Clinical Studies

Evaluation of Folate Receptor-Mediated Detection as a Diagnostic Tool for Cervical Intraepithelial Neoplasia 2+

Clinical Studies

David Moos1 and Donghong Li2 . 1 GY-Biotech, 2 Guangren Hospital

Objective: FRD ® (Folate Receptor-mediated Detection) has been proposed as a reliable method to screen cervical intraepithelial neoplasia 2+ (CIN2, CIN3 and cervical cancer). This study investigates the clinical significance of FRD® by comparing the accuracy of FRD ® with that of HPV Testing and Thinprep Cytology (TCT).
Methods: From March 2019 to April 2019, 81 patients in the gynecology clinic of the Second Hospital of Jilin University received screening with FRD®, TCT, and HPV examinations upon visiting the clinic. If any of the three tests provided a positive result, colposcopy was performed with biopsy being the gold standard for pathological diagnosis.
Results: The sensitivity of FRD®, TCT, and HPV in the diagnosis of cervical intraepithelial neoplasia 2+ (CIN2, CIN3, Cervical Cancer) were 72.22%, 72.22%, and 83.33% respectively. The specificity of FRD®, TCT, and HPV
in detection of CIN2+ was 65.07%, 60.31%, and 25.39% respectively. The accuracy of FRD®, TCT, and HPV in diagnosis of CIN2+ was 66.67%, 62.96% and 38.27%. The positive predictive value (PPV) of FRD ®, TCT, and HPV in diagnosis of CIN2+ was 37.14%, 34.21% and 38.27% respectively, while the negative  predictive value(NPV) was 89.13%, 88.37% and 84.21% respectively.
Conclusions: FRD ® provided high values of sensitivity, specificity and accuracy. FRD ® has advantages in detection speed (< 60 seconds), economic cost, and patient compliance. FRD ® can be an effective and advantageous tool for the primary screening of cervical intraepithelial neoplasia 2+ (CIN2, CIN3, Cervical Cancer), especially in regions with hard-to-reach patients. FRD® could also provide significant value as a co-test with HPV Testing

Published: 4, 2020

Journal of Lower Genital Tract Disease • Volume 24, Number 1, Supplement 1

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