Suitability of Self-Collected Vaginal Samples for Cervical Cancer Screening in Periurban Villages in Andhra Pradesh, India

Abstract

Objectives: Our aim was to determine if (1) Hybrid Capture 2 and a PCR-based method were comparable for detection of high-risk human papillomavirus (HPV) clinician-collected and self-collected samples were equally efficient to detect HPV and cervical cancer precursor lesions, and (3) if participation rates improved with home-based versus clinic-based self collection. Methods: Samples were selected from women participating in a cervical cancer screening study according to HPV, visual inspection with acetic acid, or Pap smear screening results. From 432 of 892 selected women, split sample aliquots were tested for HPV DNA using both the Hybrid Capture 2 assay and the Roche prototype line blot assay. Women from a subset of villages were recruited at two separate time points for clinic-based self-collection and home-based self-collection, and participation rates were compared. Results: Pairwise agreement between self-and clinician-collected samples was high by both Hybrid Capture 2 (90.8% agreement, K = 0.7) and PCR (92.6% agreement, K = 0.8), with significantly increased highrisk HPV detection in clinician-collected specimens (McNemar's P < 0.01). Ability to detect precursor lesions was highest by PCR testing of cliniciancollected samples and lowest by Hybrid Capture 2 testing of self-collected samples (11 of 11 and 9 of 11 cases of cervical intraepithelial neoplasia grade 2/3 and cancer detected, respectively). Participation in homebased screening was significantly higher than clinicbased screening (71.5% and 53.8%, respectively; P < 0.001) among women ages 30 to 45 years.

Hybrid Capture 2 Assay Based Evaluation of High-Risk HPV Status in Healthy Women of North-East India

“…This test can be completed in less than 4 hours. There have been a few Indian studies which provided supporting evidence that self-collected HC2 samples may have fairly similar sensitivity in comparison to the physician collected specimen when analyzed by automated HC2 system (Bhatla et al, 2009;Sowjanya et al, 2009). …”

“…The geographic regions represented in these studies were northern, eastern and southern India. The HR-HPV DNA positivity was found in the frequency range of 6% to 18% which may be attributed to the difference in study design and also to the geographical and ethnic diversity of India (Bhatla et al, 2009;Sowjanya et al, 2009;Datta et al, 2010;Piyathilake et al, 2010;Katyal et al, 2011;Pandey et al, 2012;Basu et al, 2013;Bhatla et al, 2013).…”

Self-sample HPV Tests As an Intervention for Nonattendees of Cervical Cancer Screening in Finland: a Randomized Trial

“…Samples with current self-sampling methods are at least as sensitive as a traditional Pap smear in detecting high-grade CIN lesions (8-14, 18, 26). Still, their lower specificity and PPVs compared with cytologic screening and provider-obtained samples for HPV analysis (7,(10)(11)(12)(13)(14)(43)(44)(45) make traditional participation in organized screening the current primary option.…”

“…Further HC2 analysis was conducted with positive and negative controls according to the manufacturer's guidelines similarly and simultaneously with samples from routine screening obtained by Digene Cytobrushes (22,27). The used HC2 analysis is a qualitative test that targets 13 hrHPV types (16,18,31,33,35,39,45, 51, 52, 56, 58, 59, and 68). A sample containing hrHPV DNA equivalent to concentration of 1 pg/mL or above was considered to indicate an hrHPV infection [i.e., cutoff value ¼ 1 relative luciferase units (RLU)].…”

Shedding of Epstein-Barr Virus and Cytomegalovirus from the Genital Tract of Women in a Periurban Community in Andhra Pradesh, India

“…The sample used in this analysis is a subset of the first 892 women enrolled in the study enriched for the presence of women who were positive in the cervical screen marker analyses, as previously described (22). This subset of 470 women included (i) all 220 women who screened positive on at least one of the tests (Pap smear, HPV DNA, or VIA), (ii) all women who were randomized to colposcopy but who screened negative by all three tests (n ϭ 122), and (iii) a random sample (n ϭ 128) of women negative by all three screening tests.…”