Abstract：
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.
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.
摘要：
背景：莱姆病的改良2级测试（MTTT）利用自动化，在两层中进行高通量免疫测定（AHTIs），而不涉及西方免疫印迹，与标准的2级测试（STTT；一级AHTI，然后是免疫球蛋白M（IgM）和免疫球蛋白G（IgG）免疫印迹）相比，提供性能和实际优势。对于MTTT，美国疾病控制和预防中心建议使用已被食品和药物管理局（FDA）批准的AHTI测试试剂盒专门用于此预期用途。我们通过与STTT结果比较，评估了来自3个制造商的FDA批准的MTTT商业测试试剂盒的性能。
方法：我们使用Diasorin的检测试剂盒进行了MTTT（具有分离IgM和IgGAHTIs的反射的总抗体AHTI），黄金标准诊断(GSD),和ZeusScientific于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份多余血清样本，使用κ统计量衡量MTTT和STTT之间的一致性。
结果：与STTT的总体一致性为0.87（95％置信区间[CI]，.77-.97）使用Diasorin测定法（几乎完美一致），0.80（95%CI，.68-.93）使用GSD测定（基本一致）和0.79（95%CI，.68-.90）使用Zeus测定（基本一致）。为了检测IgM反应性，MTTT和STTT之间的协议为0.70（0.51-.90；实质性），0.63（95%CI，.44-.82；实质性）和0.56（95%CI，.38-.73；中等），分别。为了检测IgG反应性，MTTT/STTT协议为0.73（95%CI，.58-.88），0.78（95%CI，.62-.94），和0.75（95%CI，.60-.90），分别(在所有情况下都有实质性协议)。
结论：使用来自3个不同制造商的商业检测试剂盒获得的MTTT结果与STTT结果总体上基本到几乎完美一致，并且对于IgM和IgG独立检测具有中等到基本的一致性。商业MTTT测试可广泛用于莱姆病的诊断。
方法：我们使用Diasorin的检测试剂盒进行了MTTT（具有分离IgM和IgGAHTIs的反射的总抗体AHTI），黄金标准诊断(GSD),和ZeusScientific于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份多余血清样本，使用κ统计量衡量MTTT和STTT之间的一致性。
结果：与STTT的总体一致性为0.87（95％置信区间[CI]，.77-.97）使用Diasorin测定法（几乎完美一致），0.80（95%CI，.68-.93）使用GSD测定（基本一致）和0.79（95%CI，.68-.90）使用Zeus测定（基本一致）。为了检测IgM反应性，MTTT和STTT之间的协议为0.70（0.51-.90；实质性），0.63（95%CI，.44-.82；实质性）和0.56（95%CI，.38-.73；中等），分别。为了检测IgG反应性，MTTT/STTT协议为0.73（95%CI，.58-.88），0.78（95%CI，.62-.94），和0.75（95%CI，.60-.90），分别(在所有情况下都有实质性协议)。
结论：使用来自3个不同制造商的商业检测试剂盒获得的MTTT结果与STTT结果总体上基本到几乎完美一致，并且对于IgM和IgG独立检测具有中等到基本的一致性。商业MTTT测试可广泛用于莱姆病的诊断。
