Cross-reactivity of the CEDIA buprenorphine assay in drugs-of-abuse screening: influence of dose and metabolites of opioids

IF 5.1 Q1 SUBSTANCE ABUSE Substance Abuse and Rehabilitation Pub Date : 2015-10-28 DOI:10.2147/SAR.S88935
J. A. Berg, J. Schjøtt, K. O. Fossan, Bettina Riedel
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引用次数: 7

Abstract

Purpose The cloned enzyme donor immunoassay (CEDIA) for buprenorphine is applied for both urine drugs-of-abuse screening and compliance monitoring. Sensitivity, specificity, and optimal cutoff of this assay have differed between studies. This may indicate that cross-reactivity has to be taken into account during assay evaluation. We therefore investigated the performance of the CEDIA buprenorphine assay for use in our patient population and explored the impact of cross-reactivity on assay accuracy. Methods The CEDIA buprenorphine assay and high-performance liquid chromatography–tandem mass spectrometry were employed to analyze drugs-of-abuse in urine samples from a healthy drug-naïve male volunteer after intake of two tablets of a prescription drug containing 400 mg paracetamol +30 mg codeine phosphate, and in urine samples (n=2,272) from drug-addicted patients. Receiver operating characteristic analyses were performed to express the diagnostic accuracy of the CEDIA buprenorphine assay. Results CEDIA buprenorphine was positive in one urine sample from the drug-naïve person after intake of the prescription drug. Twenty-five (1.1%) of the patient urine samples were positive for buprenorphine by CEDIA, but negative by high-performance liquid chromatography–tandem mass spectrometry. Codeine, morphine, and their respective metabolites were prevalent in samples that were false positive for buprenorphine. The specificity of the CEDIA buprenorphine assay increased to 99.7% when the cutoff was increased from 5 ng/mL to 10 ng/mL. Conclusion Intake of a therapeutic dose of codeine can yield a false-positive CEDIA buprenorphine result. Additive effects from metabolites of codeine contribute to cross-reactivity in concentrations much lower than listed in the manufacturer’s cross-reactivity guide. Raising the cutoff from 5 ng/mL to 10 ng/mL increased the diagnostic accuracy. Clinicians should be informed about the risk of false-positive results with the CEDIA buprenorphine assay.
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CEDIA丁丙诺啡测定在滥用药物筛选中的交叉反应性:阿片类药物剂量和代谢物的影响
目的应用丁丙诺啡克隆酶供体免疫分析法(CEDIA)进行尿液滥用药物筛查和依从性监测。灵敏度、特异性和最佳截止在不同的研究中有所不同。这可能表明在分析评估时必须考虑交叉反应性。因此,我们研究了CEDIA丁丙诺啡测定在我们患者群体中的性能,并探讨了交叉反应性对测定准确性的影响。方法采用CEDIA丁丙诺啡测定法和高效液相色谱-串联质谱法分析健康男性志愿者drug-naïve在服用含400mg对乙酰氨基酚+ 30mg磷酸可待因的2片处方药后的尿液样本和吸毒成瘾患者尿液样本(n= 2272)中的滥用药物。进行受试者工作特征分析以表达CEDIA丁丙诺啡检测的诊断准确性。结果drug-naïve患者用药后1例尿液CEDIA检测丁丙诺啡阳性。25例(1.1%)患者尿液CEDIA检测丁丙诺啡阳性,高效液相色谱-串联质谱检测阴性。在丁丙诺啡假阳性的样本中,可待因、吗啡及其各自的代谢物普遍存在。当检测下限从5 ng/mL增加到10 ng/mL时,CEDIA丁丙诺啡检测的特异性提高到99.7%。结论服用治疗剂量的可待因可导致CEDIA丁丙诺啡假阳性。可待因代谢物的加性效应导致交叉反应,其浓度远低于制造商交叉反应指南中列出的浓度。将临界值从5 ng/mL提高到10 ng/mL,可提高诊断准确性。临床医生应了解CEDIA丁丙诺啡测定假阳性结果的风险。
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9
审稿时长
16 weeks
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