TDxFLx System Operations Manual

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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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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... 1-1 Theory of Operation... 1-3 Fluorescence Polarization Immunoassay... 1-3 Competitive Binding Immunoassay... 1-4 Radiative Energy Attenuation Technology... 1-5 References... 1-6 Specifications... 1-8 Table 1-1 TDxFLx Analyzer Specifications... 1-8 RS232 Serial Port... 1-9 Barcode Scanner... 1-9 Performance Characteristics... 1-10 Throughput... 1-10 Random Access Pipetting Sequence (minutes)... 1-10 Batch Pipetting Sequence (minutes)... 1-10 Unit Dose Pipetting Sequence (minutes)... 1-11 Mode 1 Pipetting... 1-11 Reagents, Calibrators, Controls, and Pretreatment Reagents... 1-12 Precision Dispenser... 1-12 TDxFLx Analyzer... 1-12 System Components... 1-13 TDxFLx Analyzer... 1-13 Dispenser Assembly... 1-14 Optics Assembly... 1-15 Sensors... 1-16 X SYSTEMS Carousel... 1-17 TDxFLx Reagent Carousel... 1-17 TDxFLx Batch-Pack Adapter... 1-18 Unit Dose Reagent Carousel... 1-19 X SYSTEMS Fluorometric Standards Function Test Set Carousel... 1-20 TDxFLx Waste Container... 1-21 TDxFLx Barcode Scanner... 1-21 X SYSTEMS Stainless Steel Probe... 1-22 X SYSTEMS Calibrators... 1-23 X SYSTEMS Controls... 1-23 X SYSTEMS Cuvettes... 1-24 X SYSTEMS Dilution Buffer... 1-24 X SYSTEMS Cartridges... 1-25 Reagents... 1-26 TDxFLx Snap Cap Organizer... 1-28 X SYSTEMS Wrench... 1-29 Calibration Products... 1-30 Pretreatment Products... 1-31 Manuals... 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... 1-32 System Status Keypad... 1-32 Edit and Store... 1-34 Reagent Keypad... 1-34 Operational Precautions and Limitations... 1-35 TDxFLx System... 1-35 TDxFLx Reagents... 1-35 Unit Dose Reagent Cartridges... 1-36 Test Sample... 1-37 Sample Volume... 1-38 X SYSTEMS Calibrators, Controls... 1-38 Storage... 1-38 Disposables... 1-39 X SYSTEMS Dilution Buffer... 1-39 TDxFLx Pretreatment Procedures... 1-39 Prevention of Azide Formation in Laboratory Plumbing... 1-39 TDxFLx Analyzer... 1-40 Results Transmission... 1-41 Precision Dispenser... 1-41 TDxFLx Snap Caps... 1-42 Waste/Wash Station... 1-42 Decontamination Procedures... 1-42

2.0

INSTALLATION Introduction... 2-1 Component Installation... 2-2 System Initialization... 2-5 System Check... 2-6 Specification Checks... 2-7 Relocation... 2-12

3.0

OPERATION Introduction... 3-1 Quality Control... 3-2 Daily Start-Up... 3-3 Programmable Options... 3-4 Assay Parameters... 3-7 Parameters Listing... 3-7 Parameter Explanation... 3-7 Parameter Editing... 3-11 Changing Concentration Units... 3-12 Calibration Overview... 3-13 Calibration Criteria... 3-13 Calibration Acceptability Criteria (Operator)... 3-14 When to Recalibrate... 3-15 Dilution Protocol... 3-16

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3.0

OPERATION (continued) Random Access... 3-17 Initialization Checks... 3-18 Assay Process Sequence... 3-19 Calibration Procedure... 3-21 System Set-Up... 3-21 Preparing the Calibration Carousel... 3-22 Preparing the Reagent Carousel... 3-23 Run Calibration... 3-25 Clean-Up... 3-27 Calibration Acceptability Criteria (Operator)... 3-27 Reading a Therapeutic Drug Random Access Calibration Printout... 3-28 Assay Procedure... 3-29 System Set-Up... 3-29 Preparing the Sample Carousel... 3-29 Preparing the Reagent Carousel... 3-30 Run Assay... 3-32 Clean-Up... 3-35 Reading a Therapeutic Drug Random Access Assay Printout... 3-36 Panel Testing Overview... 3-38 Panel Procedure... 3-38 Selecting Assay Combinations... 3-38 Selecting Panel/Assay Combinations for a Run... 3-38 Programming... 3-39 Printing... 3-40 System Set-Up... 3-41 Preparing the Sample Carousel... 3-41 Preparing the Reagent Carousel... 3-42 Run Panel... 3-44 Clean-Up... 3-48 Reading a Panel Test Printout... 3-49 Printout Options... 3-50 Sample Printout with Collate Option Set to 0... 3-51 Sample Printout with Collate Option Set to 1... 3-52 Sample Printout with Collate Option Set to 2... 3-53 Barcode Override... 3-54 Calibration... 3-54 Assay Run... 3-57 Batch... 3-63 Initialization Checks... 3-64 Assay Process Sequence... 3-65 Calibration Procedure... 3-67 System Set-Up... 3-67 Preparing the Calibration Carousel... 3-68 Preparing the Reagent Pack... 3-69 Run Calibration... 3-69 Clean-Up... 3-70 Calibration Acceptability Criteria (Operator)... 3-71

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3.0

OPERATION (continued) Reading Batch Calibration Printouts... 3-72 Therapeutic Drug or Hormone Calibration Printouts... 3-72 Clinical Chemistry Calibration Printouts... 3-73 Abused Drug Calibration Printouts... 3-74 Assay Procedure... 3-75 System Set-Up... 3-75 Preparing the Sample Carousel... 3-76 Preparing the Reagent Pack... 3-76 Run Assay... 3-77 Clean-Up... 3-79 Reading Batch Assay Printouts... 3-80 Therapeutic Drug or Hormone Assay Printouts... 3-80 Clinical Chemistry Assay Printouts... 3-83 Abused Drug Assay Printouts... 3-85 Barcode Override... 3-87 Unit Dose... 3-89 Initialization Checks... 3-90 Assay Process Sequence... 3-91 Calibration Procedure... 3-93 System Set-Up... 3-93 Preparing the Calibration Carousel... 3-93 Run Calibration... 3-95 Clean-Up... 3-96 Calibration Acceptability Criteria (Operator)... 3-96 Reading Unit Dose Calibration Printouts... 3-97 Assay Procedure... 3-98 System Set-Up... 3-98 Preparing the Sample Carousel... 3-98 Run Assay... 3-100 Clean-Up... 3-101 Reading Unit Dose Assay Printouts... 3-102 Barcode Override... 3-104

4.0

DIAGNOSTIC CHECKS Introduction... 4-1 System Checks... 4-2 System 1 - System Status... 4-3 System 2 - System Control... 4-4 System 3 - System Parameters... 4-6 System 4 - Recall Data... 4-8 System 5 - Activate Assay... 4-13 System 6 - Identification... 4-15 System 7 - Thyroid Feature... 4-17 System 8 - Unit Dose Parameters... 4-18 System 9 - Shared Pack Options... 4-20 System 10 - Reagent Carousel... 4-21 System 11 - Panels... 4-22

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4.0

DIAGNOSTIC CHECKS (continued) Diagnostic Tests... 4-23 Test 1 - Maintenance... 4-24 Test 2 - Specification Checks... 4-25 Test 3 - Calibration... 4-26 Test 4 - Hand Controls... 4-47 Test 5 - Board Tests... 4-60 Test 6 - Special Tests... 4-61 Additional System Verifications... 4-63 Coefficient of Variation (CV) Check... 4-63 Background Subtraction Check... 4-65 Probe Performance - Carryover Check... 4-67

5.0

MAINTENANCE Introduction... 5-1 Daily Maintenance... 5-3 Empty/Wash Waste Container... 5-4 Inspect and Wash Probe... 5-4 Inspect Dispense Assembly... 5-7 Clean Waste/Wash Station... 5-7 Verify Unit Dose Probe Position... 5-7 Weekly Maintenance... 5-9 Sample and Reagent Carousel Cleaning... 5-10 Dispenser Water Wash... 5-10 Air Fan Filter Cleaning... 5-10 Photo Check (Test 2.2)... 5-11 Monthly Maintenance... 5-13 Pipet Check (Test 2.3)... 5-14 Precision Dispenser Calibration... 5-17 Temperature Check (Test 2.1)... 5-18 Diluent Syringe Wash... 5-21 Periodic Maintenance... 5-23 Barcode Reader Cleaning... 5-24 Boom-Arm Barcode Reader DAC Adjustment Check... 5-25 Boom-Arm Barcode Reader Adjustment on Sample Carousel... 5-28 Buffer Platform Adjustment... 5-30 Carousel Home Sensor Cleaning... 5-31 Circuit-Board Cleaning... 5-31 Optical or Thermal Sensor Cleaning... 5-32 Automated Probe Decontamination... 5-33 Probe-Positioning Check and Adjustment Procedures... 5-34 Random Access and Batch... 5-34 Unit Dose... 5-37 Quarterly Maintenance... 5-42 Impact Printer (cleaning and lubrication)... 5-42 TDx Centrifuge RPM Check... 5-43

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5.0

MAINTENANCE (continued) Component Replacement... 5-45 Buffer Replacement... 5-46 Circuit Board Removal and Replacement... 5-46 Lamp Replacement... 5-50 Impact Printer Paper and Ribbon Installation/Replacement... 5-52 Thermal Printer Paper Installation/Replacement... 5-54 Probe/Fluid-Sensing Electrode Replacement... 5-56 Syringe Replacement... 5-59 Tubing Replacement... 5-62 Valve Block Replacement... 5-63

6.0

TROUBLESHOOTING Introduction... 6-1 Displayed Error Codes... 6-3 Printed Error Codes... 6-53 Observed Problems... 6-95

INDEX... I-1 APPENDIX A - Assay Activation Record Lot Number Interpretation... A-1 Assay Activation Record... A-3 B - TDx Centrifuge Introduction... B-1 System Description... B-2 Centrifuge Components... B-2 Centrifuge Specifications... B-4 Precautions and Limitations... B-5 Installation... B-6 Unpacking... B-6 Installation Procedure... B-6 Operation... B-7 Centrifuge Loading... B-7 Initiating Run... B-8 Run Interruption... B-9 Speed Check/Calibration... B-10 Centrifuge Speed Check... B-10 Centrifuge Speed Calibration... B-12 Maintenance... B-14 Cleaning and Decontamination... B-14

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1.0 SYSTEM DESCRIPTION

Introduction

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

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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1.0 SYSTEM DESCRIPTION

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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1.0 SYSTEM DESCRIPTION

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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1.0 SYSTEM DESCRIPTION

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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