Objectives The objective of this study was to evaluate the cobas® HSV 1 and HSV 2 Test using clinician-collected swab specimens from external anogenital lesions as part of a large multicenter clinical trial.
Methods Two swabs were collected from patients with possible HSV infection at 8 geographically diverse sites. The first swab was used for the Quidel Lyra™ Direct HSV 1+2/VZV on the Cepheid SmartCycler II System and the second for the cobas® HSV 1 and 2 Test. The Quidel Lyra™ Direct HSV 1+2/VZV test was performed at a reference laboratory and the cobas® HSV 1 and HSV 2 Test was performed at 3 sites. Discrepant analysis included HSV culture using the ELVIS® HSV ID and D³ Typing Test, a second FDA-cleared nucleic acid amplification test (BD ProbeTecTM Herpes Simplex viruses [HSV 1 and 2] Qx Amplified DNA Assays) and Sanger sequencing. The sensitivity and specificity were calculated by comparing cobas® HSV 1 and HSV 2 Test results with the Quidel Lyra™ Direct HSV 1+2/VZV test following discrepant analysis using the majority result from the three comparator tests.
Results There were 229 HSV positive subjects, with 73 HSV-1 (44 female, 29 male) and 157 HSV-2 (78 female, 79 male) positive subjects, among 409 evaluable participants (205 female, 204 male). The sensitivity and specificity of the cobas® HSV 1 and HSV 2 Test compared to the Quidel Lyra™ Direct HSV 1+2/VZV following discrepant analysis for HSV-1 was 98.6% (72/73) and 97.0% (326/336), respectively, and for HSV-2 was 100% (157/157) and 92.9% (234/252), respectively.
Conclusion The cobas® HSV 1 and 2 Test, on the automated cobas® 4800 system, displayed excellent performance compared Quidel Lyra™ Direct HSV 1+2/VZV Test combined with discrepant analysis. The test is highly suitable to detect HSV in clinician-collected anogenital swab specimens from patients with suspected HSV infection.
Disclosure of interest This clinical trial study was supported by Roche Molecular Diagnostics.
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