A multicenter trial evaluation of the fibrin/fibrinogen degradation products test for detection and monitoring of bladder cancer.
OBJECTIVE
Presently there is a lack of effective, noninvasive tests for the detection and monitoring of bladder cancer. Measurement of fibrin/fibrinogen degradation products in urine has been shown to be a useful indicator of bladder carcinoma. The objective of this study was to evaluate the AuraTek FDP rapid immunoassay device for the detection of urinary fibrin/ fibrinogen degradation products associated with bladder cancer.


METHODS
A prospective multicenter study was conducted to compare AuraTek FDP with urinary cytology and hemoglobin dipstick for the detection of bladder cancer in 192 patients with a history of bladder cancer.


RESULTS
AuraTek FDP was significantly more sensitive (68%) than conventional urinary cytology (34%, p < 0.001) or hemoglobin dipstick (41%, p < 0.001) in the detection of bladder tumors, particularly for low stage low grade disease. In subjects with invasive disease (T2-T4) the AuraTek FDP test had a sensitivity of 100%. Specificity of AuraTek FDP was 96% for healthy subjects, 86% in patients with urological disease other than bladder cancer and 80% for patients under surveillance for bladder cancer but with a negative cystoscopic finding at the time of assay.


CONCLUSIONS
This simple, rapid (less than 7 minutes) point of care test is superior to conventional urine cytology and hemoglobin dipstick as an aid in the detection of bladder cancer.
Schmetter
B S
BS
PerImmune, Inc., Rockville, Maryland, USA.
Habicht
K K
KK
Lamm
D L
DL
Morales
A
A
Bander
N H
NH
Grossman
H B
HB
Hanna
M G
MG
Silberman
S R
SR
Butman
B T
BT
D000368:Aged; D005260:Female; D005338:Fibrin Fibrinogen Degradation Products / Q000652:urine*; D006801:Humans; D007118:Immunoassay; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D001749:Urinary Bladder Neoplasms / Q000175:diagnosis* / Q000652:urine*
D005338:Fibrin Fibrinogen Degradation Products