Prostate-specific antigen as a biomarker of condom failure: comparison of three laboratory assays and self-reported condom use problems in a randomized trial of female condom performance

Walsh, Terri; Warner, Lee; Macaluso, Maurizio; Frezieres, Ron G.; Snead, Margaret C.; Wraxall, B.G.D.

doi:10.1016/j.contraception.2011.10.018

Cited by 9 publications

(11 citation statements)

References 19 publications

(47 reference statements)

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“…Real-time polymerase chain reaction (PCR) was used for detection of Y chromosome DNA as previously described [21]. The Y chromosome assay offers a qualitative indication of the presence of Y chromosome DNA (positive at >0 ng/mL); the assay also yields quantitative results that have been shown to decrease with time since exposure (detectable up to 14 days) [5–7].…”

Section: Methodsmentioning

confidence: 99%

Does tenofovir gel or do other microbicide products affect detection of biomarkers of semen exposure in vitro?

et al. 2014

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Objectives There is currently no information on whether products evaluated in HIV microbicide trials affect the detection of the semen biomarkers prostate-specific antigen (PSA) or Y chromosome DNA. Study Design We tested (in vitro) dilutions of tenofovir (TFV), UC781 and the hydroxyethylcellulose (HEC) placebo gels using the Abacus ABAcard and the quantitative (Abbott Architect total PSA) assays for PSA and Y chromosome DNA by real-time polymerase chain reaction. Results TFV gel and the HEC placebo adversely affected PSA detection using the ABAcard but not the Abbott Architect total PSA assay. UC781 adversely affected both the ABAcard and Abbott Architect total PSA assays. While there were some quantitative changes in the magnitude of the signal, none of the products affected positivity of the Y chromosome assay. Conclusions The presence of TFV or HEC gels did not affect quantitative PSA or Y chromosome detection in vitro. Confirmation of these findings is recommended using specimens obtained following use of these gels in vivo. Implications Researchers should consider the potential for specific microbicides or any products to affect the particular assay used for semen biomarker detection. The ABAcard assay for PSA detection should not be used with TFV UC781, or HEC.

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Section: Methodsmentioning

confidence: 99%

Does tenofovir gel or do other microbicide products affect detection of biomarkers of semen exposure in vitro?

et al. 2014

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“…In many reproductive health studies, the use of semen biomarkers is often in addition to self-reported sexual behavior. Laboratory-confirmed presence of semen biomarkers in vaginal secretions is considered objective 22,24-27 as opposed to self-report, which is subject to several types of bias. When the research involves sensitive behaviors such as sex and condom use, reporting bias is known or suspected to occur.…”

Section: General Considerations For Determining the Need For Semen Bimentioning

confidence: 99%

“…27 In addition to reporting bias, sometimes participants are unaware of their exposure. 15,22 Participants in clinical trials evaluating barrier methods of contraception, for example, may not be aware of some exposures such as a condom slippage or breakage that results in small exposures to semen. 22,27 By contrast, some participants may report that they had an exposure or experienced issues with the condom, when the use of biomarkers yields negative results for semen exposure.…”

Section: General Considerations For Determining the Need For Semen Bimentioning

confidence: 99%

The Use of Biomarkers of Semen Exposure in Sexual and Reproductive Health Studies

Snead

Black

Kourtis

2014

Journal of Women's Health

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Biomarkers of semen exposure have been used in studies investigating the safety and efficacy of barrier methods of contraception. They have been used as objective indicators of semen exposure when studying sexual behaviors and in human immunodeficiency virus/sexually transmitted infection research interventions where participants are advised to avoid unprotected sex. Semen biomarkers have also been used to assess or validate self-reported sexual behaviors or condom use in reproductive health settings. Prostate-specific antigen (PSA) and Y chromosome DNA (Yc-DNA) have each been evaluated in the past as semen biomarkers and are the most widely used in the field. While both are considered reliable for evaluating exposure to semen, each has unique characteristics. In this report, we summarize the literature and provide some considerations for reproductive health researchers who are interested in using PSA or Yc-DNA as semen biomarkers. We also synthesize our previous published work on the optimal conditions of collecting and storing specimens and assay performance in the presence of other vaginal products that may influence various assays. Semen biomarkers are innovative and promising tools to further study and better understand women’s reproductive and sexual health and behavior. More research is needed to better understand the strengths, limitations, and optimal performance conditions of specific assays in vivo.

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“…Biomarkers of semen exposure have been used in condom effectiveness [1–5], female condom [6], and microbicide trials [7], as well as other women's health research [8–13]. Most studies have used prostate-specific antigen (PSA), a robust biomarker for determining the presence of semen in vaginal fluid.…”

Section: Introductionmentioning

confidence: 99%

Prostate-specific antigen concentration in vaginal fluid after exposure to semen

Kulczycki

Brill²,

Snead

et al. 2017

Contraception

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Objective Prostate-specific antigen (PSA) is the best established biomarker of semen exposure. PSA in vaginal fluid returns to pre-exposure concentrations within 24–48 h, but the speed of decay during the first 10 h is unknown. We sought to determine how fast PSA concentrations decline during the first 10 h after exposure to semen. Study design Women in the 50 enrolled couples were intravaginally inoculated with 10, 20, 100 and 200 µl of their partner's semen and then collected vaginal swabs immediately after, 30 min, 4 h and 10 h after exposure. Forty-seven sets of samples were tested for PSA. Mixed linear models for repeated measures examined the association between log-transformed PSA values and sampling time and semen exposure volume. Sensitivity analyses excluded data from nonabstainers. Fixed-effect estimates from the statistical models were graphed. Results PSA values were highest at 200 µl inoculation volumes and at earlier post-exposure time points, then decline steadily. The lowest inoculation volume (10 µl) corresponded to the smallest concentration of PSA throughout the post-inoculation time points. Average PSA levels return to clinically non-detectable levels within 10 h only at the lowest semen exposures. The PSA decay curve assumes a very similar profile across all time points and semen amounts. Conclusions The PSA decay curve is similar for varying semen exposure volumes, with average PSA concentrations remaining above clinical thresholds 10 h after exposure at all except the very smallest semen exposure levels. PSA is an objective marker of recent exposure to semen, permitting such detection with high accuracy. Implications This study clarifies how PSA values vary at different semen exposure levels and time points during the first 10 h post-exposure. Future contraceptive studies that use PSA as a semen biomarker will be better informed about PSA concentrations at different sampling times and exposure amounts.

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Prostate-specific antigen as a biomarker of condom failure: comparison of three laboratory assays and self-reported condom use problems in a randomized trial of female condom performance

Cited by 9 publications

References 19 publications

Does tenofovir gel or do other microbicide products affect detection of biomarkers of semen exposure in vitro?

Does tenofovir gel or do other microbicide products affect detection of biomarkers of semen exposure in vitro?

The Use of Biomarkers of Semen Exposure in Sexual and Reproductive Health Studies

Prostate-specific antigen concentration in vaginal fluid after exposure to semen

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