Snyder Marion L, Darragh Alicia, Flood James G, Jones Jenny, Ropar Kaitlin, Jarolim Petr, Melanson Stacy E F
LabSource, Greenville, SC 29607, USA.
Department of Pathology, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA.
J Anal Toxicol. 2014 Jul-Aug;38(6):375-9. doi: 10.1093/jat/bku045. Epub 2014 May 6.
Buprenorphine (BUP), a semi-synthetic opioid analgesic, is increasingly prescribed for the treatment of chronic pain and opioid dependence. Urine immunoassay screening methods are available for monitoring BUP compliance and misuse; however, these screens may have poor sensitivity or specificity. We evaluated whether the pretreatment of urine with β-glucuronidase (BG) improves the sensitivity and overall accuracy of three BUP enzyme immunoassays when compared with liquid chromatography-tandem mass spectrometry (LC-MS-MS). Urine samples sent to our laboratories for BUP testing (n = 114) were analyzed before and after BG pretreatment by cloned enzyme donor immunoassay (CEDIA), enzyme immunoassay (EIA) and homogenous EIA (HEIA) immunoassays using a common 5 ng/mL cutoff. Total BUP and norbuprenorphine (NBUP) concentrations were measured by LC-MS-MS as the reference method. Urine BG pretreatment improved EIA, HEIA and CEDIA sensitivities from 70, 82 and 94%, respectively, to 97% for each of the three methods, when compared with LC-MS-MS. While the specificity of the EIA and HEIA remained 100% after BG pretreatment, the specificity of the CEDIA decreased from 74 to 67%. Urine pretreatment with BG is recommended to improve sensitivity of the EIA and HEIA BUP screening methods.
丁丙诺啡（BUP）是一种半合成阿片类镇痛药，越来越多地被用于治疗慢性疼痛和阿片类药物依赖。尿液免疫分析筛查方法可用于监测丁丙诺啡的依从性和滥用情况；然而，这些筛查方法的敏感性或特异性可能较差。我们评估了与液相色谱-串联质谱法（LC-MS-MS）相比，用β-葡萄糖醛酸酶（BG）对尿液进行预处理是否能提高三种丁丙诺啡酶免疫分析的敏感性和总体准确性。将送至我们实验室进行丁丙诺啡检测的尿液样本（n = 114），在BG预处理前后，采用通用的5 ng/mL临界值，通过克隆酶供体免疫分析（CEDIA）、酶免疫分析（EIA）和均相EIA（HEIA）免疫分析法进行分析。采用LC-MS-MS测定总丁丙诺啡和去甲丁丙诺啡（NBUP）浓度作为参考方法。与LC-MS-MS相比，尿液BG预处理使EIA、HEIA和CEDIA的敏感性分别从70%、82%和94%提高到三种方法各自的97%。虽然BG预处理后EIA和HEIA的特异性仍保持100%，但CEDIA的特异性从74%降至67%。建议用BG对尿液进行预处理，以提高EIA和HEIA丁丙诺啡筛查方法的敏感性。
