Purpose: We prospectively evaluate and compare the sensitivity and specific
ity of urine cytology, BTA stat,dagger NMP22,double dagger fibrin/fibrinoge
n degradation products (FDP), telomerase, chemiluminescent hemoglobin and h
emoglobin dipstick to detect bladder cancer.
Materials and Methods: Single voided specimens were obtained from 57 patien
ts with bladder cancer, and 139 without evidence of bladder malignancy on c
ystoscopy or a negative biopsy of indeterminate lesions. A cytology report
was available for 125 patients and interpreted independently . BTA slat, NM
P22 and FDP were analyzed according to manufacturer specifications. The tel
omerase assay was performed on cells collected from urine by centrifugation
in preparation for polymerase chain reaction based amplification using the
telomeric repeat amplification protocol assay. The chemiluminescent screen
ing assay for hemoglobin in urine uses the pseudoperoxidase activity of hem
oglobin on hydrogen peroxide and subsequent oxidation of 7-dimethylaminonap
hthalene-1,2-dicarbonic acid hydrazide to generate chemiluminescence emissi
on. Hemoglobin dipstick was interpreted as positive if the hemoglobin conte
nt in the urine was trace or greater.
Results: Overall sensitivity with urine cytology, BTA stat, NMP22, FDP, tel
omerase, chemiluminescent hemoglobin and the hemoglobin dipstick was 44, 74
, 53, 52, 70, 67 and 47%, respectively. Specificity with cytology, telomera
se and FDP was high (95, 99 and 91%, respectively) but BTA stat, NMP22 (opt
imized), chemiluminescent hemoglobin (optimized) and the hemoglobin dipstic
k demonstrated lower specificity of 73, 60, 63 and 84%, respectively. Stepw
ise logistic regression analysis revealed that for all tumors, and within e
ach tumor grade and stage telomerase had the strongest association with bla
dder cancer among all tests (69% overall concordance). Telomerase was also
positive in 91% of the patients (10 of 11) with carcinoma in situ.
Conclusions: Urinary telomerase had the highest combination of sensitivity
and specificity (70 and 99%, respectively) for bladder cancer screening in
these patients. It was the strongest predictor with superior accuracy in pa
tients with grade 1 and noninvasive tumors (pTa), and extremely useful in p
atients with carcinoma in situ. Telomerase appears to be promising and outp
erformed cytology, BTA stat, NMP22, FDP, chemiluminescent hemoglobin and he
moglobin dipstick in the prediction of bladder cancer.