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Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays

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Document issued on: August 9, 2011

This document supersedes “Herpes Simplex Virus Types 1 and 2 Serological Assays” dated April 3, 2007.

The draft of this document was issued on September 28, 2010.

For questions regarding this document contact Haja Sittana El Mubarak, Ph.D., Division of Microbiology Devices at 301-796-6193 or by email: [email protected].

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Devices and Radiological Health

Office of In Vitro Diagnostic Device Evaluation and Safety

Division of Microbiology Devices

Preface

  1. Arvin, A.M., Prober, C.G., 1995. Herpes Simplex Viruses, in Manual of Clinical Microbiology, 6th Ed., Baron, E.J., et al., eds. ASM Press, Washington, D.C., 876-883.
  2. Screening for Genital Herpes Simplex, Brief Update, Guide to Clinical Preventive Services, 2nd Ed., Report of the U.S. Preventive Services Task Force, 2005. Glass, N., Nelson, H. D., Huffman, L., eds. International Medical Publishing, Alexandria, VA, 1-17.
  3. Whitley, R.J., 1996. Herpes Simplex Viruses, Fields Virology, 3rd Ed., Fields, B.N., et al., eds. Lippincott-Raven, Philadelphia, P.A., 2297-2333.
  4. Nahmias, A.J., et al. 1991. Herpes Simplex Viruses 1 and 2, in Viral Infections of Humans – Epidemiology and Control, 3rd Ed., Evans, A.S., ed. Plenum Medical Book Company, New York, 393-417.
  5. Ashley, R., 2001. Sorting out the New HSV Type Specific Antibody Tests, Sexually Transmitted Infections, 77:232-237.
  6. Centers for Disease Control and Prevention ( CDC), 2002. Sexually Transmitted Diseases Guidelines, Genital Herpes Simplex Virus Infections, http://www.cdc.gov/std/treatment/default.htm .
  7. Prober, C.G., et al. 1992. The Management of Pregnancies Complicated by Genital Infections with Herpes Simplex Virus, Clinical Infectious Diseases, 15:1031-1038.
  8. Prober, C.G., et al. 1987. Low Risk of Herpes Simplex Virus Infections in Neonates Exposed to the Virus at the Time of Vaginal Delivery to Mothers with Recurrent Genital Herpes Simplex Virus Infections, New England Journal of Medicine. 316(5):240-244.
  9. Brown, ZA, et al. 2003. Effect of Serologic Status and Cesarean Delivery on Transmission Rates of Herpes Simplex Virus From Mother to Infant, JAMA 289: 203-209.
  10. De Tiege, X, et al. 2003. Limits of Early Diagnosis of Herpes Simplex Encephalitis in Children: A Retrospective Study of 38 Cases, Brief Report, CID, 36:1335-1339.
  11. OIVD Guidance Document – Review Criteria for In Vitro Diagnostic Devices for Detection of IgM Antibodies to Viral Agents.
  12. Clinical Laboratory Standards Institute (CLSI). Procedures for Handling and Processing of Blood Specimens; Approved Guideline, CLSI Document H18-A3 ( ISBN 1-56238-555-0) CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004.
  13. Clinical Laboratory Standards Institute (CLSI). Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline, CLSI document EP5-A2 (ISBN 1-56238-542-9) CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004.
  14. Clinical Laboratory Standards Institute (CLSI). User Verification of Performance for Precision and Trueness; Approved Guideline, CLSI document EP15-A2 (ISBN 1-56238-574-7) CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2005.
  15. Clinical Laboratory Standards Institute (CLSI). User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline, CLSI document EP12-A (ISBN 1-56238-468-6) CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2002.
  16. Clinical Laboratory Standards Institute (CLSI). Interference Testing in Clinical Chemistry; Approved Guideline, CLSI document EP7-A (ISBN 1-56238-480-5) CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004.
  17. Clinical Laboratory Standards Institute (CLSI). Specifications for Immunological Testing for Infectious Diseases; Approved Guideline, CLSI document I/LA18-A2 (ISBN 1-56238-445-7) CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2001.
  18. Centers for Disease Control and Prevention, HSV IgG Panel [well characterized sera for device validation].
  19. Clinical Laboratory Standards Institute (CLSI). Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline, CLSI document EP9-A2 (ISBN 1-56238-472-4) CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2002.
  20. Clinical Laboratory Standards Institute (CLSI). User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline. CLSI document EP12-A (ISBN 1-56238-468-6) CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2002.

1 This guidance document addresses assays that detect HSV 1, HSV 2, or both.

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