Abstract：
Background: Borrelia burgdorferi sensu stricto is the causative agent of Lyme disease (LD). Possible early symptoms include flu-like symptoms and erythema migrans and later, the risk of disruption of the nervous system, joints, and heart. A two-tiered testing method is employed for serological diagnostics. The Public Health Agency of Canada guidelines recommend that samples tested negative on first-tiered test need not be confirmed by second-tiered test. Due to the challenging nature of diagnosis leading to misconceptions among physicians about false negatives, confirmatory testing is requested despite the initial negative result. Methods: Hundred screen-negative Lyme patient samples from 2007 to 2016 were tested by Western blot (WB) second-tiered confirmatory test upon physician\'s request in British Columbia to study the first-tiered screening test sufficiency. Results: Those negative for first-tiered enzyme-linked immunosorbent assay were also negative by WB. Conclusion: Results demonstrate that confirmatory testing is not necessary on screen-negative samples. Hence, first-tiered test is sufficient to rule out LD.
摘要：
背景：伯氏疏螺旋体是莱姆病（LD）的病原体。可能的早期症状包括流感样症状和游走性红斑，神经系统受到破坏的风险,接头,和心脏。采用两级测试方法进行血清学诊断。加拿大公共卫生署指南建议，在一级测试中测试为阴性的样品无需通过二级测试确认。由于诊断的挑战性，导致医生对假阴性的误解，尽管最初的结果为阴性，但仍要求进行确认性测试。方法：根据不列颠哥伦比亚省医师的要求，对2007年至2016年的百例筛查阴性莱姆患者样本进行了Westernblot（WB）二级验证试验，以研究一级筛查试验的充分性。结果:一级酶联免疫吸附试验阴性者WB也阴性。结论：结果表明，对屏幕阴性样品不需要进行确认性测试。因此，一级测试足以排除LD。
