Abstract
Objective:To determine diagnostic accuracy of NMP 22 and urine cytology in the detection of transitional cell carcinoma (TCC) urinary bladder taking cystoscopy as a gold standard in patients having provisional diagnosis of bladder cancer (BC).Methods:This cross sectional validational study enrolled 380 patients fulfilling selection criteria and was conducted at Armed Forces Institute of Urology (AFIU) Rawalpindi, Pakistan form July 2018 to July 2019. The urine sample collected underwent NMP22 and cytological analysis followed by rigid cystoscopy. Reports of all three tests divided patients into positive or negative for malignancy as per defined criteria. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and diagnostic accuracy of NMP 22, urine cytology and their combination was determined. Receiver operating characteristic (ROC) curve analysis performed and area under the curve (AUC) compared among these tests.Results:The average age of patients was 53.08 ± 12.41 years having male to female ratio 3.75:1(300 males and 80 females). NMP 22 had better sensitivity and comparable specificity to cytology (81.9 & 81.2% vs 54 & 93.9%). Combination of NMP 22 / cytology outperformed both in terms of sensitivity (91.63 vs 81.83 vs 53.96), NPV (87.59 vs 77.46 vs 61.02) and diagnostic accuracy (85.26 vs 81.58 vs 71.32) but at the cost of specificity (76.97 vs 81.21 vs 93.94) and PPV (83.83 vs 85.02 vs 92.06). ROC curve revealed statistically significant higher AUC (0.843 vs .815 vs .73) for combination as compared to NMP 22 and Cytology (p < 0.001).Conclusion:NMP22 is a quick, point of care test having higher sensitivity, NPV and accuracy but similar specificity and PPV to urine cytology for detection of TCC urinary bladder. Combination outperformed both in terms of sensitivity while having modest specificity.
Highlights
Transitional cell carcinoma (TCC) urinary bladder is one of the most common as well as lethal urologicalCorrespondence: September 12, 2019 February 24, 2020 February 26, 2020 cancer worldwide accounting for about 95% of bladder cancers (BC).[1]
We aimed to evaluate the diagnostic accuracy of Nuclear matrix protein (NMP)-22 and voided urine cytology in the detection of TCC in our target population
Collected urine was divided into two aliquots; one underwent NMP22 analysis (Qualitative ALERETM NMP22® BladderChek®)[13] at urology laboratory Armed Forces Institute of Urology (AFIU) according to manufacturers ‘protocol while other portion sent to cytopathology laboratory AFIP, Rawalpindi
Summary
Transitional cell carcinoma (TCC) urinary bladder is one of the most common as well as lethal urologicalCorrespondence: September 12, 2019 February 24, 2020 February 26, 2020 cancer worldwide accounting for about 95% of bladder cancers (BC).[1]. BC carcinogenesis revolves around genetic susceptibility, environmental exposure and unhealthy lifestyles.[4] Majority are non-muscle invasive (NMIBC) having high chances of recurrence as well as progression necessitating lifelong surveillance.[5] Comprehensive, standardized and riskadapted follow-up protocols incorporating regular cystoscopies, urinary cytology as well as regular upper urinary tract imaging (for high-risk tumors) are recommended by various international bodies like European Association of Urology (EAU), the American Urological association (AUA), society of urological oncology and National comprehensive cancer network (NCCN).[6] In addition to diagnosis, surveillance of BC recurrence pivots cystoscopy as criterion standard due to its high diagnostic accuracy. These compelling limitations lead to approval of several noninvasive biomarkers though with conflicting diagnostic accuracy quoted for primary and recurrent BC.[9]
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