Evaluation of a New Point‐of‐Care Serologic Assay for Herpes Simplex Virus Type 2 Infection

Philip, Susan; Ahrens, Katherine A.; Shayevich, Clara; Roca, Romeo De La; Williams, MaryAnn; Wilson, D L; Bernstein, Kyle T.; Klausner, Jeffrey D.

doi:10.1086/592696

Cited by 18 publications

(18 citation statements)

References 15 publications

(13 reference statements)

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“…10 Participants testing HSV-2-positive received post-test counselling, were offered a prescription for low-cost suppressive therapy (acyclovir) and were referred to their primary care physicians for continued treatment. All procedures were approved by the Indiana University/Clarian Hospitals Institutional Review Board.…”

Section: Methodsmentioning

confidence: 99%

Low acceptance of HSV-2 testing among high-risk women

Roth

Dodge²,

Pol

et al. 2011

Int J STD AIDS

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We evaluated the acceptability of a community-based herpes simplex virus type 2 (HSV-2) screening programme for at-risk women and assessed factors related to uptake of point of care HSV-2 testing. One hundred recently arrested women (median age 34 years) were recruited from a community court handling lower-level misdemeanour cases in Indianapolis, Indiana. Individuals completed a survey assessing factors related to HSV-2 screening intentions and were offered point of care HSV-2 testing. Rates of HSV-2 infection in this population are high; 61.1% of women tested were positive. The majority (81%) accepted a prescription for suppressive therapy. Women in this sample indicated that HSV-2 screening is an important component of health care but were unwilling to pay the US$10 it cost to be tested. To encourage this and other high-risk populations to be screened for HSV-2, public health resources will be needed to help individuals overcome cost-related barriers to care.

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Section: Methodsmentioning

confidence: 99%

Low acceptance of HSV-2 testing among high-risk women

Roth

Dodge²,

Pol

et al. 2011

Int J STD AIDS

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“…A challenge with these assays is the inconclusive diagnosis due to indeterminate results. Some studies have suggested raising the assay index value, especially in high HSV-2 prevalence areas [8]. Most studies however, exclude the indeterminate results [9] since there are no clear guidelines for management or therapy.…”

Section: Introductionmentioning

confidence: 99%

Prevalence, incidence and correlates of HSV-2 infection in an HIV incidence adolescent and adult cohort study in western Kenya

Akinyi¹,

Odhiambo²,

Otieno³

et al. 2017

PLoS ONE

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BackgroundHerpes simplex virus type 2 (HSV-2) infections are associated with increased risk of HIV transmission. We determined HSV-2 prevalence, incidence and associated risk factors, incidence among persons with indeterminate results, and prevalence of HSV-2/HIV co-infection among young adults (18–34 years) and adolescents (16–17 years) enrolled in an HIV incidence cohort study in western Kenya.MethodsParticipants (n = 1106; 846 adults) were screened and those HIV-1 negative were enrolled and followed-up quarterly for one year. HSV-2 was assessed using the Kalon enzyme immunoassay. HSV-2 incidence was calculated separately among HSV-2 seronegative participants and those indeterminate at baseline. Logistic regression was used to estimate the odds of HSV-2 infection and Poisson regression was used to assess HSV-2 incidence and associated factors.ResultsOverall, HSV-2 prevalence was 26.6% [95% confidence interval (CI): 23.9–29.4] and was higher in adults (31.5% [95% CI: 28.3–34.9]) than adolescents (10.7% [95% CI: 7.1–15.3]). Factors associated with prevalent HSV-2 included female gender, increasing age, HIV infection, history of sexually transmitted infection, low level of education, multiple sexual partners, and being married, divorced, separated or widowed. Overall HSV-2 incidence was 4.0 per 100 person-years (/100PY) 95% CI: 2.7–6.1 and was higher in adults (4.5/100PY) and females (5.1/100PY). In multivariable analysis only marital status was associated with HSV-2 incidence. Among 45 participants with indeterminate HSV-2 results at baseline, 22 seroconverted, resulting in an incidence rate of 53.2 /100PY [95% CI: 35.1–80.9]. Inclusion of indeterminate results almost doubled the overall incidence rate to 7.8 /100 PY [95% CI: 5.9–10.5]. Prevalence of HIV/HSV-2 co-infection was higher in female adults than female adolescents (17.1 [95% CI: 13.6–21.0] versus 3.4 [95% CI: 1.1–7.8]).ConclusionThe high incidence rate among persons with indeterminate results underscores the public health concerns for HSV-2 spread and underreporting of the HSV-2 burden. Careful consideration is needed when interpreting HSV-2 serology results in these settings.

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“…HerpeSelect Express HSV-2 rapid assay is a newer test that takes less than 10 minutes to perform. Its usefulness has yet to be widely proven, but its performance appears similar to that of Focus ELISA in the U.S population (Ladema et al 2008; Philip et al 2008). …”

Section: 0 Discussionmentioning

confidence: 99%

“…The fifth test, HerpeSelect Express HSV-2 rapid assay, developed by Focus Diagnostics Cypress CA, is a qualitative test for HSV-2 IgG antibodies in human whole blood or serum, and is used for presumptive diagnosis of HSV-2 infection in sexually active adults or pregnant women. Early reports indicate that Express has comparable performance to the Focus ELISA (Laderman et al 2008; Philip et al 2008) but no comparisons with Western blot have been published. Like Biokit, Express requires no special equipment, and costs about $30 per test.…”

Section: 0 Introductionmentioning

confidence: 99%

Performance of HSV-2 type specific serological tests in men in Kenya

Ngayo

Friedrich

Holmes

et al. 2010

Journal of Virological Methods

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This study compared five serological tests with Western blot from University of Washington to determine the most accurate method for detecting antibodies to herpes simplex virus type 2 (HSV-2) in a male population in Kisumu, Kenya. A random sample of 250 fishermen from 18 beaches along Lake Victoria underwent serological testing by two generations of the HerpeSelect HSV-2 ELISA (“Focus Gen 1” and “Focus Gen 2”), Kalon HSV-2 ELISA (“Kalon”), Biokit HSV-2 Rapid Test (“Biokit”), HerpeSelect Express Rapid HSV-2 (“Express”) against the Western blot test (“WB”) as the “gold standard”. Sensitivity and specificity of tests in this population with a high prevalence of HSV-2 (58% by WB) were: Focus Gen 1: 98.6% and 63.5%; Focus Gen 2: 99.3% and 52.3%; Biokit: 66% and 90.9%; Express: 99.3% and 44.3% and Kalon: 98.6% and 85.7%. Increasing the positive cut-off value improved the specificity of the Focus Gen 2 to 84.9% and Kalon to 92.2%. Focus Gen 2 offered no improvement in specificity over that of Focus Gen 1. Neither rapid assay could be recommended as either a stand-alone assay or as a confirmatory test. The results of Kalon using a cut-off of 1.5 were the most concordant with those of WB for all the approaches tested. However, low positive Kalon test results should be interpreted with caution as they could reflect early seroconversion or false positive results.

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Evaluation of a New Point‐of‐Care Serologic Assay for Herpes Simplex Virus Type 2 Infection

Cited by 18 publications

References 15 publications

Low acceptance of HSV-2 testing among high-risk women

Low acceptance of HSV-2 testing among high-risk women

Prevalence, incidence and correlates of HSV-2 infection in an HIV incidence adolescent and adult cohort study in western Kenya

Performance of HSV-2 type specific serological tests in men in Kenya

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