Evaluating different samples & techniques for hr-HPV DNA genotyping to improve the efficiency of risk profiling for oral & cervical cancers in Sikkim, India

Sep 21, 2026

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Background and objectives focus on how oral and genital HPV infection may contribute to cervical disease in women partners and to illness in men themselves. The study evaluates Hybrid Capture 2 (HC2) in physician-collected cervical samples and compares it with qPCR on self-collected urine and oral gargle samples to determine hr-HPV infection status and genotyping. Methods include profiling 1,200 samples from 200 women and 200 men, while results report detection rates and ROC performance. Conclusions support HC2 and qPCR urine/gargle assays for risk profiling and screening in cervical and oral cancer programs.

LanguageEnglish

CategoryResearch & Report

FormatPDF

Pages10

Reading Time25 min

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Background & objectives

Methods

Results

Interpretation & conclusions

Material & Methods

Study design and sampling technique

Study population

Indian J Med Res 160, August 2024, pp 226-235 DOI: 10.25259/ijmr_877_23 Evaluating different samples & techniques for hr-HPV DNA genotyping to improve the efficiency of risk profiling for oral & cervical cancers in Sikkim, India Chamma Gupta1, Mingma Lhamu Sherpa1, Pesona Grace Lucksom2, Anup Pradhan2 & Mohonish N. Chettri3 Departments of 1Biochemistry, 2Obstetrics and Gynaecology, & 3Ear, Nose and Throat, Sikkim Manipal Institute of Medical Sciences, Sikkim Manipal University, Gangtok, Sikkim, India Received May 9, 2023; Accepted July 30, 2024; Published: October 22, 2024 Background & objectives: Oral and genital HPV infection in men may be a source of cervical diseases in their women partners as well as disease in themselves. This study aimed to evaluate and compare the performance of Hybrid Capture 2 (HC2) in physician-collected cervical samples and qPCR in self collected urine and oral gargle samples of women and men, respectively, for hr-HPV infection status and genotyping. Methods: One thousand and two hundred biological samples were collected from 200 women (urine, oral gargle, and cervical smear) and 200 men (urine and oral gargle) visiting a referral hospital in the remote Himalayan State of Sikkim. The extracted genomic DNA from urine and gargle samples were profiled for hr-HPV genotypes using quantitative polymerase chain reaction (qPCR) and HC2 for cervical samples. Results: In women, hr-HPV was detected in 17.5 per cent of cervical samples by HC2, 25.5 per cent of urine, and 7 per cent of gargle samples by qPCR. For men, hr-HPV was detected in 8 per cent urine and 5 per cent gargle samples by qPCR. Among the HPV-positive women, 56 per cent of urine samples and 20 per cent of oral samples showed single-genotype infection, while the remaining had multiple genotypes. Amongst the HPV-positive men, 62.7 per cent of urine samples and 85.7 per cent of oral samples showed single-genotype infection while the remaining had multiple genotypes. Compared to Pap, the area under ROC was good for HC2 (AUC=0.89) and for qPCR (AUC= 0.852). Interpretation & conclusions: HC2 for cervical and qPCR-based HPV DNA assay for urine and gargle sample is suitable for risk profiling for cervical cancer (CC) and oral cancer (OC) screening programmes. Key words Cervical-high-risk human papillomavirus-hybrid capture 2-men-oral-real-time qPCR-urine-women Infection caused by Human papillomavirus (HPV) DNA is the most prevalent sexually transmitted infection (STI) around the globe 1 . HPV infection and its persistence is a recognised source and etiologic pathogen for both precancerous and cancerous lesions of the cervix uteri (99%), penis, vulva, vagina, anus, and oropharynx (47%) as reported by International Agency for Research on © 2024 Indian Journal of Medical Research, published by Scientific Scholar for Director-General, Indian Council of Medical Research This open access publication is protected under CC-BY-NC-SA 4.0 GUPTA et al: DIFFERENT SAMPLES & TECHNIQUES FOR HR-HPV GENOTYPING 227 Cancer (IARC) and Centers for Disease Control and Prevention (CDC)2-5 . Early detection and management are crucial, but challenges persist due to limited testing platforms in remote areas, inadequate information, and communication on HPV and cervical cancer. Oral cancer screening is primarily through oral examination and biopsy6. Cervical cancer screening with Papcytology and visual inspection with acetic acid (VIA) has shifted to HPV-DNA assay as the preferred method since 20206,7 . Researchers identified several gapsin HPV research wherein very few studies had used urine and oral samples for HPV-DNA assay, lack of efficient approaches for isolation and HPV detection in urine and oral sample had restricted its potential clinical use, the poor acceptance of Pap as a screening tool, and HC2 was qualitative and limited to cervical sample testing only. Furthermore, HC2 test was not available in Sikkim at

FAQs

What was the study designed to compare for hr-HPV detection?

The study compared Hybrid Capture 2 (HC2) performance on physician-collected cervical samples with qPCR performance on self-collected urine and oral gargle samples for both women and men.

How many samples were collected and from whom?

A total of 1,200 biological samples were collected from 200 women and 200 men visiting a referral hospital in Sikkim, with women providing urine, oral gargle, and cervical smear, and men providing urine and oral gargle.

What detection rates were reported for hr-HPV in women and men?

For women, hr-HPV was detected by HC2 in 17.5% of cervical samples, and by qPCR in 25.5% of urine and 7% of gargle samples. For men, hr-HPV was detected by qPCR in 8% of urine and 5% of oral gargle samples.

What do the ROC results suggest about HC2 and qPCR?

Compared with Pap, the area under the ROC curve was good for HC2 (AUC=0.89) and qPCR (AUC=0.852), supporting their usefulness for screening risk profiling.

Sep 21, 2026

Uploaded by Eden