Tumor Biology

, Volume 36, Issue 5, pp 3137–3145 | Cite as

Diagnostic accuracy of cytokeratin-19 fragment (CYFRA 21–1) for bladder cancer: a systematic review and meta-analysis

  • Yuan-Lan Huang
  • Jie Chen
  • Wei Yan
  • Ding Zang
  • Qin Qin
  • An-Mei Deng


Previous studies have evaluated the accuracy of serum and urinary measurements of cytokeratin-19 fragment (CYFRA 21–1) for the diagnosis of bladder cancer; however, the results have been inconsistent. The aim of this study was to evaluate the overall accuracy of CYFRA 21–1 for the diagnosis of bladder cancer. We performed a search for English-language publications reporting on the detection of CYFRA21-1 levels for the diagnosis of bladder cancer through November 2, 2014, using public medical databases, including EMBASE, Web of Science, and Medline. The quality of the studies was assessed by revised QUADAS tools. The performance characteristics were pooled and analyzed using a bivariate model. Publication bias was explored with the Deek’s test. Sixteen studies, with a total 1,262 bladder-cancer patients and 1,233 non-bladder-cancer patients, were included in the study. The pooled sensitivities for serum and urine CYFRA 21–1 were 0.42 (95 % confidence interval (CI), 0.33–0.51) and 0.82 (95 % CI, 0.70–0.90), respectively. The corresponding specificities were 0.94 (95 % CI, 0.90–0.96) and 0.80 (95 % CI, 0.73–0.86), respectively. The areas under the summary receiver-operating-characteristic curves for serum and urine CYFRA 21–1 were 0.88 (95 % CI, 0.85–0.91) and 0.87 (95 % CI, 0.84–0.90), respectively. The major design deficiencies of the included studies were participant-selection bias, potential review, and verification bias. Therefore, we concluded that both serum and urine CYFRA 21–1 served as efficient indexes for bladder-cancer diagnosis. Additional, well-designed studies should be performed to rigorously evaluate the diagnostic value of CYFRA 21–1 for bladder cancer.


Meta-analysis Cytokeratin-19 fragment Bladder cancer Sensitivity Specificity 



We thank Medjaden Bioscience Limited for assisting in the preparation of this manuscript. This research was supported by grants from 973 Foundation (2013CB531606), Shanghai Municipal Commission for Science and Technology (11JC1410902), Dingyuan Grant of Talent Development in Yangpu District, Wujieping Grant (320.6750.13147), and Changhai Hospital (CH125530300).

Conflicts of interest


Supplementary material

13277_2015_3352_MOESM1_ESM.doc (63 kb)
ESM 1 (DOC 63 kb)


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Copyright information

© International Society of Oncology and BioMarkers (ISOBM) 2015

Authors and Affiliations

  1. 1.Department of Laboratory MedicineShanghaiPeople’s Republic of China
  2. 2.Department of HematologyChanghai HospitalShanghaiPeople’s Republic of China
  3. 3.Department of Laboratory Diagnosis, Changhai HospitalSecond Military Medical UniversityShanghaiPeople’s Republic of China
  4. 4.Department of Laboratory Diagnosis, Changhai HospitalSecond Military Medical UniversityShanghaiChina

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