Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Comparative Study
. 2014 Aug;90(2):136-41.
doi: 10.1016/j.contraception.2014.03.009. Epub 2014 Mar 25.

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

Margaret C Snead  1 , Athena P Kourtis  2 , Johan H Melendez  3 , Carolyn M Black  4 , Christine K Mauck  5 , Ana Penman-Aguilar  2 , Dorothy M Chaney  3 , Maria F Gallo  2 , Denise J Jamieson  2 , Maurizio Macaluso  6 , Gustavo F Doncel  5
Affiliations
Comparative Study

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

Margaret C Snead et al. Contraception. 2014 Aug.

Abstract

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.

Keywords: Biomarkers; Gels; HEC placebo; Hydroxyethylcellulose; Microbicides; Prostate-specific antigen; Semen; Tenofovir; UC781; Y chromosome.

PubMed Disclaimer

Conflict of interest statement

Conflicts of Interest and Source of Funding: For all authors none were declared.

Figures

Fig. 1
Fig. 1
In vitro effects of TFV 1% gel on PSA detection by the Abbott Architect total PSA assay. The experiments were run in triplicate (on three different dates). The values presented in the graph are the means (in parentheses, standard deviations).
Fig. 2
Fig. 2
In vitro effects of HEC on PSA detection by the Abbott Architect total PSA assay. The experiments were run in triplicate (on three different dates). The values presented in the graph are the means (standard deviations).
Fig. 3
Fig. 3
In vitro effects of TFV 1% gel on Y chromosome DNA detection by real-time PCR. Semen dilutions. The experiments were run in quadruplicate. The values presented in the graph are the means (standard deviations). Asterisks denote statistically significant difference from control (p<.05).
Fig. 4
Fig. 4
In vitro effects of UC 781 on Y chromosome DNA detection by realtime PCR. The experiments were run in quadruplicate. The values presented in the graph are the means (standard deviations). Asterisks denote statistically significant difference from control (p<.05).
Fig. 5
Fig. 5
In vitro effects of HEC on Y chromosome DNA detection by realtime PCR. The experiments were run in quadruplicate. The values presented in the graph are the means (standard deviations).
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Mauck CK, va der Straten A. Using objective markers to assess participant behavior in HIV prevention trials of vaginal microbicides. J Acquir Immune Defic Syndr. 2008;49(1):64–9. - PubMed
    1. Mauck CK, Doncel GF. Biomarkers of semen in the vagina: applications in clinical trials of contraception and prevention of sexually transmitted pathogens including HIV. Contraception. 2007;75(6):407–19. - PubMed
    1. Macaluso M, Lawson L, Akers R, Valappil T, Hammond K, Blackwell R, et al. Prostate-specific antigen in vaginal fluid as a biologic marker of condom failure. Contraception. 1999;59(3):195–201. - PubMed
    1. Gallo MF, Steiner MJ, Hobbs MM, Warner L, Jamieson DJ, Macaluso M. Biological markers of semen exposure: tools for improving the assessment of sexual behavior in HIV/STI prevention research. Sex Transm Dis. 2013;40(6):447–52. - PMC - PubMed
    1. Culhane JF, Nyirjesy P, McCollum K, Casabellata G, Di Santolo M, Cauci S. Evaluation of semen detection in vaginal secretions: comparison of four methods. Am J Reprod Immunol. 2008;60(3):274–81. - PubMed

Publication types

MeSH terms