Abstract
A second-generation signal amplification, nucleic acid-based test for the rapid detection and typing of herpes simplex virus (HSV) DNA was developed and evaluated with artificial and clinical specimens. The analytical sensitivity of the Hybrid Capture II (HC II) HSV DNA assay was determined by testing either cloned HSV DNA or total genomic HSV DNA titrations and resulted in detection thresholds of between 5 x 10(3) and 1 x 10(4) copies per assay. Specificity was assessed by testing a panel of bacteria and viruses commonly found in the female genital tract. Sensitivity was assessed by testing 112 ulcerative genital lesions by the HC II assay and comparing the results to those obtained by routine cell culture. Discrepant results were resolved by PCR testing. After resolution of the discrepant results, the sensitivity of the HC II assay compared to the consensus result (the results of two of three tests, the HC II assay, culture, and PCR, were in agreement) was 93.2% (41 of 44 specimens), and the specificity was 100% (60 of 60 specimens). Culture gave a sensitivity of 84.1% (37 of 44 specimens) and a specificity of 100% (60 of 60 specimens) compared to the consensus result. The results of HSV typing by the HC II assay and culture agreed in all cases. The HC II assay is a rapid and accurate assay for detecting and typing HSV types 1 and 2, with a sensitivity comparable to that of culture and greater ease of use than culture.
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- Borriello F., Weinberg D. S., Mutter G. L. Evaluation of gene deletions by quantitative polymerase chain reaction. Experience with the alpha-thalassemia model. Diagn Mol Pathol. 1994 Dec;3(4):246–254. doi: 10.1097/00019606-199412000-00006. [DOI] [PubMed] [Google Scholar]
- Brown Z. A., Benedetti J., Ashley R., Burchett S., Selke S., Berry S., Vontver L. A., Corey L. Neonatal herpes simplex virus infection in relation to asymptomatic maternal infection at the time of labor. N Engl J Med. 1991 May 2;324(18):1247–1252. doi: 10.1056/NEJM199105023241804. [DOI] [PubMed] [Google Scholar]
- Chatis P. A., Crumpacker C. S. Resistance of herpesviruses to antiviral drugs. Antimicrob Agents Chemother. 1992 Aug;36(8):1589–1595. doi: 10.1128/aac.36.8.1589. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Diaz-Mitoma F., Ruben M., Sacks S., MacPherson P., Caissie G. Detection of viral DNA to evaluate outcome of antiviral treatment of patients with recurrent genital herpes. J Clin Microbiol. 1996 Mar;34(3):657–663. doi: 10.1128/jcm.34.3.657-663.1996. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Gleaves C. A., Wilson D. J., Wold A. D., Smith T. F. Detection and serotyping of herpes simplex virus in MRC-5 cells by use of centrifugation and monoclonal antibodies 16 h postinoculation. J Clin Microbiol. 1985 Jan;21(1):29–32. doi: 10.1128/jcm.21.1.29-32.1985. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Howard C., Friedman D. L., Leete J. K., Christensen M. L. Correlation of the percent of positive Chlamydia trachomatis direct fluorescent antibody detection tests with the adequacy of specimen collection. Diagn Microbiol Infect Dis. 1991 May-Jun;14(3):233–237. doi: 10.1016/0732-8893(91)90037-g. [DOI] [PubMed] [Google Scholar]
- Hwang C. B., Ruffner K. L., Coen D. M. A point mutation within a distinct conserved region of the herpes simplex virus DNA polymerase gene confers drug resistance. J Virol. 1992 Mar;66(3):1774–1776. doi: 10.1128/jvi.66.3.1774-1776.1992. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Kimura H., Futamura M., Kito H., Ando T., Goto M., Kuzushima K., Shibata M., Morishima T. Detection of viral DNA in neonatal herpes simplex virus infections: frequent and prolonged presence in serum and cerebrospinal fluid. J Infect Dis. 1991 Aug;164(2):289–293. doi: 10.1093/infdis/164.2.289. [DOI] [PubMed] [Google Scholar]
- Kitagawa Y., Stollar B. D. Comparison of poly(A).poly(dT) and poly(I).poly(dC) as immunogens for the induction of antibodies to RNA-DNA hybrids. Mol Immunol. 1982 Mar;19(3):413–420. doi: 10.1016/0161-5890(82)90207-3. [DOI] [PubMed] [Google Scholar]
- Kwok S., Higuchi R. Avoiding false positives with PCR. Nature. 1989 May 18;339(6221):237–238. doi: 10.1038/339237a0. [DOI] [PubMed] [Google Scholar]
- Lazar J. G. Advanced methods in PCR product detection. PCR Methods Appl. 1994 Aug;4(1):S1–14. doi: 10.1101/gr.4.1.s1. [DOI] [PubMed] [Google Scholar]
- Lörincz A. T., Quinn A. P., Goldsborough M. D., Schmidt B. J., Temple G. F. Cloning and partial DNA sequencing of two new human papillomavirus types associated with condylomas and low-grade cervical neoplasia. J Virol. 1989 Jun;63(6):2829–2834. doi: 10.1128/jvi.63.6.2829-2834.1989. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Mertz G. J. Genital herpes simplex virus infections. Med Clin North Am. 1990 Nov;74(6):1433–1454. doi: 10.1016/s0025-7125(16)30489-8. [DOI] [PubMed] [Google Scholar]
- Prober C. G., Corey L., Brown Z. A., Hensleigh P. A., Frenkel L. M., Bryson Y. J., Whitley R. J., Arvin A. M. The management of pregnancies complicated by genital infections with herpes simplex virus. Clin Infect Dis. 1992 Dec;15(6):1031–1038. doi: 10.1093/clind/15.6.1031. [DOI] [PubMed] [Google Scholar]
- Rogers B. B., Josephson S. L., Mak S. K. Detection of herpes simplex virus using the polymerase chain reaction followed by endonuclease cleavage. Am J Pathol. 1991 Jul;139(1):1–6. [PMC free article] [PubMed] [Google Scholar]
- Rüdlinger R., Norval M. Herpes simplex virus infections: new concepts in an old disease. Dermatologica. 1989;178(1):1–5. doi: 10.1159/000248375. [DOI] [PubMed] [Google Scholar]
- Safrin S. Treatment of acyclovir-resistant herpes simplex virus infections in patients with AIDS. J Acquir Immune Defic Syndr. 1992;5 (Suppl 1):S29–S32. [PubMed] [Google Scholar]
- Saiki R. K., Gelfand D. H., Stoffel S., Scharf S. J., Higuchi R., Horn G. T., Mullis K. B., Erlich H. A. Primer-directed enzymatic amplification of DNA with a thermostable DNA polymerase. Science. 1988 Jan 29;239(4839):487–491. doi: 10.1126/science.2448875. [DOI] [PubMed] [Google Scholar]
- Schiffman M. H., Kiviat N. B., Burk R. D., Shah K. V., Daniel R. W., Lewis R., Kuypers J., Manos M. M., Scott D. R., Sherman M. E. Accuracy and interlaboratory reliability of human papillomavirus DNA testing by hybrid capture. J Clin Microbiol. 1995 Mar;33(3):545–550. doi: 10.1128/jcm.33.3.545-550.1995. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Stollar B. D., Rashtchian A. Immunochemical approaches to gene probe assays. Anal Biochem. 1987 Mar;161(2):387–394. doi: 10.1016/0003-2697(87)90467-2. [DOI] [PubMed] [Google Scholar]
- Telenti A., Imboden P., Germann D. Competitive polymerase chain reaction using an internal standard: application to the quantitation of viral DNA. J Virol Methods. 1992 Sep;39(3):259–268. doi: 10.1016/0166-0934(92)90099-y. [DOI] [PubMed] [Google Scholar]
- Tidy J. A., Parry G. C., Ward P., Coleman D. V., Peto J., Malcolm A. D., Farrell P. J. High rate of human papillomavirus type 16 infection in cytologically normal cervices. Lancet. 1989 Feb 25;1(8635):434–434. doi: 10.1016/s0140-6736(89)90023-8. [DOI] [PubMed] [Google Scholar]
- Tidy J., Farrell P. J. Retraction: human papillomavirus subtype 16b. Lancet. 1989 Dec 23;2(8678-8679):1535–1535. doi: 10.1016/s0140-6736(89)92987-5. [DOI] [PubMed] [Google Scholar]
- Veal N., Payan C., Fray D., Sarol L., Blanchet O., Kouyoumdjian S., Lunel F. Novel DNA assay for cytomegalovirus detection: comparison with conventional culture and pp65 antigenemia assay. J Clin Microbiol. 1996 Dec;34(12):3097–3100. doi: 10.1128/jcm.34.12.3097-3100.1996. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Voller A., Bidwell D. E., Bartlett A. Enzyme immunoassays in diagnostic medicine. Theory and practice. Bull World Health Organ. 1976;53(1):55–65. [PMC free article] [PubMed] [Google Scholar]