BACKGROUNDCurrently, cystoscopy and urine cytology are standard modalities in therapy monitoring and follow-up of bladder carcinoma (BC). Cystoscopy is an invasive and uncomfortable procedure while cytology has a limited value because it is operator-dependent and has low sensitivity. This study was to assess the accuracy of ImmunoCyt in detecting BC by comparing it with cytology using systemic analyses of studies published in both English and Chinese.

METHODSCochrane systematic evaluation was used to search through MEDLINE, EMBASE, Cochrane Library, CMCC, and CNKI for studies regarding ImmunoCyt and cytology for detection of BC. Data were extracted and analyzed by the software MetaDiSc 1.4.

RESULTSIn total 42 relevant studies were searched, of which 15 were enrolled and 12 491 patients were included. Heterogeneity, except for threshold effects, was found within these studies. A meta-analysis was performed using the random effect model. Pooled accuracy indicators like sensitivity, specificity, and diagnostic odds ratio of ImmunoCyt™ and cytology were 0.75 (0.73-0.77) vs. 0.45 (0.43-0.48), 0.73 (0.72-0.74) vs. 0.97 (0.96-0.97), and 10.97 (7.53-15.99) vs. 16.40 (10.57-25.46), respectively. The sensitivity of both was increased with the increase of tumor grade and stage. The area under summary receiver operating characteristics curve was 0.834 4 and 0.853 4 and the Q index 0.766 7 and 0.785 3 for ImmunoCyt and cytology, respectively. Combination of both can obviously improve the accuracy of diagnosis.

CONCLUSIONSImmunoCyt has a high sensitivity in detecting BC, but its specificity is low. As an important adjunct, ImmunoCyt™ can not replace cytology, but combined with cytology it could improve sensitivity with high specificity in the detection and postoperative monitoring of BC.