Our study evaluated the BTA (bladder tumor antigen) stat test kit as a prim
ary screening device for the detection of transitional-cell carcinoma (TCC)
of the bladder; with direct comparison by voided urine cytology (VUC) on t
he sa,ne specimens. The unfixed voided urine of 100 patients with no histor
y of bladder cancer who had signs and symptoms of dysuria, incontinence, an
d gross hematuria and microhematuria were tested using the one-step BTA sta
t test kit before processing via the cytospin technique for fluid cytologic
al evaluation. The patients in the study were followed for up to 12 mo with
repented urine cytological testing cystoscopy, and bladder biopsy when cli
nically indicated Nineteen cases tested positive, and 81 cases rested negat
ive on the BTA stat test. VUC diagnosed three cases as unequivocally positi
ve for TCC, 93 cases as negative, and four cases in which unqualified atypi
cal urothelial cells were noted TCC was confirmed by cystoscopy and bladder
biopsy in three of three cases diagnosed by VUC and in three of 19 cases t
hat tested positive bl the BTA slat test. These findings resulted in an 84%
false-positive rate for the BTA stat rest and no Salse-positive cases for
VUC during the 12-mo follow-up period The results indicate that the sensiti
vity a,ld specificity of BTA stat test air comparable to those of VUC; howe
ver; owing to a relatively high false-positive rate, it can at hest act as
an adjunct to urine cytological study for bladder cancer screening. (C) 199
9 Wiley-Liss, Inc.