Testing the test strips: laboratory performance of fentanyl test strips.

Drug checking Fentanyl test strips Harm reduction Opioids Overdose Substance use

Journal

Harm reduction journal
ISSN: 1477-7517
Titre abrégé: Harm Reduct J
Pays: England
ID NLM: 101153624

Informations de publication

Date de publication:
18 Jan 2024
Historique:
received: 21 04 2023
accepted: 26 12 2023
medline: 19 1 2024
pubmed: 19 1 2024
entrez: 18 1 2024
Statut: epublish

Résumé

The overdose crisis driven by synthetic opioids continues to escalate in the USA. We evaluated the efficacy of multiple manufacturing lots of a fentanyl test strip (FTS) to detect fentanyl and fentanyl analogs and assessed cross-reactivity with possible interferences. Drug standards were dissolved in water in a laboratory setting and serially diluted. Drug dilutions were tested using five different manufacturing lots of BTNX Rapid Response (20 ng/mL cutoff) lateral flow chromatographic immunoassay strips to assess lot-to-lot variability for FTS sensitivity and cross-reactivity for the analytes of interest. All five manufacturing lots cross-reacted with fentanyl and eleven fentanyl analogs. Diphenhydramine, lidocaine, MDMA, and methamphetamine were found to cause false positives with the strips. There was notable lot-to-lot variability in the sensitivity of the strips for fentanyl, fentanyl analogs, and known interferences. FTS remains an important overdose prevention tool, but lot-to-lot variability in performance complicates robust instructions that balance the prevention of false positives and false negatives. Continued lot-to-lot performance assessment is recommended to ensure health education for FTS remains accurate. More sophisticated drug checking technologies and services are needed in the community landscape to augment personal FTS use to facilitate informed consumption and overdose risk mitigation.

Sections du résumé

BACKGROUND BACKGROUND
The overdose crisis driven by synthetic opioids continues to escalate in the USA. We evaluated the efficacy of multiple manufacturing lots of a fentanyl test strip (FTS) to detect fentanyl and fentanyl analogs and assessed cross-reactivity with possible interferences.
METHODS METHODS
Drug standards were dissolved in water in a laboratory setting and serially diluted. Drug dilutions were tested using five different manufacturing lots of BTNX Rapid Response (20 ng/mL cutoff) lateral flow chromatographic immunoassay strips to assess lot-to-lot variability for FTS sensitivity and cross-reactivity for the analytes of interest.
RESULTS RESULTS
All five manufacturing lots cross-reacted with fentanyl and eleven fentanyl analogs. Diphenhydramine, lidocaine, MDMA, and methamphetamine were found to cause false positives with the strips. There was notable lot-to-lot variability in the sensitivity of the strips for fentanyl, fentanyl analogs, and known interferences.
DISCUSSION CONCLUSIONS
FTS remains an important overdose prevention tool, but lot-to-lot variability in performance complicates robust instructions that balance the prevention of false positives and false negatives. Continued lot-to-lot performance assessment is recommended to ensure health education for FTS remains accurate. More sophisticated drug checking technologies and services are needed in the community landscape to augment personal FTS use to facilitate informed consumption and overdose risk mitigation.

Identifiants

pubmed: 38238757
doi: 10.1186/s12954-023-00921-8
pii: 10.1186/s12954-023-00921-8
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

14

Subventions

Organisme : NIH HHS
ID : DA037820
Pays : United States
Organisme : NIDA NIH HHS
ID : DA054190
Pays : United States

Informations de copyright

© 2024. The Author(s).

Références

Ciccarone D. The triple wave epidemic: supply and demand drivers of the US opioid overdose crisis. Int J Drug Policy. 2019;1(71):183–8.
doi: 10.1016/j.drugpo.2019.01.010
Spencer MR, Miniño AM, Warner M. Drug overdose deaths in the United States, 2001–2021. NCHS Data Brief No 457 Natl Cent Health Stat. 2022; 457.
Diversion Control Division. National Forensic Laboratory Information System: NFLIS-Drug 2021 Annual Report. US Department of Justice, US Drug Enforcement Administration; 2022.
Gladden RM, Martinez P, Seth P. Fentanyl law enforcement submissions and increases in synthetic opioid-involved overdose deaths–27 states, 2013–2014. MMWR Morb Mortal Wkly Rep. 2016;65(33):837–43.
pubmed: 27560775 doi: 10.15585/mmwr.mm6533a2
O’Donnell JK, Halpin J, Mattson CL, Goldberger BA, Gladden RM. Deaths involving fentanyl, fentanyl analogs, and U-47700–10 States, July–December 2016. MMWR Morb Mortal Wkly Rep. 2017;66(43):1197–202.
pubmed: 29095804 pmcid: 5689219 doi: 10.15585/mmwr.mm6643e1
O’Donnell JK, Gladden RM, Seth P. Trends in deaths involving heroin and synthetic opioids excluding methadone, and law enforcement drug product reports, by census region-United States, 2006–2015. MMWR Morb Mortal Wkly Rep. 2017;66(34):897–903.
pubmed: 28859052 pmcid: 5657786 doi: 10.15585/mmwr.mm6634a2
Unick GJ, Ciccarone D. US regional and demographic differences in prescription opioid and heroin-related overdose hospitalizations. Int J Drug Policy. 2017;1(46):112–9.
doi: 10.1016/j.drugpo.2017.06.003
Shover CL, Falasinnu TO, Dwyer CL, Santos NB, Cunningham NJ, Freedman RB, et al. Steep increases in fentanyl-related mortality west of the Mississippi River: recent evidence from county and state surveillance. Drug Alcohol Depend. 2020;1(216): 108314.
doi: 10.1016/j.drugalcdep.2020.108314
O’Donnell J. Notes from the field: opioid-involved overdose deaths with fentanyl or fentanyl analogs detected—28 states and the District of Columbia, July 2016–December 2018. MMWR Morb Mortal Wkly Rep. 2020; 69. https://www.cdc.gov/mmwr/volumes/69/wr/mm6910a4.htm
Special testing and Research Laboratory. Drug Enforcement Administration Emerging Threat Report Mid-Year 2021. Drug Enforcement Administration; 2022.
Mojica MA, Carter MD, Isenberg SL, Pirkle JL, Hamelin EI, Shaner RL, et al. Designing traceable opioid material§ kits to improve laboratory testing during the U.S. opioid overdose crisis. Toxicol Lett. 2019;317:53–8.
pubmed: 31560942 pmcid: 6855243 doi: 10.1016/j.toxlet.2019.09.017
Zhang Y, Halifax JC, Tangsombatvisit C, Yun C, Pang S, Hooshfar S, et al. Development and application of a High-Resolution mass spectrometry method for the detection of fentanyl analogs in urine and serum. J Mass Spectrom Adv Clin Lab. 2022; https://www.sciencedirect.com/science/article/pii/S2667145X22000232
Ciccarone D. Fentanyl in the US heroin supply: a rapidly changing risk environment. Int J Drug Policy. 2017;46:107–11.
pubmed: 28735776 pmcid: 5742018 doi: 10.1016/j.drugpo.2017.06.010
Armenian P, Vo KT, Barr-Walker J, Lynch KL. Fentanyl, fentanyl analogs and novel synthetic opioids: a comprehensive review. Neuropharmacology. 2018;134:121–32.
pubmed: 29042317 doi: 10.1016/j.neuropharm.2017.10.016
Suzuki J, El-Haddad S. A review: fentanyl and non-pharmaceutical fentanyls. Drug Alcohol Depend. 2017;1(171):107–16.
doi: 10.1016/j.drugalcdep.2016.11.033
Ciccarone D, Ondocsin J, Mars SG. Heroin uncertainties: exploring users’ perceptions of fentanyl-adulterated and -substituted ‘heroin.’ Int J Drug Policy. 2017;1(46):146–55.
doi: 10.1016/j.drugpo.2017.06.004
Carroll JJ, Marshall BDL, Rich JD, Green TC. Exposure to fentanyl-contaminated heroin and overdose risk among illicit opioid users in Rhode Island: a mixed methods study. Int J Drug Policy. 2017;1(46):136–45.
doi: 10.1016/j.drugpo.2017.05.023
McKnight C, Des Jarlais DC. Being “hooked up” during a sharp increase in the availability of illicitly manufactured fentanyl: adaptations of drug using practices among people who use drugs (PWUD) in New York City. Int J Drug Policy. 2018;1(60):82–8.
doi: 10.1016/j.drugpo.2018.08.004
Kral AH, Lambdin BH, Browne EN, Wenger LD, Bluthenthal RN, Zibbell JE, et al. Transition from injecting opioids to smoking fentanyl in San Francisco, California. Drug Alcohol Depend. 2021;1(227): 109003.
doi: 10.1016/j.drugalcdep.2021.109003
Lambdin BH, Bluthenthal RN, Zibbell JE, Wenger L, Simpson K, Kral AH. Associations between perceived illicit fentanyl use and infectious disease risks among people who inject drugs. Int J Drug Policy. 2019;1(74):299–304.
doi: 10.1016/j.drugpo.2019.10.004
Kandel DB, Hu MC, Griesler P, Wall M. Increases from 2002 to 2015 in prescription opioid overdose deaths in combination with other substances. Drug Alcohol Depend. 2017;1(178):501–11.
doi: 10.1016/j.drugalcdep.2017.05.047
McCall Jones C, Baldwin GT, Compton WM. Recent increases in cocaine-related overdose deaths and the role of opioids. Am J Public Health. 2017;107(3):430–2.
pubmed: 28177817 pmcid: 5296707 doi: 10.2105/AJPH.2016.303627
Palamar JJ, Ciccarone D, Rutherford C, Keyes KM, Carr TH, Cottler LB. Trends in seizures of powders and pills containing illicit fentanyl in the United States, 2018 through 2021. Drug Alcohol Depend. 2022;234: 109398.
pubmed: 35370014 pmcid: 9027012 doi: 10.1016/j.drugalcdep.2022.109398
Twillman RK, Dawson E, LaRue L, Guevara MG, Whitley P, Huskey A. Evaluation of trends of near-real-time urine drug test results for methamphetamine, cocaine, heroin, and fentanyl. JAMA Netw Open. 2020;3(1): e1918514.
pubmed: 31899527 pmcid: 6991312 doi: 10.1001/jamanetworkopen.2019.18514
Nolan ML, Shamasunder S, Colon-Berezin C, Kunins HV, Paone D. Increased presence of fentanyl in cocaine-involved fatal overdoses: implications for prevention. J Urban Health. 2019;96(1):49–54.
pubmed: 30635841 pmcid: 6391300 doi: 10.1007/s11524-018-00343-z
Brunt T. Drug Checking as a Harm Reduction Tool for Recreational Drug Users: Opportunities and Challenges. European Monitoring Centre for Drugs and Drug Addiction; 2017.
Caudevilla F, Ventura M, Fornís I, Barratt MJ, Vidal C, lladanosa CG, et al. Results of an international drug testing service for cryptomarket users. Int J Drug Policy. 2016;35:38–41.
pubmed: 27239011 doi: 10.1016/j.drugpo.2016.04.017
Harper L, Powell J, Pijl EM. An overview of forensic drug testing methods and their suitability for harm reduction point-of-care services. Harm Reduct J. 2017 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5537996/
Hondebrink L, Nugteren-van Lonkhuyzen JJ, Van Der Gouwe D, Brunt TM. Monitoring new psychoactive substances (NPS) in The Netherlands: data from the drug market and the Poisons Information Centre. Drug Alcohol Depend. 2015;147:109–15.
pubmed: 25541244 doi: 10.1016/j.drugalcdep.2014.11.033
Fairbairn N, Coffin PO, Walley AY. Naloxone for heroin, prescription opioid, and illicitly made fentanyl overdoses: challenges and innovations responding to a dynamic epidemic. Int J Drug Policy. 2017;1(46):172–9.
doi: 10.1016/j.drugpo.2017.06.005
Gilbert M, Dasgupta N. Silicon to syringe: cryptomarkets and disruptive innovation in opioid supply chains. Int J Drug Policy. 2017;1(46):160–7.
doi: 10.1016/j.drugpo.2017.05.052
McGowan CR, Harris M, Platt L, Hope V, Rhodes T. Fentanyl self-testing outside supervised injection settings to prevent opioid overdose: do we know enough to promote it? Int J Drug Policy. 2018;1(58):31–6.
doi: 10.1016/j.drugpo.2018.04.017
Socías ME, Wood E. Epidemic of deaths from fentanyl overdose. BMJ. 2017;28(358): j4355.
doi: 10.1136/bmj.j4355
Krieger MS, Yedinak JL, Buxton JA, Lysyshyn M, Bernstein E, Rich JD, et al. High willingness to use rapid fentanyl test strips among young adults who use drugs. Harm Reduct J. 2018;15(1):7.
pubmed: 29422052 pmcid: 5806485 doi: 10.1186/s12954-018-0213-2
Sherman SG, Morales KB, Park JN, McKenzie M, Marshall BDL, Green TC. Acceptability of implementing community-based drug checking services for people who use drugs in three United States cities: baltimore, Boston and Providence. Int J Drug Policy. 2019;1(68):46–53.
doi: 10.1016/j.drugpo.2019.03.003
Goldman JE, Waye KM, Periera KA, Krieger MS, Yedinak JL, Marshall BDL. Perspectives on rapid fentanyl test strips as a harm reduction practice among young adults who use drugs: a qualitative study. Harm Reduct J. 2019;16(1):3.
pubmed: 30621699 pmcid: 6325714 doi: 10.1186/s12954-018-0276-0
Peiper NC, Clarke SD, Vincent LB, Ciccarone D, Kral AH, Zibbell JE. Fentanyl test strips as an opioid overdose prevention strategy: findings from a syringe services program in the Southeastern United States. Int J Drug Policy. 2019;63:122–8.
pubmed: 30292493 doi: 10.1016/j.drugpo.2018.08.007
Park JN, Frankel S, Morris M, Dieni O, Fahey-Morrison L, Luta M, et al. Evaluation of fentanyl test strip distribution in two Mid-Atlantic syringe services programs. Int J Drug Policy. 2021;1(94): 103196.
doi: 10.1016/j.drugpo.2021.103196
Weicker NP, Owczarzak J, Urquhart G, Park JN, Rouhani S, Ling R, et al. Agency in the fentanyl era: exploring the utility of fentanyl test strips in an opaque drug market. Int J Drug Policy. 2020;84: 102900.
pubmed: 32769054 doi: 10.1016/j.drugpo.2020.102900
Maghsoudi N, Tanguay J, Scarfone K, Rammohan I, Ziegler C, Werb D, et al. Drug checking services for people who use drugs: a systematic review. Addiction. 2022;117(3):532–44.
pubmed: 34729849 doi: 10.1111/add.15734
Park JN, Sherman SG, Sigmund V, Breaud A, Martin K, Clarke WA. Validation of a lateral flow chromatographic immunoassay for the detection of fentanyl in drug samples. Drug Alcohol Depend. 2022;1(240): 109610.
doi: 10.1016/j.drugalcdep.2022.109610
BTNX INC. BTNX INC. Fentanyl Strips for Harm Reduction Use. 2022 [cited 2022 Jan 4]. BTNX INC. Fentanyl strips for harm reduction use. https://www.btnx.com/files/BTNX_Fentanyl_Strips_Harm_Reduction_Brochure.PDF
Green TC, Park JN, Gilbert M, McKenzie M, Struth E, Lucas R, et al. An assessment of the limits of detection, sensitivity and specificity of three devices for public health-based drug checking of fentanyl in street-acquired samples. Int J Drug Policy. 2020;1(77): 102661.
doi: 10.1016/j.drugpo.2020.102661
Bergh MSS, Øiestad ÅML, Baumann MH, Bogen IL. Selectivity and sensitivity of urine fentanyl test strips to detect fentanyl analogues in illicit drugs. Int J Drug Policy. 2021;1(90): 103065.
doi: 10.1016/j.drugpo.2020.103065
Lockwood TLE, Vervoordt A, Lieberman M. High concentrations of illicit stimulants and cutting agents cause false positives on fentanyl test strips. Harm Reduct J. 2021;18(1):30.
pubmed: 33750405 pmcid: 7941948 doi: 10.1186/s12954-021-00478-4
Wharton RE, Casbohm J, Hoffmaster R, Brewer BN, Finn MG, Johnson RC. Detection of 30 fentanyl analogs by commercial immunoassay kits. J Anal Toxicol. 2021;45(2):111–6.
pubmed: 33580693 doi: 10.1093/jat/bkaa181
DanceSafe. How to Test Your Drugs for Fentanyl. DanceSafe; 2020. https://dancesafe.org/wp-content/uploads/2020/10/DS-fentanly-instruction-2020.pdf
Ciccarone D. The rise of illicit fentanyls, stimulants and the fourth wave of the opioid overdose crisis. Curr Opin Psychiatry. 2021;34(4):344–50.
pubmed: 33965972 pmcid: 8154745 doi: 10.1097/YCO.0000000000000717
Clark R. URGENT: Recent batch of fentanyl strips requires different dilutions|DanceSafe. 2021. https://dancesafe.org/urgent-most-recent-batch-of-fentanyl-test-strips-requires-more-dilution-when-testing-mdma-and-meth/
Matsuda R, Rodriguez E, Suresh D, Hage DS. Chromatographic immunoassays: strategies and recent developments in the analysis of drugs and biological agents. Bioanalysis. 2015;7(22):2947–66.
pubmed: 26571109 pmcid: 4820777 doi: 10.4155/bio.15.206
Baumann MH, Tocco G, Papsun DM, Mohr AL, Fogarty MF, Krotulski AJ. U-47700 and its analogs: non-fentanyl synthetic opioids impacting the recreational drug market. Brain Sci. 2020;10(11):895.
pubmed: 33238449 pmcid: 7700279 doi: 10.3390/brainsci10110895
Delcher C, Wang Y, Vega RS, Halpin J, Gladden RM, O’Donnell JK, et al. Carfentanil Outbreak—Florida, 2016–2017. Morb Mortal Wkly Rep. 2020;69(5):125–9.
doi: 10.15585/mmwr.mm6905a2
Bhullar MK, Gilson TP, Singer ME. Trends in opioid overdose fatalities in Cuyahoga County, Ohio: multi-drug mixtures, the African-American community and carfentanil. Drug Alcohol Depend Rep. 2022;1(4): 100069.
doi: 10.1016/j.dadr.2022.100069
Drug Enforcement Administration. 2020 Drug Enforcement Administration National Drug Threat Assessment. U.S. Department of Justice; 2021.
Solomon N, Hayes J. Levamisole: a high performance cutting agent. Acad Forensic Pathol. 2017;7(3):469–76.
pubmed: 31239995 pmcid: 6474566 doi: 10.23907/2017.039
Dinwiddie AT. Notes from the Field: Antihistamine Positivity and Involvement in Drug Overdose Deaths—44 Jurisdictions, United States, 2019–2020. MMWR Morb Mortal Wkly Rep. 2022; 71. https://www.cdc.gov/mmwr/volumes/71/wr/mm7141a4.htm
McCrae K, Tobias S, Grant C, Lysyshyn M, Laing R, Wood E, et al. Assessing the limit of detection of Fourier-transform infrared spectroscopy and immunoassay strips for fentanyl in a real-world setting. Drug Alcohol Rev. 2020;39(1):98–102.
pubmed: 31746056 doi: 10.1111/dar.13004
McCrae K, Tobias S, Stunden C. BCCSU drug checking operational technician manual version 2. British Columbia Centre on Sustance Use; 2022.
Borden SA, Saatchi A, Vandergrift GW, Palaty J, Lysyshyn M, Gill CG. A new quantitative drug checking technology for harm reduction: pilot study in Vancouver, Canada using paper spray mass spectrometry. Drug Alcohol Rev. 2022;41(2):410–8.
pubmed: 34347332 doi: 10.1111/dar.13370
Ciccarone D, Moran L, Outram S, Werb D, et al. Insights from drug checking programs: practicing bootstrap public health whilst tailoring to local drug user needs. Int J Environ Res Public Health. 2023;20(11):5999.
pubmed: 37297603 pmcid: 10252652 doi: 10.3390/ijerph20115999

Auteurs

John C Halifax (JC)

Department of Laboratory Medicine, ZSFG Clinical Laboratory, UCSF, 1001 Potrero Ave. Bldg. 5 2M16, San Francisco, CA, 94110, USA. john.halifax@ucsf.edu.

Lilly Lim (L)

Department of Laboratory Medicine, ZSFG Clinical Laboratory, UCSF, 1001 Potrero Ave. Bldg. 5 2M16, San Francisco, CA, 94110, USA.

Daniel Ciccarone (D)

Department of Family and Community Medicine, University of California San Francisco, 500 Parnassus Avenue, MU-3E, Box 900, San Francisco, CA, 94143, USA.

Kara L Lynch (KL)

Department of Laboratory Medicine, ZSFG Clinical Laboratory, UCSF, 1001 Potrero Ave. Bldg. 5 2M16, San Francisco, CA, 94110, USA.

Classifications MeSH