M. Lein et al., STRIP TEST FOR THE QUICK DETECTION OF INCREASED CONCENTRATIONS OF PROSTATE-SPECIFIC ANTIGEN IN BLOOD, European journal of clinical chemistry and clinical biochemistry, 34(6), 1996, pp. 511-514
We tested the performance of the new immunochemical membrane test BioS
ign PSA for detecting serum concentrations of prostate-specific antige
n > 4 mu g/l. Measurements were simultaneously performed on 161 serum
samples, using the strip test and three quantitative assays of prostat
e specific antigen (Tandem-E, Imx, LIA-mat). Based on the upper refere
nce limit of 4 mu g/l, 11-37% of the results obtained with the BioSign
test were false-negative and 4-15% were false-positive, compared with
the data of the three quantitative assays. It is concluded that the B
ioSign test in its present form does not satisfactorily differentiate
between prostate-specific antigen concentrations above and below 4 mu
g/l, but an improved version of the test would be useful.