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.
Subject(s)
Adenine/analogs & derivatives , Chromosomes, Human, Y/chemistry , DNA/analysis , Organophosphonates/chemistry , Prostate-Specific Antigen/analysis , Reverse Transcriptase Inhibitors/chemistry , Semen/chemistry , Adenine/chemistry , Adenine/therapeutic use , Anilides/administration & dosage , Anilides/adverse effects , Anilides/therapeutic use , Antibiotic Prophylaxis , Biomarkers/analysis , Biomarkers/metabolism , Cellulose/analogs & derivatives , Cellulose/chemistry , Chromosomes, Human, Y/metabolism , DNA/metabolism , Excipients/chemistry , False Positive Reactions , Female , Furans/administration & dosage , Furans/adverse effects , Furans/therapeutic use , Humans , Limit of Detection , Organophosphonates/therapeutic use , Osmolar Concentration , Prostate-Specific Antigen/genetics , Prostate-Specific Antigen/metabolism , Real-Time Polymerase Chain Reaction , Reproducibility of Results , Reverse Transcriptase Inhibitors/therapeutic use , Reverse Transcriptase Polymerase Chain Reaction , Tenofovir , Thioamides , Vaginal Creams, Foams, and Jellies/chemistry , Vaginal Creams, Foams, and Jellies/therapeutic useABSTRACT
OBJECTIVES: Little is known about the effects of commonly used lubricants on detection of biomarkers of semen exposure. We investigated the in vitro effect of Gynol®, K-Y Jelly®, Replens®, Astroglide®, Carbopol, and Silicorel on quantitative detection of prostate specific antigen (PSA). STUDY DESIGN: A predetermined concentration of each of the gels was added to serially diluted semen samples. Additionally, serial dilutions of each of the gels were added to three different semen dilutions (high, medium, or low). The resulting samples were tested for PSA on the Abbott ARCHITECT System. RESULTS: When using the Abbott ARCHITECT system, the only products that inhibited PSA detection were Gynol® and Replens®. The inhibition caused by Gynol® was dose-dependent, but that of Replens was dose-independent. K-Y Jelly®-spiked samples had higher PSA values than controls. CONCLUSIONS: Caution is warranted when using the Abbott quantitative assay for PSA detection as a biomarker of semen exposure in settings where Gynol®, Replens® or K-Y Jelly® might also have been used. Neither Astroglide® nor Silicorel inhibited PSA detection. Additional studies evaluating other vaginal products, including microbicides, and their effects on other assays, are needed. In vivo studies will be especially important to optimize PSA detection from clinical samples. IMPLICATIONS: Researchers should consider the potential for specific lubricants or any vaginal products to affect the particular assay used for semen biomarker detection. The Abbott ARCHITECT's total PSA assay should not be used with the product Replens. Caution is warranted when using the assay in settings where Gynol or K-Y jelly may have been used.
