Description Use Procedure Draw a blood sample by using the sterile lancet provided Collect the sample indicated with the black line by using the capillary pipette provided Deposit the collected specimen into the sample well (S) indicated on the test cassette Add 2 drops of the diluent and wait 5 minutes before reading the result. Video Instructions 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. Content 1 test cassette 1 vial with dropper containing the diluent 2 sterile lancets 1 pipette for blood sampling 1 cleanser gauze instructions for use Tech Spec PROSTATE PSA TEST is an immunochromatographic device that detects PSA values above the cut-off of 4 ng/mL. Specificity – 87.13% Sensitivity – 97.22% Accuracy – 92.34% FAQ 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” secrion 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 is to be considered positive regardless of the color intensity of the test line (T).
