Kimmi: Does this test check directly for prostate cancer?

Jase: No. It checks whether PSA in a blood sample is above the test’s 4 ng/mL cut-off.

Kimmi: What can make PSA rise?

Jase: Several prostate-related and non-cancer factors can affect it, so a result needs proper medical interpretation.

Prima Prostate PSA Test is a single-use finger-prick blood screening test. PSA is not specific to cancer: an elevated result may have multiple causes, while a result below the cut-off does not rule out prostate cancer or another prostate condition. This test does not diagnose disease or replace an individual discussion with a healthcare professional about whether PSA testing is appropriate.

The supplied technical specifications state specificity of 87.13%, sensitivity of 97.22% and accuracy of 92.34%. These figures do not guarantee an individual result. Seek medical advice for a positive result or urinary and other ongoing symptoms regardless of the result.

Image check: The preserved result image below uses the same source URL as the Menopause FSH and Ovulation LH listings. Confirm the correct PSA interpretation layout in the enclosed manufacturer instructions before relying on the web image.

Contents:

• 1 test cassette
  
• 1 vial with dropper containing the diluent
  
• 2 sterile lancets
  
• 1 pipette for blood sampling
  
• 1 cleanser gauze
  
• Instructions for use
  

Directions

USE PROCEDURE

1. Draw a blood sample by using the sterile lancet provided;
   
2. Collect the sample indicated with the black line by using the capillary pipette provided;
   
3. Deposit the collected specimen into the sample well (S) indicated on the test cassette;
   
4. Add 2 drops of the diluent and wait 5 minutes before reading the result.
   

RESULTS INTERPRETATION

Negative: The PSA value obtained is within the norm.

Positive: The PSA value found is higher than the normal threshold, it is necessary to consult a specialist.

F.A.Q.

What happens if the results reading time is not met?


The test has been carried out correctly when the instructions for use are followed. It includes the reading time and the interpretation of the results shown at the "RESULTS INTERPRETATION" section of the instructions for use.

How to prove that the test worked correctly?


A colored line will appear at the control region (C) on the test device, showing that the test performed correctly. The absence of the colored line suggests to repeat the test with a new device and a new sample.


How to interpret the test if the control and test lines have different intensities?


The color and intensity of the lines do not affect the interpretation of the result. The test has to be considered positive regardless of the color intensity of the test line (T).


BIBLIOGRAPHY

1. Catalona W.J., Southwick P.C., Slawin K.M., Partin A.W., Brawer M.K., Flanigan R.C., Patel A., Richie J.P., Walsh P.C., Scardino P.T., Lange P.H., Gasior G.H., Loveland K.G., Bray K.R.: Comparison of percent free PSA, PSA density, and age-specific PSA cutoffs for prostate cancer detection and staging. Urology. 2000 Aug 1;56(2):255-60.
   
2. Fritsche H.A., Babaian R.J.: Analytical performance goals for measuring prostate specific antigen. Clin Chem. 1993 Jul;39(7):1525-29.
   
3. Michael J. Barry, M.D: Prostate-Specific–Antigen Testing for Early Diagnosis of Prostate Cancer. The New England Journal of Medicine, 2001; 344:1373-1377.