Can human papillomavirus DNA testing of self-collected vaginal samples compare with physician-collected cervical samples and cytology for cervical cancer screening in developing countries?

Abstract

Background To determine human papillomavirus (HPV) types by polymerase chain reaction (PCR)-reverse line blot assay and examine the concordance between HPV by Hybrid Capture 2 (HC2) and PCR on self-collected vaginal and physician-collected cervical samples and cytology. Methods This was a cross-sectional study of 546 sexually active women aged ≥30 years with persistent vaginal discharge, intermenstrual or postcoital bleeding or an unhealthy cervix. Participants self-collected vaginal samples (HPV-S) and physicians collected cervical samples for conventional Pap smear and HPV DNA (HPV-P) testing and performed colposcopy, with directed biopsy, if indicated. HPV testing and genotyping was done by HC2 and PCR reverse line blot assay. Concordance between HC2 and PCR results of self- and physician-collected samples was determined using a Kappa statistic (κ) and Chi-square test. Results Complete data were available for 512 sets with 98% of women providing a satisfactory self-sample. PCR detected oncogenic HPV in 12.3% of self- and 13.0% of physician-collected samples. Overall, there was 93.8% agreement between physician-collected and self-samples (κ = 76.31%, 95% confidence interval [CI]: 64.97–82.29%, p = 0.04)—complete concordance in 473 cases (57 positive, 416 negative), partial concordance in seven pairs and discordance in 32 pairs. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of self-sampling for detection of cervical intraepithelial neoplasia (CIN)2+ disease were 82.5%, 93.6%, 52.4% and 98.4%, respectively; for physician-sampling they were 87.5%, 93.2%, 52.2% and 98.9%, respectively; and for cytology they were 77.5%, 87.3%, 34.1% and 97.9%, respectively. Concordance between HC2 and PCR was 90.9% for self-samples (κ = 63.7%, 95% CI: 55.2–72.2%) and 95.3% for physician-collected samples (κ = 80.4%, 95% CI: 71.8–89.0%). Conclusions Self-HPV sampling compares favourably with physician-sampling and cytology. A rapid, affordable, HPV self-test kit can be used as the primary method of cervical cancer screening in low-resource situations.

Detection of TERC Amplification in Cervical Epithelial Cells for the Diagnosis of High-Grade Cervical Lesions and Invasive Cancer

“…Therefore, while the incidence of CIN2 ϩ was Ͼ40% in the 2316 patients whose data were used to calculate the NPV, this is much higher than the previously reported rate of 8%. [32][33][34] This would explain the low NPV of HPV testing to detect CIN2 ϩ (ie, 82.4%). Furthermore, the results of this study may be more applicable to high-risk women undergoing consultation rather than primary cervical screenings.…”

Cervical Cancer Screening and Prevention for HIV-Infected Women in the Developing World

“…HPV testing has been suggested as primary screening in place of cytology in the US and Europe (Kitchener et al 2009;Cusick et al 2006) and a negative HPV test predicts a less than 2% risk of developing cervical dysplasia (Naucler et al 2009;Lonky et al 2010;Mesher et al 2010;Kitchener et al 2009;Cusick et al 2006). An advantage of HPV testing is that a pelvic exam is not required, but simply insertion of a swab into the vagina to obtain the sample; furthermore, studies have shown that accurate results can be obtained with self-testing, where the woman inserts the swab into her own vagina (Ogilvie et al 2005;Balasubramanian et al 2010), that this compares favorably to collection by clinicians (Bhatla et al 2009;Petignat et al 2007) and is acceptable to women (Mitchell et al 2011;Lack et al 2005). However, treatment of positive results clearly requires access to and good visualization of the cervix.…”

“…An advantage of HPV testing is that pelvic exam is not required, but simply insertion of a swab into the vagina to obtain the sample; furthermore, studies have shown that accurate results can be obtained with self-testing, where the woman insert the swab into her own vagina (Ogilvie et al 2005;Balasubramanian et al 2010), that this compares favorably to collection by clinicians (Bhatla et al 2009;Petignat et al 2007) and is acceptable to women (Mitchell et al 2011;Lack et al 2005). However, treatment of positive results clearly requires access to and good visualization of the cervix.…”

Genitourinary Infections after a Routine Pelvic Exam

“…5,6 However, self-sampling for the human papillomavirus is emerging as an accurate and effective technique for cervical cancer screening through a variety of methods. [7][8][9][10] Although self-sampling research has been more focused on developing countries where access to providers is limited, self-sampling techniques that avoid speculum insertion deserve further consideration for all populations as alternatives that, in addition to being potentially less traumatic, may also increase screening rates.…”