Comparative performance of the Kalon and HerpeSelect enzyme-linked immunosorbant assays to determine the prevalence of herpes simplex virus type 2 in Papua New Guinea
Claire E. Ryan A B G H I , Cassey S. Simbiken A H , Paul A. Agius B , Joyce Allen A , Joyce Sauk C , Petronia Kaima D , Zure Kombati E , Peter Siba A , John M. Kaldor F , Andrew Vallely A F and on behalf of the Male Circumcision Acceptability and Impact Study MCAIS Team
+ Author Affiliations
- Author Affiliations
A Papua New Guinea Institute of Medical Research, Goroka, Eastern Highlands Province 441, Papua New Guinea.
B Burnet Institute, 85 Commercial Road, Melbourne, Vic. 3004, Australia.
C HOPE World Wide, Port Moresby, NCD, Papua New Guinea.
D Tininga Clinic Mount Hagen General Hospital, Mount Hagen, Western Highlands Province, Papua New Guinea.
E Pathology Department, Mount Hagen General Hospital, Mount Hagen, Western Highlands Province, Papua New Guinea.
F Kirby Institute, UNSW Australia, Sydney, NSW 2052, Australia.
G Present address: Burnet Institute, 85 Commercial Road, Melbourne, Vic. 3004, Australia.
H Authors contributed equally.
I Corresponding author. Email: claire.ryan@burnet.edu.au
Sexual Health 11(6) 575-579 https://doi.org/10.1071/SH14055
Submitted: 18 March 2014 Accepted: 2 October 2014 Published: 1 December 2014
Abstract
Background: Infection with herpes simplex virus type 2 (HSV-2) is common worldwide and an important risk factor for HIV infection. Aetiological diagnosis of HSV-2 is typically determined with the use of commercially available type-specific enzyme-linked immunosorbent assays (ELISAs). This study aimed to determine the prevalence of HSV-2 among people attending sexual health clinics in the Highlands of Papua New Guinea. The study also aimed to compare the performance of two type-specific ELISA assays, the Kalon and HerpeSelect glycoprotein G2 assays, in this context. Methods: Participants were recruited as part of a longitudinal sexual health study. Participants attended four appointments over a 12-month period and had blood taken for HSV-2 serology at each time point. Both the Kalon and HerpeSelect assays were performed as per manufacturer’s instructions. Results: A total of 132 participants were tested for HSV-2 using the Kalon and HerpeSelect ELISAs. HSV-2 prevalence was 52% (95% CI, 43–60) and 61% (95% CI, 52–69) with Kalon and HerpeSelect assays respectively. There was high concordance (87%, к = 0.75, P < 0.001, n = 115) between the two assays at the manufacturer recommended index value cut-offs. For participants with discordant results at baseline, (n = 16), three sero-conversions were observed over the 12-month period when sequential sera was tested. Conclusions: A high HSV-2 prevalence was observed in this clinic-based population. Our longitudinal data indicate the higher prevalence of HSV-2 detected with the HerpeSelect ELISA was likely due to false positives rather than a higher sensitivity in the early stages of infection.
References
[1] Looker KJ, Garnett GP, Schmid GP. An estimate of the global prevalence and incidence of herpes simplex virus type 2 infection. Bull World Health Organ 2008; 86 805–12.| An estimate of the global prevalence and incidence of herpes simplex virus type 2 infection.Crossref | GoogleScholarGoogle Scholar | 18949218PubMed |
[2] Smith JS, Robinson NJ. Age-specific prevalence of infection with herpes simplex virus types 2 and 1: a global review. J Infect Dis 2002; 186 S3–28.
| Age-specific prevalence of infection with herpes simplex virus types 2 and 1: a global review.Crossref | GoogleScholarGoogle Scholar | 12353183PubMed |
[3] Weiss H. Epidemiology of herpes simplex virus type 2 infection in the developing world. Herpes 2004; 11 24A–35A.
| 15115627PubMed |
[4] Rezza G, Danaya RT, Wagner TM, Sarmati L, Owen L, Monini P, Andreoni M, Suligoi B, Ensoli B, Pozio E. Human herpesvirus-8 and other viral infections, Papua New Guinea. Emerg Infect Dis 2001; 7 893–5.
| Human herpesvirus-8 and other viral infections, Papua New Guinea.Crossref | GoogleScholarGoogle Scholar | 1:STN:280:DC%2BD3MnpvFSitQ%3D%3D&md5=d19fa0b014622ae8195c738db524f481CAS | 11747707PubMed |
[5] Suligoi B, Danaya RT, Sarmati L, Owen IL, Boros S, Pozio E, Andreoni M, Rezza G. Infection with human immunodeficiency virus, herpes simplex virus type 2, and human herpes virus 8 in remote villages of southwestern Papua New Guinea. Am J Trop Med Hyg 2005; 72 33–6.
| 1:STN:280:DC%2BD2M7ksVartg%3D%3D&md5=7cc801ec2185fc45cd22940544f78f3eCAS | 15728864PubMed |
[6] Ashley RL. Sorting out the new HSV type specific antibody tests. Sex Transm Infect 2001; 77 232–7.
| Sorting out the new HSV type specific antibody tests.Crossref | GoogleScholarGoogle Scholar | 1:STN:280:DC%2BD3MvhsVOkug%3D%3D&md5=e48039c532a22366d6fd1aa6bffa2b1aCAS | 11463920PubMed |
[7] Delany-Moretlwe S, Jentsch U, Weiss H, Moyes J, Morrow RA, Stevens W, Mayaud P. Comparison of focus HerpesSelect and Kalon HSV-2 gG2 ELISA serological assays to detect herpes simplex virus type 2 antibodies in a South African population. Sex Transm Infect 2010; 86 46–50.
| Comparison of focus HerpesSelect and Kalon HSV-2 gG2 ELISA serological assays to detect herpes simplex virus type 2 antibodies in a South African population.Crossref | GoogleScholarGoogle Scholar | 19837726PubMed |
[8] Gamiel JL, Tobian AA, Laeyendecker OB, Reynolds SJ, Morrow RA, Serwadda D, Gray RH, Quinn T. Improved performance of enzyme-linked immunosorbent assays and the effect of human immunodeficiency virus coinfection on the serologic detection of herpes simplex virus type 2 in Rakai, Uganda. Clin Vaccine Immunol 2008; 15 888–90.
| Improved performance of enzyme-linked immunosorbent assays and the effect of human immunodeficiency virus coinfection on the serologic detection of herpes simplex virus type 2 in Rakai, Uganda.Crossref | GoogleScholarGoogle Scholar | 1:CAS:528:DC%2BD1cXlvFejtrk%3D&md5=f10e0e7bc494bb177a3259d3c76e3921CAS | 18321879PubMed |
[9] Laeyendecker O, Henson C, Gray RH, Nguyen RH-N, Horne BJ, Wawer MJ, Serwadda D, Kiwanuka N, Morrow RA, Hogrefe W, Quinn TC. Performance of a commercial, type-specific enzyme-linked immunosorbent assay for detection of herpes simplex virus type 2-specific antibodies in Ugandans. J Clin Microbiol 2004; 42 1794–6.
| Performance of a commercial, type-specific enzyme-linked immunosorbent assay for detection of herpes simplex virus type 2-specific antibodies in Ugandans.Crossref | GoogleScholarGoogle Scholar | 1:CAS:528:DC%2BD2cXjvFylurk%3D&md5=a9b057965537053dfd3abcc2faf2ab6aCAS | 15071053PubMed |
[10] Ng’ayo MO, Friedrich D, Holmes KK, Bukusia E, Morrow RA. Performance of HSV-2 type specific serological tests in men in Kenya. J Virol Methods 2010; 163 276–81.
| Performance of HSV-2 type specific serological tests in men in Kenya.Crossref | GoogleScholarGoogle Scholar | 1:CAS:528:DC%2BC3cXjtlemtg%3D%3D&md5=e58739e7bbd68363a9cf9a1d05b51336CAS | 19854222PubMed |
[11] Smith JS, Bailey RC, Westreich DJ, Maclean I, Agot K, Ndinya-Achola JO, Hogrefe W, Morrow RA, Moses S. Herpes simplex virus type 2 antibody detection performance in Kisumu, Kenya, using the Herpeselect ELISA, Kalon ELISA, Western blot and inhibition testing. Sex Transm Infect 2009; 85 92–6.
| Herpes simplex virus type 2 antibody detection performance in Kisumu, Kenya, using the Herpeselect ELISA, Kalon ELISA, Western blot and inhibition testing.Crossref | GoogleScholarGoogle Scholar | 1:STN:280:DC%2BD1M3is1Cgtw%3D%3D&md5=714a5a4d9a16d84f831f7b15825e1c37CAS | 18955387PubMed |
[12] Van Dyck E, Buve A, Weiss HA, Glynn JR, Brown DWG, De Deken B, Parry J, Hayes RJ. Performance of commercially available enzyme immunoassays for detection of antibodies against herpes simplex virus type 2 in African populations. J Clin Microbiol 2004; 42 2961–5.
| Performance of commercially available enzyme immunoassays for detection of antibodies against herpes simplex virus type 2 in African populations.Crossref | GoogleScholarGoogle Scholar | 1:CAS:528:DC%2BD2cXntFGksbo%3D&md5=79daeb056cbf84a493861a5c76ae5cc1CAS | 15243045PubMed |
[13] Biraro S, Mayaud P, Morrow RA, Grosskurth H, Weiss HA. Performance of commercial herpes simplex virus type-2 antibody tests using serum samples from Sub-Saharan Africa: a systematic review and meta-analysis. Sex Transm Dis 2011; 38 140–7.
| Performance of commercial herpes simplex virus type-2 antibody tests using serum samples from Sub-Saharan Africa: a systematic review and meta-analysis.Crossref | GoogleScholarGoogle Scholar | 1:CAS:528:DC%2BC3MXlsV2jtQ%3D%3D&md5=75bb2382dd40961a020e5b043bdd7881CAS | 20706175PubMed |
[14] Nascimento MC, Ferreira S, Sabino E, Hamilton I, Parry J, Pannuti CS, Mayaud P. Performance of the HerpeSelect (Focus) and Kalon enzyme-linked immunosorbent assays for detection of antibodies against herpes simplex virus type 2 by use of monoclonal antibody-blocking enzyme immunoassay and clinic-virological reference standards in Brazil. J Clin Microbiol 2007; 45 2309–11.
| Performance of the HerpeSelect (Focus) and Kalon enzyme-linked immunosorbent assays for detection of antibodies against herpes simplex virus type 2 by use of monoclonal antibody-blocking enzyme immunoassay and clinic-virological reference standards in Brazil.Crossref | GoogleScholarGoogle Scholar | 17507516PubMed |
[15] Ngo TD, Laeyendecker O, La H, Hogrefe W, Morrow RA, Quinn TC. Use of commercial enzyme immunoassays to detect antibodies to the herpes simplex virus type 2 glycoprotein G in a low-risk population in Hanoi, Vietnam. Clin Vaccine Immunol 2008; 15 382–4.
| Use of commercial enzyme immunoassays to detect antibodies to the herpes simplex virus type 2 glycoprotein G in a low-risk population in Hanoi, Vietnam.Crossref | GoogleScholarGoogle Scholar | 1:CAS:528:DC%2BD1cXkvVGjsLs%3D&md5=3d43c2879b2e09daba414e0c292b87e6CAS | 18077617PubMed |
[16] Mujugira A, Morrow RA, Celum C, Lingappa J, Delany-Moretlwe S, Fife KH, Heffron R, De Bruyn G, Homawoo B, Karita E, Mugo N, Vwalika B, Baeten JM. Performance of the Focus HerpeSelect-2 enzyme immunoassay for the detection of herpes simplex virus type 2 antibodies in seven African countries. Sex Transm Infect 2011; 87 238–41.
| Performance of the Focus HerpeSelect-2 enzyme immunoassay for the detection of herpes simplex virus type 2 antibodies in seven African countries.Crossref | GoogleScholarGoogle Scholar | 21307152PubMed |
[17] Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics 1977; 33 159–74.
| The measurement of observer agreement for categorical data.Crossref | GoogleScholarGoogle Scholar | 1:STN:280:DyaE2s7jsFWqtA%3D%3D&md5=7d8081fa5a75951c692c5bda10cee878CAS | 843571PubMed |
[18] Morrow RA, Friedrich D, Krantz E. Performance of the focus and Kalon enzyme-linked immunosorbent assays for antibodies to herpes simplex virus type 2 glycoprotein G in culture-documented cases of genital herpes. J Clin Microbiol 2003; 41 5212–4.
| Performance of the focus and Kalon enzyme-linked immunosorbent assays for antibodies to herpes simplex virus type 2 glycoprotein G in culture-documented cases of genital herpes.Crossref | GoogleScholarGoogle Scholar | 1:CAS:528:DC%2BD3sXpvVyhtr0%3D&md5=b73ff08c43462c3f9e9f0cc7469182fcCAS | 14605166PubMed |
[19] Morrow RA, Krantz E, Wald A. Time course of seroconversion by HerpeSelect ELISA after acquisition of genital herpes simplex virus type 1 (HSV-1) or HSV-2. Sex Transm Dis 2003; 30 310–4.
| Time course of seroconversion by HerpeSelect ELISA after acquisition of genital herpes simplex virus type 1 (HSV-1) or HSV-2.Crossref | GoogleScholarGoogle Scholar |
[20] Corey L, Wald A, Celum CL, Quinn TC. The effects of herpes simplex virus-2 on HIV-1 acquisition and transmission: a review of two overlapping epidemics. J Acquir Immune Defic Syndr 2004; 35 435–45.
| The effects of herpes simplex virus-2 on HIV-1 acquisition and transmission: a review of two overlapping epidemics.Crossref | GoogleScholarGoogle Scholar | 15021308PubMed |
[21] Wald A, Link K. Risk of human immunodeficiency virus infection in herpes simplex virus type 2-seropositive persons: a meta-analysis. J Infect Dis 2002; 185 45–52.
| Risk of human immunodeficiency virus infection in herpes simplex virus type 2-seropositive persons: a meta-analysis.Crossref | GoogleScholarGoogle Scholar | 11756980PubMed |
[22] PNG National AIDS Council. Papua New Guinea HIV prevalence: 2009 Estimates. Port Moresby: PNG National AIDS Council & PNG National Department of Health; 2010.
[23] Vallely A Ryan CE Allen J Sauk JC Simbiken CS Wapling J Kaima P Kombati Z Law G Fehler G Murray JM Siba P Kaldor JM
[24] Vallely A, Page A, Dias S, Siba P, Lupiwa T, Law G, Millan J, Wilson DP, Murray JM, Toole M, Kaldor JM. The prevalence of sexually transmitted infections in Papua New Guinea: a systematic review and meta-analysis. PLoS ONE 2010; 5 e15586
| The prevalence of sexually transmitted infections in Papua New Guinea: a systematic review and meta-analysis.Crossref | GoogleScholarGoogle Scholar | 1:CAS:528:DC%2BC3MXjvVSksQ%3D%3D&md5=6a5e2f4d6b4a8a9e8323dc6d1f9d61feCAS | 21203468PubMed |
[25] Rai G, Ryan CE, Vallely L, Wapling JA, Phuanukoonnon S, Wand H, Law G, Mola G, Siba P, Kaldor JM, Vallely A. The prevalence of sexually transmitted infections, including HPV, among antenatal antendees in Asaro, Papua New Guinea. International Union Against Sexually Transmitted Infections World Congress, Melbourne, Australia, 15–17 October 2012.
