A DNA methylation assay (MPap) using self-collected tampon versus cytology collection swab for endometrial cancer detection.

OBJECTIVE

To evaluate the practicability of self-collected tampons with the MPap assay for endometrial cancer (EC) detection, by comparing with the results of cervical swabs.

METHODS

A total of 85 women at Tri-Service General Hospital (TSGH) were included to directly compare the performance of physician-collected swabs and self-collected tampons. An additional cohort of 39 self-collected tampons from patients at Shuang Ho Hospital (SHH) was included for further validation. The effects of age, body mass index (BMI), and BHLHE22 and CDO1 methylation levels on MPap test performance were analyzed across samples from patients with and without EC. The performance of the MPap test is presented as percentage of sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy (ACC). The Pearson's correlation test was used to examine the association between swab and tampon in the MPap test.

RESULTS

The area under the curve (AUC) of MPap to detect EC in 85 swabs and tampons both were 0.94 (0.88-1.00). The sensitivity, specificity, PPV, NPV, and ACC of the two collection methods did not show significant differences. The testing results using a tampon were highly correlated with the results using a physician-collected swab (R2 = 0.6810, P < 0.001). Furthermore, the AUC of MPap to detect EC in 39 tampons was 0.97 (0.93-1.02). The sensitivity, specificity, PPV, NPV, and ACC were 90.48%, 94.44%, 95.00%, 89.47%, and 92.31%, respectively.

CONCLUSION

Our data inferred the potential of the MPap test in early detection of EC using vaginal secretion collected by an intravaginal self-collected tampon.