To evaluate the significance of the Folate Receptor-Mediated Staining Solution (FRD™) when used for cervical cancer detection, by comparing it with the results of the thin-prep cytology test and high risk HPV test and using pathological results as the gold standard.
The FRD™ is a special staining method for rapid visualization of CIN2+. Results are determined by the color changes of the stain. The FRD™ was applied on the cervix and the cervical canal separately, and the color change was observed. Brown or green indicates a negative result, and blue, bluish-black, or black indicates a positive result. The women included in this study were returning for evaluation by colposcopy based on an abnormal cervical cytology result, a postive HPV result, or showed symptoms of increased leucorrhea discharge or postcoital bleeding. The FRD™ test was performed before colposcopy. A biopsy, and histopathological examination were conducted as needed.
Patients with a positive FRD™ result of the cervical canal, colposcopy assessment type is II-III, or the result of cytology was AGC, were required to complete an ECC as well.
1,504 women with histological findings were included in the study. CIN2+ was found in 561 patients (37.3%) including 50 patients with cervical invasive cancer (3.3%). CIN1 and negative cases accounted for 29.3% and 33.4%, respectively. Pap results included NILM in 394 women (26.2%), ASC-US in 476 women (31.6%), LSIL in 334 women (22.2%), ASC-H in 96 women (6.4%), AGC in 10 women (0.7%), and HSIL in 194 women (12.9%). The HPV positive rate was 89.0% (1338/1504). A positive FRD™ test was determined in 54.1% of the women (813/1504). The sensitivity to detect CIN2+ lesions for TCT, HPV, and FRD™ was 80.4%, 95.5%, and 77.7%, respectively. The specificity was 30.1%, 15.0%, and 60.0% respectively.
From this study we found that the results of the FRD™ and the cytology examination are similar when detecting CIN 2+. The FRD™ can indicate the tumor tendency of epithelial tissue in direct proportional to the organization of the morphological changes. Furthermore, the more serious the nature of lesion and the higher the level, then the more accurate the results of the FRD™ were. Also, this study shows that the FRD™ results can accurately reveal the level of the epithelial tissue lesions.
Finally, in this study, we compared the sensitivity and specificity of the FRD™ to the cytology examination, and found that the FRD™ can meet the demands of clinical requirements needed for the detection of abnormal cervical lesions (CIN 2+). Furthermore, the FRD™ is an easy and very inexpensive method that can be used in less-developed countries.