BACKGROUND The Aptima Herpes Simplex Virus (HSV) 1&2 Assay recently received Health Canada approved for detection and differentiation of HSV-1 and HSV-2 from anogenital sites. This assay uses target capture, transcription mediated amplification, and real-time detection of messenger RNA (mRNA) produced in host cells during active HSV infection. To evaluate its performance, the Aptima assay was compared to another Health Canada approved assay, the BD ProbeTec Herpes Simplex Viruses HSV 1&2 Qx Amplified DNA Assay, which uses strand displacement amplification technology. METHODS As recommended by the manufacturers, the Aptima and ProbeTec assays were performed on the Panther and Viper instruments, respectively. Analytical sensitivity and specificity were assessed using 10-fold serial dilution of viruses in viral universal transport media (UTM), and nucleic acids extracted and concentrated from other viruses including all members of the Herpesviridae family. The clinical sensitivity and specificity were assessed retrospectively using 60 archived specimens, and prospectively using 158 swabs in UTM. Discrepant results were resolved with real-time PCR using the Altona Diagnostics RealStar alpha Herpes assay. RESULTS Both the Aptima and ProbeTec assays showed excellent analytical and clinical specificity. However, the Aptima HSV assay failed to detect HSV in specimens with low viral loads, resulting in reduced sensitivity for HSV-2 during the retrospective evaluation at 85.0%, and for HSV-1 at 85.0% during the prospective evaluation. CONCLUSIONS This study compared the Aptima and ProbeTec HSV assays and demonstrated that detection of HSV mRNA using the Aptima HSV assay was less sensitive in both retrospective and prospective analyses.

中文翻译：

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两种自动方法在临床标本中检测和区分单纯疱疹病毒的比较。

背景技术最近，美国卫生部批准了Aptima单纯疱疹病毒（HSV）1＆2分析用于从生殖器部位检测和区分HSV-1和HSV-2。该测定法使用靶标捕获，转录介导的扩增以及在主动HSV感染过程中实时检测宿主细胞中产生的信使RNA（mRNA）。为了评估其性能，将Aptima分析与另一项加拿大卫生部批准的分析，即使用链置换扩增技术的BD ProbeTec单纯疱疹病毒HSV 1＆2 Qx扩增DNA分析进行了比较。方法按照制造商的建议，Aptima和ProbeTec分析分别在Panther和Viper仪器上进行。使用病毒在病毒通用转运介质（UTM）中进行10倍系列稀释，并从包括疱疹病毒科的所有成员在内的其他病毒中提取和浓缩的核酸，评估了分析的敏感性和特异性。使用60份存档标本进行回顾性评估，并使用UTM中的158个拭子进行前瞻性评估。使用Altona Diagnostics RealStarα疱疹测定法通过实时PCR解决了不一致的结果。结果Aptima和ProbeTec分析均显示出出色的分析和临床特异性。但是，Aptima HSV分析未能在低病毒载量的标本中检测到HSV，导致回顾性评估期间对HSV-2的敏感性降低，为85.0％，而前瞻性评估期间对HSV-1的敏感性为85.0％。