Cervical Human Papillomavirus Testing With Two Home Self-Collection Methods Compared With a Standard Clinically Collected Sampling Method

Abstract

Background The purpose of this study was to compare the outcomes of 2 self-collection methods to detect cervical human papillomavirus (HPV) DNA with outcomes from a standard clinical method. The standard method samples were collected by a clinician at a routine pelvic examination. Self-samples were taken at home and mailed to the clinical laboratory. Methods The 2 self-collection methods were a tampon-based method and a swab-based method using a commercial device, an Eve Medical HerSwab. All HPV samples were processed by a clinical laboratory using the Food and Drugs Administration approved Roche Cobase HPV method, which specifically identifies HPV 16, HPV 18, and a set of 12 other high-risk subtypes. Patients were recruited from 2 cancer screening clinics 2015 to 2017. All patients signed an informed consent. Screening outcomes, such as prevalence, percent agreement with standard, sensitivity, and specificity, were calculated for each self-collection method. Measures of similarity between self and standard collection outcomes, Cohen’s κ, percent concordance, McNemar equivalence, and others were tested statistically. Results One hundred seventy-four patients were randomized. The prevalence of 1 or more positive HPV high-risk subtypes from the standard clinical specimens was 13.5%. All clinical specimens were sufficient for valid HPV detection. For the tampon method, 15 (27%) of the specimens were insufficient quality. Only 1 (2%) swab specimen was insufficient. Only the swab self-collection method was found to be statistically noninferior to the clinical method. The tampon method had an unacceptably high rate of insufficient quality specimens and also failed the equivalency tests. Conclusions The swab home collection samples were equivalent to the clinical samples, but the tampon method had an unacceptably high rate of specimens insufficient for HPV detection.

Comparison of Different Self-Sampling Devices for Molecular Detection of Human Papillomavirus (HPV) and Other Sexually Transmitted Infections (STIs): A Pilot Study

“…Moreover, equivalence testing using McNemar’s paired test showed high p -values, further confirming equivalence. McLarty and colleagues reported high p -values and 100% concordance between swab self-collected specimens and clinical-collected specimens [ 34 ].…”

Mapping Evidence of Self-Sampling to Diagnose Sexually Transmitted Infections in Women: A Scoping Review

“…Nine studies had an average score of 60–75% [ 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 ] and seven other studies scored an average score of 65%. The remaining 27 studies scored a high-quality score between 76–100% [ 6 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 ].…”

“…Studies were conducted in various HICs and LMICs ( Figure 2 ). Eleven (24%) studies were conducted in the United States of America (USA) [ 20 , 22 , 28 , 29 , 33 , 35 , 37 , 45 , 47 , 54 , 55 ], five (11%) in Canada [ 21 , 52 , 53 , 56 , 57 ], three (7%) in Australia [ 32 , 41 , 58 ], two (5%) in the United Kingdom (UK) [ 25 , 38 ], and two (4%) in The Netherlands [ 44 , 59 ]. Two studies (4%) were conducted in South Africa [ 27 , 60 ], two (4%) in Lithuania [ 40 , 48 ], and two (4%) in Kenya [ 23 , 30 ].…”

“…Nucleic acid amplification-based tests (NAATs) were used to diagnose STIs in 95% ( n = 42) of studies [ 6 , 18 , 19 , 20 , 21 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 42 , 44 , 45 , 47 , 48 , 49 , 51 , 52 , 53 , 54 , 55 , 57 , 58 , 59 , 60 , 62 , 63 , 64 ], while only one study used a NAAT, conventional culture, and wet mount techniques [ 41 ]. The NAAT tests included Aptima Combo 2, Polymerase Chain Reaction (PCR), IVD-marked multiplex real-time PCR Allplex STI Essential Assay, Digene Hybrid Capture II (HCII) Chlamydia trachomatis/ Neisseria gonorrhoea (CT/NG) Test, PCR for CT (cobas ® TaqMan 48 real time PCR), cobas ® Amplicor CT/NG test, the Anyplex II Huma papillomavirus (HPV)28 Detection assay, Real-time PCR using CFX9, care HPV Assay, Ligase Chain Reaction (LCR), and Strand Displacement Amplification.…”

Self-Sampling Devices for HPV Testing

“…21 The results of further studies published since 2018, including participants who were due or overdue for cervical cancer screening and did not have a previously diagnosed cervical abnormality, are summarized in Table 1 and Table 2. Self-and clinician-collected HPV samples did not produce significantly different results in HPV prevalence [22][23][24] or histologically important results. 23 When randomized to self-collection for HPV testing or clinician collection for cytology testing (Pap test), significantly more participants completed screening in the self-collection group.…”