HPV E6/E7 mRNA Versus HPV DNA as Triage for Cervical Cancer Screening

AIM: To develop and standardize a cost effective methodology or algorithm for mRNA E6/E7 for HPV genotypes 16, 18, 31, 33 and 45 as compared to commercially available assays which can be incorporated to triage excess false positives from primary screening for cervical cancers Objectives: 1. Development and standardization of methodology /algorithm for mRNA E6/E7 testing for HPV genotypes 16, 18, 31, 33 and 45 using Real-time RT-PCR, in cervical samples. 2. To compare the test performance of this HPV E6/E7 mRNA assay to HPV DNA by HC 2 as secondary screening test, with the reference standard of colposcopy with biopsy, to triage women found positive in primary screening by VIA , in a population based screening for cancer of cervix. 3. To determine number of false positives in the primary screening test after testing VIA positives with a known high specificity secondary screening test (HPV-DNA HC II ) compared to HPV E6/E7 mRNA testing. Study Population: Women in the age group of 30-65 years, who test positive on primary cervical screening test VIA will be enrolled for the proposed diagnostic tests along with reference standard of colposcopy with guided biopsy. Methodology: Women in the age group of 30-65 years undergoing routine cervical cancer screening through hospital ( Preventive Oncology screening clinic) and community based screening programs with abnormal test result using the primary cervical cancer screening test VIA will be recruited in the study. The primary screening test VIA will be administered by application of 5% Acetic Acid to the cervix and visualizing the cervix with the help of a halogen focus lamp. VIA will be considered to be positive if definite acetowhite lesions are visualized close to the squamocolumnar junction.

Sex

Female

Minimum age

30 Years

Maximum age

65 Years

Inclusion Criteria:

1. Female between 30-65years of age
2. Not pregnant by menstrual history
3. No history of prior treatment for cancer of the cervix
4. No history of hysterectomy
5. Healthy enough to undergo a pelvic examination, i.e., not seriously ill with a debilitating condition

Exclusion Criteria:

1. Women below and above this age group
2. Women already screened and detected for cervical precencers and cancers
3. Women with debilitating condition
4. Women with Hysterectomy
5. Women whom are pregnant