The Study of Folate Receptor-Mediated Staining Solution (FRD™) In Cervical Lesion Detection
The Study of Folate Receptor-Mediated Staining Solution (FRD™) In Cervical Lesion Detection
The FRDTM is easy to perform and does not require sophisticated laboratory technology and/or
 experienced pathologists for test result interpretation. Compared to the Pap smear and HPV
 test, the FRDTM enables clinicians to obtain test results immediately (within 60 seconds)
 after the screening. This empowers clinicians in making timely decisions on appropriate
 patient management, and facilitating patient compliance with follow-up procedures. In
 addition, the FRDTM requires minimal training and technical support. Due to its advantage of
 rapid visualization of abnormal cervical lesions (CIN2+) in a cost-effective way, health care
 professionals can make cervical cancer detection accessible to women worldwide, especially in
 regions with limited medical resources. This is a cross-sectional study to evaluate the
 clinical performance of Folate Receptor-Mediated Epithelium Staining (FRDTM) in detecting
 cervical neoplastic lesions (CIN2+).
The Folate Receptor-Mediated Staining Solution is a dye solution that stains for medical
 purposes used in staining cells and tissues for detecting neoplastic diseases. The main
 purpose of this product is to detect abnormal cervical lesions (CIN2+) during a gynecological
 speculum examination. Therefore, the purpose of this study is to evaluate the clinical
 performance of Folate Receptor-Mediated Epithelium Staining (FRDTM) in detecting cervical
 neoplastic lesions (CIN2+).

 The subjects who are enrolled in this study will first undergo the FRD test, then cytology
 and HPV test. Women with abnormal cytology (≥ ASCUS/AGC), positive FRD test in either the
 cervix or cervical canal, and/or positive HPV test will be referred to colposcopy. In
 addition, 10% of the subjects who tested negative for all three tests and are ≥ 25 years old
 will be randomly selected to complete a colposcopy as well.

 According to the colposcopy assessment, if the results show satisfied (type I) then a biopsy
 will be taken. Subjects with a positive FRD test for the cervical canal, unsatisfied
 colposcopy (type II-III), and/or detection of AGC during cytology will have to complete an
 ECC procedure as well. Finally, a histopathological examination will be done and used as the
 gold standard. Subjects with a histopathological examination result of < CIN2 will be asked
 to come back for a follow up visit within 6 months or 1 year, according to the investigator's
 discretion. Subjects can exit the study at any time after colposcopy.
Inclusion Criteria:

 -  Diagnosis: Patients who need to do gynecological pelvic examination

 -  Age and sex: Women between the ages of 20 - 65

 Exclusion Criteria:

 -  Women with total hysterectomy

 -  Women who have done cervical surgeries, including physiotherapy of conization, LEEP,
 infrared ray, and microarray

 -  Women with serious cervical contact bleeding

 -  Women who are pregnant or menstrual period before the examination

 -  Women with acute inflammation of cervix and/or vagina

 -  Women who were already diagnosed with CIN2+

 -  Women who are taking an oral and/or injection of anti-cancer drugs