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P1.18 Evaluation of the cobas® hsv 1 and 2 test in a japanese population
  1. Elizabeth Marlowe1,
  2. Takashi Kawana2,
  3. Tomohiko Onoe3,
  4. Yasuhiko Onoe4,
  5. Masayuki Sawamura5,
  6. Kenichi Hayakawa6,
  7. Michael Lewinski1,
  8. Rui Ohse7,
  9. Ai Takiyama7
  1. 1Roche Molecular Systems, Pleasanton, USA
  2. 2Teikyo University Mizonokuchi Hospital, Kanagawa – Japan
  3. 3The Jikei University Katsushika Medical Centre, Tokyo – Japan
  4. 4Miyamoto-Cho Central Clinic, Kanagawa – Japan
  5. 5Shinjuku Sakura Clinic, Tokyo – Japan
  6. 6Seiwakai Hayakawa Clinic Medical Corporation, Osaka – Japan
  7. 7Roche Diagnostics K.K., Tokyo – Japan

Abstract

Introduction Herpes is a common cause of sexually transmitted disease, which is often asymptomatic. Identification of genital herpes can impact the clinical management of patients who are HIV positive, immunosuppressed, pregnant, and individuals with HSV seronegative partners. The objective of this study was to evaluate the performance of the cobas® HSV 1 and 2 test in a Japanese population.

Methods A total of 165 specimens of anogential lesions and endocervcal swabs from 122 patients were tested from clinical sites in Tokyo, Kanagawa and Osaka (36% Female, 64% Male). Specimens were tested by cobas® HSV 1 and 2 test (cHSV) and compared to shell vial culture (SV) as well as Prime Check HSV Antigen Detection Kit (PCA) and direct immunofluorescence (DFA). Diagnostic agreement was evaluated and discrepant analysis was performed by Sanger sequencing.

Results The overall percent agreement (OPA), sensitivity and specificity of cHSV compared to SV for HSV-1 was 98.8% (95% CI 95.7–99.9), 100% (95% CI 97.8%–100%), and 98.5% (95% CI 95.3–99.8), and for HSV-2 was 87.9% (95% CI 81.9–92.5), 98.6% (95% CI 95.4%–99.8%), and 79.6% (95% CI 72.6%–85.4%), respectively. For HSV-1 there were 2 cHSV+/SV-. For HSV-2 there were 20 discordant results, 19 cHSV+/SV- and 1 cHSV-/SV+. Sanger Sequencing for HSV-1 confirmed 1 of 2 positive for HSV-1 and for HSV-2 confirmed 20/20 as HSV-2 positive. Both PCA and DFA missed more than twice as many confirmed positive HSV specimens as SV. The OPA, sensitivity and specificity of cHSV compared to DFA for HSV-1 was 84.8% (95% CI 78.4–89.9), 85.7% (95% CI 79.4%–90.7%), and 84.7% (95% CI 78.3%–89.8%), and for HSV-2 was 59.8% (95% CI 51.9%–67.4%), 100% (95% CI 97.8%–100%), and 53.2% (95% CI 45.3%–61.0%), respectively. PCA does not type positive HSV. The OPA, sensitivity and specificity of cHSV compared to PCA was 74.5% (95% CI 67.1%–81.0%), 98.8% (95% CI 95.6%–99.8%), and 51.8% (95% CI 43.9%–59.6%).

Conclusion This study demonstrated improved diagnostic performance of the cobas HSV 1 and 2 test compared to routine methods in a Japanese population.

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