PSA-CHECK-1 Quantitative determination of Prostate-Specific Antigen in whole blood, plasma or serum samples

The PSA-CHECK-1 is a manual quantitative immunochromatographic test used in combination with VEDALAB’s EASY READER+® instrument for the determination of prostate specific antigen (PSA) concentration in men from serum, plasma (citrate, EDTA or heparin) or whole blood samples. It can be used by medical healthcare professionals (not for self-testing nor near-patient testing) as an aid to assess the status of the prostate gland in men. The determination of sole PSA is not sufficient to diagnose specifically prostate cancer or benign hypertrophy of the prostate gland. The PSA-CHECK-1 only allows the determination of normal or abnormal level in PSA. Additional investigation such as biopsy and/or rectal digital examination are necessary for the final diagnosis.

Each kit contains everything needed to perform 20 tests: - Aluminium pouches containing: 20 1 PSA-CHECK-1 test device 1 desiccant bag - Disposable plastic pipettes in a protective plastic bag - Diluent bottle (saline buffer, detergent and NaN3 < 0.1%) 20 5 mL - Leaflet 1 Available with ref. 8091/GB only: - 1 PSA medium positive control in a glass vial. - 1 PSA strong positive control in a glass vial. - 1 PSA negative control in a glass vial. Material required but not provided: - Timer.