Does Tenofovir Gel or Do Other Microbicide Products Affect Detection of Biomarkers of Semen Exposure in Vitro?

Overview

Journal Contraception

Publisher Elsevier

Specialty Reproductive Medicine

Date 2014 Apr 22

PMID 24746557

Citations 3

Authors

Margaret C Snead

Athena P Kourtis

Johan H Melendez

Carolyn M Black

Christine K Mauck

Ana Penman-Aguilar

Dorothy M Chaney

Maria F Gallo

Denise J Jamieson

Maurizio Macaluso

Gustavo F Doncel

Affiliations

Soon will be listed here.

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.

Citing Articles

A novel nested polymerase chain reaction targeting the testis-specific protein Y-encoded family of genes for high sensitivity of recent semen exposure detection: Comparison with four other assays of semen detection.

Giguere K, Leblond F, Goma-Matsetse E, Dave V, Behanzin L, Guedou F PLoS One. 2019; 14(7):e0220326.

PMID: 31344101 PMC: 6657882. DOI: 10.1371/journal.pone.0220326.

Differences in Local and Systemic TFV PK Among Premenopausal Versus Postmenopausal Women Exposed to TFV 1% Vaginal Gel.

Thurman A, Chandra N, Yousefieh N, Kimble T, Anderson S, Cottrell M J Acquir Immune Defic Syndr. 2018; 78(1):82-92.

PMID: 29424790 PMC: 5902131. DOI: 10.1097/QAI.0000000000001648.

The use of biomarkers of semen exposure in sexual and reproductive health studies.

Snead M, Black C, Kourtis A J Womens Health (Larchmt). 2014; 23(10):787-91.

PMID: 25268551 PMC: 4285335. DOI: 10.1089/jwh.2014.5018.

References

Mauck C, Doncel G . 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. DOI: 10.1016/j.contraception.2007.02.007. View

Ghanem K, Melendez J, McNeil-Solis C, Giles J, Yuenger J, Smith T . Condom use and vaginal Y-chromosome detection: the specificity of a potential biomarker. Sex Transm Dis. 2007; 34(8):620-3. DOI: 10.1097/01.olq.0000258318.99606.d9. View

Grant R, Lama J, Anderson P, McMahan V, Liu A, Vargas L . Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010; 363(27):2587-99. PMC: 3079639. DOI: 10.1056/NEJMoa1011205. View

Jamshidi R, Penman-Aguilar A, Wiener J, Gallo M, Zenilman J, Melendez J . Detection of two biological markers of intercourse: prostate-specific antigen and Y-chromosomal DNA. Contraception. 2013; 88(6):749-57. PMC: 5845849. DOI: 10.1016/j.contraception.2013.08.003. View

Pang B, Cheung B . Identification of human semenogelin in membrane strip test as an alternative method for the detection of semen. Forensic Sci Int. 2006; 169(1):27-31. DOI: 10.1016/j.forsciint.2006.07.021. View

Johnson E, Kotowski T . Detection of prostate specific antigen by ELISA. J Forensic Sci. 1993; 38(2):250-8. View

Bitner S . False positives observed on the Seratec® PSA SemiQuant Cassette Test with condom lubricants. J Forensic Sci. 2012; 57(6):1545-8. DOI: 10.1111/j.1556-4029.2012.02141.x. View

Stowell L, Sharman L, Hamel K . An enzyme-linked immunosorbent assay (ELISA) for prostate-specific antigen. Forensic Sci Int. 1991; 50(1):125-38. DOI: 10.1016/0379-0738(91)90141-5. View

Maher J, Vintiner S, Elliot D, Melia L . Evaluation of the BioSign PSA membrane test for the identification of semen stains in forensic casework. N Z Med J. 2002; 115(1147):48-9. View

10.

Melendez J, Giles J, Yuenger J, Smith T, Ghanem K, Reich K . Detection and quantification of Y-chromosomal sequences by real-time PCR using the LightCycler system. Sex Transm Dis. 2007; 34(8):617-9. DOI: 10.1097/01.olq.0000258336.65285.31. View

11.

Anton P, Saunders T, Elliott J, Khanukhova E, Dennis R, Adler A . First phase 1 double-blind, placebo-controlled, randomized rectal microbicide trial using UC781 gel with a novel index of ex vivo efficacy. PLoS One. 2011; 6(9):e23243. PMC: 3182160. DOI: 10.1371/journal.pone.0023243. View

12.

Snead M, Kourtis A, Black C, Mauck C, Brown T, Penman-Aguilar A . Effect of topical vaginal products on the detection of prostate-specific antigen, a biomarker of semen exposure, using ABAcards. Contraception. 2012; 88(3):382-6. PMC: 4547343. DOI: 10.1016/j.contraception.2012.10.034. View

13.

Schwartz J, Ballagh S, Kwok C, Mauck C, Weiner D, Rencher W . Fourteen-day safety and acceptability study of the universal placebo gel. Contraception. 2007; 75(2):136-41. DOI: 10.1016/j.contraception.2006.09.003. View

14.

Laffan A, Sawyer I, Quinones I, Daniel B . Evaluation of semen presumptive tests for use at crime scenes. Med Sci Law. 2011; 51(1):11-7. DOI: 10.1258/msl.2010.010040. View

15.

Gallo M, Steiner M, Hobbs M, Warner L, Jamieson D, Macaluso M . Biological markers of sexual activity: tools for improving measurement in HIV/sexually transmitted infection prevention research. Sex Transm Dis. 2013; 40(6):447-52. PMC: 3812692. DOI: 10.1097/OLQ.0b013e31828b2f77. View

16.

Hochmeister M, Budowle B, Rudin O, Gehrig C, Borer U, Thali M . Evaluation of prostate-specific antigen (PSA) membrane test assays for the forensic identification of seminal fluid. J Forensic Sci. 1999; 44(5):1057-60. View

17.

Sutton J, Bosley C, Rands A . The detection by enzyme linked immunosorbent assay of P30 and 19-OH prostaglandin F1/F2, in the presence of a range of possible contaminants. Sci Justice. 1998; 38(3):157-64. DOI: 10.1016/S1355-0306(98)72100-8. View

18.

Jadack R, Yuenger J, Ghanem K, Zenilman J . Polymerase chain reaction detection of Y-chromosome sequences in vaginal fluid of women accessing a sexually transmitted disease clinic. Sex Transm Dis. 2005; 33(1):22-5. DOI: 10.1097/01.olq.0000194600.83825.81. View

19.

Minnis A, Steiner M, Gallo M, Warner L, Hobbs M, van der Straten A . Biomarker validation of reports of recent sexual activity: results of a randomized controlled study in Zimbabwe. Am J Epidemiol. 2009; 170(7):918-24. PMC: 3888136. DOI: 10.1093/aje/kwp219. View

20.

Culhane J, 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. DOI: 10.1111/j.1600-0897.2008.00632.x. View