Quest Diagnostics Infectious Disease, Inc., San Juan, Capistrano, CA, USA.
Diagn Microbiol Infect Dis. 2019 Nov;95(3):114864. doi: 10.1016/j.diagmicrobio.2019.07.002. Epub 2019 Jul 13.
CDC guidelines recommend confirmatory testing of sera with low-positive indices (1.10-3.50) in the HerpeSelect® (HSLT) HSV-2 IgG screening assay. To determine if this recommendation is adequate for our patient population, we reviewed HSLT HSV-2 IgG screening indices for 262 screen-positive sera (index >1.10) tested in our confirmatory assay, which assesses inhibition of binding to recombinant gG2 by HSV-1- and HSV-2-infected cell lysates. To determine how the recommendation affects other screening assays, we tested these samples in the Liaison® HSV-2 IgG assay. Of 124 false-positive sera, 20% and 39% had an index >3.50 in the HSLT and Liaison screening assays, respectively. In both assays, 51% of 63 indeterminate sera (inhibition by HSV-1 lysate) had indices >3.50. Similarly, ≥75% of 75 true-positive samples exhibited indices >3.50 in both assays. Thus, confirmatory testing only of sera with low-positive HSV-2 IgG indices misses some false-positive and indeterminate samples, leading to misdiagnosis of HSV-2 infection.
疾病预防控制中心的指南建议对 HerpeSelect®（HSLT）HSV-2 IgG 筛选检测中低阳性指数（1.10-3.50）的血清进行确认性检测。为了确定这一建议是否适用于我们的患者群体，我们回顾了在我们的确认性检测中对 262 份血清阳性（指数>1.10）的 HSLT HSV-2 IgG 筛选指数进行了检测，该检测评估了 HSV-1 和 HSV-2 感染细胞裂解物对重组 gG2 结合的抑制作用。为了确定该建议如何影响其他筛选检测，我们在 Liaison®HSV-2 IgG 检测中测试了这些样本。在 124 份假阳性血清中，20%和 39%在 HSLT 和 Liaison 筛选检测中的指数>3.50。在这两种检测中，51%的 63 份不确定血清（HSV-1 裂解物抑制）的指数>3.50。同样，在这两种检测中，≥75%的 75 份真阳性样本的指数>3.50。因此，仅对低阳性 HSV-2 IgG 指数的血清进行确认性检测会错过一些假阳性和不确定的样本，导致 HSV-2 感染的误诊。
