cervical cancer rapid diagnostic test


Catalog excerpts

cervical cancer rapid diagnostic test - 1

FRD™ Folate Receptor-mediated Detection staining solution For Identification of late stages of HPV related Cervical Lesions Real-time Affordable Localization High Sensitivity Point of Care Auxiliary Diagnosis

Open the catalog to page 1
cervical cancer rapid diagnostic test - 2

Product Description Folate Receptor-mediated Detection (FRD™) Staining Solution is composed of folic acid, reduced methylene blue, acetic acid, and dimethyl sulfoxide. FRD™ enables rapid in vitro chemical staining of cervical exfoliated cells to detect folate receptor overexpression. In clinical practice, FRD™ can be used as a primary screening tool for precancerous and cancerous lesions, in triage for women with ASCUS cytology, and as a co-test for women with an HPV-positive test result. Epithelium Staining Applicator is used for collecting and adhering exfoliated cervical cells during a...

Open the catalog to page 2
cervical cancer rapid diagnostic test - 3

FRD™ Clinical Value Early Detection for High-Grade Cervical Lesions The Beijing Multicenter study (1,504 cases) indicated sensitivity and specificity of FRD™ were 77.72% and 60.02% for detecting CIN2+, and 86.64% and 54.30% for detecting CIN3+. The Third Xiangya Hospital study (404 cases) indicated sensitivity and specificity of FRD™ were 80.00% and 51.92% for detecting CIN2+, and 86.67% and 50.97% for detecting CIN3+. After summarizing all the known data, the results showed that overall sensitivity was 82.00% and specificity was 76.00% for detecting CIN2+, while overall sensitivity was...

Open the catalog to page 3
cervical cancer rapid diagnostic test - 4

FRD™ Mechanism of Action Folic acid-reduced methylene blue (MB) conjugate binds to the folate receptor expressed on the cervical epithelium membrane and then endocytosis occurs. The acidic micro-environment in the endosome causes dissociation between the folic acid and reduced MB from the folate receptor. Reduced MB is released into cytoplasm, where the oxidation-reduction reaction occurs and reduced MB becomes oxidized. The folate receptors recycle back to the cell membrane. Oxidized MB exits from the cell and can be detected, providing visual result. Reduced Methylene Blue Linker Folate...

Open the catalog to page 4
cervical cancer rapid diagnostic test - 5

New Proposal for Cervical Lesion Detection and Management After more than 30,000 cases published in the most prestigious OB-GYN journals, it’s evident that FRD™, used as a point of care diagnostic aid, can detect high-grade cervical lesions and invasive cancer (CIN2+). Patients with negative FRD™ results should be recommended for a high-risk HPV test, which will be beneficial in ensuring the detection interval and follow-up time. FRD™ FRD™ (Positive) and/or Cytology > ASCUS Regular review FRD™ (Negative), Cytology (Negative) or FRD™ (Negative), HPV (Negative) or FRD™ (Negative), Cytology...

Open the catalog to page 5
cervical cancer rapid diagnostic test - 6

About Us GY Highland Biotech LLC is an innovative solution researcher and manufacturer of in vitro diagnostics with a growing portfolio in cancer diagnostics. The company has developed its patented Folate Receptor-mediated Detection (FRD™) staining solution, designed to detect precancerous and cancerous lesions on the cervix in real-time, into a platform for cancer diagnosis with continuing R&D investments to expand its product portfolio into other clinical and research areas. We aim to be a leading provider dedicated to women’s healthcare by providing easy-to-use, accurate, affordable, and...

Open the catalog to page 6

All GY Highland Biotech catalogs and technical brochures