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P07.25 Comparison of cobas® hsv 1/2 test, quidel lyra™ direct hsv 1+2/vzv, bd probetectm hsv  1/2 qx assay and sanger sequencing using clinician-collected anogenital lesion swabs
  1. S Young1,
  2. B Van Der Pol2,
  3. S Taylor3,
  4. K Fife4,
  5. E Hook2,
  6. R Patel5,
  7. K Ding6,
  8. P Hemyari6,
  9. J Duncan6,
  10. S Tang6,
  11. O Liesenfeld6,
  12. J Osiecki6,
  13. M Lewinski6
  1. 1TriCore Reference Laboratories, Albuquerque, NM, USA
  2. 2University of Alabama at Birmingham, Birmingham, AL, USA
  3. 3Louisiana State University School of Medicine, New Orleans, LA, USA
  4. 4Indiana University School of Medicine, Indianapolis, Indiana, USA
  5. 5Royal South Hants Hospital, Southampton, England, UK
  6. 6Roche Molecular Diagnostics, Pleasanton, CA, USA

Abstract

 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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