Validation of a Semiquantitative Screening Assay for PSA
Screening and surveillance of prostate cancer typically involves sensitive laboratory
techniques for the quantification of plasma prostate specific antigen (PSA). In this study,
we determine the sensitivity and specificity of a simple test strip based PSA assay using
only a few drops of whole blood as compared to a standard plasma PSA assay. Blood samples
will be taken from hundred patients who are followed for a prostatic disease needing PSA
surveillance. Before decantation of the samples, a few drops of blood will serve for the
rapid test on strips. Plasma PSA levels will be determined with the TRACE ("Time Resolved
Amplified Cryptate Emission") technology in homogeneous liquid phase. The results from the
rapid test can then be compared to the plasma levels obtained by TRACE.
Interventional
Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
Determination of the sensitivity and specificity of the rapid PSA assay by comparing the results obtained from the test strip reading by three independent blinded observers with those from standard plasma PSA assay.
day of test
No
Dominique BELLET, Pr
Principal Investigator
Centre Rene Huguenin
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
ID RCB 2008-A01497-48
NCT00853710
March 2009
July 2009
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