ABBOTT LABORATORIES

Fluorescence Polarization Immunoassay System

TDxFLx SYSTEM Operations Manual March 1993

Operations Manual

466 Pages

File Type: PDF

File Size: 2.68 MB

File Name: tdxflx_system_operations_manual_march_1993.pdf

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TDxFLx® SYSTEM OPERATIONS MANUAL

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Table of Contents System Description Installation Operation Diagnostic Checks Maintenance Troubleshooting Index Assay Activation Record TDx Centrifuge

Customer Support Center 800–527–1869 (USA) For all other areas of the world, please call your local Customer Service Department. ABBOTT LABORATORIES DIAGNOSTICS DIVISION Abbott Park, IL 60064 U.S.A. PROPRIETARY INFORMATION Abbott Laboratories’ software programs are protected by copyright. All rights are reserved. This software was developed solely for use with Abbott Laboratories equipment and for in vitro diagnostic applications as specified in the operating instructions. All operating instructions must be followed. Copying or other reproduction of this program except for archival purposes is prohibited without the prior written consent of Abbott Laboratories’ Diagnostics Division. Entire contents copyright, Abbott Laboratories, 1993 TDxFLx is a registered trademark of Abbott Laboratories.

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FOREWORD

As an operator of the TDxFLx System, you are using state-of-the-art technology. This instrument is designed to function consistently and dependably. The TDxFLx System is backed by professionals who excel in engineering, training, and technical expertise. As part of our customer commitment, we teach you how to operate, maintain, and troubleshoot your instrument in our PACE* accredited training program at our Dallas, Texas facility. All information necessary to the operation of the TDxFLx System is available in this manual. Section 1.0

System Description details the use or function and provides characteristics, specifications, hazards, precautions, and limitations.

Section 2.0

Installation describes unpacking, installation procedures, and any special requirements.

Section 3.0

Operation provides principles of operation and detailed operating instructions and calibration procedures.

Section 4.0

Diagnostic Checks includes descriptions and detailed instructions for the diagnostic checks.

Section 5.0

Maintenance details service and maintenance procedures.

Section 6.0

Troubleshooting provides detailed troubleshooting procedures.

For continuing service, we provide twenty-four hour technical assistance. Additional information or assistance in diagnosing a problem is available through our toll-free number, 800-527-1869 (USA). For all other areas of the world, please call your local Customer Service Department. If a problem cannot be resolved by telephone, on-site support is offered by Abbott’s Field Engineers. These engineers are extensively trained in all disciplines of Abbott instrumentation to ensure proficient diagnosis, isolation, and correction of any problems. Abbott Laboratories demonstrates dedication to productivity by manufacturing the highest quality, most reliable instrumentation available. We look forward to serving your needs.

*Professional Acknowledgment for Continuing Education is a system designed by the American Society for Medical Technology to evaluate, approve, and document continuing education activities.

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FOREWORD

March 1993

Dear Abbott TDx /TDxFLx Customer: Abbott Laboratories recognizes the importance of complying with Approved Guidelines for Clinical Laboratory Procedure Manuals, especially National Committee for Clinical Laboratory Standards (NCCLS) Document GP2-A (1984) or GP2-A2 (1992). The Abbott TDx /TDxFLx System Operation and Assays Manuals are in substantial compliance with the NCCLS Guidelines for developing laboratory procedure manuals. The College of American Pathologists (CAP) interprets substantial compliance as the following: “. . . the components of the Document are, where appropriate, included in the procedure manual. The format does not have to be identical to NCCLS GP2-A (1984) or GP2-A2 (1992).” Both the CLIA 88 Final Rule (493.1211(c)), effective September 1, 1992 and the CAP Accreditation Inspection Checklist state that manufacturer’s package inserts or operator manuals may be used, when applicable, to meet the requirements for a laboratory procedure manual. Any requirements not provided by the manufacturer must be provided by the laboratory. In addition, any variation from the printed package insert should be detailed in the laboratory procedure manual. Any modification to or deviation from the manufacturer’s procedure manual, must be clearly documented. Laboratory Procedure Manuals must be approved, signed and dated by the responsible person. The CAP requires a copy of NCCLS GP2-A or GP2-A2 to be available to the person responsible for the preparation of the procedure manual. This document can be ordered from NCCLS at (215) 525-2435. The letter should be kept on file with your Abbott TDx /TDxFLx Operation/Assays Manual. If you have any further questions, please contact the Customer Support Center at 1-800-527-1869 (U.S.A.) Thank you for your continued support of the Abbott TDx /TDxFLx System. Sincerely,

Nancy Grondhuis Manager, Laboratory Quality Assurance

TDx is a registered trademark of Abbott Laboratories.

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ABBOTT INSTRUMENT WARRANTY

For U.S. Customers Only Abbott Laboratories warrants the TDxFLx Instrument sold by the Abbott Diagnostic Division to be free from defects in workmanship and materials during normal use by the original purchaser, excluding items subject to normal wear and tear which require replacement with normal use. This warranty shall continue for a period of ninety (90) days commencing twenty-one (21) days from the date of Instrument shipment to the original purchaser, or until title is transferred from the original purchaser, whichever occurs first (the “Warranty Period”). If any defects occur during the Warranty Period, contact your Abbott Customer Support Center immediately, and be prepared to furnish pertinent details concerning the defect, the model number, and the serial number. Warranty service is provided from 8:30 a.m. through 5:00 p.m., Monday through Friday, except on Abbott-observed holidays. Any service performed at other times, and all service required to correct defects or malfunctions not covered by this Warranty, will be billed at Abbott’s labor rates then in effect. This Warranty does not cover any defects or malfunctions which: (1) are not reported to Abbott during the Warranty Period and within one week of occurrence; (2) result from the use of any reagent, calibrator, sample cartridge, cuvette, centrifuge tube or other system disposable not supplied by Abbott Laboratories; (3) are caused by the reuse of sample cartridges, cuvettes or centrifuge tubes; (4) result from chemical decomposition or corrosion; (5) are caused primarily by failure to comply with any requirement or instruction contained in the current Abbott TDxFLx System Operation manual; or (6) result from maintenance, repair or modification performed without Abbott’s authorization. Abbott’s liability for all matters arising from the supply, installation, use, repair and maintenance of the Instrument, whether arising under this Warranty or otherwise, shall be limited solely to the repair or (at Abbott’s sole discretion) replacement of the instrument or of components thereof. In no event shall Abbott be liable for injuries sustained by third parties, incidental or consequential damages, or lost profits. Replaced parts shall become the property of Abbott Laboratories. The foregoing is the sole warranty made by Abbott Laboratories regarding the instrument, and Abbott specifically disclaims all other warranties, expressed or implied, including the warranties of merchantability and of fitness for a particular purpose.

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REVISION STATUS

The TDxFLx System is manufactured by Abbott Laboratories, Diagnostics Division, P.O. Box 152020, Irving, Texas, 75015-2020, U.S.A. Please direct all inquiries concerning information in this manual to the foregoing address. The revision status of the manual is indicated below. Be sure that the manual contains the latest revision number of all pages. Additional copies of this manual may be purchased (List No. 04A24-51). NOTE:

Direct all inquiries regarding equipment problems to the Customer Support Center (CSC), Telephone No. 800-527-1869.

Revision Number

Pages Revised and Added

Originally Issued (Rev. 1.0 software) 12/90

Not applicable.

R-102

02/91

vi, 1-8, 1-9, 1-14, 1-15, 1-19, 1-20, 1-22, 1-35, 1-36, 2-7, 3-22, 3-28, 3-29, 3-47, A-1

R-103 (Rev. 1.2 software)

07/91

vi, 1-21, 3-12, 6-5, 6-9, 6-42, A-1

R-104

01/93

v, vi, 1-35, 1-36

R-105 (Rev. 2.0 software)

06/93

All pages

R-106 (Rev. 2.1 software)

12/93

vi, 1-8, 1-10, 3-27, 3-71, 3-96, 4-61, 6-4, 6-22, 6-45, 6-95, 6-103, A-3, A-4, B-5, B-10, B-12

R-107

03/94

vi, 3-16

R-108

06/94

vi, 4-41, 4-48, 4-54, 4-58, 5-27, 5-28, 5-59, 6-97, I-2, I-5, I-6

R-109

09/94

vi, ix, x, 1-11, 1-12, 2-1, 2-2, 2-3, 2-4, 2-5, 2-6, 2-7, 2-8, 2-9, 2-10, 2-11, 2-12, 3-2, 3-5, 3-56, 3-59, 3-60, 3-61, 4-16, I-1, I-3, I-4, I-5, I-8, I-9, I-11 Deleted: 2-13 and 2-14

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TDxFLx System Operations Manual

REVISION LOG

Revision Number*

Revision Incorporated By

Software Version

Date Incorporated

*User should record revision number and sign and date this log to provide a permanent record of revisions.

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TABLE OF CONTENTS

1.0

SYSTEM DESCRIPTION Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Theory of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fluorescence Polarization Immunoassay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Competitive Binding Immunoassay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Radiative Energy Attenuation Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Table 1-1 TDxFLx Analyzer Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . RS232 Serial Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Barcode Scanner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Throughput . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Random Access Pipetting Sequence (minutes) . . . . . . . . . . . . . . . . . . . . . . . . . . . Batch Pipetting Sequence (minutes) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Unit Dose Pipetting Sequence (minutes) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Mode 1 Pipetting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Reagents, Calibrators, Controls, and Pretreatment Reagents . . . . . . . . . . . . . . . . . . . . Precision Dispenser . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . TDxFLx Analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . TDxFLx Analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Dispenser Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Optics Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . X SYSTEMS Carousel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . TDxFLx Reagent Carousel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . TDxFLx Batch-Pack Adapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Unit Dose Reagent Carousel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . X SYSTEMS Fluorometric Standards Function Test Set Carousel . . . . . . . . . . . . . TDxFLx Waste Container . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . TDxFLx Barcode Scanner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . X SYSTEMS Stainless Steel Probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . X SYSTEMS Calibrators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . X SYSTEMS Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . X SYSTEMS Cuvettes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . X SYSTEMS Dilution Buffer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . X SYSTEMS Cartridges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . TDxFLx Snap Cap Organizer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . X SYSTEMS Wrench . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Calibration Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Pretreatment Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Manuals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1-1 1-3 1-3 1-4 1-5 1-6 1-8 1-8 1-9 1-9 1-10 1-10 1-10 1-10 1-11 1-11 1-12 1-12 1-12 1-13 1-13 1-14 1-15 1-16 1-17 1-17 1-18 1-19 1-20 1-21 1-21 1-22 1-23 1-23 1-24 1-24 1-25 1-26 1-28 1-29 1-30 1-31 1-31

X SYSTEMS is a registered trademark of Abbott Laboratories.

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TABLE OF CONTENTS

1.0

SYSTEM DESCRIPTION (continued) Keypad Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . System Status Keypad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Edit and Store . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Reagent Keypad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Operational Precautions and Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . TDxFLx System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . TDxFLx Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Unit Dose Reagent Cartridges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Test Sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Sample Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . X SYSTEMS Calibrators, Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Disposables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . X SYSTEMS Dilution Buffer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . TDxFLx Pretreatment Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Prevention of Azide Formation in Laboratory Plumbing . . . . . . . . . . . . . . . . . . . . . . TDxFLx Analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Results Transmission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Precision Dispenser . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . TDxFLx Snap Caps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Waste/Wash Station . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Decontamination Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2.0

INSTALLATION Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Component Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . System Initialization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . System Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Specification Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Relocation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.0

1-32 1-32 1-34 1-34 1-35 1-35 1-35 1-36 1-37 1-38 1-38 1-38 1-39 1-39 1-39 1-39 1-40 1-41 1-41 1-42 1-42 1-42

2-1 2-2 2-5 2-6 2-7 2-12

OPERATION Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Daily Start-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Programmable Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Assay Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Parameters Listing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Parameter Explanation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Parameter Editing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Changing Concentration Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Calibration Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Calibration Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Calibration Acceptability Criteria (Operator) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . When to Recalibrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Dilution Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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3-1 3-2 3-3 3-4 3-7 3-7 3-7 3-11 3-12 3-13 3-13 3-14 3-15 3-16

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TABLE OF CONTENTS

3.0

OPERATION (continued) Random Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Initialization Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Assay Process Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Calibration Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . System Set-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preparing the Calibration Carousel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preparing the Reagent Carousel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Run Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Clean-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Calibration Acceptability Criteria (Operator) . . . . . . . . . . . . . . . . . . . . . . . . . . . . Reading a Therapeutic Drug Random Access Calibration Printout . . . . . . . . . . . Assay Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . System Set-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preparing the Sample Carousel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preparing the Reagent Carousel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Run Assay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Clean-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Reading a Therapeutic Drug Random Access Assay Printout . . . . . . . . . . . . . . . Panel Testing Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Panel Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Selecting Assay Combinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Selecting Panel/Assay Combinations for a Run . . . . . . . . . . . . . . . . . . . . . . . . . . Programming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Printing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . System Set-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preparing the Sample Carousel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preparing the Reagent Carousel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Run Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Clean-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Reading a Panel Test Printout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Printout Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Sample Printout with Collate Option Set to 0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . Sample Printout with Collate Option Set to 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . Sample Printout with Collate Option Set to 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . Barcode Override . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Assay Run . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Batch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Initialization Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Assay Process Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Calibration Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . System Set-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preparing the Calibration Carousel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preparing the Reagent Pack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Run Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Clean-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Calibration Acceptability Criteria (Operator) . . . . . . . . . . . . . . . . . . . . . . . . . . . .

45122-105

3-17 3-18 3-19 3-21 3-21 3-22 3-23 3-25 3-27 3-27 3-28 3-29 3-29 3-29 3-30 3-32 3-35 3-36 3-38 3-38 3-38 3-38 3-39 3-40 3-41 3-41 3-42 3-44 3-48 3-49 3-50 3-51 3-52 3-53 3-54 3-54 3-57 3-63 3-64 3-65 3-67 3-67 3-68 3-69 3-69 3-70 3-71

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3.0

OPERATION (continued) Reading Batch Calibration Printouts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Therapeutic Drug or Hormone Calibration Printouts . . . . . . . . . . . . . . . . . . . . . . Clinical Chemistry Calibration Printouts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Abused Drug Calibration Printouts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Assay Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . System Set-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preparing the Sample Carousel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preparing the Reagent Pack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Run Assay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Clean-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Reading Batch Assay Printouts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Therapeutic Drug or Hormone Assay Printouts . . . . . . . . . . . . . . . . . . . . . . . . . . Clinical Chemistry Assay Printouts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Abused Drug Assay Printouts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Barcode Override . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Unit Dose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Initialization Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Assay Process Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Calibration Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . System Set-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preparing the Calibration Carousel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Run Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Clean-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Calibration Acceptability Criteria (Operator) . . . . . . . . . . . . . . . . . . . . . . . . . . . . Reading Unit Dose Calibration Printouts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Assay Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . System Set-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preparing the Sample Carousel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Run Assay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Clean-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Reading Unit Dose Assay Printouts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Barcode Override . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4.0

3-72 3-72 3-73 3-74 3-75 3-75 3-76 3-76 3-77 3-79 3-80 3-80 3-83 3-85 3-87 3-89 3-90 3-91 3-93 3-93 3-93 3-95 3-96 3-96 3-97 3-98 3-98 3-98 3-100 3-101 3-102 3-104

DIAGNOSTIC CHECKS Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . System Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . System 1 - System Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . System 2 - System Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . System 3 - System Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . System 4 - Recall Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . System 5 - Activate Assay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . System 6 - Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . System 7 - Thyroid Feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . System 8 - Unit Dose Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . System 9 - Shared Pack Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . System 10 - Reagent Carousel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . System 11 - Panels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

45122-105

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4-1 4-2 4-3 4-4 4-6 4-8 4-13 4-15 4-17 4-18 4-20 4-21 4-22

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4.0

5.0

DIAGNOSTIC CHECKS (continued) Diagnostic Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Test 1 - Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Test 2 - Specification Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Test 3 - Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Test 4 - Hand Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Test 5 - Board Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Test 6 - Special Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Additional System Verifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Coefficient of Variation (CV) Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Background Subtraction Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Probe Performance - Carryover Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-23 4-24 4-25 4-26 4-47 4-60 4-61 4-63 4-63 4-65 4-67

MAINTENANCE Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Daily Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Empty/Wash Waste Container . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Inspect and Wash Probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Inspect Dispense Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Clean Waste/Wash Station . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Verify Unit Dose Probe Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Weekly Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Sample and Reagent Carousel Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Dispenser Water Wash . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Air Fan Filter Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Photo Check (Test 2.2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Monthly Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Pipet Check (Test 2.3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Precision Dispenser Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Temperature Check (Test 2.1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Diluent Syringe Wash . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Periodic Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Barcode Reader Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Boom-Arm Barcode Reader DAC Adjustment Check . . . . . . . . . . . . . . . . . . . . . . . . Boom-Arm Barcode Reader Adjustment on Sample Carousel . . . . . . . . . . . . . . . . . . Buffer Platform Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Carousel Home Sensor Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Circuit-Board Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Optical or Thermal Sensor Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Automated Probe Decontamination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Probe-Positioning Check and Adjustment Procedures . . . . . . . . . . . . . . . . . . . . . . . . Random Access and Batch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Unit Dose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Quarterly Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Impact Printer (cleaning and lubrication) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . TDx Centrifuge RPM Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5-1 5-3 5-4 5-4 5-7 5-7 5-7 5-9 5-10 5-10 5-10 5-11 5-13 5-14 5-17 5-18 5-21 5-23 5-24 5-25 5-28 5-30 5-31 5-31 5-32 5-33 5-34 5-34 5-37 5-42 5-42 5-43

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5.0

6.0

MAINTENANCE (continued) Component Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Buffer Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Circuit Board Removal and Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Lamp Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Impact Printer Paper and Ribbon Installation/Replacement . . . . . . . . . . . . . . . . . . . . Thermal Printer Paper Installation/Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Probe/Fluid-Sensing Electrode Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Syringe Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Tubing Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Valve Block Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5-45 5-46 5-46 5-50 5-52 5-54 5-56 5-59 5-62 5-63

TROUBLESHOOTING Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Displayed Error Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Printed Error Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Observed Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6-1 6-3 6-53 6-95

INDEX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-1 APPENDIX A - Assay Activation Record Lot Number Interpretation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1 Assay Activation Record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3 B - TDx Centrifuge Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . System Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Centrifuge Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Centrifuge Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Precautions and Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Unpacking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Installation Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Centrifuge Loading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Initiating Run . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Run Interruption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Speed Check/Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Centrifuge Speed Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Centrifuge Speed Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cleaning and Decontamination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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B-1 B-2 B-2 B-4 B-5 B-6 B-6 B-6 B-7 B-7 B-8 B-9 B-10 B-10 B-12 B-14 B-14

TDxFLx System Operations Manual

1.0 SYSTEM DESCRIPTION

Introduction

This section provides details on:

•

Theory of Operation

•

Specifications

•

Performance Characteristics

•

System Components

•

Keypad Functions

•

Operational Precautions and Limitations

The TDxFLx System is an automated system that performs a variety of laboratory tests:

•

Therapeutic Drug Assays

•

Hormones

•

Clinical Chemistries

•

Specific Proteins

•

Toxicology/Abused Drugs

The TDxFLx System is designed for use by a trained laboratory technician in hospitals and private laboratories. The analyzer performs tests in three modes: random access, batch, and unit dose. The user can perform 1 to 8 different assays with up to 20 samples on a single carousel run. NOTE: Toxicology/abused drug assays are tested in the batch mode of operation. This manual describes the TDxFLx System and its components, installation procedures, theory of operation, and operating procedures. The manual also provides a description of the various diagnostic checks, routine maintenance procedures, and a troubleshooting guide.

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1.0 SYSTEM DESCRIPTION

Theory of Operation

This section provides a brief overview of the theory behind the operation of the TDxFLx System. The system uses fluorescence polarization technology and competitive binding immunoassay methodology. The system also uses radiative energy attenuation (REA) technology to perform clinical chemistry assays, specific antisera and endpoint nephelometry technology to perform Turbo Specific Protein assays (refer to the TDxFLx & TDx Turbo Operation Supplement for further information). More in-depth information may be obtained from your Abbott Sales Representative or the Customer Support Center (CSC). Fluorescence Polarization Immunoassay The TDxFLx System uses fluorescence polarization immunoassay (FPIA) technology as detailed in the following paragraphs. The tungsten halogen lamp in the system emits light of different wavelengths or colors with random spatial orientation. An interference filter, located in front of the light source, allows only blue light (481-489 nm) to pass through. The light is then passed through a liquid-crystal polarizer to produce plane polarized blue light. The plane polarized blue light excites the tracer, or fluorophore, and raises it to an excited state. After excitation, the fluorophore returns to steady state by emitting green light (525-550 nm). When the fluorophore is bound to a large antibody molecule, it does not rotate freely, and the emitted green light will be in the same plane as the blue excitation light and polarization is retained. Conversely, when the fluorophore is free to rotate, the emitted green light will be in a different plane than the blue excitation light and polarization will be lost. Therefore, because of the rotational properties of molecules in solution, the degree of polarization is directly proportional to the size of the molecule. That is, polarization increases as molecular size increases.

REA is a registered trademark of Abbott Laboratories. Turbo is a registered trademark of Abbott Laboratories.

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Theory of Operation

Competitive Binding Immunoassay The TDxFLx System uses a competitive binding immunoassay methodology to allow tracer-labeled antigen and patient antigen to compete for binding sites on the antibody molecules. The components in this competitive binding reaction are the antibody, the patient antigen, and the antigen labeled with fluorescein (tracer-antigen complex). When competitive binding occurs, the more tracer-antigen complex that binds to the antibody molecule, the less tracer-antigen complex that remains in solution. If a patient sample contains a low concentration of antigen, after the competitive binding reaction reaches steady-state, there is a high concentration of bound tracer in the reaction mixture and polarization is high. Conversely, if a patient sample contains a high concentration of antigen, after the competitive binding reaction reaches steady-state, there is a low concentration of bound tracer in the reaction mixture and polarization is low. The precise relationship between polarization and concentration of the unlabeled drug or hormone in the sample is established by measuring the polarization values of calibrators with known concentrations of the drug or hormone. Using the polarization values generated for each sample in the assay, concentrations of drugs or hormones in unknown samples are calculated using the stored calibration curve, and the results are printed out in reportable units.

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Theory of Operation

Radiative Energy Attenuation Technology Radiative Energy Attenuation (REA) technology applies the fundamental principles of Beer’s Law. These principles are used in order to perform analysis of clinical chemistries on the TDxFLx System. The measured fluorescence intensity of a solution containing a fluorophore is proportional to the absorbance of the solution. If the solution has an absorbance greater than zero, an attenuation of the fluorescence intensity will be observed. The degree of attenuation will be directly proportional to the absorbance of the solution. Radiative energy attenuation can be used to measure the concentration of specific analytes. When a reagent-analyte reaction generates a chromogen in the presence of a fluorophore, an attenuation of the fluorescence intensity is observed when the chromogen absorbs either the blue fluorophore-excitation or green fluorophore-emission light. If the chromogen absorbs the excitation light only, primary attenuation will be observed. If the chromogen absorbs the emission radiation only, secondary attenuation will be observed. If the chromogen absorbs both the excitation and emission radiation, the total attenuation will be proportional to the sum of the absorbances of the solution at each wavelength. Final fluorescence intensity will be inversely proportional to the amount of chromogen in the solution. Through the use of calibrators, fluorescent intensities can be compared, and the analyte concentration in a patient’s sample can be calculated. In a sample containing a low concentration of analyte, a small amount of chromogen will be produced, a small amount of light will be absorbed, the attenuation will be small, and the fluorescence intensity will be large. In a sample containing a high concentration of analyte, a large amount of chromogen will be produced, a large amount of light will be absorbed, the attenuation will be large and the fluorescence intensity will be small. The fluorescence intensity is measured before and after the generation of the chromogen and the percent of light that was not attenuated is calculated. Concentrations of analyte are determined from a previously stored calibration curve and printed in reportable units.

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Theory of Operation

References 1. Weber G. Rotational Brownian motion and polarization of the fluorescence of solutions. Adv Protein Chem 1953; 8: 415-59. 2. Dandliker WB, Feigen GA. Quantification of the antigen-antibody reaction by polarization of fluorescence. Biochem Biophys Res Commun 1961; 5: 299-304. 3. Dandliker WB, de Saussure VA. Review article: Fluorescence polarization in immunochemistry. Immunochemistry 1970; 7: 799-828. 4. Dandliker SB, Kelly RJ, Dandliker J, et al. Fluorescence polarization immunoassay. Theory and experimental method. Immunochemistry 1973; 10: 219-27. 5. Jolley ME. Fluorescence polarization immunoassay for determination of therapeutic drug levels in human plasma. J Anal Toxicol 1981; 5: 236-40. 6. Popelka SR, Miller DM, Holen JT, Kelso DM. Fluorescence polarization immunoassay II. Analyzer for the rapid and precise measurement of fluorescence polarization using disposable cuvettes. Clin Chem 1981; 27: 1198-201. 7. Jolley ME, Stroupe SD, Schwenzer KS, et al. Fluorescence polarization immunoassay III. An automated system. Clin Chem 1981; 27:1575-9. 8. Jolley ME, Stroupe SD, Wang CJ, et al. Fluorescence polarization immunoassays for the determination of aminoglycoside levels in human plasma. Abstracts of the Annual Meeting of the American Society for Microbiology, Abstract E87, 1981; 69. 9. Jolley ME, Stroupe SD, Wang CJ, et al. Fluorescence polarization immunoassay I. Monitoring aminoglycoside antibiotics in serum and plasma. Clin Chem 1981; 27: 1190-7. 10. Lu-Steffes M, Pittluck GW, Jolley ME, et al. Fluorescence polarization immunoassay IV. Determination of phenytoin and phenobarbital in human serum and plasma. Clin Chem 1982; 28: 2278-82.

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Theory of Operation

11. Hill HD, Jolley ME, Wang CJ, et al. Fluorescence polarization immunoassay (FPIA) for theophylline: clinical correlation and reagent stability. Clin Chem 1981; 27: 1086. 12. Finley PR, Williams RJ, Lichti DA. Evaluation of a new homogeneous enzyme inhibitor immunoassay of serum thyroxine with use of a bichromatic analyzer. Clin Chem 1980; 26: 1723-6. 13. Khalil OS, Routh WS, Lingenfelter K, Carr DB, Ladouceur P. Automated in-line ratio-correcting filter fluorometer. Clin Chem 1981; 27: 1586-91. 14. Shaffar MR, Stroupe SD. A general method for performing routine clinical chemistry on the Abbott TDx analyzer. Clin Chem 1983; 129, 1251. Abstract.

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1.0 SYSTEM DESCRIPTION

Specifications

Table 1-1

TDxFLx Analyzer Specifications

General Characteristics Capacity Sample Volume Carryover Intensity/Stability Polarization Range

Sample Carousel: 1 to 20 samples Reagent Carousel: 1 to 8 TDxFLx wedge reagent packs 50 to 500 µL < 1.5% at concentrations ≥ the highest calibrator, unless otherwise specified Better than 0.1% over the duration of an assay 0 to 500 mP

Physical Characteristics Size Weight

24″ D × 28″ W × 15″ H (60 cm D × 70 cm W × 37.5 cm H) 107 lbs (49 kg) maximum

Electrical Characteristics Voltage Frequency Power Requirements Fusing Power Connection IEC Equipment Classification

100 (+10%, –5%) 120, 220, or 240 VAC (+10%, –15%) 50 or 60 Hz 600 V-A 100/120 VAC: 6.25 Amps T (SLO-BLO), 250 VAC 220/240 VAC: 3 Amps T (SLO-BLO), 250 VAC 3-prong grounded outlet (U.S.) Class I, Type B, Ordinary Equipment, Continuous Operation

Environmental Requirements Room Temperature Humidity Location

15° to 30°C (59° to 86°F) 15% to 85% humidity Flat, level surface No direct sunlight or drafts Removed from sources of direct heat and moisture Ventilation space at least 6″ on top, sides, and back

Optical Characteristics Light Source Detector Excitation Peak Excitation Bandwidth Emission Band

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Tungsten halogen lamp, 50 watts, 8 volts Photomultiplier tube 485 nm 8 nm 525 to 550 nm

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1.0 SYSTEM DESCRIPTION

RS232 Serial Port

Specifications

The TDxFLx System has a 25-pin connector for an RS232 serial communications port. The port has two modes of operation: 1. Echo Mode - All printed run information is also sent to the port. 2. Spooler Mode - Printed information is held in the system until called for by the host system. For further information, contact the Customer Support Center for the system interface specification.

Barcode Scanner

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Maximum Code Length: 2.75″ (70 mm) Narrow Bar Width: .004″ (.08 mm) minimum Barcode Symbology: Codabar, Code 3 of 9, Code 128 and Interleaved 2 of 5 Print Contrast Ratio: 25% minimum

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1.0 SYSTEM DESCRIPTION

Performance Characteristics

The following performance characteristics apply to the TDxFLx System and to its test components.

Throughput Random Access Pipetting Sequence (minutes)

One Sample: Full Carousel:

Mode 1

Mode 17

9 min.

22 min.

Batch Pipetting Sequence (minutes)

One Sample: Full Carousel:

Mode 1*

Mode 2

Mode 4

Mode 5

Mode 6

16 min.

Mode 3 All Dilutes 13 min.

6 min.

14 min.

9 min.

13 min.

24 min.

20 min.

24 min.

18 min.

Mode 7

Mode 8

Mode 9

Mode 10

Mode 11

Mode 12

22 min.

12 min.

16 min.

3 min.

16 min.

9 min.

30 min.

18 min.

25 min.

19 min.

Mode 14

Mode 17

Mode 18

Mode 19

Mode 21

Mode 23

9 min.

16 min.

13 min.

14 min.

19 min.

18 min.

15 min.

24 min.

19 min.

30 min.

Mode 24

Mode 25

Mode 26

Mode 27

Mode 28

Mode 30

16 min.

15 min.

13 min.

24 min.

22 min.

23 min.

19 min.

Mode 31

Mode 33

Mode 37

16 min.

12 min.

Mode 42 All Dilutes 16 min.

Mode 43

27 min.

Mode 40 All Dilutes 13 min.

14 min.

30 min.

24 min.

20 min.

22 min.

24 min.

21 min.

*Since most TDx /TDxFLx System assays are run in the Mode 1 pipetting sequence, it is described on the following page. For more details on sequences of pipetting modes, contact the Customer Support Center.

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1.0 SYSTEM DESCRIPTION

Performance Characteristics

Unit Dose Pipetting Sequence (minutes) One Sample: Full Carousel:

Mode 1

Mode 4

Mode 17

Mode 22*

Mode 23

8 min.

16 min.

8 min.

23 min.

26 min.

19 min.

25 min.

19 min.

29 min.

35 min.

*Mode 22 is reserved for Turbo (Specific Protein) assays.

Mode 1 Pipetting After the instrument passes all the initialization checks, the pipetting sequence begins. In Mode 1, sample is aspirated from the sample well and dispensed with X SYSTEMS Dilution Buffer into the predilution well of the sample cartridge. This dilution of sample provides greater accuracy of pipetting the sample volume, because a larger volume of diluted sample will be pipetted into the cuvette for the assay. One-half the final volume of the diluted sample, the “P” reagent, and X SYSTEMS Dilution Buffer are dispensed into the cuvette to give one-half the final reaction volume. Background intensity readings are taken on this mixture. The second half of the diluted sample volume is added to the cuvette along with the “T” reagent, “S” reagent, and X SYSTEMS Dilution Buffer to give the final reaction volume. The cuvette is incubated until the reaction reaches equilibrium, then final intensity readings are taken.

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1.0 SYSTEM DESCRIPTION

Performance Characteristics

Reagents, Calibrators, Controls, and Pretreatment Reagents

Shipped ready-to-use Stable calibration X SYSTEMS products expire the last day of the month printed on the label, unless otherwise specified

Precision Dispenser

Spring-loaded plunger Repetitive pipettings Chemically inert disposable tip

TDxFLx Analyzer

Automatically reads sample blank when required by the specific assay mode

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TDxFLx Analyzer (No. 04A24-XX)

System Components

The external features shown are: A. Printer Access Door B. Buffer Access Door C. Waste Container (Under Left Side) D. System Status Display E. Control Keypad F. Reagent Display G. Reagent Keypad H. Reagent Display Panel I. Carousel Access Door J. Barcode Scanner (Mounted on Side Panel)

LEFT SIDE

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RIGHT SIDE

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1.0 SYSTEM DESCRIPTION

System Components

The internal components of the TDxFLx System consist of the dispenser assembly, the optics assembly, and the sensors.

Dispenser Assembly The features of the dispenser assembly are: A. Valve Block B. Inlet Tubing C. Diluent Syringe D. Sample Syringe E. Interconnect Tubing F. Waste Container (underneath baseplate) G. Buffer Platform H. Liquid Heater Block I. Probe Connector Tubing J. Waste/ Wash Station K. Boom Arm L. Probe

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1.0 SYSTEM DESCRIPTION

System Components

Optics Assembly The optics assembly features:

LAMP LAMP COVER LAMP HOUSING TWO OPTICAL LENSES

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System Components

Sensors The sensors in the TDxFLx System are: A. Paper Out Sensor (on printer assembly) B. Door Sensor (behind display panel) C. Waste Container Sensor (behind pump) D. Buffer Sensor (underneath platform) E. Reagent Carousel Barcode Reader F. Reagent Carousel Home Sensor G. Boom-Arm Barcode Reader H. Sample Carousel Home Sensor I. Liquid-Level Sensors J. Cuvette/Carousel-Locked Sensor K. Thermal Detector

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X SYSTEMS Carousel (No. 9518-11)

System Components

This carousel is used in the random-access and batch modes for assay and calibration runs. The barcode label identifies the carousel’s function. Carousels and barcode labels are shipped with the instrument. The carousel accommodates up to 20 samples. This carousel contains: SAMPLE/CUVETTEPOSITION NUMBER

CAROUSEL LOCKING MECHANISM

SAMPLE CARTRIDGE POSITION CUVETTE POSITION

CAROUSEL BARCODE-LABEL POSITION

TDxFLx Reagent Carousel (No. 04A24-10)

This reagent carousel holds reagents for random-access testing. The carousel holds eight of the wedge-shaped reagent packs.

UNLOADED

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TDxFLx Batch-Pack Adapter (No. 04A24-11)

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System Components

The TDxFLx Batch-Pack Adapter allows the operator to run in batch mode on the TDxFLx analyzer. The adapter is a platform that holds the batch reagent pack.

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Unit Dose Reagent Carousel (No. 9520-50)

System Components

The unit dose reagent carousel enables the TDxFLx analyzer to perform unit dose testing. The unit dose reagent carousel accommodates up to 20 individual cartridges. The features of the carousel are:

CAROUSEL LOCKING MECHANISM

CAROUSEL BARCODE-LABEL POSITION

SAMPLE/CUVETTEPOSITION NUMBER

UNIT DOSE REAGENT CARTRIDGE/ CUVETTE POSITION

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X SYSTEMS Fluorometric Standards Function Test Set Carousel (No. 9520-31)

System Components

X SYSTEMS Fluorometric Standards Function Test Set Carousel contains 10 sealed ampules of fluorescent dye (Rhodamine 110) in solution.

AMPULE

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TDxFLx Waste Container (No. 04A24-12)

System Components

The TDxFLx Waste Container is a high density polyethylene waste receptacle that nests under the left side of the instrument.

WASTE CONTAINER

TDxFLx Barcode Scanner (No. 04A24-15)

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The hand-held barcode scanner reads Code 3 of 9, Code 128, Interleaved 2 of 5 and Codabar symbologies. The scanner accepts alpha-numerics characters for Patient ID and Operator ID even though the keypad does not have alpha keys. The holder permits mounting on either side of the instrument in a variety of positions.

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X SYSTEMS Stainless Steel Probe (No. 9967-02)

System Components

TDxFLx System requires the TEFLON coated, stainless steel probe for random-access, batch, and unit dose modes of operation. The stainless steel probe features sturdy construction, fluid-sensing electrodes, and LUER-LOK fitting for disconnect/reconnect. LUER-LOK PROBE SUPPORT BRACKET

PROBE-GUIDE CLIPS FLUID-SENSING ELECTRODE

CONNECTOR TUBING

TEFLON is a registered trademark of E.I. duPont de Nemours & Co., Inc. LUER-LOK is a registered trademark of Becton Dickinson & Co.

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System Components

X SYSTEMS Calibrators

The calibrators consist of six vials, A through F. For further details, refer to the assays manual.

X SYSTEMS Controls

The controls for most assays consist of three vials, Low, Medium, and High. Controls for some assays contain vial quantities other than three. For further details, refer to the appropriate assay section in the assays manual.

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System Components

X SYSTEMS Cuvettes (No. 9518-06)

Glass cuvettes are available in quantities of 100.

X SYSTEMS Dilution Buffer (No. 9519-02) or (No. 9519-05)

The dilution buffer is a 0.1M phosphate buffer containing 0.1% sodium azide as a preservative.

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X SYSTEMS Cartridges (No. 9518-05)

System Components

These sample cartridges are used for random-access and batch testing. Cartridges are packaged in quantities of 100. The sample cartridges have a sample well and a predilution well. SAMPLE WELL PREDILUTION WELL

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Reagents

System Components

The TDx /TDxFLx 3- and 4-pot reagent packs are used with the batch-pack adapter to run TDxFLx in batch mode. Refer to the assays manual for details on the contents of each reagent vial/well. The 3-pot reagent pack consists of: “S” Vial “T” Vial “P” Vial

3-POT REAGENT PACK

NOTE: Vials in the T-Uptake reagent pack are in the order P-T-P. The 4-pot reagent pack consists of: “W” Vial “S” Vial “T” Vial “P” Vial

4-POT REAGENT PACK

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1.0 SYSTEM DESCRIPTION

System Components

The TDxFLx Reagent Pack is a wedge-shaped, 3-pot pack that is used for the random-access mode. The TDxFLx System reagent carousel holds eight reagent packs. Each pack snaps onto the carousel and contains: “S” Vial “T” Vial “P” Vial

TDxFLx REAGENT PACK

The TDxFLx wedge reagent pack has snap caps that are used for storing the reagent packs after the initial use. The caps snap into place sealing all three pots simultaneously as shown below.

TDxFLx REAGENT PACK WITH SNAP CAPS

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1.0 SYSTEM DESCRIPTION

System Components

The features of the unit dose reagent cartridge are: CUVETTE WELL ASSAY NAME ASSAY BARCODE LABEL PREDILUTION WELL

SAMPLE WELL

“P” WELL

“S” WELL “T” WELL

CARTRIDGE EXPIRATION DATE AND LOT NUMBER LABEL UNIT DOSE REAGENT CARTRIDGE

TDxFLx Snap Cap Organizer (No. 4A24-35)

The snap cap organizer is provided as an aid to organize and store wedge reagents. The organizer can hold up to eight snap caps while the wedge reagent packs are in use during a random access run. Wedge reagent packs sealed with snap caps can be stored on the organizer before and after a random access run. Place items on the organizer as shown below:

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X SYSTEMS Wrench (No. 9684-25)

System Components

The X SYSTEMS wrench is provided to assist with loosening or tightening reagent vial lids. To loosen a vial lid with the wrench, perform the following steps: 1. Hold the wrench so that the Abbott Laboratories logo ( up.

) is face

2. Place the ring portion of the wrench around the vial lid. 3. Squeeze the opposite end of the wrench between your thumb and index finger. 4. Turn the wrench in a counterclockwise direction until the lid loosens.

To tighten a vial lid using the wrench, perform the following steps: 1. Hold the wrench so that the Abbott Laboratories logo ( down.

) is face

2. Place the ring portion of the wrench around the vial lid. 3. Squeeze the opposite end of the wrench between your thumb and index finger. 4. Turn the wrench in a clockwise direction until the vial lid is tightened.

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Calibration Products

System Components

The TDxFLx System requires the following products for instrument specification checks and calibration procedures. 1. X SYSTEMS Pipet Check Solution (No. 9531-02)

2. Probe Positioning Cartridges Batch and Random Access (No. 9520-28)

SAMPLE WELL

PREDILUTION WELL POSITION

CUVETTE WELL

“P” WELL “S” WELL PREDILUTION WELL POSITION

Unit Dose (No. 9520-41) SAMPLE WELL “T” WELL POSITION

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1.0 SYSTEM DESCRIPTION

Pretreatment Products

System Components

The TDxFLx System requires the following additional products for assays requiring pretreatment steps: NOTE: Any additional materials required for individual assays are described in the appropriate assays manual section. 1. TDx Precision Dispenser (No. 9528-02)

2. X SYSTEMS Centrifuge Tubes (No. 9527-40) Centrifuge tubes are packaged in quantities of 100.

Manuals

The TDxFLx System uses the following manuals: TDxFLx System Operations Manual List Number 04A24-51 TDx /TDxFLx Systems Assays Manual List Number 04A24-52 These system manuals are shipped with the instrument.

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Keypad Functions

The following is a description of the system status keypad functions of the TDxFLx Analyzer.

System Status Keypad Command

Function

RUN

Starts assay and calibration runs and some diagnostic checks.

ASSAY RUN (Random Access)

Starts the random-access run regardless of the carousel label. Random-access barcode override is described in Section 3.0 Operation.

ASSAY XX RUN (Batch)

Starts the particular batch assay indicated by the number XX, regardless of the reagent-pack label or the carousel label. Barcode override is described in Section 3.0 Operation.

ASSAY . RUN (Unit Dose)

Starts a unit dose run, regardless of the carousel label. Unit dose barcode override is described in Section 3.0 Operation.

TEST X.X RUN

Starts the instrument specification check, calibration procedure, or diagnostic test specified by the number X.X or X.X.X.

SYSTEM X.X RUN

Starts the system functions.

STOP

Stops any assay, test, system, prime, or printout in progress. Returns the TDxFLx Analyzer to READY.

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PRIME

Keypad Functions

Moves the boom arm to home then to the waste/wash station. The system then primes the dispenser assembly with buffer. PRIME only functions in the READY state. The carousel returns to home before the prime is initiated. You may press the PRIME key a maximum of three times to initiate the consecutive priming sequence. NOTE: Automatic primes are initiated if the liquid temperature is too high after an assay.

PRINT or DISPLAY PRINT

Advances the paper one line at a time.

ASSAY PRINT

Prints the list of assays programmed in memory.

ASSAY XX PRINT

Prints the parameters for the assay indicated by the assay number (XX).

ASSAY XX.X PRINT

Prints the assay parameter specified by the number (XX.X) along with remaining assay parameters.

SYSTEM PRINT

Prints the system monitors programmed in memory.

SYSTEM X PRINT

Prints the system status indicated by the number (X).

SYSTEM X.X PRINT

Prints the system parameter indicated by the number (X.X) along with the remaining system parameters.

TEST PRINT

Prints the list of diagnostic test categories programmed in memory.

TEST X PRINT

Lists subcategories of diagnostic tests within the major category indicated by the number (X). NOTE: If DISPLAY is substituted for PRINT in any of the above commands, the data are shown on the display instead of being printed. If the data consist of several lines, the succeeding line can be displayed by pressing NEXT.

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Keypad Functions

EDIT and STORE ASSAY XX.X EDIT SYSTEM X.X EDIT TEST X.X.X EDIT

Displays the value requested by the parameter number (XX.X, X.X, or X.X.X). New values are entered by pressing the appropriate numbers on the keypad and stored by pressing STORE. The numbers appear on the display as entered, but the new value is not substituted unless the STORE key is pressed. If you must edit another parameter for this assay, system, or test, press NEXT until that parameter is displayed. Enter the new value, and press STORE. If an error is made when entering a number, press CLEAR then enter the correct number. NOTE: If the value is not intended for operator editing, the display shows [WRT PROTECT] and the value will not change.

Reagent Keypad The reagent keypad is used to select the assays/panels to be run in the random-access mode. This keypad activates when the reagent-barcode reader scans the loaded carousel. Command * A-H

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Function Activates the panel mode. Displays the assay names and indicates the number of test used [t used = XXX] or test left [t left = XXX].

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TDxFLx System

Operational Precautions and Limitations

For In Vitro Diagnostic Use. Components are designed by Abbott Laboratories for optimal performance as a system. Substitution of reagents, accessories, or instrument components may adversely affect performance and may invalidate any warranty agreements. Abbott Laboratories does not accept responsibility for the accuracy of any assay results produced by the use of reagents, calibrators, controls, disposables, buffer, or pretreatment manufactured by anyone other than Abbott Laboratories.

TDxFLx Reagents

Refer to the Important Note Card included in each reagent pack for the stability of the reagent after application of the Snap Cap. Do not use reagents beyond the expiration date printed on the kit label. Some reagents contain sodium azide as a preservative. Use accepted guidelines for disposal. To avoid possible contamination, do not combine the contents of different reagent packs. Some reagents contain human blood components. Consider all clinical specimens and reagent controls, calibrators, etc., as potentially infectious. Wear gloves, lab coats, and safety glasses, and follow other biosafety practices as specified in the OSHA Bloodborne Pathogen Rule or other equivalent biosafety procedures. Some reagents contain human urine. Handle with appropriate care. Do not freeze reagents unless specified. If reagents are frozen during shipment, contact the Customer Support Center. Abbott Laboratories cannot accept responsibility for the accuracy of any assay results produced by use of reagents manufactured by anyone other than Abbott Laboratories. Wedge Mix TDxFLx reagent pack(s) by swirling. Place wedge reagent pack(s) into the reagent carousel and place the reagent carousel onto a level worksurface. Hold the carousel firmly and swirl by moving in a circular motion for at least five seconds. DO NOT INVERT. CAUTION: Inversion of the TDxFLx (wedge) reagent pack(s) may cause liquid entrapment in the snap cap. Batch Mix TDx / TDxFLx reagent pack(s) by gentle inversion. Avoid excessive agitation to prevent foaming which could affect results. If excessive foaming does occur, allow the reagent pack to sit until the foam has dissipated.

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Operational Precautions and Limitations

Do not leave reagent vials uncapped for prolonged periods of time. Immediately following a run, remove reagents from the TDxFLx System, cap securely, and return them to proper storage conditions. Place only the reagents to be used on the current run in the instrument. CAUTION: Reagent packs not being used for the immediate run must be removed and recapped and returned to proper storage conditions.

Unit Dose Reagent Cartridges

Some reagents contain sodium azide as a preservative. Use accepted guidelines for disposal. Do not use cartridges past their expiration date. Ensure that the cuvette is securely attached to the unit dose reagent cartridge. To easily attach and prevent breakage of the cuvette, firmly squeeze the cuvette attachment port on the unit dose reagent cartridge with the thumb and forefinger, and release. Attach the cuvette. Avoid dropping or shaking unit dose reagent cartridges. Prolonged exposure of individual cartridges to light may be detrimental to assay performance. Store in the light-protective package provided. Do not puncture foil on the cartridge prior to use. Some reagents contain human blood components. Consider all clinical specimens and reagent controls, calibrators, etc., as potentially infectious. Wear gloves, lab coats, and safety glasses, and follow other biosafety practices as specified in the OSHA Bloodborne Pathogen Rule or other equivalent biosafety procedures. Do not freeze reagents unless specified. If the reagents are frozen during shipment, contact the Customer Support Center. Abbott Laboratories cannot accept responsibility for the accuracy of any assay results produced by use of reagents manufactured by anyone other than Abbott Laboratories.

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