Clinical Studies

Effectiveness of novel folate receptor-mediated staining solution detection (FRD™) for cervical cancer screening

Clinical Studies

Yuping Dai, MDᵃ, Lirong Wangᵃ, Donghong Liᵇ,∗

Abstract
Folate receptor-mediated staining solution detection (FRD™) has been recently suggested as an effective tool in the cervical cancer screening. We aim to compare the accuracy of FRD™ to human papillomavirus (HPV) and thinprep cytology test (TCT) based on cytology-based biopsy.
During May 2016 and December 2016, we recruited women who presented for routine cervical lesion screening. The eligible cases were nonpregnant women and not in the menstrual period, aging between 25 and 65. All eligible women were screened with TCT, HPV, FRD™ testing, and colposcopy.
A total of 216 women include 137 (63.4%) cases of cervical inflammation, 27 (12.5%) cases of cervical intraepithelial neoplasia 1 (CIN 1), 51 (23.6%) cases of CIN 2, 34 (15.7%) cases of CIN 3, and 12 (5.6%) cases of cervical cancer. The sensitivity were 93.81%, 76.29%, 80.41% for HPV testing, TCT testing, and FRD™ testing, respectively. The specificities were 16.46%, 34.15%, and 68.29%, respectively. FRD™ has statistically significant higher specificity than HPV testing and TCT (both P < .05). However, no differences were found in sensitivity (both P>.05). The positive predictive value (PPV), negative predictive value (NPV), and Kappa consistency coefficient were 39.91%, 81.82%, and 0.08% for HPV testing, 40.66%, 70.89%, and 0.09% for TCT, and 60%, 85.5%, and 0.46% for FRD™ testing.
FRD™ had favorable accuracy and efficacy in detecting cervical cancer, and therefore could be used as an effective screening tool for cervical cancer screening.

Abbreviations: CR = coincidence rate, FRD™ = folate receptor-mediated staining solution detection, HC2 = hybrid capture 2, LEEP = loop electrosurgical excision procedure, NLR = negative likelihood ratio, NPV = negative predictive value, PLR = positive likelihood ratio, PPV = positive predictive value, TCT = thinprep cytology testing.

Keywords: cervical cancer, folate receptor-mediated staining solution detection, FRD™, HPV, screening, TCT, thinprep cytologic test

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