Objectives: To investigate the role of cytokeratin-19 fragment (CYFRA21-1) in cervical lesions screening in high-risk hu-man papillomavirus (HR-HPV) infected women.
Material and methods: The study was a retrospective study. First, the results of CYFRA21-1, cytology (TCT), and HR-HPV examinations of 1039 outpatients from gynecology department in Tumor Hospital Affiliated to Xinjiang Medical University were collected. Then, the data was analyzed using a series of statistical methods.
Results: There was a correlation between CYFRA21-1 levels and HPV-DNA load in HR-HPV infected women (rs = 0.711, p = 0.015). CYFRA21-1 levels and positive rate increased along with deepening of cervical cell lesions. In HR-HPV infected women, there was a statistically significant difference (t = 6.022, p < 0.001) in CYFRA21-1 levels between the group with cytological lesions (4.87 ± 1.58 ng/mL) and the group with normal cytology (2.52 ± 0.96 ng/mL). Positive rates of CYFRA21-1 in the two groups were 62.06% and 7.83%, respectively, and also exhibited statistically significant differences (χ2 = 74.624, p < 0.001). When diagnosing cytological lesions via CYFRA21-1 in HR-HPV infected women, sensitivity was 62.07%, specificity was 92.17%, positive predictive value was 88.89%，negative predictive value was 70.67%. Compared to CYFRA21-1 negative women, cytological lesions were detected 19.273 times more often in CYFRA21-1 positive women.
Conclusion: CYFRA21-1 could provide a reference idea for further diagnosis of women who are infected with HR-HPV but whose cytology is normal.
Keywords: CYFRA21-1; cervical lesions; high-risk; human papillomavirus.