The ACL TOP Hemostasis Testing System

32 Pages·2004·0.29 MB·English

C 15
OAGULATION
The ACL TOPTM
Hemostasis Testing System:
Features and Technical
Description

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

I. Overview
5
What It Is
The new ACL TOP hemostasis system from Instrumentation Laboratory is
a fully automated, benchtop, random-access analyzer, designed specifically
for in vitrocoagulation and fibrinolysis diagnostic testing in the assessment
of thrombosis and hemostasis. As the new standard in hemostasis, the ACL
TOP works harder and smarter to meet the increasing demands of the high-
volume test lab, offering more capabilities while reducing time-consuming
QC and maintenance tasks.
What It Does
The ACL TOP combines flexibility, intelligence, ease-of-use and speed to
deliver complete “Testing Process Automation” for the demanding hemostasis
laboratory.
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 high
performance for the high-volume lab.
How It Works
The ACL TOP system provides results for both direct hemostasis
measurementsand calculated parameters. The ACL TOP performs
the following types of tests:
Coagulometric (Turbidimetric) Tests
Chromogenic (Absorbance) Tests
Immunological Tests
The following describes the operating principles for each of the three
types of tests. (For additional detail, please see the “ACL TOP Operator’s
Manual”.)
Coagulometric (Turbimetric) Measurements
The principle of coagulometric clot detection is used to measure and record
the amount of time required for a plasma specimen to clot. The technique
assesses coagulation endpoints by measuring change in optical density.
Chromogenic (Absorbance) Measurements
Chromogenic tests use the colorimetric principle of measuring absorbance
of light by the solution in a cuvette. The amount of light that reaches the
photodector is converted into an electrical signal that is proportional to
enzyme activity.
6
Immunological Measurements
The principle of immunological measurement is used to directly measure
and record the concentration of an analyte in a sample (and not its activity)
by measuring change in optical density. Although similar to the turbimetric
method, the immunological method relies on the formation of antigen-antibody
complexes to affect light transmission.
The ACL TOP testing process is fully automated, with on-board QC and
maintenance, enhancing performance and productivity. Please see below
for more on system features and benefits.
Why It Works (Better, Faster, and Easier)
The ACL TOP was developed based on feedback from the people who use
the instruments. Created by Instrumentation Laboratory (IL), who has been
at 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 following
features 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
7
In addition to automation of the testing process, the ACL TOP takes care
of itself so users can minimize time performing QC and maintenance. QC
software allows for set-up of automatic QC analysis utilizing Westgard Rules.
Minimal maintenance is needed (less than five minutes daily), ordered by
the 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 operation
fast and easy. The result is more capabilities, greater assurance of high
performance, with less effort.
ACL TOP Benefits
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
II. Technical Description
8
Hardware
The ACL TOP hardware was designed for efficiency and effectiveness in
the high-throughput hemostasis laboratory. IL’s innovative development
team limited the number of moving components without compromising
the throughput of the system. The end result is a reliable system, requiring
minimal 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.
Analytical Module
Control Module Sample Area Reagent Area
Cuvette Cuvette External Rinse
Loading Area Waste Drawer and Clean