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Evaluation of Saliva/Oral Fluid As an Alternate Drug Testing Specimen

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Evaluation of Saliva/Oral Fluid As an Alternate Drug Testing Specimen The author(s) shown below used Federal funds provided by the U.S. Department of Justice and prepared the following final report: Document Title: Evaluation of Saliva/Oral Fluid as an Alternate Drug Testing Specimen Author(s): Dennis J. Crouch, Jayme Day, Jakub Baudys, Alim A. Fatah Document No.: 203569 Date Received: February 2005 Award Number: 94-IJ-R-004 This report has not been published by the U.S. Department of Justice. To provide better customer service, NCJRS has made this Federally- funded grant final report available electronically in addition to traditional paper copies. Opinions or points of view expressed are those of the author(s) and do not necessarily reflect the official position or policies of the U.S. Department of Justice. This document is a research report submitted to the U.S. Department of Justice. This report has not been published by the Department. Opinions or points of view expressed are those of the author(s) and do not necessarily reflect the official position or policies of the U.S. Department of Justice. Evaluation of Saliva/Oral Fluid as an Alternate Drug Testing Specimen NIJ Report 605−03 Dennis J. Crouch Jayme Day Jakub Baudys University of Utah, Center for Human Toxicology (CHT) Salt Lake City, UT 84112–9457 and Alim A. Fatah National Institute of Standards and Technology Gaithersburg, MD 20899 July 2004 NCJ 203569 This report was prepared for the National Institute of Justice, U.S. Department of Justice, by the Office of Law En- forcement Standards (OLES) of the National Institute of Standards and Technology (NIST) under the direction of Alim A. Fatah, Program Manager for Chemical Systems and Materials, and Kathleen M. Higgins, Director of OLES. This report was conducted under Interagency Agreement 94−IJ−R−004, Project No. 03–002. This document is a research report submitted to the U.S. Department of Justice. This report has not been published by the Department. Opinions or points of view expressed are those of the author(s) and do not necessarily reflect the official position or policies of the U.S. Department of Justice. iii This document is a research report submitted to the U.S. Department of Justice. This report has not been published by the Department. Opinions or points of view expressed are those of the author(s) and do not necessarily reflect the official position or policies of the U.S. Department of Justice. CONTENTS Page COMMONLY USED SYMBOLS AND ABBREVIATIONS...................................................... iv ABOUT THIS REPORT..................................................................................................................v 1. INTRODUCTION ..................................................................................................................1 1.1 Drug Testing Methods ......................................................................................................1 1.2 Oral Fluid as a Drug-Testing Specimen............................................................................1 1.3 Oral Fluid: Pros and Cons.................................................................................................2 1.4 Objectives .........................................................................................................................2 2. LITERATURE SEARCH .......................................................................................................3 2.1 Search Results................................................................................................................3 2.2 Controlled Clinical Study 1 .........................................................................................16 2.3 Clinical Study 2............................................................................................................25 3. REPORT ON THE EFFECTS OF COLLECTION DEVICES ON DRUG CONCENTRATION.............................................................................................................35 3.1 Introduction..................................................................................................................35 3.2 Study Design and Results of In Vitro Oral Fluid Volume Absorption (Part 1)...........35 3.3 Conclusions of In Vitro Oral Fluids Absorption (Part 1) ............................................36 3.4 Study Design and Results of In Vitro Drug Recovery (Part 2)....................................42 3.5 Conclusions of In Vitro Drug Absorption (Part 2) ......................................................43 3.6 Study Design and Results of In Vitro Drug Recovery (Part 3), Volume Corrected....49 3.7 Conclusions of In Vitro Drug Absorption (Part 3), Volume Corrected.......................51 4. REPORT OF SPECIMEN VALIDITY—IMMUNOGLOBULIN G (IgG) CONCENTRATION.............................................................................................................60 4.1 Introduction..................................................................................................................60 4.2 Study Design and Results ............................................................................................60 4.3 Conclusions..................................................................................................................61 5. REFERENCES .....................................................................................................................65 TABLES Table 1. Mean PK summary ...................................................................................................21 Table 2. Mean S/P ratios.........................................................................................................22 Table 3. Concentration comparisons by device ......................................................................28 Table 4. Duration of positive codeine detection by device.....................................................29 Table 5. Mean PK estimates ...................................................................................................29 Table 6. Codeine concentrations in saliva collected by the control method and the Orasure device with corresponding ratios of control/Orasure concentrations, n=2 subjects .....................................................................................32 Table 7. In vitro study data for Salivette from Sarstedt Company .........................................37 Table 8. In vitro study data for Intercept from STC Company...............................................38 Table 9. In vitro study data for ORALscreen from Avitar Company.....................................39 Table 10. In vitro study data for Finger Collector from Avitar Company................................40 Table 11. In vitro study data for Hooded Collector from Avitar Company..............................41 Table 12. Summary of amphetamine recovery .........................................................................44 ii This document is a research report submitted to the U.S. Department of Justice. This report has not been published by the Department. Opinions or points of view expressed are those of the author(s) and do not necessarily reflect the official position or policies of the U.S. Department of Justice. Table 13. Summary of methamphetamine recovery .................................................................45 Table 14. Summary of phenylcyclidene (PCP) recovery..........................................................46 Table 15. Summary of morphine recovery ...............................................................................47 Table 16. Summary of codeine recovery ..................................................................................48 Table 17. Summary of amphetamine recovery .........................................................................52 Table 18. Summary of methamphetamine recovery .................................................................53 Table 19. Summary of PCP recovery........................................................................................54 Table 20. Summary of morphine recovery ...............................................................................55 Table 21. Summary of codeine recovery ..................................................................................56 Table 22. Summary of cocaine recovery ..................................................................................57 Table 23. Summary of BZE recovery .......................................................................................58 Table 24. Summary of THC-COOH recovery..........................................................................59 Table 25. IgG concentrations (µg/mL) .....................................................................................62 Table 26. The effect of dilution on IgG concentration .............................................................63 Table 27. The effect of rinsing on IgG concentration...............................................................64 FIGURES Figure 1. Chromatogram of 5 ng/mL codeine..........................................................................19 Figure 2. Mean saliva and plasma codeine concentrations versus time...................................20 Figure 3. Saliva concentration versus plasma codeine concentrations ....................................23 Figure 4. Mean S/P ratio over time ..........................................................................................23 Figure 5. pH versus codeine concentration ..............................................................................24
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