To evaluate the sensitivity and specificity of Folate Receptor-Mediated Staining Solution (FRD™) used in detecting high grade cervical lesions and invasive cancer.
The FRD™ is designed for rapid visualization of CIN2+. Results are determined immediately (within 30 sec) after staining of the entire cervical epithelia. Patients who visited the outpatient clinic were recruited for this study. HR-HPV and cytology tests were performed before FRD™ testing. During the FRD™ testing both the cervix and cervical canal were stained. Colposcopy and biopsy was performed on the patients with either ≥ASC-US cytology test, positive HPV test, or positive FRD™ test. An ECC was completed on patients if the result was positive for the FRD™ test in the cervical canal, cytology result was AGC, or after a colposcopy the transformation zone of cervix was type II, III.
This study involved 404 women. CIN 2+ was found in 65 patients (16.1%) including 9 patients with cervical invasive cancer. CIN 1 and inflammation accounted for 7.4% (30/404) and 76.5% (309/404), respectively. Cytology results included: NILM: 140 (34.7%), ASC-US: 119（29.5%), ASC-H: 5 (1.2%), LSIL: 81 (20.0%), HSIL: 59 (14.6%). The HPV positive rate was 93.6% (378/404). Positive FRD™ test was determined in 53.2% women (215/404). The sensitivity of cytology, HPV, and FRD™ in detecting CIN 2+ lesions was 90.8%, 96.9%, and 80.0%, respectively. The specificity was 39.5%, 7.1%, and 51.9%, respectively.
The specificity of the FRD™ is the highest, comparing with cytology and HPV test, and the sensitivity is compatible. The FRD™ is suitable for detecting high grade cervical lesions and invasive cancer. Test results are determined immediately (within 30 sec) after staining of the entire cervical epithelia for detecting abnormal cervical lesions (CIN2+). Also, the FRD™ is easy to operate, since operators do not need professional training or professional equipment. Therefore, the FRD™ testing is an accessible and inexpensive method, especially for less-developed countries, and can be used as alternative cervical cancer detecting method.