Clinical Toxicology Testing
Drug testing determines the presence or absence of drugs and/or drug metabolites. Drug testing may be quantitative (particularly useful for therapeutic drug monitoring [TDM]) or qualitative to verify compliance with prescribed therapy or identify inappropriate drug use. Pharmacogenetic (PGx) testing may be performed to help explain an adverse drug reaction or to help guide selection of drugs for an individual patient. TDM can help to optimize the dose of a therapeutic drug and is complementary to PGx testing.
- Pain Management
- Newborn Drug Testing
- Germline Pharmacogenetics
- Therapeutic Drug Monitoring
- Videos
- References
PM Tab Group
NB Tab Group
GP Tab Group
TDM group
General Guidelines
Caudle KE, Thorn CF, Klein TE, Swen JJ, McLeod HL, Diasio RB, Schwab M. Clinical Pharmacogenetics Implementation Consortium guidelines for dihydropyrimidine dehydrogenase genotype and fluoropyrimidine dosing. Clin Pharmacol Ther. 2013; 94(6): 640-5. PubMed
Crews KR, Gaedigk A, Dunnenberger HM, Klein TE, Shen DD, Callaghan JT, Kharasch ED, Skaar TC, Clinical Pharmacogenetics Implementation Consortium. Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines for codeine therapy in the context of cytochrome P450 2D6 (CYP2D6) genotype. Clin Pharmacol Ther. 2012; 91(2): 321-6. PubMed
Dowell D, Haegerich T, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. March 18, 2016 / 65(1);1–49. Centers for Disease Control and Prevention. Atlanta, GA [Last updated Mar 2016; Accessed: Jan 2017]
General References
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Becquemont L, Alfirevic A, Amstutz U, Brauch H, Jacqz-Aigrain E, Laurent-Puig P, Molina MA, Niemi M, Schwab M, Somogyi AA, Thervet E, van der Zee AM, van Kuilenburg AB, van Schaik RH, Verstuyft C, Wadelius M, Daly AK. Practical recommendations for pharmacogenomics-based prescription: 2010 ESF-UB Conference on Pharmacogenetics and Pharmacogenomics. Pharmacogenomics. 2011; 12(1): 113-24. PubMed
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Cone EJ, Huestis MA. Interpretation of oral fluid tests for drugs of abuse. Ann N Y Acad Sci. 2007; 1098: 51-103. PubMed
Cone EJ, Zichterman A, Heltsley R, Black DL, Cawthon B, Robert T, Moser F, Caplan YH. Urine testing for norcodeine, norhydrocodone, and noroxycodone facilitates interpretation and reduces false negatives. Forensic Sci Int. 2010; 198(1-3): 58-61. PubMed
de Castro A, Jones HE, Johnson RE, Gray TR, Shakleya DM, Huestis MA. Methadone, cocaine, opiates, and metabolite disposition in umbilical cord and correlations to maternal methadone dose and neonatal outcomes Ther Drug Monit. 2011; 33(4): 443-52. PubMed
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Fonseca F, de la Torre R, Díaz L, Pastor A, Cuyàs E, Pizarro N, Khymenets O, Farré M, Torrens M. Contribution of cytochrome P450 and ABCB1 genetic variability on methadone pharmacokinetics, dose requirements, and response PLoS One. 2011; 6(5): e19527. PubMed
Gareri J, Klein J, Koren G. Drugs of abuse testing in meconium. Clin Chim Acta. 2006; 366(1-2): 101-11. PubMed
Gervasini G, Benítez J, Carrillo JA. Pharmacogenetic testing and therapeutic drug monitoring are complementary tools for optimal individualization of drug therapy. Eur J Clin Pharmacol. 2010; 66(8): 755-74. PubMed
Gutstein H, Akil H. Opioid Analgesics, Ch 18. In Hardman JG et al. Goodman and Gilman's The Pharmacological Basis of Therapeutics, 12th ed. New York: McGraw-Hill, 2010.
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Marcellus L. Is meconium screening appropriate for universal use? Science and ethics say no. Adv Neonatal Care. 2007; 7(4): 207-14. PubMed
Mauri MC, Volonteri LS, Colasanti A, Fiorentini A, De Gaspari IF, Bareggi SR. Clinical pharmacokinetics of atypical antipsychotics: a critical review of the relationship between plasma concentrations and clinical response. Clin Pharmacokinet. 2007; 46(5): 359-88. PubMed
McMillin GA, Wood KE, Strathmann FG, Krasowski MD. Patterns of Drugs and Drug Metabolites Observed in Meconium: What Do They Mean? Ther Drug Monit. 2015; 37(5): 568-80. PubMed
McMillin GA. Pharmacogenetics. Accepted, 2016 to Clarke W (Ed). Contemporary Practice in Clinical Chemistry , 3rd ed. American Association for Clinical Chemistry, 2016.
McMillin GA. Pharmacogenetics. In Bruns DE, Ashwood ER, Burtis CA. Tietz Fundamentals of Clinical Chemistry, 6th ed. St. Louis: WB Saunders, 2007.
McMillin GA. Pharmacogenetics. In Burtis CA and Bruns DE (Eds). Tietz Fundamentals of Clinical Chemistry and Molecular Diagnostics, 7th ed. St. Louis, MO: Elsevier Saunders, 2015.
McMillin GA. Pharmacogenetics. In Burtis CA, Ashwood EA, Bruns DE. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, 5th. St. Louis, MO: Elsevier Saunders, 2012.
Moeller KE, Lee KC, Kissack JC. Urine drug screening: practical guide for clinicians. Mayo Clin Proc. 2008; 83(1): 66-76. PubMed
Moller M, Gareri J, Koren G. A review of substance abuse monitoring in a social services context: a primer for child protection workers Can J Clin Pharmacol. 2010; 17(1): e177-93. PubMed
Moyer T, McMillin G. Therapeutic Drugs. In Burtis CA, Ashwood ER and Burns DE. Tietz Fundamentals of Clinical Chemistry, 6th ed. MO: Saunders/Elsevier, 2008.
Moyer T, Shaw L. Therapeutic drugs and their management. In Burtis CA, Ashwood ER and Burns DE. Clinical Chemistry & Molecular Diagnositcs, 4th ed. Philadelphia: WB Saunders, 2005.
Murray M. Role of CYP pharmacogenetics and drug-drug interactions in the efficacy and safety of atypical and other antipsychotic agents. J Pharm Pharmacol. 2006; 58(7): 871-85. PubMed
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Pragst F, Balikova MA. State of the art in hair analysis for detection of drug and alcohol abuse. Clin Chim Acta. 2006; 370(1-2): 17-49. PubMed
Rayburn WF. Maternal and fetal effects from substance use. Clin Perinatol. 2007; 34(4): 559-71, vi. PubMed
Riedel M, Musil R, Seemüller F, Spellmann I, Möller H, Schennach-Wolff R. Safety evaluation of zotepine for the treatment of schizophrenia. Expert Opin Drug Saf. 2010; 9(4): 659-66. PubMed
Samer CF, Daali Y, Wagner M, Hopfgartner G, Eap CB, Rebsamen MC, Rossier MF, Hochstrasser D, Dayer P, Desmeules JA. Genetic polymorphisms and drug interactions modulating CYP2D6 and CYP3A activities have a major effect on oxycodone analgesic efficacy and safety Br J Pharmacol. 2010; 160(4): 919-30. PubMed
Schultz SH, North SW, Shields CG. Schizophrenia: a review. Am Fam Physician. 2007; 75(12): 1821-9. PubMed
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Tobin DG, Andrews R, Becker WC. Prescribing opioids in primary care: Safely starting, monitoring, and stopping. Cleve Clin J Med. 2016; 83(3): 207-15. PubMed
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References from the ARUP Institute for Clinical and Experimental Pathology
Barakauskas VE, Davis R, Krasowski MD, McMillin GA. Unresolved discrepancies between cannabinoid test results for infant urine. Clin Chem. 2012; 58(9): 1364-7. PubMed
Borgman MP, Pendleton RC, McMillin GA, Reynolds KK, Vazquez S, Freeman A, Wilson A, Valdes R, Linder MW. Prospective pilot trial of PerMIT versus standard anticoagulation service management of patients initiating oral anticoagulation. Thromb Haemost. 2012; 108(3): 561-9. PubMed
Caravati M, Juenke JM, Crouch BI, Anderson KT. Quetiapine cross-reactivity with plasma tricyclic antidepressant immunoassays. Ann Pharmacother. 2005; 39(9): 1446-9. PubMed
Chittamma A, Marin SJ, Williams JA, Clark C, McMillin GA. Detection of in utero marijuana exposure by GC-MS, ultra-sensitive ELISA and LC-TOF-MS using umbilical cord tissue. J Anal Toxicol. 2013; 37(7): 391-4. PubMed
Coles R, Clements TT, Nelson GJ, McMillin GA, Urry FM. Simultaneous analysis of the Delta9-THC metabolites 11-nor-9-carboxy-Delta9-THC and 11-hydroxy-Delta9-THC in meconium by GC-MS. J Anal Toxicol. 2005; 29(6): 522-7. PubMed
Coles R, Kushnir MM, Nelson GJ, McMillin GA, Urry FM. Simultaneous determination of codeine, morphine, hydrocodone, hydromorphone, oxycodone, and 6-acetylmorphine in urine, serum, plasma, whole blood, and meconium by LC-MS-MS. J Anal Toxicol. 2007; 31(1): 1-14. PubMed
Dasgupta A, Davis B, Slawson MH, Johnson-Davis KL. Effect of Carbamazepine 10, 11-Epoxide on Serum Carbamazepine Measurement Using a New CMIA Assay: Comparison of Values Obtained by Using PETINIA, CEDIA and Liquid Chromatography Combined with Tandem Mass Spectrometry. Ann Clin Lab Sci. 2016; 46(3): 242-6. PubMed
Dasgupta A, Khalil SA, Johnson-Davis KL. Analytical Performance Evaluation of a New Cobas Tacrolimus Assay on Cobas e411 Analyzer: Comparison of Values Obtained by the CMIA Tacrolimus Assay and a Liquid Chromatography Combined with Tandem Mass Spectrometric Method. Ann Clin Lab Sci. 2016; 46(2): 204-8. PubMed
Horne BD, Lenzini PA, Wadelius M, Jorgensen AL, Kimmel SE, Ridker PM, Eriksson N, Anderson JL, Pirmohamed M, Limdi NA, Pendleton RC, McMillin GA, Burmester JK, Kurnik D, Stein M, Caldwell MD, Eby CS, Rane A, Lindh JD, Shin J, Kim H, Angchaisuksiri P, Glynn RJ, Kronquist KE, Carlquist JF, Grice GR, Barrack RL, Li J, Gage BF. Pharmacogenetic warfarin dose refinements remain significantly influenced by genetic factors after one week of therapy. Thromb Haemost. 2012; 107(2): 232-40. PubMed
Johnson-Davis KL, Sadler AJ, Genzen JR. A Retrospective Analysis of Urine Drugs of Abuse Immunoassay True Positive Rates at a National Reference Laboratory. J Anal Toxicol. 2016; 40(2): 97-107. PubMed
Johnson-Davis KL, Slawson MH. Ethyl Glucuronide Positivity Rate in a Pain Management Population J Anal Toxicol. 2015; 39(9): 686-90. PubMed
Johnson-Davis KL, Thompson CD, Clark CJ, McMillin GA, Lehman CM. Method comparison of the Ortho Vitros Fusion 5,1 chemistry analyzer and the Roche COBAS Integra 400 for urine drug screen testing in the emergency department. J Anal Toxicol. 2012; 36(5): 345-8. PubMed
Juenke JM, Brown PI, Urry FM, Johnson-Davis KL, McMillin GA. Simultaneous UPLC-MS/MS assay for the detection of the traditional antipsychotics haloperidol, fluphenazine, perphenazine, and thiothixene in serum and plasma. Clin Chim Acta. 2013; 423: 32-4. PubMed
Kalman LV, Agúndez J, Appell L, Black JL, Bell GC, Boukouvala S, Bruckner C, Bruford E, Caudle K, Coulthard SA, Daly AK, Del Tredici A, Dunnen JT, Drozda K, Everts RE, Flockhart D, Freimuth RR, Gaedigk A, Hachad H, Hartshorne T, Ingelman-Sundberg M, Klein TE, Lauschke VM, Maglott DR, McLeod HL, McMillin GA, Meyer UA, Müller DJ, Nickerson DA, Oetting WS, Pacanowski M, Pratt VM, Relling MV, Roberts A, Rubinstein WS, Sangkuhl K, Schwab M, Scott SA, Sim SC, Thirumaran RK, Toji LH, Tyndale RF, van Schaik R, Whirl-Carrillo M, Yeo K, Zanger UM. Pharmacogenetic allele nomenclature: International workgroup recommendations for test result reporting Clin Pharmacol Ther. 2016; 99(2): 172-85. PubMed
Lee CC, McMillin GA, Babic N, Melis R, Yeo KJ. Evaluation of a CYP2C19 genotype panel on the GenMark eSensor® platform and the comparison to the Autogenomics Infiniti™ and Luminex CYP2C19 panels Clin Chim Acta. 2011; 412(11-12): 1133-7. PubMed
Lin C, Nelson GJ, McMillin GA. Evaluation of the NexScreen and DrugCheck Waive RT urine drug detection cups. J Anal Toxicol. 2013; 37(1): 30-6. PubMed
Lin C, Strathmann FG. Elevated urine zinc concentration reduces the detection of methamphetamine, cocaine, THC and opiates in urine by EMIT. J Anal Toxicol. 2013; 37(9): 665-9. PubMed
Marin SJ, Christensen RD, Baer VL, Clark CJ, McMillin GA. Nicotine and metabolites in paired umbilical cord tissue and meconium specimens. Ther Drug Monit. 2011; 33(1): 80-5. PubMed
Marin SJ, Coles R, Merrell M, McMillin GA. Quantitation of benzodiazepines in urine, serum, plasma, and meconium by LC-MS-MS. J Anal Toxicol. 2008; 32(7): 491-8. PubMed
Marin SJ, Coles R, Urry FM, McMillin GA. Confirmation of cannabinoids in meconium using two-dimensional gas chromatography with mass spectrometry detection. J Chromatogr B Analyt Technol Biomed Life Sci. 2007; 858(1-2): 59-64. PubMed
Marin SJ, Doyle K, Chang A, Concheiro-Guisan M, Huestis MA, Johnson-Davis KL. One Hundred False-Positive Amphetamine Specimens Characterized by Liquid Chromatography Time-of-Flight Mass Spectrometry. J Anal Toxicol. 2016; 40(1): 37-42. PubMed
Marin SJ, Hughes JM, Lawlor BG, Clark CJ, McMillin GA. Rapid screening for 67 drugs and metabolites in serum or plasma by accurate-mass LC-TOF-MS. J Anal Toxicol. 2012; 36(7): 477-86. PubMed
Marin SJ, Keith L, Merrell M, McMillin GA. Comparison of drugs of abuse detection in meconium by EMIT II and ELISA. J Anal Toxicol. 2009; 33(3): 148-54. PubMed
Marin SJ, Keith L, Merrell M, McMillin GA. Evaluation of a new ELISA kit for the detection of benzodiazepines in meconium. J Anal Toxicol. 2009; 33(3): 177-81. PubMed
Marin SJ, McMillin GA. Quantitation of Buprenorphine, Norbuprenorphine, Buprenorphine Glucuronide, Norbuprenorphine Glucuronide, and Naloxone in Urine by LC-MS/MS. Methods Mol Biol. 2016; 1383: 69-78. PubMed
Marin SJ, McMillin GA. Quantitation of Total Buprenorphine and Norbuprenorphine in Meconium by LC-MS/MS. Methods Mol Biol. 2016; 1383: 59-68. PubMed
Marin SJ, Moore C, McMillin GA. Cross-reactivity of phentermine with an immunoassay designed to detect amphetamine in a meconium specimen. Clin Chem. 2009; 55(3): 589-90. PubMed
Marin SJ, Roberts M, Wood M, McMillin GA. Sensitive UPLC-MS-MS assay for 21 benzodiazepine drugs and metabolites, zolpidem and zopiclone in serum or plasma. J Anal Toxicol. 2012; 36(7): 472-6. PubMed
Marin SJ, Sawyer JC, He X, Johnson-Davis KL. Comparison of drug detection by three quadrupole time-of-flight mass spectrometry platforms J Anal Toxicol. 2015; 39(2): 89-95. PubMed
McMillin GA, Davis R, Carlisle H, Clark C, Marin SJ, Moody DE. Patterns of free (unconjugated) buprenorphine, norbuprenorphine, and their glucuronides in urine using liquid chromatography-tandem mass spectrometry. J Anal Toxicol. 2012; 36(2): 81-7. PubMed
McMillin GA, Marin SJ, Johnson-Davis KL, Lawlor BG, Strathmann FG. A hybrid approach to urine drug testing using high-resolution mass spectrometry and select immunoassays Am J Clin Pathol. 2015; 143(2): 234-40. PubMed
McMillin GA, Slawson MH, Marin SJ, Johnson-Davis KL. Demystifying analytical approaches for urine drug testing to evaluate medication adherence in chronic pain management. J Pain Palliat Care Pharmacother. 2013; 27(4): 322-39. PubMed
McMillin GA, Vazquez SR, Pendleton RC. Current challenges in personalizing warfarin therapy. Expert Rev Clin Pharmacol. 2011; 4(3): 349-62. PubMed
Melis R, Fauron C, McMillin G, Lyon E, Shirts B, Hubley LM, Slev PR. Simultaneous genotyping of rs12979860 and rs8099917 variants near the IL28B locus associated with HCV clearance and treatment response. J Mol Diagn. 2011; 13(4): 446-51. PubMed
Melis R, Lewis T, Millson A, Lyon E, McMillin GA, Slev PR, Swensen J. Copy number variation and incomplete linkage disequilibrium interfere with the HCP5 genotyping assay for abacavir hypersensitivity. Genet Test Mol Biomarkers. 2012; 16(9): 1111-4. PubMed
Powers JL, Buys SS, Fletcher D, Melis R, Johnson-Davis K, Lyon E, Malmberg EM, McMillin GA. Multi-gene and Drug Interaction Approach for Tamoxifen Metabolite Patterns Reveals Possible Involvement of CYP2C9, CYP2C19 and ABCB1 J Clin Pharmacol. 2016; PubMed
Profaizer T, Eckels D. HLA alleles and drug hypersensitivity reactions. Int J Immunogenet. 2012; 39(2): 99-105. PubMed
Rule GS, Rockwood AL, Johnson-Davis KL. Quantitation of Teriflunomide in Human Serum/Plasma Across a 40,000-Fold Concentration Range by LC/MS/MS. Methods Mol Biol. 2016; 1383: 195-203. PubMed
Slawson MH, Johnson-Davis KL. Quantitation of Carisoprodol and Meprobamate in Urine and Plasma Using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS). Methods Mol Biol. 2016; 1383: 105-14. PubMed
Slawson MH, Johnson-Davis KL. Quantitation of Ethyl Glucuronide and Ethyl Sulfate in Urine Using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS). Methods Mol Biol. 2016; 1383: 167-75. PubMed
Slawson MH, Johnson-Davis KL. Quantitation of Flecainide, Mexiletine, Propafenone, and Amiodarone in Serum or Plasma Using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS). Methods Mol Biol. 2016; 1383: 11-9. PubMed
Slawson MH, Johnson-Davis KL. Quantitation of Haloperidol, Fluphenazine, Perphenazine, and Thiothixene in Serum or Plasma Using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS). Methods Mol Biol. 2016; 1383: 49-57. PubMed
Ward MB, Hackenmueller SA, Strathmann FG, Education Committee of the Academy of Clinical Laboratory Physicians and Scientists. Pathology consultation on urine compliance testing and drug abuse screening. Am J Clin Pathol. 2014; 142(5): 586-93. PubMed
Whittington JE, Pham HD, Procter M, Grenache DG, Mao R. A patient with prolonged paralysis. Clin Chem. 2012; 58(3): 496-500. PubMed
Wood KE, Krasowski MD, Strathmann FG, McMillin GA. Meconium drug testing in multiple births in the USA. J Anal Toxicol. 2014; 38(7): 397-403. PubMed
Wood KE, Sinclair LL, Rysgaard CD, Strathmann FG, McMillin GA, Krasowski MD. Retrospective analysis of the diagnostic yield of newborn drug testing. BMC Pregnancy Childbirth. 2014; 14: 250. PubMed
Medical Reviewers
Last Update: July 2017