Development and Clinical Validation of a Sensitive Lateral Flow Assay for Rapid Urine Fentanyl Screening in the Emergency Department
| Autor: | Keng-Ku Liu, Zhao Li, Ping Wang, Sheng Feng, Hui Chen |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
0301 basic medicine
education.field_of_study business.industry 010401 analytical chemistry Biochemistry (medical) Clinical Biochemistry Population Liter Urine 01 natural sciences 0104 chemical sciences Carfentanil Fentanyl 03 medical and health sciences 030104 developmental biology Anesthesia Naloxone Morphine Medicine business education Buprenorphine medicine.drug |
| Zdroj: | Clinical Chemistry. 66:324-332 |
| ISSN: | 1530-8561 0009-9147 |
| Popis: | Background Rapid identification of fentanyl at the point-of-care is critical. Urine fentanyl concentrations in overdose cases start at single-digit nanograms per milliliter. No fentanyl point-of-care assay with a cutoff at single-digit nanograms per milliliter is available. Methods A competitive lateral flow assay (LFA) was developed using gold nanoparticles and optimized for rapid screening of fentanyl in 5 minutes. Urine samples from 2 cohorts of emergency department (ED) patients were tested using the LFA and LC-MS/MS. The 2 cohorts consisted of 218 consecutive ED patients with urine drug-of-abuse screen orders and 7 ED patients with clinically suspected fentanyl overdose, respectively. Results The LFA detected fentanyl (≥1 ng/mL) and the major metabolite norfentanyl (≥10 ng/mL) with high precision. There was no cross-reactivity with amphetamine, cocaine, morphine, tetrahydrocannabinol, methadone, buprenorphine, naloxone, and acetaminophen at 1000 ng/mL and 0.03%, 0.4%, and 0.05% cross-reactivity with carfentanil, risperidone, and 9-hydroxyrisperidone, respectively. In 218 consecutive ED patients, the prevalence of cases with fentanyl ≥1 ng/mL or norfentanyl ≥10 ng/mL was 5.5%. The clinical sensitivity and specificity of the LFA were 100% (95% CI, 75.8–100%) and 99.5% (95% CI, 97.3–99.9%), respectively. The positive and negative predictive values were 92.3% (95% CI, 66.7–98.6%) and 100% (95% CI, 98.2–100%), respectively. The concordance between the LFA and LC-MS/MS was 100% in the 7 suspected fentanyl overdose cases (5 positive, 2 negative). Conclusions The LFA can detect fentanyl and norfentanyl with high clinical sensitivity and specificity in the ED population with rapid fentanyl screening needs. |
| Databáze: | OpenAIRE |
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