Department of Pathology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Division of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, USA.
J Infect Dis. 2024 Aug 14;230(Supplement_1):S76-S81. doi: 10.1093/infdis/jiae229.
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.
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.
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).
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.
莱姆病改良 2 级检测（MTTT）利用了两级中的自动化高通量免疫测定法（AHTI），而不涉及免疫印迹，与标准 2 级检测（STTT；第一级 AHTI 后进行免疫球蛋白 M（IgM）和免疫球蛋白 G（IgG）免疫印迹）相比，具有性能和实际优势。对于 MTTT，疾病控制与预防中心建议使用食品和药物管理局（FDA）专门为此预期用途批准的 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 商业检测试剂盒的性能。
我们使用 DiaSorin、Gold Standard Diagnostics（GSD）和 Zeus Scientific 的试剂盒在 2018 年 7 月对 382 份多余的血清样本进行 MTTT（总抗体 AHTI，反射性检测单独的 IgM 和 IgG AHTI），使用 κ 统计量测量 MTTT 与 STTT 之间的一致性。
使用 DiaSorin 检测试剂盒的总一致性为 0.87（95%置信区间[CI]，0.77-0.97）（几乎完美的一致性），使用 GSD 检测试剂盒的总一致性为 0.80（95% CI，0.68-0.93）（高度一致），使用 Zeus 检测试剂盒的总一致性为 0.79（95% CI，0.68-0.90）（高度一致）。对于 IgM 反应性的检测，MTTT 与 STTT 之间的一致性为 0.70（0.51-0.90；高度），0.63（95% CI，0.44-0.82；高度）和 0.56（95% CI，0.38-0.73；中度），分别。对于 IgG 反应性的检测，MTTT/STTT 一致性分别为 0.73（95% CI，0.58-0.88）、0.78（95% CI，0.62-0.94）和 0.75（95% CI，0.60-0.90）（在所有情况下均为高度一致）。
使用来自 3 家不同制造商的商业 MTTT 检测试剂盒获得的结果与 STTT 结果总体上具有高度至几乎完美的一致性，并且对 IgM 和 IgG 的检测具有中度至高度的一致性。商业 MTTT 测试可广泛用于莱姆病的诊断。
