Background Modified 2-tiered testing (MTTT) for Lyme disease utilizes automatable, high throughput immunoassays (AHTIs) in both tiers without involving western immunoblots, offering performance and practical advantages over standard 2-tiered testing (STTT; first-tier AHTI followed by immunoglobulin M (IgM) and immunoglobulin G (IgG) western immunoblots). For MTTT, Centers for Disease Control and Prevention recommends using AHTI test kits that have been cleared by Food and Drug Administration (FDA) specifically for this intended use. We evaluated performance of FDA-cleared MTTT commercial test kits from 3 manufacturers by comparing with STTT results. Methods We performed MTTT (total antibody AHTI with reflex to separate IgM and IgG AHTIs) using test kits from Diasorin, Gold Standard Diagnostics (GSD), and Zeus Scientific on 382 excess serum samples submitted to the clinical laboratory for routine Lyme disease serologic testing in July 2018, measuring agreement between MTTT and STTT using the κ statistic. Results Overall agreement with STTT was 0.87 (95% confidence interval [CI], .77–.97) using Diasorin assays (almost perfect agreement), 0.80 (95% CI, .68–.93) using GSD assays (substantial agreement) and 0.79 (95% CI, .68–.90) using Zeus assays (substantial agreement). For detection of IgM reactivity, agreement between MTTT and STTT was 0.70 (.51–.90; substantial), 0.63 (95% CI, .44–.82; substantial) and 0.56 (95% CI, .38–.73; moderate), respectively. For detection of IgG reactivity, MTTT/STTT agreement was 0.73 (95% CI,.58–.88), 0.78 (95% CI, .62–.94), and 0.75 (95% CI, .60–.90), respectively (substantial agreement in all cases). Conclusions MTTT results obtained using commercial test kits from 3 different manufacturers had substantial to almost perfect agreement with STTT results overall and moderate to substantial agreement for IgM and IgG detection independently. Commercial MTTT tests can be used broadly for the diagnosis of Lyme disease.

中文翻译：

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获准用于莱姆病血清诊断的改良两级检测算法的商业检测试剂盒的比较评价


背景 莱姆病的改良 2 层检测 （MTTT） 在两层中都使用可自动化的高通量免疫测定 （AHTI），而不涉及蛋白质印迹，与标准 2 层检测（STTT;一级 AHTI 后是免疫球蛋白 M （IgM） 和免疫球蛋白 G （IgG） 免疫印迹）相比，具有性能和实用优势。对于 MTTT，疾病控制和预防中心建议使用美国食品和药物管理局 （FDA） 批准的专门用于此预期用途的 AHTI 检测试剂盒。我们通过与 STTT 结果进行比较，评估了来自 3 家制造商的 FDA 批准的 MTTT 商业测试试剂盒的性能。方法 我们使用 Diasorin、Gold Standard Diagnostics （GSD） 和 Zeus Scientific 的检测试剂盒对 2018 年 7 月提交给临床实验室进行常规莱姆病血清学检测的 382 份过量血清样本进行了 MTTT （反射分离 IgM 和 IgG AHTIs的总抗体 AHTI），使用 κ 统计量测量 MTTT 和 STTT 之间的一致性。结果使用散居素测定法（几乎完全一致）与 STTT 的总体一致性为 0.87（95% 置信区间 [CI]，.77-.97），使用 GSD 测定法为 0.80（95% CI，.68-.93）（实质性一致）和 0.79（95% CI，.68-.90）使用 Zeus 测定法（实质性一致）。对于 IgM 反应性的检测，MTTT 和 STTT 之间的一致性分别为 0.70 （.51-.90;实质性）、0.63 （95% CI，.44-.82;实质性）和 0.56 （95% CI，.38-.73;中等）。对于 IgG 反应性的检测，MTTT/STTT 一致性分别为 0.73 （95% CI，.58–.88）、0.78 （95% CI，.62–.94） 和 0.75 （95% CI，.60–.90） （在所有情况下基本一致）。 结论 使用 3 家不同制造商的商业检测试剂盒获得的 MTTT 结果与 STTT 结果总体上基本一致至几乎完全一致，IgM 和 IgG 检测独立中度至基本一致。商业 MTTT 检测可广泛用于莱姆病的诊断。