This study was aimed to evaluate the significance of the Epithelium Staining Applicator in cervical staining with the Folate Receptor-Mediated Staining Solution (FRD™) in detecting cervical abnormal lesions (CIN2+), based on biopsy being used as the gold standard.
The FRD™ test was performed before colposcopy, on patients with abnormal TCT and/or positive HPV test. The cervical epithelium was stained by the Epithelium Staining Applicator, by first dipping the applicator into the FRD™ staining solution, and then by pressing the applicator against the cervix with the aid of speculum. After staining, the Epithelium Staining Applicator was placed into the FRD™ Colorimeter, which scans the applicator for any color change and prints out the scanning results. The FRD™ test results were determined by the readings found on the scanning results.
261 women with histological findings were included in the study. CIN2+ was found in 97 patients (37.16%) including 12 cervical cancers cases (4.60%). CIN1 accounted for 10.34%. TCT results included NILM in 82 women (31.42%), ASC-US in 114 women (43.68%), LSIL in 42 women (16.09%), ASC-H in 7 women (2.68%), HSIL and above in 16 women (6.13%). The HPV positive rate was 87.36% (228/261). A positive FRD™ test was determined in 49.81% women (130/261). The sensitivity to detect CIN2+ lesions for abnormal TCT, positive HPV, and positive FRD™ were 76.29%, 93.81%, and 80.41%, respectively. The specificity to detect CIN2+ lesions for abnormal TCT, positive HPV, and positive FRD™ were 35.98%, 16.46%, and 68.29% , respectively.
The FRD™ is an alternative method which is suitable for cervical cancer detection. In addition, the Epithelium Staining Applicator is a suitable assistive device to complete the FRD™ test.