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Oral Fluid Method Validation for Bowling Green State University

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Oral Fluid Method Validation for Bowling Green State University ORAL FLUID METHOD VALIDATION FOR BOWLING GREEN STATE UNIVERSITY Nathan Bunch A Thesis Submitted to the Graduate College of Bowling Green State University in partial fulfillment of the requirements for the degree of MASTER OF SCIENCE May 2020 Committee: Jon Sprague, Advisor Phillip Gibbs Travis Worst © 2020 Nathan Bunch All Rights Reserved iii ABSTRACT Jon Sprague, Advisor Oral fluid (OF) is rapidly becoming a new media for assisting law enforcement in determining if a subject is driving under the influence of drugs (DUID). Preliminary research shows that drugs can be identified in OF in conjunction with blood, and drug concentrations in OF and blood correlate. Despite availability of several roadside devices to test for drugs in OF, the roadside devices are considered a presumptive test. The results from these roadside tests must be confirmed with a validated liquid chromatography- mass spectrometer (LC-MS) instrumentation. A validated instrument for confirmation of OF results is important, and this study validates BGSU’s Shimadzu 8050 LC-MS. For validation, the instrument must pass various guidelines set by Scientific Working Group for Forensic Toxicology (SWGTOX) Standard Practices for Method Validation in Forensic Toxicology and others for accuracy, precision, linearity, Limit of Detection (LOD) and Limit of Quantitation (LOQ), carryover, interference, stability, and matrix effects. Due to the Covid-19 global pandemic, only accuracy, precision, linearity, and LOD and LOQ were accessed. The validation studies were conducted over five days (not consecutive) with two runs being conducted during each 24-hour period for a total of 10 runs. A total of 81 different analytes were accessed. The 81 analytes covered a broad range of drugs with abuse potential. The results of the validation study showed that the instrument is highly precise for the vast majority of analytes, but the cannabinoids, particularly delta-9-tetrahydrocannabinol (THC), were troublesome. Linearity for all analytes were accessed using the R^2 of the calibration curve, and all analytes were above the 0.95 limit. The LOD and LOQ study proved that the cutoff for each analyte is higher than the factor of 2 limit for cutoff/LOQ. The method proved to be an overwhelming success for all analytes. iv Dedicated to my family, Trevor Bunch, Patricia Bunch, James Bunch, and Emily Jones for providing me with structure and support throughout my life, and to all my friends, mentors, and teachers who have helped and guided me along the way. v ACKNOWLEDGMENTS When I started as a young 18-year-old college student in the fall of 2013, I had no idea what I wanted to do with my life. It’s an unusually vulnerable position that many students encounter. I bounced around several majors and two universities before finally landing on Forensic Science at BGSU. Having a great support structure of family, friends, and mentors kept me on the right track towards success. First and foremost, I would like to thank Dr. Jon Sprague. Dr. Sprague is a family friend and to have him double as a mentor is extremely fortunate. It was his insight into the world of forensics and pharmacology that really pushed me towards majoring in forensic science at BGSU, and eventually a Master of Science in forensic science at BGSU. Dr. Sprague exemplifies excellence, is confidently humble, and has truly taught me that actions speak louder than words. Next, I would like to thank the entire Sprague family for a lifetime of support and friendship. I am eternally grateful to have known their family throughout my life. During the last semester of my undergraduate career, I was taking a Monday night class and a class early Tuesday morning. I was living at home during this time, which was a 40-minute drive from BGSU. The Sprague family graciously invited me to stay at their home in Bowling Green on Monday nights after my night class. I will never forget this kind gesture and I cannot thank them enough. I would like to thank Dr. Travis Worst for being a great mentor and role model for my forensic science career at BGSU. Dr. Worst is someone who can keep a conversation with anyone. He is always thinking about how to improve his students’ life. I truly appreciate his commitment to me and my well-being as a student and more so, as a person. I am grateful to have gotten to know Dr. Worst. vi I would like to thank Dr. Phillip Gibbs for being another great mentor in my life. Almost all of the knowledge I have gained about chromatography and mass spectrometry is due to Dr. Gibbs’ teaching and mentorship. He is willing to explain and teach about the instrumentation whenever possible, and best of all, he really cares if you learn it. There is no way I would have been able to complete this project without him. I would like to thank Mrs. M. Michele Nagel. She is a blessing for anyone working in the forensic science department. This project would not have been possible without her. I would like to thank Dr. Crystal Oechsle for teaching me how to read and understand scientific articles. Her help made this research much easier. Lastly, I would like to thank my research partner, Ms. Latisha Pipes. We became de facto research partners due to the nature of the studies we were working on. While we tend to be polar opposites, I would not have chosen anyone else. I believe all good relationships require some conflict and I am very appreciative to have met Latisha. I cannot thank her enough for putting up with me for the past two years. Her hard work and endless effort have greatly influenced me to become a better student and researcher. I am notorious for not expressing the proper gratitude, so if I have not acknowledged anyone else that has helped me on this journey, I truly am sorry. Just know, that I am grateful for the sacrifices people have made to get me to where I am today. This gratitude extends to my family. Where they have made great sacrifices to raise me and help put me through college. I am a better person because of my family. Thank you. vii LIST OF ABBREVIATIONS OF: oral fluid DUID: driving under the influence of drugs DRE: drug recognition expert LC-MS: liquid chromatography mass spectrometry GC-MS: gas chromatography mass spectrometry SWGTOX: scientific working group for forensic toxicology LOD: limit of detection LOQ: limit of quantitation OMT: oral mucosal transudate OSHP: Ohio State Highway Patrol CO: cutoff HiQC: high quality control LoQC: low quality control NegQC: negative quality control SST (CO): system suitability test (cutoff) 30% (CO): 30% (cutoff) BGSU: Bowling Green State University EI: electron impact ionization TOF MS: time-of-flight mass spectrometry SIMS: secondary ion mass spectrometry NASA: National Aeronautics and Space Administration QMS: quadrupole mass spectrometer viii QIT: quadrupole ion trap CID: collision-induced dissociation CI: chemical ionization ESI: electrospray ionization IRMS: isotope ratio mass spectrometry MALDI: matrix-assisted laser desorption ionization ME: matrix effects CC: calibration curve QC: quality control %CV: coefficient variable RSS: residual sum of squares RS: residual sum 6-MAC: 6-monoacetylcodeiene 6-MAM: 6-monoacetylmorphine EDDP: 2-Ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine MDA: methylenedioxyamphetamine MDMA: methylenedioxymethamphetamine MDPV: methylenedioxypyrovalerone PCP: Phencyclidine THC: delta-9-tetrahydrocannabinol THC-COOH: 11-nor-9-carboxy-delta-9-tetrahydrocannabinol THC-OH: 11-hydroxy-delta-9-tetrahydrocannabinol ix TABLE OF CONTENTS Page CHAPTER I: INTRODUCTION AND BACKGROUND ................................................... 1 1.1 Current Methods for Drug Identification and Determination of Impaired Drivers ....................................................................................................... 1 1.2 Oral Fluid ............................................................................................................ 2 1.3 OF Collection Methods ....................................................................................... 3 1.4 Does OF Accurately Depict Blood Drug Concentrations? ................................. 4 1.5 Advantages and Disadvantages of Oral Fluid for Drug Analysis ....................... 5 1.6 Preliminary Results ............................................................................................. 6 1.7 Purpose ................................................................................................................ 9 1.8 Approach ............................................................................................................. 9 CHAPTER II: INSTRUMENTATION AND THEORY ..................................................... 11 2.1 Immunoassay ...................................................................................................... 11 2.2 Mass Spectrometer .............................................................................................. 12 2.2.1 History .............................................................................................................. 12 2.3 Liquid Chromatography and Gas Chromatography ............................................ 18 2.3.1 Liquid Chromatography- Tandem Mass Spectrometry .............................. 19 2.3.2 Gas Chromatography- Mass Spectrometry ................................................. 22 2.3.3 Liquid Chromatography- Tandem Mass Spectrometry vs Gas Chromatography-Mass Spectrometry .................................................................... 23 CHAPTER III: MATERIALS AND METHODS ...............................................................
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