Clinical Studies

Compare two different usages of FRD™ for detecting high‐grade cervical lesions and invasive cancer

Clinical Studies

Yuping Dai¹ · Lirong Wang¹ · Donghong Li²

Received: 25 May 2017 / Accepted: 2 February 2019 © Springer-Verlag GmbH Germany, part of Springer Nature 2019

Abstract
Objective To evaluate two usages of the folate receptor-mediated staining solution (FRD™) for detecting high-grade cervical lesions and invasive cancer, and compared with cytology test (TCT) and human papillomavirus (HPV) testing.
Methods FRD™ sampling and FRD™ direct staining methods were used for detecting high-grade cervical lesions and invasive cancer. As a comparison, TCT and HPV testing were also applied for screening high-grade cervical lesions and invasive cancer. The sensitivity and specificity of TCT, HPV testing, and staining results of FRD™ were analyzed by the SPSS software.
Results In this study, 317 patients with biopsy were collected. The positive rate of FRD™ sampling method was 35.33% (112/317), and positive rate of FRD™ direct staining was 48.90% (155/317). Area under the curve (AUC) of TCT, HPV test- ing, FRD™ sampling and FRD™ direct staining were 0.53, 0.55, 0.58, and 0.75, respectively. The sensitivity of TCT, HPV, FRD™ sampling and FRD™ direct staining was 69.72%, 97.25%, 64.22% and 81.65%, respectively, and the specificity was 37.98%, 12.98%, 79.81% and 68.27%, respectively.
Conclusion Compared with TCT and HPV testing, two usages of FRD™ methods have compatible sensitivity and high speci- ficity to detect high-grade cervical lesions and invasive cancer. FRD™ direct staining may be comfortable for routine cervical cancer screening

Keywords Folate receptor-mediated staining solution (FRD™) · High-grade cervical lesions · Invasive cancer · Cytology test · Human papillomavirus testing

Published online : 05 March 2019

Share :

Share on facebook
Share on twitter
Share on linkedin
Close Menu

In R&D Pipeline