tPSA Rapid Quantitative Test

Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood.

Precision
Intra-lot Precision

Intra-lot precision was determined by testing of tPSA reference materials using 10 test devices from the same lot. CV ≤ 15%.

Inter-lot Precision

Inter-lot precision was determined by testing of tPSA reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.

Accuracy
tPSA control materials with two different concentrations were tested by every lot of test device, and the deviations were within ± 15%.