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Fifth-generation Digital Immunoassay For Prostate-specific Antigen By Single Molecule Array Technology

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Clinical Chemistry | October 13, 2011

David H. Wilson, David W. Hanlon, Gail K. Provuncher, Lei Chang, Linan Song, Purvish P. Patel, Evan P. Ferrell, Herbert Lepor, Alan W. Partin, Dan W. Chan, Lori J. Sokoll, Carol D. Cheli, Robert P. Thiel, David R. Fournier, and David C. Duffy
Clinical Chemistry

Background: Measurement of prostate-specific antigen (PSA) in prostate cancer patients following radical prostatectomy (RP) has been hindered by the limit of quantification of available assays. Because radical prostatectomy removes the tissue responsible for PSA production, postsurgical PSA is typically undetectable with current assay methods. Evidence suggests, however, that more sensitive determination of PSA status following RP could improve assessment of patient prognosis and response to treatment and better target secondary therapy for those who may benefit most. We developed an investigational digital immunoassay with a limit of quantification 2 logs lower than current ultrasensitive third-generation PSA assays.