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Clinical performance of a new lateral flow immunoassay for xylazine detection

  • Lindsey Contella , Marion L. Snyder , Phillip Kang , Nicole V. Tolan ORCID logo and Stacy E.F. Melanson ORCID logo EMAIL logo
Published/Copyright: October 14, 2024
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 63 Issue 4

Abstract

Objectives

Xylazine is a potent sedative used in veterinary medicine. Recently, recreational drugs such as fentanyl have been found to contain xylazine, increasing the risk of respiratory depression and death. Despite a similar presentation to opioid overdose, patients who ingest xylazine do not respond to treatment with Narcan. Therefore, rapid detection of xylazine could improve patient management and prevent adverse outcomes.

Methods

We evaluated the XYL500 one-step xylazine drug of abuse test for its ability to detect xylazine in 152 urine samples from patients on chronic opioid therapy for pain management or in treatment for substance use disorder. Results were compared to LC-MS/MS as the reference method. Precision, cross-reactivity, interference and stability studies were performed.

Results

Pooled patient samples were consistently negative or positive when tested five times on the same day and over three days of testing. The diagnostic sensitivity, specificity and accuracy of the XYL500 assay were 74, 98, and 82 % respectively, as compared with LC-MS/MS. XYL500 detected 77 of the 104 LC-MS/MS positive samples identified in our initial evaluation, including some that contained low levels of xylazine (n=8), <10 ng/mL. Minimal cross-reactivity with other opioid analgesics and commonly encountered drugs was seen with only one false positive result. Interferences by common urine contaminants were negligible. Specimens were stable up to 160 days refrigerated and up to 80 days at room temperature.

Conclusions

XYL500 allows for rapid detection of xylazine, illustrating its utility in monitoring patients who ingested recreational drugs containing the additive, xylazine, and its potential to improve patient management.

Keywords: fentanyl; heroin; lateral flow immunoassay; liquid chromatography-tandem mass spectrometry; xylazine
Corresponding author: Stacy E.F. Melanson, Department of Pathology, Brigham and Women’s Hospital, 75 Francis Street, Boston, MA 02115, USA; and Harvard Medical School, Boston, MA, USA, E-mail:

  1. Research ethics: This study was approved by the Mass General Brigham Institutional Review Board and this study was conducted in accordance with the Declaration of Helsinki (as revised in 2013).

  2. Informed consent: Not applicable.

  3. Author contributions: The authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  4. Use of Large Language Models, AI and Machine Learning Tools: None declared.

  5. Conflict of interest: The authors state no conflict of interest.

  6. Research funding: None declared.

  7. Data availability: The raw data can be obtained on reasonable request from the corresponding author.

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Supplementary Material

This article contains supplementary material (https://doi.org/10.1515/cclm-2024-0947).

Received: 2024-08-14
Accepted: 2024-09-24
Published Online: 2024-10-14
Published in Print: 2025-03-26

© 2024 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2024-0947
Keywords for this article
fentanyl; heroin; lateral flow immunoassay; liquid chromatography-tandem mass spectrometry; xylazine

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Beyond test results: the strategic importance of metadata for the integration of AI in laboratory medicine
  4. Reviews
  5. Reference, calibration and referral laboratories – a look at current European provisions and beyond
  6. How has the external quality assessment/proficiency testing of semen analysis been developed in the past 34 years: a review
  7. Opinion Papers
  8. Data flow in clinical laboratories: could metadata and peridata bridge the gap to new AI-based applications?
  9. A comprehensive survey of artificial intelligence adoption in European laboratory medicine: current utilization and prospects
  10. Guidelines and Recommendations
  11. Guidelines for the correct use of the nomenclature of biochemical indices of bone status: a position statement of the Joint IOF Working Group and IFCC Committee on Bone Metabolism
  12. Candidate Reference Measurement Procedures and Materials
  13. Absolute quantitation of human serum cystatin C: candidate reference method by 15N-labeled recombinant protein isotope dilution UPLC-MS/MS
  14. General Clinical Chemistry and Laboratory Medicine
  15. Performance evaluation of the introduction of full sample traceability system within the specimen collection process
  16. Pre-analytical stability of haematinics, lactate dehydrogenase and phosphate in whole blood at room temperature up to 24 h, and refrigerated serum stability of lactate dehydrogenase, folate and vitamin B12 up to 72 h using the CRESS checklist
  17. Comparison of capillary finger stick and venous blood sampling for 34 routine chemistry analytes: potential for in hospital and remote blood sampling
  18. Performance evaluation of enzymatic total bile acid (TBA) routine assays: systematic comparison of five fifth-generation TBA cycling methods and their individual bile acid recovery from HPLC-MS/MS reference
  19. Clinical performance of a new lateral flow immunoassay for xylazine detection
  20. Evaluation of revised UK-NEQAS CSF-xanthochromia method for subarachnoid hemorrhage: outcome data provide evidence for clinical value
  21. Strategies to verify equimolar peptide release in mass spectrometry-based protein quantification exemplified for apolipoprotein(a)
  22. Evaluation of the clinical performance of anti-mutated citrullinated vimentin antibody and 14-3-3 eta testing in rheumatoid arthritis
  23. Diagnostic performance of specific biomarkers for interstitial lung disease: a single center study
  24. Reference Values and Biological Variations
  25. Neonatal reference intervals for serum steroid hormone concentrations measured by LC-MS/MS
  26. Paediatric reference intervals for haematology parameters analysed on Sysmex XN-9000: a comparison of methods in the framework of indirect sampling
  27. Cardiovascular Diseases
  28. Analytical characteristics and performance of a new hs-cTnI method: a multicenter-study
  29. Diabetes
  30. Use of labile HbA1c as a screening tool to minimize clinical misinterpration of HbA1c
  31. Letters to the Editor
  32. Current trends and future projections in the clinical laboratory test market: implications for resource management and strategic planning
  33. Particulate matter in water: an overlooked source of preanalytical error producing erroneous chemistry test results
  34. “Activation” of macro-AST by pyridoxal-5-phosphate in the assay for aspartate aminotransferase
  35. The correlation of albumin with total protein concentrations in cerebrospinal fluid across three automated analysers – relevance to the diagnosis of subarachnoid haemorrhage in clinical chemistry practice
  36. Adult reference intervals for serum thyroid‐stimulating hormone using Abbott Alinity i measuring system
  37. Cell population data in venous thrombo-embolism and erysipelas: a potential diagnostic tool?
  38. Diagnostic performances and cut-off verification of blood pTau 217 on the Lumipulse platform for amyloid deposition in Alzheimer’s disease
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