Abstract
Due to a high rate of transient human papillomavirus (HPV) infection, HPV genotyping has a low specificity for high-grade cervical lesions, especially in young women. p16/Ki-67 dual immunocytochemical staining can also be used for the detection of oncogenic changes in cervical cells. Our aim was to compare the performance of p16/Ki-67 dual staining and HPV genotyping in the detection of high-grade cervical lesions in patients with atypical squamous cells of undetermined significance (ASCUS)/low-grade squamous intraepithelial lesion (LSIL) on Pap smear. We retrospectively analyzed 310 patients with ASCUS/LSIL on Pap smear, who underwent colposcopy. Among these, 161 patients with suspected lesions detected by colposcopy were referred for biopsy. HPV genotyping by LINEAR ARRAY HPV Genotyping Test (CE-IVD) and p16/Ki-67 dual staining by CINtec PLUS Cytology kit was performed prior to cervical biopsy. The overall sensitivity and specificity of HPV genotyping for the detection of cervical intraepithelial neoplasia (CIN) 2-3 was 79% and 72%, respectively in patients with ASCUS, and 85% and 64%, respectively in patients with LSIL. For p16/Ki-67 test, sensitivity and specificity rate was 66% and 93%, respectively in ASCUS and 59% and 79%, respectively in LSIL group. The specificity of p16/Ki-67 staining was significantly higher in both groups in patients aged <30 years compared to patients >30 years old (p < 0.001). Our results showed that p16/Ki-67 dual staining has a higher specificity compared to HPV genotyping, especially in patients under 30 years old. This indicates the usefulness of p16/Ki-67 testing in the triage of patients with ASCUS/LSIL and <30 years old, prior to referral for colposcopy and biopsy.
Highlights
Cervical cancer represents one of the most common gynecological malignancies
The objective of this study is to compare the performance of p16/Ki-67 dual staining and human papillomavirus (HPV) genotyping in the detection of high-grade cervical lesions in patients with atypical squamous cells of undetermined significance (ASCUS) or low-grade squamous intraepithelial lesion (LSIL) on cervical cytology (Pap smear)
A total of 310 patients with ASCUS or LSIL on cervical cytology were referred for colposcopy at the Department of Obstetrics and Gynecology of County Hospital Timişoara
Summary
Screening programs for cervical cancer are available in a majority of countries, and cervical cytology (Papanicolaou [Pap] smear) is the most frequently used screening tool. It is estimated that almost 30% of patients with cervical cancer had at least one previous false-negative Pap smear, indicating that more accurate screening tests are required [1]. The important role of persistent human papillomavirus (HPV) infection in the etiopathogenesis of cervical cancer has drawn attention to Submitted: 02 May 2018/Accepted: 22 May 2018. Because of a high incidence rate of transient HPV infections, HPV genotyping has a low specificity for high-grade cervical lesions, especially in young women. According to the American College of Obstetricians and Gynecologists (ACOG) guidelines, HPV testing is not currently recommended as a screening test for cervical cancer in women younger than 30 years [2]
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