starter. Positions 3-4 are crossoverpositions that can be utilized for either. Separation of the reagents into twotypes allows for both probes to be active simultaneously.

Reagent Area

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The diluent rack in this area is located to the left of the six reagent racks.The rack can hold eight materials including: a reagent diluent, deficient plasma or an intermediate reagent. This area, like the reagent rack area, is maintained at approximately 15° C.

Any of the reagent or diluent positions can be accessed by pressing a button below the desired location on the analyzer. This activates the barcodereader to position itself respectively. The barcode reader traverses the frontof the system along with a rigid curtain. The curtain mantains the area at theoptimal temperature during analysis. Once the reader is positioned, a rackcan be inserted while the barcodes are read. Positioning the reader besidethe rack minimizes stray light from impacting the barcode reading. Once arack is latched into position, the LED for the location turns green. Duringanalysis, it turns orange and the rack is locked and non-removable. After thebarcode homes itself or is positioned in another location, the appropriate reagent probe for the rack location checks the volume within each vial inthe rack. Following the reagent aspiration of the vials in a rack, the LEDreturns to green. The reagent rack can then be removed and the reagentsrefilled or changed.

Reagents and materials in the reagent area are aspirated using the appropriatereagent probe. The probe incorporates a sensor that recognizes the presenceof liquid and stops at the optimized liquid level. During aspiration and transport,the probes heat the liquid to 37° C +/- 1° C. A Teflon tube connects theprobe to a syringe pump that is capable of delivering 4-250 µL.

Reagent Rack Loading

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Optical Read Unit (ORU)

The uniquely designed ORU contributes significantly to the system throughputspeed. The system has four ORUs. Each ORU accommodates one cuvettestrip; thus, 16 reactions can be read simultaneously. The design of the fiberoptics in the ORU allows each cuvette to be read at two wavelengths: 671 nmand 405 nm. The sophisticated software then determines which reading toutilize, based on the contents of the cuvette. Simultaneous readings allow a mixof assays to be processed within a cuvette strip, utilizing different wavelengths.This results in minimal cuvette wastage and enhances throughput.

Waste Systems

The used cuvettes are deposited into the cuvette waste bin (a drawer locatedon the right side of the analyzer), containing a disposable liner that holdsup to 800 cuvette strips. The drawer is monitored for volume. The operatoris alerted visually and audibly when the drawer is nearly full. The drawer canbe removed and emptied at any time during operation without affecting testprocessing.

The liquid waste collects within an internal accumulator that collects wastefrom the sample and reagent rinse baths. The fluid collected is periodicallypumped out of the system. The fluid pumped out can be collected in anexternal waste container or pumped directly to a drain. The external wastecontainer contains a level sensor. The operator is alerted visually and audiblywhen the container is nearly full. The operator can empty the container at anytime during operation without affecting test processing.

Cuvette Waste Drawer

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System Rinse and Clean

The right side of the analyzer holds the bottle for the system rinse andclean. The rinse is used for cleaning the probes between aspirations and is packaged in a 4 L bottle. The clean solution is an acid cleaner usedto prevent carryover between reagent aspirations for particular tests. The clean is automatically aspirated and utilized, based upon the testing in process. It is packaged in a 500 mL bottle. Sensors monitor the level ofliquid in the bottles. The operator is alerted visually and audibly when thecontainers are running low, allowing for the appropriate system actions.

System Rinse and Clean

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The ACL TOP software was designed to compliment the Analytical Modulehardware. The program operates under a MS Windows 2000™ platform.The universality of MS Windows simplifies training and integration of theanalyzer into the laboratory. Included in the software are several key featuresthat separate the ACL TOP from other systems. They are described below.

Reagent Management

The ACL TOP provides a completely automated reagent tracking system.When the reagents are loaded on-board and the barcode is read, the systemtakes complete control over management of the vial. First, it performs an initial volume measurement. If the measurement increases by 30% over theprevious reading, the vial is considered to be new and the onboard stabilityis reset. The system then counts down stability time from that point. Whenthe stability time is approaching zero, the operator is alerted, allowing time toprepare a new vial. If the time reaches zero, an alarm is sounded and alltesting of that vial is flagged with a onboard stability flag. The system providesthe operator the ability to manually reset the stability time at any point. This isuseful if a vial is removed from the system, refrigerated and later returned.

In addition, the system will also monitor lot number expiration via the barcode.When a lot is expired, the operator is warned. In certain situations, reagent lotexpirations may be extended by Instrumentation Laboratory, after testing. Inthis case, through the system software, the operator can extend the expirationdate, thereby eliminating the warning when the reagent barcode is read.

The system also allows multiple vials of the same reagent on-board to beentered. When this occurs, the vials are aspirated in a “first in-first out” fashion.

III. Main System Features

Reagent Rack Status Display

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Calibration

Calibration on the ACL TOP can be performed any time, including when thesystem is running patient samples or calibrations for other tests. The userhas the option to set up each individual test for automatic calibration ineither hourly or test-count intervals. If this option is not used, the operatorcan calibrate the tests as needed.

The system stores the last five calibrations for each test handled in a “first in-first out” order. Once a calibration is complete, the system can auto-validatethe curve based upon user-selectable criteria. If the auto-validation option is not used, the operator can manually validate the curve prior to use. Thesystem allows validation of any of the available five stored calibrations. Priorto validation of any curve, the operator can view the clot curves.

Reagent Rack Detailed Display

Calibration Curve Details Display

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Quality Control (QC)

The QC program on the system makes extensive use of automation andimplementation of “Westgard Rules.” The automated functions of QC aresimilar to those for the calibration features, allowing QC to be performed atany time or automatically on the system at set intervals. For automatic QC, theoperator can set the frequency in either hourly or test-count intervals. Forboth manual and automatic QC, the bar-coded QC vials can be placed onthe system, eliminating the need to pour the QC material into sample cups.QC can be set-up and run for both an active lot and an alternate lot of material.

The data generated for QC can be displayed in either a table or a Levey-Jennings format. The user can select to view the data for a particular daterange or number of points. The QC review screen allows the operator toreview data for the active and alternate lot.

Sample Management

The powerful result database enhances the system’s ease of operation. Thedatabase will hold 20,000 sample IDs. Each of these IDs can have 30 testsassociated with them. The database will, therefore, maintain 600,000results. The IDs can be entered into the database either manually or, morecommonly, via the bi-directional host interface. The host interface can functioneither using host query or dynamic download. The host query operateswithout operator intervention. When a rack is introduced and the barcodesare read, the host is automatically queried for the requests.

STAT samples are always given priority over routine samples onboard.STAT samples can be placed in any rack and in any position within the rackand do not need to be segregated. Even if they are mixed among routinesamples, the system can track them and process them with priority. STATPT results are available in as little as two and a half minutes.

Upon completion of the results, they are available for viewing, printing orhost-transmitting. The database on the system can be customized with fourviews by the operator, providing flexibility to laboratory staff. For example,the main database screen can be customized to meet the varying needs of each shift. Results in the database can be filtered using multiple criteria to

QC Graph Display

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select specific samples or results. In addition, samples can be selected andthe results recalculated to reflect calibration updates on the system. For long-term off-line result storage, the system provides the ability to export results intodata files in various formats (e.g., pdf). These files can then be viewed usingcommonly available database programs on a separate computer system.

Factor Parallelism

Factor assays on the system can be processed using multiple dilutions. The dilutions are automatically prepared by the system and the results arechecked for integrity and plotted against the calibration curve. If a sampleis void of factor inhibitors, the sample dilution curve and the calibrationcurve will parallel each other. If a sample contains an inhibitor, the two curves often intersect one another. In addition to the visual representation,the ACL TOP utilizes algorithmic data checks to flag potential samples with potential inhibitors.

Parallelism Display with No Inhibitor

Parallelism Display with Inhibitor

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Auto-Validation of Results

The ACL TOP is ideally suited for high-volume, hemostasis laboratorieswhich process hundreds of samples each day. Generally, the results ofthese samples fall within the normal range without any system flags. TheACL TOP can be set-up to automatically validate these results. The resultscan then be automatically transmitted to the host system. This feature eliminatesmanual validation of results by an operator and decreases result turn-aroundtime. The criteria used for auto-validation can be customized.The user selectsfrom a list of errors and conditions for which results should not be automaticallyvalidated. In addition to routine patient sample results, auto-validation canalso be set-up for factor parallelism and calibration curves.

Parallel Lot Testing

In the hemostasis laboratory, changes in lot numbers for controls and reagents necessitate a cross-over study in which a result comparison is run on the original and new lots. The ACL TOP facilitates this process byproviding an automated system to track the original and a new lot ofmaterial for reagents and quality control liquids. The reagent alternate lot allows calibration and sample processing for result evaluation. Thequality control liquids allow a new control range to be established, whilethe original material is processed. Once a sufficient number of control determinations have been performed, the alternate lot can be activatedand thus becomes the primary lot.

Clot Curves

The ACL TOP provides the ability to view clot signature curves for patients,QC and calibrations. Clot curves visually demonstrate the reaction readingsthat occur within a cuvette. They are a valuable aid to assess result concerns.The system will maintain the last 100,000 clot curves in its database, managedin a “first in-first out” fashion.

Sample Result Clot Curve

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Reflex Testing

Reflex testing is an automated method for evaluation of an initial set ofresults and the triggering of additional testing, based upon evaluations ofrules. The reflex-testing program on the ACL TOP provides extensive flexibilityand options for setting up reflex testing. The system permits 100 reflex logicdefinitions. Each of these definitions can have up to ten rules, which can utilize numeric limits or error conditions. If rules are met, additional tests canbe added to the sample. Since each sample can have a maximum of 30tests, up to 29 can be added if the sample initially had one test ordered.

Security

The ACL TOP security program allows each laboratory to define 100 uniqueusers for the system. Each user can then be assigned one of four accesslevels: Administrator, Supervisor, Senior Operator or Operator. At theAdministrator level, the operator can define which level has access to eachsubmenu on the system. When a user logs onto the system, they are requiredto enter a unique username and password. A user can only enter submenusif their access level is equal to or greater than the level assigned for thesubmenu. This flexible program allows each lab to customize the securitysystem. Actions performed on the ACL TOP are tracked by user, and therefore,provide an audit trail for laboratory management.

Log File

All system modifications, warnings and errors on the ACL TOP are tracked inthe system log book. This provides an automated method for the laboratoryto maintain an audit trail for the analyzer and is also useful for trouble-shoo-ting. The log book lists the date and time, user and a description for the last10,000 entries. The log file is managed in a “first in-first out” fashion. Whenthe log book file is opened on the system, the user can easily sort, usingmultiple sorting criteria. This makes it simple for the operator to monitor thesystem for a certain action or time interval.

22IV. Specification Table

Feature Description

Test menu Clotting, chromogenic and immunological assays

Continuous sample loading YES

Continuous reagent loading YES

Continuous operation YES

Samples transport system Racks

Samples on-board 120 (10 samples/rack)

Reagents transport system Racks

Reagents on-board 60 (44 refrigerated + 16 room temperature)

Reagents barcode reader YES (integrated)

Barcoded reagents YES (barcode includes lot, exp. date and vial size)

Cuvettes on-board 800

Total number of materials (calibrators, QC, reagents) 1000

IL materials 500

User-programmable materials 500

Total number of applications 500

IL applications 250

User-programmable applications 250

Tests per sample 30

Profiles 100

Tests in a single profile 15

Throughput (Base model) PT tests/hour 360 (360 samples/hour)APTT tests/hour 320 (320 samples/hour)PT and APTT tests/hour 330 (165 samples/hour)

Sample predilution YES

Calibration curve predilution YES

Stored calibrations for each test 5

Factor parallelism YES

STAT capability YES (at any time in any position)

Rerun testing YES (configurable)

Reflex testing YES (configurable)

Reflex rules 100

Criteria in each single reflex rule 10

Tests generated by each single reflex rule 29

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Feature Description

Quality Control program YES (with configurable multi-rules)

QC results in each statistic file Unlimited

Reaction curves in QC database 10,000

Displayable QC results 20,000

Results autovalidation YES

Patient samples results database 20,000 samples

Reportable units per test 4

Reaction curves in patient database 100,000

Results in AR database 5/test

Reaction curves in AR database 5/test

Results in NPP database 5/test

Reaction curves in NPP database 5/test

Security system YES (configurable)

Operators 100

Events log system YES

Messages in logbook 10,000

Bi-directional interface YES

Host query function YES

PC External

Operating system Windows 2000

Monitor 17” color LCD touch-screen (external)

Keyboard YES (external)

Mouse YES (external)

Printer YES (external)

User interface Windows-based, powerful, easy to use

Environmental conditions 15-32° C (59-89° F) with a relative humidity of 5-85% (non-condensing)

Electrical requirements Voltage 100-240 V AC ±10%Current 5-10 AFrequency 47-63 Hz

Noise Emission 70 dBA

Dimensions (analyzer) W x D x H 151 cm x 76 cm x 73 cm

Weight (analyzer) 150 Kg

24V. Hemostasis Assays

IL offers a broad and comprehensive panel of hemostasis assays.

PT

APTT

Fibrinogen

Thrombin Time

Intrinsic Factors

Extrinsic Factors

D-Dimer

Antithrombin

Protein C

Protein S

Factor V Leiden (APC-R)

Lupus Anticoagulant

von Willebrand Factor

Plasminogen

Plasmin Inhibitor

Heparin (UF and LMW)

HS-CRP

Please contact your local IL representative for information about the availabilityof specific products and applications on the ACL TOP, in your area.

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A series of monographs devoted to relevant topics in the field of hemostasisare available from your local IL representative.

1. Monitoring of the Anticoagulant Therapy with Vitamin K Antagonists.F. D’Agostino, G Cambiè, D. Fugazza, M. Nardella, L. Bevilacqua, A. Lombardi, L. Preda.

2. Multicentre Assessment of a New High Sensitivity Thromboplastin for Analysis of Patients Receiving Oral Anticoagulant Therapy. A. Buggiani, N. Erba, B. Morelli, M. Spagnotto.

3. Protein C Activity Measurement. Evaluation of a New Snake Venom-ActivatedMethod (ProClot) in Comparison with a Thrombin-Activated Method.A. Tripodi, F. Franchi, P.M. Mannucci.

4. A New Thromboplastin Based Method (IL Test Protein S) for the Determination of Functional Protein S. R.G. Malia, P.C. Cooper.

5. The Anticoagulants: Protein C And Protein S.M.R. Ledford.

6. Coagulation Glossary.E. Finotto, A. Lombardi, L. Preda, G. Semprini.

7. Algorithms for Diagnosis of Disorders in Hemostasis.

8. Quality Control. Practical Applications for the Clinical Laboratory.D. Delucia.

9. APC Resistance.F. Axelsson, S. Rosén.

10. D-Dimer.J. Serra.

11. Design of a New Synthetic Phospholipid APTT Reagent: APTT-SP (liquid).M. Rose.

12. Clot Signature Curves and the ACL Futura™.K. Doubleday, S. Kumnick.

13. IL Test™ vWF: Ag, A Diagnostic Tool for von Willebrand Disease.M. Piñol, J. Serra, E. Botta.

14. IL Test Free Protein S, A Diagnostic Tool for Protein S Deficiency. M. Sales, B. Arza, S. Rosén.

VI. IL Monographs

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IL has been at the forefront of discovery in diagnostics for over 40 years.From critical care testing sites to high-volume laboratories, you can count on IL for advanced technology and superior performance.For more information about the ACL TOP, please contact your local IL representative or visit us at www.ilww.com

ACL TOP is a trademark of Instrumentation Laboratory. Windows is a registered trademark of Microsoft Corporation. Teflon is a registered trademark of E.I. du Pont de Nemours and Company.

Instrumentation Laboratory - A History of Innovation

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Notes

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Notes

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