Nucleic acid amplification technology for the diagnosis of genital herpes infection

Expert Review of Molecular Diagnostics

Volumn 4, Issue 4, 2004, Pages 485-493

  Stellrecht, Kathleen A ^a  

^a ALBANY MEDICAL CENTER   (United States)

Author keywords

Genital herpes; Herpes simplex virus; HSV; NAAT; Nucleic acid amplification; PCR

Indexed keywords

CLINICAL PRACTICE; FOOD AND DRUG ADMINISTRATION; GENE AMPLIFICATION; GENITAL HERPES; HEALTH CARE COST; HERPES SIMPLEX ENCEPHALITIS; HERPES SIMPLEX VIRUS; HUMAN; INTERMETHOD COMPARISON; LABORATORY; NONHUMAN; NUCLEIC ACID AMPLIFICATION; POLYMERASE CHAIN REACTION; REVIEW; STAFF; UNITED STATES; VIRUS CULTURE; VIRUS DIAGNOSIS; VIRUS IDENTIFICATION;

DNA, VIRAL; FLUORESCENT DYES; HERPES GENITALIS; HERPESVIRUS 1, HUMAN; HERPESVIRUS 2, HUMAN; HUMANS; NUCLEIC ACID AMPLIFICATION TECHNIQUES; QUALITY CONTROL; SENSITIVITY AND SPECIFICITY; SEROLOGIC TESTS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 3142706535     PISSN: 14737159     EISSN: None     Source Type: Journal    
DOI: 10.1586/14737159.4.4.485     Document Type: Review

References (78)

1. Cusini M, Ghislanzoni M. The importance of diagnosing genital herpes. J. Antimicrob. Chemother. 47(Suppl. T1), 9-16 (2001).
2. Fleming DT, McQuillan GM, Johnson RE et al. Herpes simplex virus Type 2 in the United States, 1976 to 1994. N. Engl. J. Med. 337, 1105-1111 (1997). Most current summary of statistics on herpes simplex virus (HSV) infection in the USA compiled by the Sexually Transmitted Disease (STD) Division of the Centers for Disease Control and Prevention.
3. Ross JD, Smith JW, Elton RA. The epidemiology of herpes simplex types 1 and 2 infection of the genital tract in Edinburgh 1978-1991. Genitourin. Med. 69, 381-383 (1993).
4. Scoular A, Gillespie G, Carman WF. Polymerase chain reaction for diagnosis of genital herpes in a genitourinary medicine clinic. Sex. Transm. Infect. 78, 21-25 (2002).
5. Mindel A. Psychological and psychosexual implications of herpes simplex virus infections. Scand. J. Infect. Dis. (Suppl.) 100, 27-32 (1996).
6. Vanderplate C, Aral SO. Psychosocial aspects of genital herpes virus infection. Health Psychol. 6, 57-72 (1987).
7. Mindel A, Taylor J. Debate: the argument against. Should every STD clinic patient be considered for type-specific serological screening for HSV? Herpes 9, 35-37 (2002).
8. Malkin JE. Herpes simplex virus: who should be tested? Herpes 9, 31 (2002).
9. Whitley RJ. Neonatal herpes simplex virus infections. J. Med. Virol. 1 (Suppl.), 13-21 (1993). Comprehensive review of neonatal HSV infection.
10. Kesson AM. Management of neonatal herpes simplex virus infection. Paediatr. Drugs 3, 81-90 (2001).
11. Schacker T. The role of HSV in the transmission and progression of HIV. Herpes 8, 46-49 (2001).
12. Corey L. The current trend in genital herpes. Progress in prevention. Sex. Transm. Dis. 21, S38-S44 (1994).
13. Corey L, Wald A. Herpes Simplex Virus. In: Sexually Transmitted Diseases. Sparling PF, Mardh PA (Eds), McGraw Hill, NY, USA, 285-312 (1998). Comprehensive review of genital HSV infection.
14. Koutsky LA, Ashley RL, Holmes KK et al. The frequency of unrecognized Type 2 herpes simplex virus infection among women. Implications for the control of genital herpes. Sex. Transm. Dis. 17, 90-94 (1990).
15. Koutsky LA, Stevens CE, Holmes KK et al. Underdiagnosis of genital herpes by current clinical and viral-isolation procedures. N. Engl. J. Med. 326, 1533-1539 (1992).
16. Wald A, Corey L, Cone R et al. Frequent genital herpes simplex virus 2 shedding in immunocompetent women. Effect of acyclovir treatment. J. Clin. Invest. 99, 1092-1097 (1997).
17. Centers for Disease Control and Prevention - Division of Sexually Transmitted Diseases. Report of the Genital Herpes Prevention Consultants Meeting. CDC/DSTD, 1-19, 7-30 (1998). Summary of recommendations regarding diagnosing and managing HSV infections.
18. Ashley RL, Wu L, Pickering JW, Tu MC, Schnorenberg L. Premarket evaluation of a commercial glycoprotein G-based enzyme immunoassay for herpes simplex virus type-specific antibodies. J. Clin. Microbiol. 36, 294-295 (1998).
19. Prince HE, Ernst CE, Hogrefe WR. Evaluation of an enzyme immunoassay system for measuring herpes simplex virus (HSV) Type 1-specific and HSV Type 2-specific IgG antibodies. J. Clin. Lab. Anal. 14(1), 13-6 (2000).
20. Ashley RL. Sorting out the new HSV type specific antibody tests. Sex. Transm. Infect. 77, 232-237 (2001).
21. Boggess K, Watts D, Hobson A et al. Herpes simplex virus Type 2 detection by culture and polymerase chain reaction and relationship to genital symptoms and cervical antibody status during the third trimester of pregnancy. Am. J. Obstet. Gynecol. 176, 443-451 (1997).
22. Burrows J, Nitsche A, Bayly B et al. Detection and subtyping of Herpes simplex virus in clinical samples by LightCycler PCR, enzyme immunoassay and cell culture. BMC Microbiol. 2, 12 (2002).
23. Cone RW, Hobson AC, Brown Z et al. Frequent detection of genital herpes simplex virus DNA by polymerase chain reaction among pregnant women. JAMA 272, 792-796 (1994).
24. Cone RW, Hobson AC, Palmer J, Remington M, Corey L. Extended duration of herpes simplex virus DNA in genital lesions detected by the polymerase chain reaction. J. Infect. Dis. 164, 757-760 (1991).
25. Espy MJ, Uhl JR, Mitchell PS et al. Diagnosis of herpes simplex virus infections in the clinical laboratory by LightCycler PCR. J. Clin. Microbiol. 38, 795-799 (2000). Describes what is currently the most widely used method of real-time PCR for the amplification of HSV.
26. Wald A, Huang ML, Carrell D, Selke S, Corey L. Polymerase chain reaction for detection of herpes simplex virus (HSV) DNA on mucosal surfaces: comparison with HSV isolation in cell culture. J. Infect. Dis. 188, 1345-1351 (2003). Although not the primary focus, this paper demonstrates factors affecting HSV recovery in clinical specimens.
27. Lucotte G, Bathelier C, Lespiaux V, Bali C, Champenois T. Detection and genotyping of herpes simplex virus types 1 and 2 by polymerase chain reaction. Mol. Cell. Probes 9, 287-290 (1995).
28. Schomogyi M, Wald A, Corey L. Herpes simplex virus-2 infection. An emerging disease? Infect. Dis. Clin. North Am. 12, 47-61 (1998).
29. Benedetti J, Corey L, Ashley R. Recurrence rates in genital herpes after symptomatic first-episode infection. Ann. Intern. Med. 121, 847-854 (1994).
30. Lafferty WE, Coombs RW, Benedetti J, Critchlow C, Corey L. Recurrences after oral and genital herpes simplex virus infection. Influence of site of infection and viral type. N. Engl. J. Med. 316, 1444-1449 (1987).
31. Brown ZA, Wald A, Morrow RA et al. Effect of serologic status and cesarean delivery on transmission rates of herpes simplex virus from mother to infant. JAMA 289, 203-209 (2003). Describes a multicenter analysis of risk factors associated with neonatal HSV transmission.
32. Hobson A, Wald A, Wright N, Corey L. Evaluation of a quantitative competitive PCR assay for measuring herpes simplex virus DNA content in genital tract secretions. J. Clin. Microbiol. 35, 548-552 (1997).
33. Wiedbrauk DL, Cunningham W. Stability of herpes simplex virus DNA in cerebrospinal fluid specimens. Diagn. Mol. Pathol. 5, 249-252 (1996).
34. Jerome KR, Huang ML, Wald A, Selke S, Corey L. Quantitative stability of DNA after extended storage of clinical specimens as determined by real-time PCR. J. Clin. Microbiol. 40, 2609-2611 (2002).
35. Barnard DL, Farnes K, Richards DF, Croft GF, Johnson FB. Suitability of new chlamydia transport medium for transport of herpes simplex virus. J. Clin. Microbiol. 24, 692-695 (1986).
36. Behets FM, Liomba G, Lule G et al. Sexually transmitted diseases and human immunodeficiency virus control in Malawi: a field study of genital ulcer disease. J. Infect. Dis. 171, 451-455 (1995).
37. Dickerson MC, Johnston J, Delea TE, White A, Andrews E. The causal role for genital ulcer disease as a risk factor for transmission of human immunodeficiency virus. An application of the Bradford Hill criteria. Sex. Transm. Dis. 23, 429-440 (1996).
38. Beyrer C, Jitwatcharanan K, Natpratan C et al. Molecular methods for the diagnosis of genital ulcer disease in a sexually transmitted disease clinic population in Northern Thailand: predominance of herpes simplex virus infection. J. Infect. Dis. 178, 243-246 (1998).
39. Risbud A, Chan-Tack K, Gadkari D et al. The etiology of genital ulcer disease by multiplex polymerase chain reaction and relationship to HIV infection among patients attending sexually transmitted disease clinics in Pune, India. Sex. Transm. Dis. 26, 55-62 (1999).
40. Coyle PV, Desai A, Wyatt D, McCaughey C, O'Neill HJ. A comparison of virus isolation, indirect immunofluorescence and nested multiplex polymerase chain reaction for the diagnosis of primary and recurrent herpes simplex Type 1 and Type 2 infections. J. Virol. Methods 83, 75-82 (1999).
41. Espy MJ, Rys PN, Wold AD et al. Detection of herpes simplex virus DNA in genital and dermal specimens by LightCycler PCR after extraction using the IsoQuick, MagNA Pure and BioRobot 9604 methods. J. Clin. Microbiol. 39, 2233-2236 (2001).
42. Schloss L, van Loon AM, Cinque P et al. An international external quality assessment of nucleic acid amplification of herpes simplex virus. J. Clin. Virol. 28, 175-185 (2003).
43. Hirsch HH, Bossart W. Two-centre study comparing DNA preparation and PCR amplification protocols for herpes simplex virus detection in cerebrospinal fluids of patients with suspected herpes simplex encephalitis. J. Med. Virol. 57, 31-35 (1999).
44. Kimberlin DW, Lakeman FD, Arvin AM et al. Application of the polymerase chain reaction to the diagnosis and management of neonatal herpes simplex virus disease. National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group. J. Infect. Dis. 174, 1162-1167 (1996).
45. Sun Y, Chan RK, Tan SH, Ng PP. Detection and genotyping of human herpes simplex viruses in cutaneous lesions of erythema multiforme by nested PCR. J. Med. Virol. 71, 423-428 (2003).
46. Anderson TP, Werno AM, Beynon KA, Murdoch DR. Failure to genotype herpes simplex virus by real-time PCR assay and melting curve analysis due to sequence variation within probe binding sites. J. Clin. Microbiol. 41, 2135-2137 (2003).
47. Barratt K, Mackay JF. Improving real-time PCR genotyping assays by asymmetric amplification. J. Clin. Microbiol. 40, 1571-1572 (2002).
48. Kwok S, Higuchi R. Avoiding false positives with PCR. Nature 339, 237-238 (1989). Describes practices and procedures necessary to minimize nucleic acid amplification technology contamination.
49. Pang J, Modlin J, Yolken R. Use of modified nucleotides and uracil-DNA glycosylase (UNG) for the control of contamination in the PCR-based amplification of RNA. Mol. Cell. Probes 6, 251-256 (1992).
50. Bezold G, Volkenandt M, Gottlober P, Peter RU. Detection of herpes simplex virus and varicella-zoster virus in clinical swabs: frequent inhibition of PCR as determined by internal controls. Mol. Diagn. 5, 279-284 (2000).
51. Puchhammer-Stockl E, Presterl E, Croy C et al. Screening for possible failure of herpes simplex virus PCR in cerebrospinal fluid for the diagnosis of herpes simplex encephalitis. J. Med. Virol. 64, 531-536 (2001).
52. Weil AA, Glaser CA, Amad Z, Forghani B. Patients with suspected herpes simplex encephalitis: rethinking an initial negative polymerase chain reaction result. Clin. Infect. Dis. 34, 1154-1157 (2002).
53. Coyle PV, Jain S, Wyatt D, McCaughey C, O'Neill HJ. Description of a nonlethal herpes simplex virus Type 1 glycoprotein D deletion mutant affecting a site frequently used for PCR. Clin. Diagn. Lab. Immunol. 7, 322-324 (2000).
54. Corey L, Wald A, Patel R et al. Once-daily valacyclovir to reduce the risk of transmission of genital herpes. N. Engl. J. Med. 350, 11-20 (2004).
55. Rouse DJ, Stringer JS. An appraisal of screening for maternal type-specific herpes simplex virus antibodies to prevent neonatal herpes. Am. J. Obstet. Gynecol. 183, 400-406 (2000).
56. Mertz GJ, Benedetti J, Ashley R, Selke SA, Corey L. Risk factors for the sexual transmission of genital herpes. Ann. Intern. Med. 116, 197-202 (1992).
57. Beutner K, Corey L, Mertz G et al. Once daily valacyclovir reduces transmission of genital herpes. The 42nd Interscience Conference on Antimicrobial Agents and Chmotherapy (2002) (Abstract LB-3).
58. Brown ZA, Benedetti J, Ashley R et al. Neonatal herpes simplex virus infection in relation to asymptomatic maternal infection at the time of labor. N. Engl. J. Med. 324, 1247-1252 (1991).
59. Kulhanjian JA, Soroush V, Au DS et al. Identification of women at unsuspected risk of primary infection with herpes simplex virus Type 2 during pregnancy. N. Engl. J. Med. 326, 916-920 (1992).
60. Ward J. Laboratory guidelines screening tests to Detect Chlamydia trachomatis and Neisseria gonorrhoeae infections. MMWR Recomm. Rep. 51(RR-15), 1-48 (2002).
61. Austin H, Macaluso M, Nahmias A et al. Correlates of herpes simplex virus seroprevalence among women attending a sexually transmitted disease clinic. Sex. Transm. Dis. 26, 329-334 (1999).
62. Janier M, Lassau F, Bloch J et al. Seroprevalence of herpes simplex virus Type 2 antibodies in an STD clinic in Paris. Int. J. STD AIDS 10, 522-526 (1999).
63. Cates W Jr. Estimates of the incidence and prevalence of sexually transmitted diseases in the United States. American Social Health Association Panel. Sex. Transm. Dis. 26, S2-S7 (1999).
64. Wald A, Langenberg AG, Link K et al. Effect of condoms on reducing the transmission of herpes simplex virus Type 2 from men to women. JAMA 285, 3100-3106 (2001).
65. Casper C, Wald A. Condom use and the prevention of genital herpes acquisition. Herpes 9, 10-4 (2002).
66. Corey L, Wald A, Davis LG. Subclinical shedding of HSV: its potential for reduction by antiviral therapy. Adv. Exp. Med. Biol. 394, 11-6 (1996).
67. Newton EA, Kuder JM. A model of the transmission and control of genital herpes. Sex. Transm. Dis. 27, 363-370 (2000).
68. Rogers BB, Josephson SL, Mak SK. Detection of herpes simplex virus using the polymerase chain reaction followed by endonuclease cleavage. Am. J. Pathol. 139, 1-6 (1991).
69. Koenig M, Reynolds KS, Aldous W, Hickman M. Comparison of Light-Cycler PCR, enzyme immunoassay and tissue culture for detection of herpes simplex virus. Diagn. Microbiol. Infect. Dis. 40, 107-110 (2001).
70. Lakeman FD, Whitley RJ. Diagnosis of herpes simplex encephalitis: application of polymerase chain reaction to cerebrospinal fluid from brain-biopsied patients and correlation with disease. National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group. J. Infect. Dis. 171, 857-863 (1995).
71. Kessler HH, Muhlbauer G, Rinner B et al. Detection of Herpes simplex virus DNA by real-time PCR. J. Clin. Microbiol. 38, 2638-2642 (2000).
72. Kimura H, Ito Y, Futamura M et al. Quantitation of viral load in neonatal herpes simplex virus infection and comparison between Type 1 and Type 2. J. Med. Virol. 67, 349-353 (2002).
73. Marshall DS, Linfert DR, Draghi A, McCarter YS, Tsongalis GJ. Identification of herpes simplex virus genital infection: comparison of a multiplex PCR assay and traditional viral isolation techniques. Mod. Pathol. 14, 152-156 (2001).
74. Meijer A, van der Vliet JA, Schouls LM et al. Detection of microorganisms in vessel wall specimens of the abdominal aorta: development of a PCR assay in the absence of a gold standard. Res. Microbiol. 149, 577-583 (1998).
75. Ryncarz AJ, Goddard J, Wald A et al. Development of a high-throughput quantitative assay for detecting herpes simplex virus DNA in clinical samples. J. Clin. Microbiol. 37, 1941-1947 (1999).
76. Aurelius E, Johansson B, Skoldenberg B, Staland A, Forsgren M. Rapid diagnosis of herpes simplex encephalitis by nested polymerase chain reaction assay of cerebrospinal fluid. Lancet 337, 189-192 (1991).
77. O'Neill HJ, Wyatt DE, Coyle PV, McCaughey C, Mitchell F. Real-time nested multiplex PCR for the detection of herpes simplex virus types 1 and 2 and varicella zoster virus. J. Med. Virol. 71, 557-560 (2003).
78. van Doornum GJ, Guldemeester J, Osterhaus AD, Niesters HG. Diagnosing herpesvirus infections by real-time amplification and rapid culture. J. Clin. Microbiol. 41, 576-580 (2003).