Prosta-Check

Overview

Rapid self-test for the detection of PSA (Prostate Specific Antigen) in blood

In man, the prostate antigen (PSA) is secreted by the prostate. The prostate antigen level gives information about the prostate physiological condition. Thus, levels above the norm may show pathology of the prostate (benign hypertrophy, prostatitis, cancer, etc.). The PSA assay could be performed at least once a year in men over 50 years or having a family history of prostate problems.

In case of prostate problem, early screening allows considerably increasing recovery possibilities.

Who is the test for?

For individuals seeking to discern whether their prostate-specific antigen level falls within the normal range or exceeds the established norm.

How to use

  1. Prepare the test device, the pipette and the diluent dropper vial. Take them out from the protective pouch (tear at the notch. Remove the screw cap of the diluent dropper vial and leave it nearby).
  2. Clean the tip of the middle finger or ring finger with cotton wool moistened with alcohol. Press the lancet firmly against the side of the previously cleaned finger and press the release button.
  3. Without pressing the bulb, put in contact the plastic pipette with the blood sample. The whole blood migrates into the pipette through capillarity to the line indicated on the pipette.
  4. Dispense the blood into the sample well of the cassette, pressing down on the bulb of the pipette. Wait 30-40 seconds for blood absorption. Unscrew the blue cap from the dropper bottle, keeping the white cap secure. Add 4 drops of diluent to the well, spacing each drop 2-3 seconds apart. Read the result after 10 minutes. Do not interpretafter 15 minutes.

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Results and recommendations

Analyze

Result

Summery

  The test is positive
Two coloured lines appear in thewindow under the marks T (Test) and C (Control). Theintensity of the T line may be clearer than the intensityof the C line. This result means that the prostatespecifi c antigen level is higher than the norm and thatyou should consult a doctor
 Test is negative
Only one coloured line appearsunder the mark C (Control). This result means that thepros-tate specifi c antigen level is normal.
 Invalid result
No line appears or a coloured lineappears under the T (Test) mark without any line underthe C mark. In this case, it is not possible to interpretthe test, which must be considered as invalid. It isrecommended to repeat the test with a new PROSTACheck® and a new blood sample.

Questions and answers

How does PROSTA-Check® work?

Prostate specific antigen is a protein secreted in semen by the prostate. A part of this protein is found in blood. The blood PSA level allows an estimation of the prostate physiological condition. A value higher than the norm indicates prostate hypertrophy. This hypertrophy may be benign, may be due to prostatitis or may be cancerous in case of adenocarcinoma. Prostate pathology screening is for men over 50 years and is performed up to 75 years. The PROSTA-Check® test uses a couple of antibodies that specifically detect PSA by producing a coloured test line under the T mark on the cassette. A control line that captures excess antibodies appears as a coloured line under the C mark on the cassette. The PROSTA-Check® test allows one to determine a high blood level, above 4 ng/mL (determined against W.H.O.* reference), of prostate specific antigen likely to show benign or malignant prostate hypertrophy.

*World Health Organization

The PROSTA-Check® test can be performed at any time of the day. However, in the following cases, it is recommended to wait the indicated time before using the test, to avoid false positive results:

waiting time

  • Cycling/Ergometry 24 hours
  • Ejaculation 24 hours
  • Prostate massage 2-3 days
  • Transrectal ultrasounds 2-3 days
  • Cystoscopy 1 week
  • Prostate transurethral resection / biopsy 4-6 weeks
The results are accurate as long as the instructions are carefully respected. Nevertheless, the result can be incorrect if the PROSTA-Check® test getswet before performing the test or if the quantity of blood in the samplewell is not correct. The plastic pipette provided in the box makes sure thecollected blood volume is correct.
The colour and intensity of the lines have no importance for resultinterpretation. The lines should only be homogeneous and complete. The test should be considered as positive regardless of the colour intensityof the test line (T), even weak.
When this line appears, it only means that the test has been performed well. If I read the result after 15 minutes, will the result be reliable? No. The test should be read within 10 minutes after adding the diluent.The results are reliable up to 15 minutes.
If the result is positive, it means that the PSA level present in your bloodis higher than the norm (4 ng/mL) and that you should consult a doctor toshow him the test results. Then, the doctor will decide what you have to do.
If the result is negative, it means that the PSA level in your blood is below4 ng/mL. For patients aged between 50 and 75 years or having relativessuffering from prostate cancer, it is recommended to perform a testregularly.

The PROSTA-Check® test is accurate and has been used for more than 10 years by professionals (hospitals, laboratories) in the field. Evaluation reports show an overall agreement higher than 87% [81.82 – 92.33**] with referenced methods. Although this test is reliable, false positive or false negative results could be obtained.

**CI 95%: 95% Confidence Interval