Seminal Fluid, Acid Phosphatase Test (6 tests)

The BLUESTAR ® Identi-PSA is a rapid qualitative analysis device for the detection of PSA from traditional biological samples (serum, plasma, or blood) and also from semen samples collected with a swab either at the clothing or on the body of the alleged victim of a sexual assault.

BLUESTAR ® Identi-PSA is perfectly indicated for use in forensic medicine:

     • High sensitivity: detects PSA levels greater than or equal to 4 ng/ml

     • Reliable

     • Fast: reacts in 10 minutes.

     • Easy comparison with the traditional ELISA method.

Content BLUESTAR® Identi–PSA is a test that consists of two parts:

The sample to be examined is transferred to the tube with the extraction buffer. This mixture is added dropwise to the wheel of the test device.

A positive sample is typically detected within 10 minutes.

A single burgundy line in zone "C" means that the control fluid is working well, but no PSA has been detected, while two burgundy lines mean that the test has worked correctly and PSA has been detected. .

Principle:

Prostate-specific antigen (PSA) is an intracellular glycoprotein (molecular weight: 34,000 daltons) synthesized only by the male prostate gland and in seminal plasma.

This protein is now used by forensics as a chosen marker to detect sexual assaults, even when committed by men who have had a vasectomy.

BLUESTAR ® Identi -PSA is a rapid qualitative assay for the detection of PSA from traditional biological samples (serum, plasma or blood) and also from semen samples collected with swabs, either on clothing or on bodies of the victims.

The method employs a unique combination of monoclonal color conjugate (mouse) and monoclonal antibodies (solid phase) to selectively identify PSA antigen in samples, with a high degree of sensitivity.

As the sample flows through the absorbent paper, the colored conjugated antibody label binds to the antigen, thus forming an antigen-antibody complex. This complex binds to anti-PSA antibodies in the positive reaction zone (T) and produces a burgundy line if the PSA antigen level is greater than 4 ng/ml. If there is no antigen, no lines appear in the test zone.

The reaction mixture continues to flow through the absorbent paper, past the test zone and the control zone (C). Unbound conjugate binds to the reagents in the control zone, producing a burgundy line - indicating that the reagents are working properly.

Precision:

An evaluation of the BLUESTAR® Identi -PSA test was performed in 1997 for the purpose of using it in forensic medicine. The publication of these results shows that the BLUESTAR® Identi -PSA test is perfectly suitable for this use in terms of sensitivity, specificity and feasibility. The test offers both very high sensitivity and high speed, as well as simplicity compared to the traditional ELISA method.

Reproducibility:

Intra-assay: Within-assay precision was determined by using 10 replicates of three samples with 0, 5, and 10 ng/mL PSA. Negative and positive values were correctly identified 100% of the time.

Inter-trial:

Between-assay precision was determined by using the same three specimens of 0, 5, and 10 ng/mL PSA in 10 independent assays and with three different batches of the reaction device over a 6-month period. Again, the negative and positive values were correctly identified 100% of the time.

Sensitivity:

The BLUESTAR ® Identi-PSA can detect PSA levels greater than or equal to 4 ng / ml according to the international PSA standard (CRM 613 N ° 1004 of the European Standard Office, Belgium 1998). However, some samples containing less than 5 ng/mL may produce positive results.

Hook effect:

Some samples containing very high PSA levels (up to 10 mg/ml) consistently caused positive results. However, some negative sperm samples caused positive results after 1/100 or 1/1,000 dilution. In case of doubt for some samples, it is then necessary to do another test after 1/100 or 1/1,000 dilution.

Storage temperature:

All the components of BLUESTAR ® Identi -PSA have a storage temperature range between 4ºC and 30ºC.

Also available in packs of 24 tests.