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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.
| Mean (ng PSA/mL) |
Standard Deviation |
% Coefficient of Variation |
| 3.42 23.5 |
0.349 1.431 |
10.20% 6.09% |
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).
| Mean (ng PSA/mL) |
Standard Deviation |
% Coefficient of Variation |
| 3.4 23.5 |
0.535 3.831 |
15.64% 16.30% |
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.
| Expected Concentration ng PSA/mL |
Observed Concentration ng PSA/mL |
% Recovery* |
| 19.01 9.50 4.75 2.38 1.19 0.59 |
19.02 9.86 5.21 2.51 1.30 0.51 |
100% 104% 110% 106% 109% 86% |
*% 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.
|
Serum vs. BIOSAFE DBS - PSA Detection System |
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BIOSAFE |
Tandem Serum Disposition | |
| Normal (<4.0 ng/mL) |
Elevated (4.0 ng/mL or greater) |
|
| (<3.0 ng/mL) | 55 | 0 |
| (3.0 - 4.0 ng/mL) | 2 | 1 |
| (4.0 ng/mL or greater) | 3 | 57 |
| Total (n=118) | 60 | 58 |
| BIOSAFE PSA Detection System Sensitivity & Specificity | ||
| Value | Sensitivity | Specificity |
| 3.0 ng/mL 4.0 ng/mL |
100% 98% |
92% 95% |
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:
For more Technical Bulletin's click here.
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