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Qualitative method validation and uncertainty evaluation via the binary output: II - Application to a multi-analyte LC-MS/MS method for oral fluid

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Qualitative method validation and uncertainty evaluation via the binary output: II - Application to a multi-analyte LC-MS/MS method for oral fluid

Desharnais, Brigitte ORCID: https://orcid.org/0000-0001-7373-656X, Lajoie, Marie-Jo, Laquerre, Julie, Mireault, Pascal and Skinner, Cameron D. (2019) Qualitative method validation and uncertainty evaluation via the binary output: II - Application to a multi-analyte LC-MS/MS method for oral fluid. Journal of Analytical Toxicology . ISSN 0146-4760 (Submitted)

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Abstract

A study of impaired driving rates in the province of Québec is currently planned following the legalization of recreational cannabis in Canada. Oral fluid (OF) samples are to be collected with a Quantisal device and sent to the laboratory for analysis. In order to prepare for this project, a qualitative decision point analysis method monitoring for the presence of 97 drugs and metabolites in OF was validated according to the guidelines presented in the first part of this paper (I – Validation guidelines and statistical foundations).

This high throughput method uses incubation with a precipitation solvent (acetone:acetonitrile 30:70 v:v) to boost drug recovery from the collecting device and improve stability of benzodiazepines (e.g. α-hydroxyalprazolam, clonazepam, 7-aminoclonazepam, flunitrazepam, 7-aminoflunitrazepam, N-desmethylflunitrazepam, nitrazepam). The Quantisal device has polyglycol in its stabilizing buffer but timed use of the mass spectrometer waste valve proved sufficient to avoid the glycol interferences for nearly all analytes. Interferences from OF matrices and 140 potentially interfering compounds, carryover, ion ratios, stability, recovery, reproducibility, robustness, false positive rate, false negative rate, selectivity, sensitivity and reliability rates were tested in the validation process. Five of the targeted analytes (olanzapine, oxazepam, 7-aminoclonazepam, flunitrazepam and nitrazepam) did not meet the set validation criteria but will be monitored for identification purposes (no comparison to a cut-off level).

Blind internal proficiency teting was performed, where six OF samples were tested and analytes were classified as “negative”, “likely positive” or “positive” with success. The final validated OF qualitative decision point method covers 92 analytes, and the presence of 5 additional analytes is screened in this high hroughput analysis.

Divisions:Concordia University > Faculty of Arts and Science > Chemistry and Biochemistry
Item Type:Article
Refereed:No
Authors:Desharnais, Brigitte and Lajoie, Marie-Jo and Laquerre, Julie and Mireault, Pascal and Skinner, Cameron D.
Journal or Publication:Journal of Analytical Toxicology
Corporate Authors:Laboratoire de sciences judiciaires et de médecine légale, Department of Toxicology, 1701 Parthenais Street, Montréal, Québec, Canada H2K 3S7, Concordia University, Department of Chemistry & Biochemistry, 7141 Sherbrooke Street West, Montréal, Québec, Canada H4B 1R6
Date:19 June 2019
Projects:
  • Qualitative method validation guidelines
Funders:
  • National Sciences and Engineering Research Council of Canada
  • Fonds de recherche du Québec - Nature et technologies
Keywords:Qualitative decision point methods, oral fluid, saliva, Quantisal, liquid chromatography mass spectrometry, oral fluid, roadside survey
ID Code:985534
Deposited By: BRIGITTE DESHARNAIS
Deposited On:27 Jun 2019 14:24
Last Modified:27 Jun 2019 14:24

References:

[1] Borzelleca, JF and Cherrick, HM, The excretion of drugs in saliva. Antibiotics., Journal of Oral Therapeutics and Pharmacology 2 (1965) 180.
[2] Horning, Marjorie G and Brown, Linda and Nowlin, Jean and Lertratanangkoon, Khing and Kellaway, Peter and Zion, Tomas E, Use of saliva in therapeutic drug monitoring, Clinical Chemistry
23 (1977) 157–164.
[3] Drummer, Olaf H, Drug testing in oral fluid, Clinical Biochemist Reviews 27 (2006) 147.
[4] Quintela, Oscar and Crouch, Dennis J and Andrenyak, David M, Recovery of drugs of abuse from the Immunalysis Quantisal oral fluid collection device, Journal of Analytical Toxicology 30 (2006)
614–616.
[5] Tang, Magdalene HY and Ching, CK and Poon, Simon and Chan, Suzanne SS and Ng, WY and Lam, M and Wong, CK and Pao, Ronnie and Lau, Angus and Mak, Tony WL, Evaluation of three rapid oral fluid test devices on the screening of multiple drugs of abuse including ketamine, Forensic Science International 286 (2018) 113–120.
[6] Gröschl, Michael, Saliva: a reliable sample matrix in bioanalytics, Bioanalysis 9 (2017) 655–668.
[7] Vindenes, V and Yttredal, B and Øiestad, EL and Waal, H and Bernard, JP and Mørland, JG and Christophersen, AS, Oral fluid is a viable alternative for monitoring drug abuse: detection of drugs
in oral fluid by liquid chromatography-tandem mass spectrometry and comparison to the results from urine samples from patients treated with methadone or buprenorphine, Journal of Analytical
Toxicology 35 (2011) 32–39.
[8] Doyon, Alexandra and Paradis-Tanguay, Laurence and Crispino, Frank and Lajeunesse, André, Les analyses médico-légales de salives: expertise vis-à-vis l’analyse des drogues, Canadian Society of Forensic Science Journal 50 (2017) 90–102.
[9] Wille, Sarah MR and Di Fazio, Vincent and Toennes, Stefan W and van Wel, Janelle HP and Ramaekers, Johannes G and Samyn, Nele, Evaluation of Δ9-tetrahydrocannabinol detection using DrugWipe5S screening and oral fluid quantification after Quantisal collection for roadside drug detection via a controlled study with chronic cannabis users, Drug Testing and Analysis 7 (2015)
178–186.
[10] Cohier, Camille and Mégarbane, Bruno and Roussel, Olivier, Illicit drugs in oral fluid: Evaluation of two collection devices, Journal of Analytical Toxicology 41 (2017) 71–76.
[11] Krotulski, Alex J and Mohr, Amanda LA and Friscia, Melissa and Logan, Barry K, Field detection of drugs of abuse in oral fluid using the Alere DDS 2 mobile test system with confirmation by
liquid chromatography tandem mass spectrometry (LC–MS/MS), Journal of Analytical Toxicology 42 (2017) 170–176.
[12] S. M. Wille, V. Di Fazio, N. Samyn, La salive dans les investigations toxicologiques: considérations pratiques et analytiques, in: P. Kintz (Ed.), Traité De Toxicologie Médico-judiciaire, Elsevier Masson, Paris, 2012, pp. 219–255.
[13] Verstraete, Alain G, Oral fluid testing for driving under the influence of drugs: history, recent progress and remaining challenges, Forensic Science International 150 (2005) 143–150.
[14] Justice Canada, S.C. 2018, c. 16: Cannabis Act, Standard, https://lawslois.justice.gc.ca/eng/acts/C-24.5/, Ottawa, Canada, 2018.
[15] Parliament of Canada, S.C. 2018, c. 21: Bill C-46 – An Act to amend the Criminal Code (offences relating to conveyances) and to make consequential amendments to other Acts, Standard,
http://www.parl.ca/DocumentViewer/en/42-1/bill/C-46/royal-assent, Ottawa, Canada, 2018.
[16] Justice Canada, SOR/2018-179: Approved Drug Screening Equipment Order, Standard, https://laws-lois.justice.gc.ca/PDF/SOR-2018-179.pdf, Ottawa, Canada, 2018.
[17] Canadian Society of Forensic Science Drugs and Driving Committee, Drug Screening Equipment – Oral Fluid Standards and Evaluation Procedures, Standard, https://www.csfs.ca/wpcontent/
uploads/2017/11/Approval-Standards-for-Drug-Screening-Equipment.pdf, Ottawa, Canada, 2017.
[18] Justice Canada, Order Amending the Approved Drug Screening Equipment Order, Standard, http://www.gazette.gc.ca/rp-pr/p1/2019/2019-04-20/html/reg4-eng.html, Ottawa, Canada, 2019.
[19] Edwards, Lorrine D and Smith, Katherine L and Savage, Theodore, Drugged driving in Wisconsin: oral fluid versus blood, Journal of Analytical Toxicology 41 (2017) 523–529.
[20] Strano-Rossi, Sabina and Castrignano, Erika and Anzillotti, Luca and Serpelloni, Giovanni and Mollica, Roberto and Tagliaro, Franco and Pascali, Jennifer P and Di Stefano, Delfina and Sgalla,
Roberto and Chiarotti, Marcello, Evaluation of four oral fluid devices (DDS, Drugtest 5000, Drugwipe 5+ and RapidSTAT) for on-site monitoring drugged driving in comparison with UHPLC–MS/MS analysis, Forensic Science International 221 (2012) 70–76.
[21] Veitenheimer, Allison M and Wagner, Jarrad R, Evaluation of Oral Fluid as a Specimen for DUID, Journal of Analytical Toxicology 41 (2017) 517–522.
[22] Furuhaugen, Havard and Jamt, Ragnhild EG and Nilsson, Galina and Vindenes, Vigdis and Gjerde, Hallvard, Roadside survey of alcohol and drug use among Norwegian drivers in 2016–2017: A followup of the 2008–2009 survey, Traffic Injury Prevention 19 (2018) 555–562.
[23] Viel, Édith and Blais, Estelle and Mireault, Pascal, Statistical overview of drug findings in urine sample from the DRE program in the province of Qu´ebec, Canada, Standard, 2013 Society of
Forensic Toxicologists Meeting (SOFT), Orlando, USA, 2013.
[24] ISO/IEC 17025:2005, General requirements for the competence of testing and calibration laboratories, Standard, International Organization for Standardization, Geneva, Switzerland, 2005.
[25] ISO/IEC 17025:2017, General requirements for the competence of testing and calibration laboratories, Standard, International Organization for Standardization, Geneva, Switzerland, 2017.
[26] D. Menasco, C. Summit, J. Neifeld, S. Marin, L. Williams, E. Gairloch, Practical Considerations using Quantisal Oral Fluid Collection Devices & SPE Method Development by Polymeric Mixed- Mode Cation Exchange, Standard, Annual Congress in Clinical Mass Spectrometry, Palm Springs, USA, 2018.
[27] R. Gudihal, S. Babu CV, N. Tang, S. Palaniswamy, U. S, S. Basingi, Analysis of Polyethylene Glycol (PEG) and a Mono and Di-PEGylated Therapeutic Protein Using HPLC and Q-TOF Mass
Spectrometry, Standard, Agilent Technologies, 2012.
[28] Scientific Working Group for Forensic Toxicology, Scientific Working Group for Forensic Toxicology (SWGTOX) Standard Practices for Method Validation in Forensic Toxicology, Journal of Analytical Toxicology 37 (2013) 452–474.
[29] CAN-P-1578, Guidelines for the Accreditation of Forensic Testing Laboratories, Standard, Standards Council of Canada (Conseil canadien des normes), Ottawa, Canada, 2009.
[30] Côté, Cynthia and Desharnais, Brigitte and Morel, Marc-André and Laquerre, Julie and Taillon, Marie-Pierre and Daigneault, Gabrielle and Skinner, Cameron D and Mireault, Pascal, High
Throughput Protein Precipitation: Screening and Quantification of 106 Drugs and their Metabolites using LC-MS/MS, Standard, 2017 Society of Forensic Toxicologists Meeting (SOFT) and 55th
Annual Meeting of the International Association of Forensic Toxicologists (TIAFT), Boca Raton, USA, 2018.
[31] Fabresse, Nicolas and Aouad, Hassan and Knapp, Adeline and Mayer, Charlotte and Etting, Isabelle and Larabi, Islam Amine and Alvarez, Jean-Claude, Development and validation of a liquid
chromatography-tandem mass spectrometry method for simultaneous detection of 10 illicit drugs in oral fluid collected with FLOQSwabs and application to real samples, Drug Testing and Analysis 11 (2019) 824–832.
[32] Leverence, Rachael and Avery, Michael J and Kavetskaia, Olga and Bi, Honggang and Hop, Cornelis ECA and Gusev, Arkady I, Signal suppression/enhancement in HPLC-ESI-MS/MS from
concomitant medications, Biomedical Chromatography 21 (2007) 1143–1150.
[33] Lee, Dayong and Milman, Garry and Barnes, Allan J and Goodwin, Robert S and Hirvonen, Jussi and Huestis, Marilyn A, Oral fluid cannabinoids in chronic, daily cannabis smokers during sustained, monitored abstinence, Clinical Chemistry 57 (2011) 1127–1136.
[34] Saar, Eva and Gerostamoulos, Dimitri and Drummer, Olaf H and Beyer, Jochen, Assessment of the stability of 30 antipsychotic drugs in stored blood specimens, Forensic Science International
215 (2012) 152–158.
[35] Mata, Dani C, Stability of 26 sedative hypnotics in six toxicological matrices at different storage conditions, Journal of Analytical Toxicology 40 (2016) 663–668.

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