Department of Pathology and Laboratory Medicine, University of Pennsylvania, Philadelphia, PA.
Clin Chem. 2020 Feb 1;66(2):324-332. doi: 10.1093/clinchem/hvz023.
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.
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.
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).
The LFA can detect fentanyl and norfentanyl with high clinical sensitivity and specificity in the ED population with rapid fentanyl screening needs.
在即时护理环境下快速识别芬太尼至关重要。在过量用药情况下，尿液中的芬太尼浓度起始于纳克每毫升的个位数。目前尚无检测限达到纳克每毫升的个位数的即时护理芬太尼检测方法。
我们开发了一种竞争性侧向流测定法（LFA），使用金纳米颗粒进行优化，以在 5 分钟内快速筛选芬太尼。使用 LFA 和 LC-MS/MS 对来自急诊科（ED）的 2 组患者的尿液样本进行了检测。这 2 组患者分别包括 218 例连续进行尿液药物滥用筛检的 ED 患者和 7 例临床疑似芬太尼过量的 ED 患者。
LFA 对芬太尼（≥1ng/mL）和主要代谢物去甲芬太尼（≥10ng/mL）的检测具有高精度。在 1000ng/mL 时，对安非他命、可卡因、吗啡、四氢大麻酚、美沙酮、丁丙诺啡、纳洛酮和对乙酰氨基酚没有交叉反应，对卡芬太尼、利培酮和 9-羟基利培酮的交叉反应率分别为 0.03%、0.4%和 0.05%。在 218 例连续的 ED 患者中，芬太尼≥1ng/mL 或去甲芬太尼≥10ng/mL 的病例发生率为 5.5%。LFA 的临床灵敏度和特异性分别为 100%（95%CI，75.8-100%）和 99.5%（95%CI，97.3-99.9%）。阳性和阴性预测值分别为 92.3%（95%CI，66.7-98.6%）和 100%（95%CI，98.2-100%）。在 7 例疑似芬太尼过量的病例中，LFA 与 LC-MS/MS 的一致性为 100%（5 例阳性，2 例阴性）。
LFA 可在有快速芬太尼筛查需求的 ED 人群中以高临床灵敏度和特异性检测芬太尼和去甲芬太尼。
