Efficacy of HPV E6/E7 mRNA assay, HPV DNA test and cytology in detection of high grade cervical lesions and invasive cancer at a tertiary care center in India

Sangeeta Pankaj¹*, Jyotsna Rani¹, Pratibha Kumari¹, Kavya Abhilashi¹, Vijayanand Choudhary², Satya Kumari¹, Shivendra Kumar Shahi³, Anima Xess³, Rajesh Kumar Singh⁴, Shishir Kumar⁵, Abhay Kumar³, Nihar Ranjan Biswas⁶, Babban Jee⁷

1. Department of Gynecological Oncology, State Cancer Institute, Indira Gandhi Institute of Medical Sciences, Patna, India.
2. Department of Pathology, Indira Gandhi Institute of Medical Sciences, Patna, India.
3. Department of Microbiology, Indira Gandhi Institute of Medical Sciences, Patna, India.
4. Department of Radiation Oncology, State Cancer Institute, Indira Gandhi Institute of Medical Sciences, Patna, India.
5. Department of Biostatistics, Indira Gandhi Institute of Medical Sciences, Patna, India.
6. Indira Gandhi Institute of Medical Sciences, Patna, India.
7. Department of Health Research, Ministry of Health and Family Welfare, Government of India, New Delhi, India.

*Corresponding Author: Sangeeta Pankaj; E-mail: drsangeetapankaj@gmail.com

Abstract
Background
Cervical cancer is caused by human papillomavirus (HPV) and remains a major public health issue. There are several methods for its diagnosis. Knowing their comparative usefulness may help in devising an appropriate strategy for early detection of this gynecological cancer in resource-constrained setting.
Aim
This study aims to evaluate the efficacy of human papillomavirus (HPV) E6/E7 mRNA assay, HPV DNA test and cytology in detection of high grade cervical lesions and invasive cervical carcinoma at a tertiary care center in India.
Methods
A total of 106 women were recruited in this hospital based study and underwent molecular tests (HPV DNA test and mRNA assay), cytological test and colposcopic-guided biopsy. Histopathological diagnosis was considered as the gold standard.
Results
We observed that 56 out of 106 participants had abnormal results in the terms of positive HPV DNA or E6/E7 mRNA with or without abnormal cytology or had histopathologically confirmed pre-malignant/malignant lesion. 47.2% (50/106) and 32% (34/106) women were positive for HPV DNA and E6/E7 mRNA respectively. 33% (35/106) women had abnormal cytology and 29.2% (31/106) had histologically confirmed CIN II and higher lesions. Sensitivity and specificity of cytology and HPV DNA for CIN III+ lesions were calculated as 92%, 90.4% versus 88% & 68% respectively. mRNA assay was found to be more sensitive (96%) and specific (93.3%) than other tests in detecting CIN II + lesions.
Conclusion
E6/E7 mRNA assay seems superior to HPV DNA test and cytology in detection of high grade cervical lesions and invasive carcinoma. It may be used as an alternative or adjunct to HPV DNA test or cytology for the purpose of cervical cancer screening and also be helpful in reducing the load for colposcopy.