Cervical Cancer
Product Description
FRD™ Staining Solution
Folate Receptor-mediated Detection (FRD™) Staining Solution
FRD™ is mainly composed of folic acid, and reduced methylene blue. FRD™ enables rapid chemical staining of cervical exfoliated cells in the presence of folate receptor overexpression.
Epithelium Staining Applicator
Epithelium Staining Applicator
Applicator is used for collecting and adhering exfoliated cervical cells during a gynecological speculum examination.
Colorimeter II
Colorimeter II
Colorimeter II is intended for in vitro diagnosis. The device capabilities include: sample transmission, sample rotation, automatic sample staining, interpretation, classification, color scanning and data management.
Instruction for Use
1. Visual Inspection
Collect a sample of cervical exfoliated cells using the Applicator.
Dip the Applicator into the FRD™ staining solution for 30 seconds.
Inspect color changes on the Applicator, and compare them with the reference colors.
2. Automatic Inspection
Collect a sample of cervical exfoliated cells using the Applicator.
Place the Applicator into the Colorimeter II for automatic staining of the sample with the FRD™ staining solution. The Colorimeter II will automatically analyze the sample. The results can be printed, stored, and transmitted to internet connected devices.
FRD™ Clinical Value
Early Detection for High-Grade Cervical Lesions
1. The Beijing Multi-center study indicated sensitivity and specificity of FRD™ were 77.72% and 60.02% for detecting CIN2+, and 86.64% and 54.30% for detecting CIN3+.
2. The results from Third Xiangya Hospital study indicated sensitivity and specificity of FRD were 80.00% and 51.92% for detecting CIN2+, and 86.67% and 50.97% for detecting CIN3+.
Complement to Cytology Testing
1.The FRD™ staining solution is a complement to the cytology test and improves the detection rate of precancerous and cancerous cervical lesions.
2. The sensitivity of FRD™ staining solution combined with cytology was 95.93%
Co-test with HPV Testing
1. In the positive result of the HPV test, the incidence rate of CIN2+ was 40.11% (217/541). When co-tested with FRD™, the detection rate of CIN2+ was 75.12% (163/217), while the examination rate of colposcopy reduced to 57.49% (311/541). (Data from the Beijing Multi-center study)
2. Co-testing of positive HPV results with FRD™ can contribute to decrease overtreatment and improve the accuracy of colposcopy.
Clinical Benefits
Summary
FRD™ is a patented technology of GY Highland Biotech with the ability to screen for precancerous and cancerous cervical lesions in real-time. The screening process does not require a cytopathologist or medical laboratory, greatly reducing the cost of screening. FRD™ is portable and provides reliable screening results, reducing the incidence of cervical cancer and improving women’s health. The following images display the comparison of FRD™, cytology, HPV testing, and colposcopy; with biopsy used as the gold standard for diagnosis.
New Proposal for Cervical Lesion Detection and Management
After the validation of more than 30,000 cases, it’s evident that the FRD™ has the ability to detect high-grade cervical lesions and invasive cancer (CIN2+) with the aid of vaginal speculum.
Patients with negative FRD™ results is recommended for a high-risk HPV test, which will be beneficial in ensuring the detection interval and follow-up time.
