Abstract

We aimed to evaluate the interference of lamotrigine (LMG) on the synthetic cannabinoids metabolite-K2/1 (SCm/K1) urine test by Homogeneous Enzyme Immunoassay (Immune-SCm/K1). This study consists of two parts: case-control and interference effect research. In the case-control study, two groups using LMG and a non-use of LMG were formed, all of them non-SC users. In the interference effect research, four groups were formed by adding either a LMG stock solution or a LMG user’s urine to a SCm/K1 negative urine, and Immune-SCm/K1 test calibrators and quality control (QC) materials. Immune-SCm/K1, SCm/K1 by LC/MS-MS and LMG tests were performed on all samples in the study. The case-control study was performed on a total of 55 participants (mean age 39.76 ± 9.84 years). Both groups were statistically insignificant in terms of age and gender. Urine LMG levels were 5.71 ± 10.61 mg/L in the LMG group and <0.30 mg/L in the control group. Immune-SCm/K1 results were 35.84 ± 7.62 ng/mL in the LMG group, <3.00 ng/mL in the control group and the LC/MS-SCm/K1 urine test of both groups were found to be ‘NEGATIVE’. Results were interpreted as a cross-reaction in the interference study and a statistically significant relationship was found between LMG levels and Immune-SCm/K1 levels in the SCm/K1 negative samples (groups 1 and 2) (R² = 0.9341 and R² = 0.9941, respectively; p < .001). LMG interference was observed in SCm/K1 positive samples ranging from −6.17 to 714.77%. LMG in the specimen interferes with the Immune-SCm/K1 screening test and causes false positivities.

摘要

我们旨在通过均相酶免疫测定法 (Immune-SCm/K1) 评估拉莫三嗪 (LMG) 对合成大麻素代谢物-K2/1 (SCm/K1) 尿液检测的干扰。本研究由病例对照研究和干扰效应研究两部分组成。在病例对照研究中，形成了使用 LMG 和不使用 LMG 的两组，他们都是非 SC 用户。在干扰效应研究中，通过将 LMG 原液或 LMG 使用者尿液添加到 SCm/K1 阴性尿液、Immune-SCm/K1 测试校准品和质量控制 (QC) 材料中，形成四组。对研究中的所有样品进行了免疫-SCm/K1、LC/MS-MS 的 SCm/K1 和 LMG 测试。对总共 55 名参与者（平均年龄 39.76 ± 9.84 岁）进行了病例对照研究。两组在年龄和性别方面均无统计学意义。LMG组尿LMG水平为5.71±10.61 mg/L，对照组<0.30 mg/L。LMG 组的 Immune-SCm/K1 结果为 35.84 ± 7.62 ng/mL，对照组 <3.00 ng/mL，并且发现两组的 LC/MS-SCm/K1 尿检结果均为“阴性”。结果被解释为干扰研究中的交叉反应，并且在 SCm/K1 阴性样本（第 1 组和第 2 组）中发现 LMG 水平和免疫-SCm/K1 水平之间存在统计学上的显着关系（R ²  = 0.9341 和R ²  = 0.9941；p  < .001)。在 SCm/K1 阳性样品中观察到 LMG 干扰，范围为 -6.17 至 714.77%。样本中的 LMG 会干扰 Immune-SCm/K1 筛查测试并导致假阳性。