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Technical Bulletin

BIO SAFE PSA4 
An Aid in Prostate Cancer Detection
Utilizing the proven Hybritech-Beckman Tandem-MP PSA assay. 

BIOSAFE Diagnostic Products, Inc. has applied the Hybritech-Beckman Tandem PSA assay technology for the determination of PSA value from self-collected capillary dried blood spot (DBS) samples. This extended application will greatly enhance the access and compliance of PSA screening for men whose age or risk warrant testing.

Analytical Performance
The equivalence of the DBS test method and the "gold standard" serum based method was demonstrated in both a clinical and analytical study conducted by BIOSAFE Laboratories, Inc. The clinical validity of the capillary DBS sample collection method was established in a clinical trial of 139 men with previously diagnosed prostate disease. The PSA values of the patient population ranged from <0.6 ng/ml to 45 ng/ml. In summary, each study participant provided four types of specimens for analysis; serum, whole venous blood spotted onto BIOSAFE dried blood collection cards, healthcare professional-collected capillary blood on DBS collection cards, and self-collected capillary blood on DBS collection cards. Serum PSA results were compared to each of the DBS-PSA results and statistically analyzed by the linear regression method. A summary of the data generated is as follows:

The data demonstrate stat istical equivalence between the PSA values obtained from the DBS collection method  when compared to the "gold standard" serum PSA assay.

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