Infectious Disease Diagnostics, Northwell Health Laboratories, Lake Success, New York, USA.
Department of Pathology and Laboratory Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, New York, New York, USA.
J Clin Microbiol. 2024 Sep 11;62(9):e0013124. doi: 10.1128/jcm.00131-24. Epub 2024 Aug 12.
Bloodstream HSV-1 and HSV-2 infections can cause devastating outcomes with high morbidity and mortality, especially in neonates or immunocompromised individuals. Proper patient management for herpes simplex virus (HSV) bloodstream infections is time-sensitive and requires a rapid, accurate, and definitive diagnosis. The absence of the U.S. Food and Drug Administration (FDA)-approved molecular assays for HSV detection in blood, coupled with a lack of consensus on the optimal sample type, underscores the unmet need for improved diagnostics. We prospectively compared the cycle threshold values in paired samples including whole blood (WB), plasma, serum, and peripheral blood mononuclear cells (PBMCs) from patients with bloodstream HSV infections. This analysis employed a modified use of the FDA-cleared Simplexa HSV-1 & 2 Direct assay. The clinical performance in serum was assessed by comparing the results of 247 remnant specimens on this sample-to-answer platform to established laboratory-developed tests in a blinded fashion. Serum samples exhibited significantly lower cycle thresholds than whole blood samples [2.6 cycle threshold (Ct) bias, < 0.001]. The modified Simplexa assay demonstrated 100% positive percent agreement for the detection of HSV-1 and HSV-2 DNA in serum samples and yielded an overall agreement of 95% (95% CI, 0.92 to 0.97), with a κ statistic of 0.75 (95% CI, 0.62 to 0.86) compared to the composite reference method. Discordance rates were 5.20% for HSV-1 and 0.81% for HSV-2. This investigation demonstrates that serum is an optimal specimen type for HSV detection when compared to several blood compartments. Serum offers a promising sample type for rapid and accurate diagnosis of HSV bloodstream infections using the modified Simplexa assay.
Rapid, accurate, and definitive diagnosis of herpes simplex virus (HSV) infections is crucial in clinical settings for patient management. The absence of FDA-authorized molecular assays for HSV-1/2 detection in blood, coupled with a lack of consensus on the optimal sample type, underscores the need for improved diagnostic methods. Furthermore, rapid diagnosis of HSV bloodstream infections enables timely administration of antiviral treatment, influences patient management decisions for those at high risk, and can contribute to shorter hospital stays, thereby reducing healthcare costs.
血液单纯疱疹病毒 1 型和 2 型感染可导致高发病率和死亡率的毁灭性后果，尤其是在新生儿或免疫功能低下者中。单纯疱疹病毒（HSV）血流感染患者的适当管理需要及时、准确和明确的诊断。美国食品和药物管理局（FDA）尚未批准血液中用于单纯疱疹病毒检测的分子检测方法，并且对于最佳样本类型也缺乏共识，这突显了对改进诊断方法的迫切需求。我们前瞻性地比较了包括血流感染患者的全血（WB）、血浆、血清和外周血单核细胞（PBMC）在内的配对样本中的循环阈值值。该分析采用了经修改的 FDA 批准的 Simplexa HSV-1 和 2 直接检测法。通过将此样本到答案平台上的 247 个剩余标本的结果与盲法中的已建立的实验室开发测试进行比较，评估了血清中的临床性能。血清样本的循环阈值明显低于全血样本[2.6 个循环阈值（Ct）偏差，<0.001]。改良的 Simplexa 检测法在血清样本中对 HSV-1 和 HSV-2 DNA 的检测具有 100%的阳性百分比一致性，总一致性为 95%（95%CI，0.92 至 0.97），κ 统计量为 0.75（95%CI，0.62 至 0.86）与综合参考方法相比。HSV-1 的不一致率为 5.20%，HSV-2 的不一致率为 0.81%。该研究表明，与几个血液隔室相比，血清是检测 HSV 的最佳样本类型。使用改良的 Simplexa 检测法，血清提供了一种有前途的样本类型，可用于快速准确地诊断 HSV 血流感染。
快速、准确和明确的单纯疱疹病毒（HSV）感染诊断在临床环境中对患者管理至关重要。由于缺乏 FDA 授权的血液 HSV-1/2 检测的分子检测方法，并且对于最佳样本类型也缺乏共识，因此需要改进诊断方法。此外，HSV 血流感染的快速诊断可以实现抗病毒治疗的及时给药，影响高危患者的管理决策，并有助于缩短住院时间，从而降低医疗保健成本。
