Prostate-specific antigen in vaginal fluid as a biologic marker of condom failure

Macaluso, Maurizio; Lawson, Louise; Akers, Rachel; Valappil, Thamban; Hammond, Karen R.; Blackwell, Richard E.; Hortin, Glen L.

doi:10.1016/s0010-7824(99)00013-x

Cited by 112 publications

(147 citation statements)

References 19 publications

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“…Previously conducted studies [2][3][4]7,[12][13][14][15][16] have typically employed only a single PSA assay. Our findings indicated a remarkable consistency of biomarker results regarding the presence or absence of semen exposure across the three PSA assays.…”

Section: Discussionmentioning

confidence: 99%

“…For the EIA assay, we set our threshold for an evaluable pre-coital PSA concentration of <5 ng/mL based on a reanalysis of results from a previous study of 40 women in Alabama where the decay of PSA concentrations was evaluated following vaginal inoculation with measured amounts of semen [3]. As shown in Appendix, most vaginal samples taken between 24 and 48 h after inoculation with semen yielded a PSA value <5 ng/mL.…”

Section: 12mentioning

confidence: 99%

“…Objective biomarkers of semen exposure, most notably prostate-specific antigen (PSA), are valid predictors of exposure to semen and may offer a reliable counterpart to user self-report for assessing condom performance during penile-vaginal intercourse [1]. An increasing number of clinical trials have incorporated testing for PSA levels to assess the performance of male and female condoms [2][3][4][5][6][7][8][9][10][11][12].…”

Section: Introductionmentioning

confidence: 99%

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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

et al. 2012

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Background-Prostate-specific antigen (PSA), a biomarker for semen exposure, may provide a more objective measure of condom failure than subject self-reports. Methods for measuring PSA vary and their comparability with respect to assessing condom performance has not been adequately evaluated. This study compared results from three different PSA assays of vaginal samples collected by subjects in a randomized clinical trial which compared the performance of female condoms.Study Design-We selected 30 pairs of pre-and post-coital vaginal samples from subjects who reported condom functionality problems or whose original PSA assay was positive. Samples were retested using three different PSA assays [quantitative enzyme-linked immunoassay (EIA), rocket immune-electrophoresis (RIE) and chromatographic immunoassay (CIA)]. We compared the proportion of condom uses where the post-coital PSA result indicated semen exposure for each of the three assays.Results-Despite varying levels of sensitivity, the results from all three assays were remarkably consistent. Self-reported condom failures did not correlate well with positive PSA results, suggesting that exclusive reliance on either PSA or user self-report may be inadequate for assessing condom functionality. HHS Public Access Author Manuscript Author ManuscriptAuthor Manuscript Author ManuscriptConclusion-In combination with user self-report of condom failure, PSA testing provides a reliable, objective marker of condom functionality. Studies based on PSA testing may improve on conventional contraceptive clinical trials by offering a more direct assessment of a condom product's ability to prevent semen exposure.

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Section: Discussionmentioning

confidence: 99%

Section: 12mentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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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

et al. 2012

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“…Interviewers were trained not to press women too hard for an explanation following presentation of their PSA test results. Though false positives are rare with this particular test [18], the interviewers were trained to tell women that there might have been a laboratory error in their testing in the case that a participant showed signs of discomfort with the test result.…”

Section: Methodsmentioning

confidence: 99%

“…In controlled trials, the sensitivity of PSA tests to the presence of even moderate levels of semen in the vagina was 99 % [17]. However, studies also show that PSA degrades rapidly in the vagina, returning to baseline levels in 24-48 h after exposure [18]. Studies comparing PSA test results with self-reported sexual behaviors have identified high levels of discordance between the two, confirming concerns about the under-reporting of unprotected sexual activity and over-reporting of condom use [7,[19][20][21][22][23].…”

Section: Introductionmentioning

confidence: 99%

Exploring Discordance Between Biologic and Self-Reported Measures of Semen Exposure: A Qualitative Study Among Female Patients Attending an STI Clinic in Jamaica

Carter¹,

Bailey

Snead³

et al. 2012

AIDS Behav

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Correspondence to: Marion W. Carter, acq0@cdc.gov. HHS Public Access Author Manuscript Author ManuscriptAuthor Manuscript Author ManuscriptWe explored the use of qualitative interviews to discuss discrepancies between two sources of information on unprotected sex: biomarker results and self-reported survey data. The study context was a randomized trial in Kingston, Jamaica examining the effect of STI counseling messages on recent sexual behavior using prostate-specific antigen (PSA) as the primary study outcome. Twenty women were interviewed. Eleven participants were selected because they tested positive for PSA indicating recent semen exposure, yet reported no unprotected sex in a quantitative survey ("discordant"): 5 reported abstinence and 6 reported condom use. Nine participants who also tested positive for PSA but reported unprotected sex in the survey were interviewed for comparison ("concordant"). Qualitative interviews with 6 of the 11 discordant participants provided possible explanations for their PSA test results, and 5 of those were prompted by direct discussion of those results. Rapid PSA testing combined with qualitative interviews provides a novel tool for investigating and complementing self-reported sexual behavior.

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The Validity of Teens' and Young Adults' Self-reported Condom Use

Rose¹,

DiClemente²,

Wingood³

et al. 2009

Arch Pediatr Adolesc Med

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Prostate-specific antigen in vaginal fluid as a biologic marker of condom failure

Cited by 112 publications

References 19 publications

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

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

Exploring Discordance Between Biologic and Self-Reported Measures of Semen Exposure: A Qualitative Study Among Female Patients Attending an STI Clinic in Jamaica

The Validity of Teens' and Young Adults' Self-reported Condom Use

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