title: Does tenofovir gel or do other microbicide products affect detection of biomarkers of semen exposure in vitro?
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: The Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion, Baltimore, MD, USA. Electronic address: msnead@cdc.gov.
authors.forename: Margaret C
authors.initials: MC
authors.lastname: Snead
authors.affiliation: The Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion, Baltimore, MD, USA.
authors.forename: Athena P
authors.initials: AP
authors.lastname: Kourtis
authors.affiliation: Johns Hopkins University School of Medicine, Baltimore, MD, USA.
authors.forename: Johan H
authors.initials: JH
authors.lastname: Melendez
authors.affiliation: The Division of Scientific Resources, National Center for Emerging and Ζοοnotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.
authors.forename: Carolyn M
authors.initials: CM
authors.lastname: Black
authors.affiliation: CONRAD, Eastern Virginia Medical School (EVMS), Arlington, VA, USA.
authors.forename: Christine K
authors.initials: CK
authors.lastname: Mauck
authors.affiliation: The Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion, Baltimore, MD, USA.
authors.forename: Ana
authors.initials: A
authors.lastname: Penman-Aguilar
authors.affiliation: Johns Hopkins University School of Medicine, Baltimore, MD, USA.
authors.forename: Dorothy M
authors.initials: DM
authors.lastname: Chaney
authors.affiliation: The Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion, Baltimore, MD, USA.
authors.forename: Maria F
authors.initials: MF
authors.lastname: Gallo
authors.affiliation: The Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion, Baltimore, MD, USA.
authors.forename: Denise J
authors.initials: DJ
authors.lastname: Jamieson
authors.affiliation: Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Macaluso
authors.affiliation: CONRAD, Eastern Virginia Medical School (EVMS), Arlington, VA, USA.
authors.forename: Gustavo F
authors.initials: GF
authors.lastname: Doncel
mesh_terms: D000225:Adenine / Q000031:analogs & derivatives* / Q000737:chemistry / Q000627:therapeutic use; D000813:Anilides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D019072:Antibiotic Prophylaxis; D015415:Biomarkers / Q000032:analysis / Q000378:metabolism; D002482:Cellulose / Q000031:analogs & derivatives / Q000737:chemistry; D041322:Chromosomes, Human, Y / Q000737:chemistry* / Q000378:metabolism; D004247:DNA / Q000032:analysis* / Q000378:metabolism; D005079:Excipients / Q000737:chemistry; D005189:False Positive Reactions; D005260:Female; D005663:Furans / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D057230:Limit of Detection; D063065:Organophosphonates / Q000737:chemistry* / Q000627:therapeutic use; D009994:Osmolar Concentration; D017430:Prostate-Specific Antigen / Q000032:analysis* / Q000235:genetics / Q000378:metabolism; D060888:Real-Time Polymerase Chain Reaction; D015203:Reproducibility of Results; D018894:Reverse Transcriptase Inhibitors / Q000737:chemistry* / Q000627:therapeutic use; D020133:Reverse Transcriptase Polymerase Chain Reaction; D012661:Semen / Q000737:chemistry*; D000068698:Tenofovir; D013854:Thioamides; D014622:Vaginal Creams, Foams, and Jellies / Q000737:chemistry / Q000627:therapeutic use
chemical_list: D000813:Anilides; D015415:Biomarkers; D005079:Excipients; D005663:Furans; D063065:Organophosphonates; D018894:Reverse Transcriptase Inhibitors; D013854:Thioamides; D014622:Vaginal Creams, Foams, and Jellies; D002482:Cellulose; C002283:hydroxyethylcellulose; D004247:DNA; D000068698:Tenofovir; D017430:Prostate-Specific Antigen; D000225:Adenine; C100668:UC-781
keywords: Biomarkers; Gels; HEC placebo; Hydroxyethylcellulose; Microbicides; Prostate-specific antigen; Semen; Tenofovir; UC781; Y chromosome
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