Background: With the emergence of human papillomavirus-based primary screening, the option of vaginal self-collected sample may overcome the barrier of speculum examination. Despite evidence of high acceptability of self-collection, there is need to evaluate the validity of such samples for HPV detection. This research aimed to determine the validity of self-collected vaginal samples for HPV detection among Nigerian women.
Methods: A cross-sectional analytic study was conducted among 230 asymptomatic women, selected by multi-stage sampling method in Orhuwhorun community in Udu Local Government Area of Delta State between May to June 2021. Participants were instructed on self-collection (SC) of vaginal samples using Flobam female sample collection kit and a clinician-collected (CC) cervical sample was obtained using a similar swab. Paired specimens were tested for HPV genotyping using 21 HPV GenoArray Diagnostic kits. SPSS vs 25 was used for data analysis. Agreement between the two collection methods was calculated using concordance and discordance rates and Cohen's kappa statistic. A 2 by 2 contingency table was used to calculate sensitivity and specificity of both sampling methods. A p < 0.05 was considered statistically significant.
Results: 230 women of mean age 41.08 years (SD ± 8.45) were enrolled and 228 paired SC and CC results were analyzed. Of the 228 samples, 44 (19.3%) and 48 (21.1%) had HPV on clinician-collected and self-collected samples respectively. The HPV detection concordance was 92.9% (95%CI: 89.7–96.3), Kappa value of 0.66 (p < 0. 001), showing substantial agreement. Sensitivity and specificity of SC compared to CC were 86.4% (95%CI: 76.2–96.5) and 94.6% (95%CI: 91.3–97.8) respectively. Odds ratio was 1.15 indicating SC is as good as CC for HPV detection.
Conclusions: The excellent validity of SC support its use as an alternative form of HPV screening among Nigerian women hence the government should consider its introduction into the national cervical screening programme.
Eze JN, Emeka-Irem EN, Edegbe FO. A six-year study of the clinical presentation of cervical cancer and the management challenges encountered at a state teaching hospital in southeast Nigeria. Clinical Medicine Insights: Oncology. 2013: CMO-S12017.
Ver AT, Notarte KI, Velasco JV, Buac KM, Nazareno III J, Lozañes JA, et al. A systematic review of the barriers to implementing human papillomavirus vaccination programs in low‐and middle‐income countries in the Asia‐Pacific. Asia‐Pacific Journal of Clinical Oncology. 2021; 17(6): 530-45.
Kashyap N, Krishnan N, Kaur S, Ghai S. Risk factors of cervical cancer: a case-control study. Asia-Pacific Journal of Oncology Nursing. 2019; 6(3): 308-14.
Orah NO, Banjo AA. Prevalence and distribution of high risk human papillomavirus subtypes in invasive cervical cancer in South-West Nigeria. Annals of Tropical Pathology. 2018; 9(2): 106.
Jedy-Agba E, Curado MP, Ogunbiyi O, Oga E, Fabowale T, Igbinoba F, et al. Cancer incidence in Nigeria: a report from population-based cancer registries. Cancer Epidemiology. 2012; 36(5): e271-8.
Cholli P, Bradford L, Manga S, Nulah K, Kiyang E, Manjuh F, et al. Screening for cervical cancer among HIV-positive and HIV-negative women in Cameroon using simultaneous co-testing with careHPV DNA testing and visual inspection enhanced by digital cervicography: findings of initial screening and one-year follow-up. Gynecologic Oncology. 2018; 148(1): 118-25.
Hawkes D, Keung MH, Huang Y, McDermott TL, Romano J, Saville M, et al. Self-collection for cervical screening programs: from research to reality. Cancers. 2020; 12(4): 1053.
Arbyn M, Weiderpass E, Bruni L, de Sanjosé S, Saraiya M, Ferlay J, Bray F. Estimates of incidence and mortality of cervical cancer in 2018: a worldwide analysis. The Lancet Global Health. 2020; 8(2): e191-203.
Kirkwood BR, Sterne JA. Essential Medical Statistics 2003 ed 2 Oxford.
Esber A. Feasibility, validity and acceptability of self-collected samples for human papillomavirus (HPV) testing in rural Malawi. Malawi Medical Journal. 2018; 30(2): 61-6.
Ajenifuja OK, Ikeri NZ, Adeteye OV, Banjo AA. Comparison between self sampling and provider collected samples for Human Papillomavirus (HPV) Deoxyribonucleic acid (DNA) testing in a Nigerian facility. The Pan African Medical Journal. 2018; 30.
Haile EL, Cindy S, Ina B, Belay G, Geertruyden Jean-Pierre V, Sharon R, et al. HPV testing on vaginal/cervical nurse-assisted self-samples versus clinician-taken specimens and the HPV prevalence, in Adama Town, Ethiopia. Medicine. 2019; 98(35).
Flores CA, Gutierrez GG, Leon JO, Rodriguez DC, Sørbye SW. Self-collected versus clinician-collected cervical samples for the detection of HPV infections by 14-type DNA and 7-type mRNA tests. BMC Infectious Diseases. 2021; 21(1): 1-9.
Nutthachote P, Oranratanaphan S, Termrungruanglert W, Triratanachat S, Chaiwongkot A, Baedyananda F, et al. Comparison of detection rate of high risk HPV infection between self-collected HPV testing and clinician-collected HPV testing in cervical cancer screening. Taiwanese Journal of Obstetrics and Gynecology. 2019; 58(4): 477-81.
Des Marais AC, Zhao Y, Hobbs MM, Barclay L, Brewer NT, Smith JS. Home self-collection by mail to test for human papillomavirus and sexually transmitted infections. Obstetrics and Gynecology. 2018; 132(6): 1412.
Kamath Mulki A, Withers M. Human Papilloma Virus self-sampling performance in low-and middle-income countries. BMC women's health. 2021; 21(1): 1-1.
Boggan JC, Walmer DK, Henderson G, Chakhtoura N, McCarthy SH, Beauvais HJ, et al. Vaginal self-sampling for HPV infection as a primary cervical cancer screening tool in a Haitian population. Sexually Transmitted Diseases. 2015; 42(11): 655.
Shan L, Ying J, Lu N. HER2 expression and relevant clinicopathological features in gastric and gastroesophageal junction adenocarcinoma in a Chinese population. Diagnostic Pathology. 2013; 8(1): 1-7.
Kamal EM, El Sayed GA, El Behery MM, El Shennawy GA. HPV detection in a self-collected vaginal swab combined with VIA for cervical cancer screening with correlation to histologically confirmed CIN. Archives of Gynecology and Obstetrics. 2014; 290(6): 1207-13.
Nilyanimit P, Wanlapakorn N, Niruthisard S, Takahashi M, Vongpunsawad S, Poovorawan Y. Comparison of detection sensitivity for human papillomavirus between self-collected vaginal swabs and physician-collected cervical swabs by electrochemical DNA chip. Asian Pacific Journal of Cancer Prevention. 2015; 15(24): 10809-12.
Adler DH, Laher F, Lazarus E, Grzesik K, Gray GE, Allan B, et al. A viable and simple self-sampling method for human papillomavirus detection among South African adolescents. Journal of Immunological Techniques in Infectious Diseases. 2013; 2(3).
Obiri-Yeboah D, Adu-Sarkodie Y, Djigma F, Hayfron-Benjamin A, Abdul L, Simpore J, et al. Self-collected vaginal sampling for the detection of genital human papillomavirus (HPV) using careHPV among Ghanaian women. BMC Women's Health. 2017; 17(1): 1-6.
Haile EL, Woldemichae GB, Lebelo RL, Bogers JP. Comparison and acceptability of HPV self-collected cervical cancer samples versus doctor-collected samples in Africa: a systematic review. PAMJ-Clinical Medicine. 2020; 2(82).
Mitchell SM, Pedersen HN, Eng Stime E, Sekikubo M, Moses E, Mwesigwa D, et al. Self-collection based HPV testing for cervical cancer screening among women living with HIV in Uganda: a descriptive analysis of knowledge, intentions to screen and factors associated with HPV positivity. BMC Women's Health. 2017; 17(1): 1-0.
Nelson EJ, Maynard BR, Loux T, Fatla J, Gordon R, Arnold LD. The acceptability of self-sampled screening for HPV DNA: a systematic review and meta-analysis. Sexually Transmitted Infections. 2017; 93(1): 56-61.
Gupta S, Palmer C, Bik EM, Cardenas JP, Nunez H, Kraal L, et al. Self-sampling for human papillomavirus testing: increased cervical cancer screening participation and incorporation in international screening programs. Frontiers in Public Health. 2018: 77.
This work is licensed under a Creative Commons Attribution 4.0 International License.