False Positives Observed on the Seratec® PSA SemiQuant Cassette Test with Condom Lubricants

Abstract: In the course of the validation of a new component of the prostate‐specific antigen (PSA) SemiQuant Cassette Test marketed by Seratec^®, a false‐positive reaction was observed when testing samples collected from the surface of unused, lubricated condoms. A variety of personal lubricants and condoms were tested to determine the frequency of the false positive, as well as its potential source. Samples were extracted in both water and the manufacturer‐provided buffer, and the test was performed according to the manufacturer’s suggested protocol. The false positive was observed intermittently, but occurred consistently with samples containing nonoxynol‐9, a strong detergent utilized as a spermicide. The reaction may be attributable to the combination of latex and nonoxynol‐9. Because of the unreliability of the test to confirm the presence of PSA in samples collected from condoms, the PSA cassette is an unsuitable method for confirming the presence of seminal fluid in condoms.