PSA4 PSA4 measures levels of prostate-specific antigen (PSA) in the blood and is one of the best tools currently available for detecting prostate cancer in its earliest--and most curable--stages. (Prescription required for New York residents)

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Technical Bulletin

BIOSAFE Laboratories, Inc.
Technical Bulletin 
Dried Blood Spot (DBS) Prostate Specific Antigen (PSA) Assay 
Performance Characteristics

Within-Run Precision
Within-run precision was determined by assaying dried blood spots containing various concentrations of PSA. Each of the samples was assayed in replicates of two, in twenty different runs randomly divided between two lots of kit reagents (n=20). The data are presented below.

Between-Run Precision
Between-run precision was determined by a series of duplicate measurements of two different dried blood spot samples over a series of twenty individually calibrated runs (n=20).

Recovery and Dilution
Whole blood containing elevated levels of endogenous PSA was diluted with the 0 ng/mL calibrator, spotted onto specimen collection cards and dried. The specimens were assayed in quadruplicate.

*% recovery equals observed concentration of PSA divided by the expected concentration of PSA times 100.

Reportable Ranges
The BIOSAFE Laboratories Dried Blood Spot Prostate Specific Antigen Assay is intended as a screen to determine PSA levels. In this analysis using the BIOSAFE DBS - PSA Detection method, the upper level of normal (<4.0 ng/mL) was validated by our clinical laboratory using the Hybritech Tandem(R) serum method.

Based on these data, PSA values of 4.0 ng/mL or greater are considered statistically elevated when using the BIOSAFE DBS-PSA assay. Patients are strongly encouraged to have follow-up testing performed when results fall between 3.0 and 4.0 ng/mL.

Minimum Detectable Concentration
The minimum detectable concentration of the BIOSAFE Laboratories Dried Blood Spot PSA Assay is less than 0.6 ng/mL. The minimum detectable concentration is defined as that concentration of PSA that corresponds to the absorbance that is two standard deviations greater than the mean absorbance of 20 replicate determinations of the Zero Diluent/Calibrator

Specimen Requirements
The BIOSAFE Laboratories Dried Blood Spot Prostate Specific Antigen Assay requires three (3) 50 uL drops of capillary whole blood placed onto the BIOSAFE Blood Collection Card. The blood is dried and placed into a waterproof outer envelope provided for shipping via regular mail to BIOSAFE Laboratories for testing

Specimen Stability
Dried blood spot PSA specimens are stable for more than 14 days when stored at room temperature and for greater than 28 days when stored at -20 degrees C.

Convenient and Simple to Administer
Simple instructions guide the patient through self-collection of a capillary blood sample onto a collection card using a finger lancet. BIOSAFE PSM requires only four simple steps:

1. Collection kit provided to patient.
2. Patient applies blood sample onto card.
3. Blood sample sent to BIOSAFE Laboratories in provided  mailer.
4. "Gold Standard" Hybritech Tandem(TM) PSA results returned within  days.

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