Low-Cost Molecular Biomarker HPV-16/18 E6 Oncoprotein Expression in Cervical Intraepithelial Neoplasia (CIN) and Cervical Cancer with Its Relation with Severity of Neoplastic State

Abstract

This research was carried out with the intention to see the detection rate of HPV-16/18 E6 oncoprotein expression in different categories of cervical neoplasia and to find out its association with increasing neoplastic state, using lateral flow test “Onco E6 Cervical Test” designed for low-resource settings. A cross-sectional study was conducted at Gynecologic Oncology Outpatient Department (OPD) of Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, Bangladesh, from May 2018 to April 2019. Histopathologically diagnosed CIN I, CIN II, CIN III, and cervical cancer cases of age 21–70 years who were compliant to allow cervical swab collection for E6 oncoprotein test were selected by purposive sampling. E6 oncoprotein expression was 4.44% (2/45), 28.57% (4/14), 50% (2/4), and 77.78% (28/36) for CIN I, CIN II, CIN III, and cervical cancer cases, respectively. Thirty-six women of total 99 (N = 99) study participants were found E6 positive (detection rate 36.36%). Type distribution showed 83.33% (30/36) type 16, 13.89% (5/36) type 18, and 2.78% (1/36) co-infection with types 16 and 18. Considering CIN I the reference category, E6 oncoprotein expression was found associated with CIN II (OR = 6.95, p = 0.052), significantly associated with CIN III (OR = 18.10, p = 0.026), and highly significantly associated with cervical cancer (OR = 43.57, p < 0.001). Association of E6 oncoprotein expression is significant for CIN III and highly significant for cervical cancer. The presence of E6 oncoprotein expression in CIN lesions can identify true cancer precursors with risk of cancer development in the future and can be utilized in cancer screening program.