From the Departments of Pathology and Laboratory Medicine.
Medicine, Alpert Medical School of Brown University, Providence, RI.
Sex Transm Dis. 2020 May;47(5):301-305. doi: 10.1097/OLQ.0000000000001153.
Treponema-specific assays are widely adopted in the first step of the reverse algorithm of serologic syphilis screening. The new BioPlex 2200 Syphilis Total and rapid plasma reagin (RPR) test is designed to perform the first 2 steps of the algorithm simultaneously. However, limited data regarding the BioPlex Syphilis Total and RPR in clinical practice exist.
A total of 293 random samples at a tertiary medical center were tested by BioPlex Syphilis Total and RPR, BioPlex Syphilis IgG, Architect Syphilis TP, and BD Macro-Vue RPR card. Treponema pallidum particle agglutination (TP-PA) assay and clinical chart review were used to resolve discrepancies. Comparisons were performed among treponemal-specific assays and between 2 RPR tests.
Good overall agreements (>91%) were achieved between BioPlex Syphilis Total, BioPlex Syphilis IgG, and Architect Syphilis TP. Overall agreement between BioPlex RPR and BD RPR was 86.8% with positive percent agreement of 66.7% and negative percent agreement of 96.3%. There were 37 discordant samples including 30 with BD RPR+/BioPlex RPR- and 7 with BD RPR-/BioPlex RPR+. Negative BioPlex RPR results were observed in samples with reactive BD RPR: 10 (91%) of 11 for BD RPR 1:1, 13 (65%) of 20 for BD RPR 1:2, 6 (35%) of 17 for BD RPR 1:4, and 1 (7%) of 14 for BD RPR 1:8. The discordant samples were predominantly from patients with high-risk of syphilis reinfection and included 9 patients with an early reinfection.
Our results demonstrated that BioPlex Syphilis Total and Architect Syphilis TP performed similarly. The BioPlex RPR missed a small number of early syphilis reinfections, and its implementation should depend on the patient population that the laboratory serves.
梅毒螺旋体特异性检测在血清学梅毒筛查反向算法的第一步中被广泛采用。新型 BioPlex 2200 梅毒总抗体和快速血浆反应素（RPR）检测旨在同时完成算法的前两步。然而，关于临床实践中的 BioPlex 梅毒总抗体和 RPR 的数据有限。
在一家三级医疗中心，对 293 例随机样本进行了 BioPlex 梅毒总抗体和 RPR、BioPlex 梅毒 IgG、Architect 梅毒 TP 和 BD Macro-Vue RPR 卡检测。使用梅毒螺旋体颗粒凝集（TP-PA）检测和临床病历回顾解决差异。比较了梅毒螺旋体特异性检测之间的差异以及两种 RPR 检测之间的差异。
BioPlex 梅毒总抗体、BioPlex 梅毒 IgG 和 Architect 梅毒 TP 之间的总体一致性良好（>91%）。BioPlex RPR 和 BD RPR 的总体一致性为 86.8%，阳性符合率为 66.7%，阴性符合率为 96.3%。有 37 个不一致的样本，其中 30 个为 BD RPR+/BioPlex RPR-，7 个为 BD RPR-/BioPlex RPR-。在反应性 BD RPR 的样本中观察到阴性的 BioPlex RPR 结果：BD RPR 1:1 为 11 个中的 10 个（91%），BD RPR 1:2 为 20 个中的 13 个（65%），BD RPR 1:4 为 17 个中的 6 个（35%），BD RPR 1:8 为 14 个中的 1 个（7%）。不一致的样本主要来自梅毒再感染高危患者，包括 9 例早期再感染患者。
我们的结果表明，BioPlex 梅毒总抗体和 Architect 梅毒 TP 表现相似。BioPlex RPR 漏检了少数早期梅毒再感染，其实施应取决于实验室服务的患者人群。
