Evaluation of the Polyclonal ELISA HPV Serology Assay as a Biomarker for Human Papillomavirus Exposure

Coseo, Sarah; Porras, Carolina; Dodd, Lori E.; Hildesheim, Allan; Rodríguez, Ana Cecilia; Schiffman, Mark; Herrero, Rolando; Wacholder, Sholom; González, Paula; Sherman, Mark E.; Jiménez, Silvia; Solomon, Diane; Bougelet, Catherine; Doorn, Leen Jan Van; Quint, Wim; Safaeian, Mahboobeh

doi:10.1097/olq.0b013e31822545c0

Cited by 18 publications

(13 citation statements)

References 21 publications

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“…This is consistent with documented associations between GST-L1 seropositivity and ever/never sexual activity, age at sexual debut, and lifetime number of sexual partners [22,31,40]. VLP-ELISA is an established HPV exposure marker [11], and we observed moderate concordance between GST-L1 and VLP-ELISA. A previous study compared GST-L1 to a VLP multiplex immunoassay, which is biologically similar but technically different from our VLP-ELISA.…”

Section: Discussionsupporting

confidence: 92%

Glutathione S-transferase L1 multiplex serology as a measure of cumulative infection with human papillomavirus

Robbins

Porras

et al. 2014

BMC Infect Dis

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BackgroundSeveral assays are used to measure type-specific serological responses to human papillomavirus (HPV), including the bead-based glutathione S-transferase (GST)-L1 multiplex serology assay and virus-like particle (VLP)-based ELISA. We evaluated the high-throughput GST-L1, which is increasingly used in epidemiologic research, as a measure of cumulative HPV infection and future immune protection among HPV-unvaccinated women.MethodsWe tested enrollment sera from participants in the control arm of the Costa Rica Vaccine Trial (n = 488) for HPV16 and HPV18 using GST-L1, VLP-ELISA, and two assays that measure neutralizing antibodies (cLIA and SEAP-NA). With statistical adjustment for sampling, we compared GST-L1 serostatus to established HPV seropositivity correlates and incident cervical HPV infection using odds ratios. We further compared GST-L1 to VLP-ELISA using pair-wise agreement statistics and by defining alternate assay cutoffs.ResultsOdds of HPV16 GST-L1 seropositivity increased with enrollment age (OR = 1.20 per year, 95%CI 1.03-1.40) and lifetime number of sexual partners (OR = 2.06 per partner, 95%CI 1.49-2.83), with similar results for HPV18. GST-L1 seropositivity did not indicate protection from incident infection over 4 years of follow-up (HPV16 adjusted OR = 1.72, 95%CI 0.95-3.13; HPV18 adjusted OR = 0.38, 95%CI 0.12-1.23). Seroprevalence by GST-L1 (HPV16 and HPV18, respectively) was 5.0% and 5.2%, compared to 19.4% and 23.8% by VLP-ELISA, giving positive agreement of 39.2% and 20.8%. Lowering GST-L1 seropositivity cutoffs improved GST-L1/VLP-ELISA positive agreement to 68.6% (HPV16) and 61.5% (HPV18).ConclusionsOur data support GST-L1 as a marker of cumulative HPV infection, but not immune protection. At lower seropositivity cutoffs, GST-L1 better approximates VLP-ELISA.

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Section: Discussionsupporting

confidence: 92%

Glutathione S-transferase L1 multiplex serology as a measure of cumulative infection with human papillomavirus

Robbins

Porras

et al. 2014

BMC Infect Dis

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“…ELISA positivity was 3-fold higher than cLIA positivity suggesting that the observed differences in vaccine efficacies among the subset of HPV na€ vepopulations may be due, in part, to the inconsistent cutoffs in the assays used to define the HPV-na€ ve populations. The fact that cLIA did not classify as many seropositives as the ELISA suggests that the cutoff used in the cLIA assay is higher (thus not sensitive) for detecting exposure; in contrast, previous published work suggests that ELISA assays are a good measure of HPV exposure (20)(21)(22).…”

Section: Discussionmentioning

confidence: 49%

“…While this resulted in an efficient sampling, a limitation was that the samples selected were on the basis of seropositivity by ELISA. We believe this does not bias our study, as it measures a broader range of antibodies, and we previously showed this ELISA assay to be a good biomarker of exposure at the suggested cutoff (20,21). ELISA and cLIA are different from each other based on the laboratory-determined cutoff.…”

Section: Discussionmentioning

confidence: 99%

Direct Comparison of HPV16 Serological Assays Used to Define HPV-Naïve Women in HPV Vaccine Trials

Safaeian

Ghosh

Porras

et al. 2012

Cancer Epidemiology, Biomarkers &Amp; Prevention

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Background: Two HPV serological assays, the competitive Luminex immunoassay (cLIA), and an enzymelinked immunoassay (ELISA) against HPV16 have been used to define HPV-na€ ve subcohorts within large HPV vaccination trials. Some of the variation in estimated vaccine efficacies may be due to the differences in these assays used to define the HPV-na€ ve subgroups. To guide the interpretation of published results, we compared these assays.Methods: Replicate enrollment sera from a stratified sample of 388 unvaccinated women from the control arm of the Costa Rica HPV 16/18 Vaccine Trial were measured for antibodies against HPV16 using cLIA and ELISA. Agreement between the assays was estimated using standard and alternative assay cutoffs.Results: Using laboratory-determined seropositivity cutoffs, sampling-adjusted HPV16 seropositivity was 24.8% by ELISA and 7.2% by cLIA. Comparing cLIA and ELISA antibody levels based on the standard cutoffs, overall agreement was 53% (positive-agreement ¼ 49%). The poor agreement was mainly driven by the higher sensitivity of the ELISA than cLIA, resulting in 30% of the ELISA-positive sample that were cLIA-negative (none of the ELISA-negatives were cLIA-positive). Increasing ELISA cutoff to 54 ELISA units (EU)/mL (the level which maximized agreement with cLIA; ELISA standard cutoff is 8 EU/mL) resulted in higher agreement (overall agreement ¼ 91%; positive agreement ¼ 78%).Conclusions: ELISA and cLIA are different from each other based on the laboratory-determined cutoff. Increasing ELISA cutoff increased agreement with cLIA, which could facilitate comparisons among studies that use different assays.Impact: Keeping cLIA at the laboratory-determined cutoff but altering ELISA cutoff for seropositivity might facilitate vaccine efficacy comparisons in the na€ ve cohorts defined by cLIA. Cancer Epidemiol Biomarkers Prev; 21(9); 1547-54. Ó2012 AACR.

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“…Detection of antibodies has been used as an epidemiological measure of HPV exposure and as a marker of immunity or protection from subsequent infections to inform vaccine policy. 13,14 Serological studies suggest that approximately 20% to 50% of women with active cervical HPV infection do not have detectable type-specific anti-HPV antibodies, 15,16 and that it can take more than a year after the initial infection to develop antibodies 17 but, once present, has been shown to persist for many years. 18,19 Studies using detection of antibodies to HPV have mostly been performed on plasma or serum samples, but Waterboer and colleagues 20 recently demonstrated the successful use of dried blood spots (DBS) for detection of antibodies to HPV.…”

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confidence: 99%

Human Papillomavirus Seropositivity and Subsequent Risk of HIV Acquisition in Rural South African Women

Tanser¹,

Jones²,

Viljoen³

et al. 2013

Sexually Transmitted Diseases

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Objective This study aimed to provide a population-based estimate of human papillomavirus (HPV) seropositivity for women in a rural African context and to evaluate the impact of HPV serostatus on subsequent acquisition of HIVoutside a clinical setting. Design A random sample of women participating in a longitudinal, population-based HIV survey combined with a case-control study. Methods Blood samples of women participating in a single round of population-based HIV surveillance (N = 1049) in a rural South African population were used to measure vaccine-preventable HPV seropositivity (types 6, 11, 16, and 18) in the general population in 2010. Using results from the repeat HIV surveys, a case-control analysis was then performed comparing HPV sero-status in samples taken from HIV sero-converting women (prior to infection with HIV) against samples from HIV-uninfected, sexually-active controls matched 1:1 according to 5-year age band (377:377). Unconditional multivariable logistic regression with multiple imputations was used to control for sociodemographic and behavioral variables associated with HIV acquisition. Results Human papillomavirus seropositivity in the population-based sample of women was 20.8% (95% confidence interval [CI], 18.3–23.4), and HIV prevalence was 27.6% (95% CI, 24.9–30.4). In the case-control analysis, allowing for variables known to be associated with HIV incidence, HPV seropositivity was associated with nearly 2.5 times the odds of subsequent acquisition of HIV (adjusted odds ratio, 2.33 [95% CI, 1.61–3.39]; P < 0.001). Conclusions These results suggest that HPV vaccination before or soon after sexual debut could lower HIV infection risk. Randomized trials that quantify the impact of HPV vaccination in girls on the risk of acquiring HIV are urgently required.

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Evaluation of the Polyclonal ELISA HPV Serology Assay as a Biomarker for Human Papillomavirus Exposure

Cited by 18 publications

References 21 publications

Glutathione S-transferase L1 multiplex serology as a measure of cumulative infection with human papillomavirus

Glutathione S-transferase L1 multiplex serology as a measure of cumulative infection with human papillomavirus

Direct Comparison of HPV16 Serological Assays Used to Define HPV-Naïve Women in HPV Vaccine Trials

Human Papillomavirus Seropositivity and Subsequent Risk of HIV Acquisition in Rural South African Women

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