Department of Pathology and Laboratory Medicine, University of Rochester Medical Center, Rochester, NY, United States.
J Appl Lab Med. 2024 Sep 3;9(5):877-885. doi: 10.1093/jalm/jfae056.
Fentanyl, a synthetic opioid, has caused many recent overdose deaths. Diagnosis of fentanyl abuse is not served by traditional opiate assays due to differences in chemical structure between synthetics and natural opioids. To our knowledge, this is the first study that uses liquid chromatography-tandem mass spectrometry (LC-MS/MS) as the reference method to evaluate and compare the ARK Fentanyl II Assay (ARK II) and the Fentanyl II Enzyme Immunoassay by Roche (FEN2). The ARK II is designed to detect fentanyl in urine samples, whereas the FEN2 is designed to detect norfentanyl, which is the major metabolite.
Two hundred patient urine samples including 100 positive and 100 negative samples according to an in-house LC-MS/MS assay were selected for the study. These samples were tested using the ARK II and the FEN2 to determine their performances relative to LC-MS/MS results.
The FEN2 showed a positive and negative predictive value of 100% and 97% and a concordance with LC-MS/MS of 98.5% (kappa 0.97). The ARK II showed a positive and negative predictive value of 100% and 95% and a concordance with LC-MS/MS of 97.5% (kappa 0.95). Additionally, the FEN2 accurately identified 9 positive samples with a range of fentanyl concentrations from 0 to 18 ng/mL for which norfentanyl levels were less than the cutoff of 5 ng/mL, indicating potentially greater sensitivity than otherwise stated.
The FEN2 and the ARK II were evaluated to be similar in terms of positive and negative predictive value during the analysis of 200 patient samples, as well as equally concordant with the LC-MS/MS reference, despite differences in design.
芬太尼是一种合成阿片类药物，已导致许多近期的过量死亡事件。由于合成阿片类药物和天然阿片类药物的化学结构存在差异，传统的阿片类药物检测方法无法诊断芬太尼滥用。据我们所知，这是首次使用液相色谱-串联质谱法（LC-MS/MS）作为参考方法评估和比较 ARK 芬太尼 II 检测试剂盒（ARK II）和罗氏芬太尼 II 酶免疫测定试剂盒（FEN2）的研究。ARK II 旨在检测尿液样本中的芬太尼，而 FEN2 旨在检测去甲芬太尼，这是主要的代谢物。
选择了 200 例患者尿液样本进行研究，包括 100 例阳性样本和 100 例阴性样本，这些样本根据内部 LC-MS/MS 检测进行了检测。使用 ARK II 和 FEN2 对这些样本进行检测，以确定它们与 LC-MS/MS 结果的相关性。
FEN2 的阳性和阴性预测值分别为 100%和 97%，与 LC-MS/MS 的一致性为 98.5%（kappa 值 0.97）。ARK II 的阳性和阴性预测值分别为 100%和 95%，与 LC-MS/MS 的一致性为 97.5%（kappa 值 0.95）。此外，FEN2 准确地鉴定了 9 例芬太尼浓度在 0 至 18ng/ml 之间的阳性样本，其中去甲芬太尼水平低于 5ng/ml 的截止值，这表明其灵敏度可能比预期的更高。
在分析 200 例患者样本时，FEN2 和 ARK II 的阳性和阴性预测值相似，与 LC-MS/MS 参考值的一致性也相当，尽管设计有所不同。
