US CUSTOMER 
BLUESTAR® Identi-PSA® is a rapid test for the detection of prostate specific antigen (PSA) from traditional biological samples such as serum, plasma, or blood, and also from semen samples collected using a swab on clothing or directly on the body of a suspected sexual assault victim.
The test is perfectly suited for forensic applications. It is highly sensitive, reliable, fast (results in under 10 minutes), and much simpler to use than traditional ELISA methods.
Product codes: VD-PSA-24 (box of 24) and VD-PSA-6 (box of 6)
PSA is a glycoprotein produced exclusively by the male prostate gland and present in seminal plasma. It is now recognized in forensic medicine as a key marker in cases of suspected sexual assault, even when committed by men who have undergone vasectomy.
BLUESTAR® Identi-PSA® uses monoclonal antibodies both in a dye-conjugated format and in the test’s solid phase to ensure high sensitivity and specificity.
As the sample flows across the absorbent membrane, the dye-conjugated antibodies bind to any PSA present, forming an antigen-antibody complex. This complex is captured by anti-PSA antibodies in the test zone (“T”), producing a wine-colored line when PSA levels are greater than 4 ng/ml.
A second wine-colored control line appears in the “C” zone to confirm correct test operation. If no PSA is present, only the control line appears.
The test was evaluated in 1997 for forensic use and showed excellent sensitivity, specificity, and ease of use. It provides high sensitivity and speed, with simpler operation compared to ELISA.
Intra-assay testing using specimens with 0, 5, and 10 ng/ml of PSA produced 100% correct results across 10 replicates.
Inter-assay testing using three different lots over six months also yielded 100% accuracy for the same concentrations.
The test detects PSA levels ≥ 4 ng/ml according to the European PSA reference standard (CRM 613 N°1004, 1998).
However, some samples containing less than 5 ng/ml may yield positive results.
Very high PSA concentrations (up to 10 μg/ml) consistently yield positive results.
Some negative samples may produce false positives after 1/100 or 1/1,000 dilutions. If a result is doubtful, it is recommended to re-test the sample after dilution.
- 1 collection tube with 1 ml of extraction buffer
- 1 sterile swab
- 1 test device
- Transfer the test sample into the diluent vial
- Add four drops into the well of the test device
- Read results at 10 minutes but not after 15 for accuracy
- One wine-colored line in the control zone (“C”) confirms the test is valid
- A second line in the test zone (“T”) indicates a positive result for PSA
Store all components in a dry place between 4°C and 30°C (40°F to 90°F)
Packaging
- Box of 24 tests (code VD-PSA-24):
Includes 24 collection tubes, 24 sterile swabs, 24 Identi-PSA® test devices, and 1 instruction sheet
Dimensions: 21.5 x 14 x 7.5 cm (8.5 x 5.5 x 3 in)
Weight: 365 grams (12.9 oz) - Box of 6 tests (code VD-PSA-6):
Includes 6 collection tubes, 6 sterile swabs, 6 Identi-PSA® test devices, and 1 instruction sheet
Dimensions: 21.5 x 14 x 7.5 cm (8.5 x 5.5 x 3 in)
Weight: 193 grams (6.9 oz)