To evaluate the two usages of the Folate Receptor-Mediated Staining Solution (FRD™) for detecting CIN2+, and compare it to TCT and HPV testing.
The FRD™ is a staining method for rapid visualization of CIN2+. Test results are determined immediately with the aid of the FRD™ Colorimeter after staining of the entire cervical epithelia. The two methods of the FRD™ test were performed on patients who had ASC-US & above TCT, and/or positive HPV test, before undergoing colposcopy and biopsy. The first FRD™ testing method (sampling method), the cervical epithelium is collected with the Epithelium Staining Applicator, and then the applicator is stained by the FRD™ staining solution. The second method (direct dyeing method), the Epithelium Staining Applicator is dipped into the FRD™ staining solution, and then the cervical epithelium is collected and stained by the applicator.
317 women with histological findings were included. CIN2+ was found in 109 women (34.38%) including 16 cervical cancer cases (3.3%). CIN1 and negative cases accounted for 9.46% and 56.15%, respectively. TCT results included NILM in 103 women (32.49%), ASC-US in 130(41.01%), LSIL in 51(16.09%), ASC-H in 12(4.73%), and HSIL & above in 21(6.62%). HPV positive rate was 90.54% (287/317). Positive FRD™ test was determined in 35.33% women (112/317) by the sampling method, and 48.90% (155/317) by the direct dyeing method. The sensitivity to detect CIN2+ for abnormal TCT, positive HPV, and positive FRD™ by the sampling method and direct dyeing method were 69.72%, 97.25%, 64.22%, and 81.65%, respectively. The specificity to detect CIN2+ for abnormal TCT, positive HPV, and positive FRD™ by the sampling and direct dyeing method were 37.98%, 12.98%, 78.81%, and 68.27%, respectively.
Compared with TCT and HPV test, both the usages of the FRD™ had a compatible sensitivity and high specificity to detect high grade cervical lesions. The sensitivity of the direct dyeing method was higher than the sampling method, and its specificity was lower than sampling method, but there was no significant difference between them. Sensitivity is more significant in cervical cancer detection, therefore the direct dyeing method of the FRD™ is more suitable in clinical settings. In addition, the FRD™ is a very inexpensive and easy method, which can be used in less-developed counties or areas that lack the resources and trained personnel required for routine cervical cancer detection.