Concordance of Primary Human Papillomavirus Testing Among Clinicians and Patients: A Systematic Review

Abstract

Objective:

Primary high risk human papilloma virus (hrHPV) testing is recommended as first-line screening for cervical cancer. Testing involves either a clinician-collected or a self-collected cervicovaginal swab. This study examines concordance between methods of collection of primary HPV testing.

Methods:

Ovid MEDLINE, Ovid Embase, and Cochrane were searched for relevant studies on self-collected and clinician-collected primary HPV testing published before December 31, 2022. English-language studies for primary HPV testing of average-risk patients were included. Studies conducted in screening settings rather than colposcopy clinics, that used standard devices for HPV collection, and that directly compared methods of collection were included. Outcomes were concordance and kappa between paired samples, and rate of HPV detection in self-collected and clinician-collected samples.

Results:

A total of 2381 studies were screened, of which 228 were included for full-text evaluation. Thirty-six studies, including 23,328 individuals screened, met the inclusion criteria. The rate of HPV detection ranged from 4.7% to 63% for self-collection and from 3.7% to 62% for clinician-collection. The concordance ranged from 78.2% to 96.9%, and kappa had substantial agreement for 26 of the 36 studies and moderate agreement for 7 of the 36 studies.

Conclusions:

This study directly compares clinician-collected and self-collected primary HPV screening rates. Studies were conducted in methods which are widely reproducible in the primary care setting. Primary HPV self-collection is a reliable and accurate method for cervical cancer screening.

Introduction

Cervical cancer mortality has decreased from 3.2/100,000 in 1996 to 2.2/100,000 after the initial recommendations for widespread cervical cancer screening over 20 years ago.^1,2 Human papillomavirus (HPV) testing has improved risk stratification, reduced the incidence and mortality from cervical cancer, and altered screening recommendations since first routinely available in early 2010s.^3,4 Cervical cancer screening recommendations were most recently updated by the United States Preventive Services Taskforce (USPSTF) in 2018.¹ Screening options included the following: cytology alone for women aged 21–29 years every 3 years and screening by either HPV alone every 5 years, screening with HPV and cytology every 5 years, or screening with cytology alone every 3 years for women aged 30–65 years. Primary HPV testing is defined as the use of high-risk HPV testing alone for cervical cancer screening.

Primary HPV testing can be performed by either clinician-collected samples or a self-collected cervicovaginal swab. While the USPSTF recommended primary HPV screening as an option, the group did not specify the direct method of testing in their recommendation. Self-collected samples, so-called “self-sampling,” have many acknowledged advantages compared with clinician-collected samples. Self-sampling is less costly, less invasive for patients, and causes less psychological stress.^5
–7 However, the task force identified a gap in research regarding high risk human papilloma virus (hrHPV) testing—self-sampling had not been robustly evaluated in comparison to clinician-collected samples.¹

In addition to the self-sampling advantages above, it also offers a solution to another gap identified by the USPSTF. Individuals in minority groups, those of low socioeconomic status, and those in communities with low access to health care have lower rates of screening for cervical cancer.⁸ Self-sampling may benefit these under-screened groups and promote equitable screening strategies as self-sampling may take place at home via mailed kit, reduce the need for pelvic examinations, and reduce visits to the clinician's office.⁹

This systematic review aims to fill the USPSTF-identified gap in the literature and identify the rates of concordance and reliability between paired clinician-collected and self-collected hrHPV samples in average-risk women undergoing cervical cancer screening.

Methods

Prospero ID

This systematic review was reported following the Preferred Reporting Item for Systematic Reviews and Meta-Analyses (PRISMA) statement. The study protocol was registered with the PROSPERO ID CRD42021250098 before data extraction.

Sources

Eligible trials were identified by searches of Ovid MEDLINE, Ovid Embase, and Cochrane up to December 31, 2022, using keywords and controlled vocabulary for the concepts of HPV and cervical cancer screening. The full search strategies for each database are included in Supplementary Appendix SA1.

Eligibility criteria

Studies were included if they met the following criteria: (1) the study was published in the peer-reviewed literature before December 31, 2022; (2) the study design was one of the following: randomized control trial, well-designed controlled clinical trial, cohort study, case–control study; (3) target population was average-risk and asymptomatic people with a cervix between 30 and 65 years old; (4) the modality of HPV self-collection was performed via vaginal/cervical swab; (5) the comparison was clinician-collected HPV testing; (6) the outcomes included rate of HPV detection by self/patient collection, rate of HPV detection by clinician collection, rate of concordance (kappa) between self-collection and clinician-collection; and (7) of robust quality, which we defined as fewer than four high-risk categories on the National Institute of Health (NIH) Quality Assessment Tool for Observational Cohort and Cross-sectional Studies.¹⁰

Studies were excluded if they were conference abstracts, commentaries, or review articles. Studies that were not written in English or able to be translated into English were excluded. Studies were excluded if their study populations included individuals with pre-existing cervical cancer, those with signs of high-grade dysplasia or cervical cancer such as abnormal uterine bleeding, those attending a colposcopy clinic, or individuals with other high-risk features for increased cervical cancer screening as defined by the USPSTF.

Study selection

The titles and abstracts of all retrieved articles were screened for inclusion by the two investigators (A.N.H. and S.B.) independently. Disagreements were resolved by a third reviewer (J.W.C.). Next, the two investigators (A.N.H. and S.B.) performed a full-text review on all articles included after the first round of screening. One investigator thoroughly reviewed the studies and extracted relevant data from the articles (the “full reviewer”). A second investigator reviewed and checked the extracted data (the “checker”). Articles were categorized into seven categories based on the primary exclusion criteria: population, preliminary data such as conference abstracts, outcomes, study design, language, article not available, and duplicate data. Finally, the remaining articles were included in another full-text review for data extraction.

Data abstraction, quality review, and analysis

Data extraction

Data were extracted from the selected articles by two study authors (A.N.H. and S.B.) using a standardized form in Covidence™ software. The following information was extracted from each article: author identification, year of publication, type of study design, country of study location, setting (academic-based or community-based), years study was conducted, and device used by patients or clinician. The inclusion and exclusion criteria of each study were also extracted. Detection rates of HPV positivity for self-collected and clinician-collected swabbing were recorded.

Finally, the concordance and kappa between self-collected and clinician-collected samples were recorded. Data were independently extracted by two investigators (S.B. and A.N.H.). Comparison of the data was reviewed by investigator S.B. Agreements were pushed forward as final data, and disagreements were resolved by discussion and consensus between two investigators (S.B. and A.N.H.). If consensus was not met, a third reviewer resolved the decision (J.W.C.). If there were missing data, this was indicated in the table as “not available.” Final data were exported from Covidence in a Microsoft Excel file.

Quality review

A quality assessment of the 36 studies included in the data extraction review was performed using the NIH Quality Assessment Tool for Observational Cohort and Cross-sectional Studies.¹⁰ This tool consists of 14 criteria to assess various aspects of each study's population, methods, and data analysis. Three of the criteria were removed because they were not applicable to cross-sectional studies according to the NIH guidelines (Question 8 on different levels of exposure of interest, Question 10 on repeated exposure assessment, and Question 13 on follow-up rate). Each criterion was graded with either a “low,” “high,” or “unclear” response to indicate level of potential bias. Two researchers (S.B. and A.N.H.) independently reviewed each study using these guidelines. Disagreements were discussed and resolved by S.B. and A.N.H. Any unresolved disagreements were reviewed and resolved by a third researcher (J.W.C).

Statistical analysis

The primary outcome, the concordance and kappa of the clinician-collected and self-collected samples, is provided as a range of values. The rates of HPV detection by self-collected and clinician-collected swabbing are reported as ranges.

Results

A total of 2381 eligible studies were identified. Of those, 36 articles were included in the final data analysis. The results of the study selection are summarized in a PRISMA diagram (Fig. 1). Overall, there was excellent interrelated reliability in both the primary title and abstract review as well as the full-text review. The proportionate agreement for the decision of inclusion or exclusion of studies in the “Title and Abstract” review was 0.94, with a Cohen's kappa of 0.65. The proportionate agreement for the decision of inclusion or exclusion of studies in the “Full Text” review was 0.97, with a Cohen's kappa of 0.90.

FIG. 1.

Preferred Reporting Items for Systematic Reviews and Meta-Analyses diagram outlining the inclusionary path of articles available in the peer-reviewed literature (n = number of studies).

Characteristics of the 36 included studies can be found in Table 1. Studies represented 22 countries; 6 studies took place in the United States and 30 were from outside the United States. Twenty-five of the 36 studies took place in a community-based setting, while 8 took place in an academic-based setting, and 2 were combined community-based and academic-based. The age range of participants was 16 to >60 years. Methods and education for self-collection varied between studies, but all used commercially available products such as polyester (Dacron) or rayon tipped swabs, Rovers Vibra Brush^®, or similar.

Table 1.

Characteristics of Articles That Met the Inclusion Criteria, Including Author, Title, Years Conducted, Country, Setting, and Type of Device Used by Clinician and Patient

Study	Study title	Date of study conducted	Country	Setting	Self-detection device	Clinician-detection device
Aftab et al. (2006)¹²	Detection of Carcinogenic Human Papillomavirus in Specimens Collected with a Novel Self-Sampling Device	Does not state	United States	Academic	Fournier device	Plastic specula, cytobrushes, and Ayer's spatulas
Agorastos et al. (2005)¹³	Self-Sampling Versus Physician-Sampling for Human Papillomavirus Testing	March 2000–April 2001	Greece	Community	Cytobrush	Cytobrush
Ajenifuja et al. (2018)¹⁴	Comparison Between Self Sampling and Provider Collected Samples for Human Papillomavirus (HPV) Deoxyribonucleic Acid (DNA) Testing in a Nigerian Facility	Does not state	Nigeria	Academic	Cytobrush	Cytobrush
Aranda Flores et al. (2021)¹⁵	Self-Collected Versus Clinician-Collected Cervical Samples for the Detection of HPV Infections by 14-type DNA and 7-Type mRNA Tests	August 2018–April 2019	Mexico	Community	XytoTest	Rovers Cervex-Brush
Boa et al. (2021)¹⁶	Performance of Xpert HPV on Self-Collected Vaginal Samples for Cervical Cancer Screening Among Women in South Africa	Does not state	South Africa	Community	Standard flock tip swab	Endocervical cytobrush
Boggan et al. (2015)¹⁷	Vaginal Self-Sampling for Human Papillomavirus Infection as a Primary Cervical Cancer Screening Tool in a Haitian Population	Does not state	Haiti	Community	Dacron brush	Dacron brush
Cerigo (2012)¹⁸	Dry Self-Sampling Versus Provider-Sampling of Cervicovaginal Specimens for Human Papillomavirus Detection in the Inuit Population of Nunavik, Quebec	December 2007–June 2010	Canada	Community	Dacron swab (Copan 159C)	Dacron swab (Copan 159C)
Des Marais et al. (2018)¹⁹	Home Self-Collection by Mail to Test for Human Papillomavirus and Sexually Transmitted Infections	February 2012–October 2014	United States	Community	Viba-Brush	Endocervical brush and spatula
Dijkstra et al. (2012)²⁰	Brush-Based Self-Sampling in Combination with GP5+/6+-PCR-Based hrHPV Testing: High Concordance with Physician-Taken Cervical Scrapes for HPV Genotyping and Detection of High-Grade CIN	October 2009–November 2010	The Netherlands	Academic	Viba-Brush	Rovers Cervex-Brush
Du et al. (2021)²¹	Evaluation of Cobas HPV and SeqHPV Assays in the Chinese Multicenter Screening Trial	August 2016–August 2018	China	Community	Conical-shaped brush (“JustForMe” brush)	Broom sampler (Rovers Medical Devices)
Gage et al. (2011)²²	Comparative Performance of Human Papillomavirus DNA Testing Using Novel Sample Collection Methods	2007–2009	United States	Community	Fournier self-sampler	Fournier self-sampler
Guan et al. (2013)²³	Agreement for HPV Genotyping Detection Between Self-Collected Specimens on a FTA Cartridge and Clinician-Collected Specimens	Does not state	China	Community	Qiagen cervical sampler brush	Qiagen cervical sampler brush
Haguenoer et al. (2014)²⁴	Accuracy of Dry Vaginal Self-Sampling for Detecting High-Risk Human Papillomavirus Infection in Cervical Cancer Screening: A Cross-Sectional Study	September 2009–March 2011	France	Both	Dry nylon flocked swab	Dry nylon flocked swab
Holanda et al. (2006)²⁵	Primary Screening for Cervical Cancer Through Self Sampling	August–December 2002	Brazil	Community	Does not state	Ayre spatula and small conical brush
Howard et al. (2006)²⁶	Vaginal Self Sampling Versus Physician Cervical Sampling for HPV Among Younger and Older Women	1999–2000	Canada	Community	Dacron swab	Cervical brush sampler (Digene Corporation)
Ilardo et al. (2022)²⁷	Performance and Pre-Analytical Stability of Self-Collected Samples Versus Clinician Cervical Samples for the Detection of HPV16, HPV18 and a Pool of 12 Other HPV Types on the Roche Cobas 8800 System	August 2021–September 2021	France	Community	Dry nylon flocked swab	Dry nylon flocked swab
Johnson et al. (2014)²⁸	Assessment of High-Risk Human Papillomavirus Infections Using Clinician- and Self-Collected Cervical Sampling Methods in Rural Women from Far Western Nepal	July 5, 2013	Nepal	Community	APTIMA CSCT kit (cytobrush)	APTIMA CSCT kit (cytobrush)
Jones et al. (2007)²⁹	Agreement Between Self- and Clinician-Collected Specimen Results for Detection and Typing of High-Risk Human Papillomavirus in Specimens from Women in Gugulethu, South Africa	January 2002–August 2002	South Africa	Community	Digene HC2 high-risk HPV test	Digene HC2 high-risk HPV test
Katanga et al. (2021)³⁰	Concordance in HPV Detection Between Self-Collected and Health Provider-Collected Cervicovaginal Samples Using careHPV in Tanzanian Women	August 2015–November 2017	Tanzania	Community	Evalyn Brush	Evalyn Brush
Latiff et al. (2015)³¹	Comparative Assessment of a Self-Sampling Device and Gynecologist Sampling for Cytology and HPV DNA Detection in a Rural and Low Resource Setting: Malaysian Experience	May 2010–July 2010	Malaysia	Community	Kato self-sampling device	Cytobrush
Lim et al. (2022)³²	Self-Sampling HPV DNA Test for Cervical Cancer Screening in Singapore: A Prospective Study	April 2019–September 2020	Singapore	Academic	Does note state	Does note state
Madhivanan et al. (2021)³³	Acceptability and Concordance of Self- Versus Clinician-Sampling for HPV Testing Among Rural South Indian Women	May and August 2017	India	Community	Digene HC2 NA Collection Device	Digene HC2 NA Collection Device
McLarty et al. (2019)³⁴	Cervical Human Papillomavirus Testing With Two Home Self-Collection Methods Compared with a Standard Clinically Collected Sampling Method	2015–2017	United States	Academic	Eve Medical HerSwab self-collection HPV kit	Roche Cobase HPV method
Nilyanimit (2014)³⁵	Comparison of Detection Sensitivity for Human Papillomavirus Between Self-Collected Vaginal Swabs and Physician-Collected Cervical Swabs by Electrochemical DNA Chip	October 2013–March 2014	Thailand	Academic	Flexible minitip flocked swab (Copan Diagnostics)	Flexible minitip flocked swab (Copan Diagnostics)
Nutthachote et al. (2019)³⁶	Comparison of Detection Rate of High Risk HPV Infection Between Self-Collected HPV Testing and Clinician-Collected HPV Testing in Cervical Cancer Screening	January 1, 2015–May 31, 2016	Thailand	Academic	QIAGEN	SurePath (broom-type cervical brush)
Ortiz et al. (2013)³⁷	Human Papillomavirus Infection in Women in Puerto Rico: Agreement Between Physician-Collected and self-Collected Anogenital Specimens	November 2007–June 2008	United States	Academic	Cytobrush	Cytobrush
Pilotto et al. (2018)³⁸	Cervico-Vaginal Self-Collection in HIV-Infected and Uninfected Women from Tapajos Region, Amazon, Brazil: High Acceptability, hrHPV Diversity and Risk Factors	August 2015–August 2016	Brazil	Community	Does not state	Endocervical brush
Prado et al. (2017)³⁹	Self-Sampling for Human Papillomavirus DNA Detection: A Preliminary Study of Compliance and Feasibility in BOLIVIA	Does not state	Bolivia	Both	Cotton swab	Cervical brushes
Reisner et al. (2018)⁴²	Test Performance and Acceptability of Self- Versus Provider-Collected Swabs for High-Risk HPV DNA Testing in Female-to-Male Trans Masculine Patients	March 2015–September 2016	United States	Not stated	Polyester-tipped swab (Puritan Medical Products)	Medsc and Pap-Perfect Spatula and Cytobrush Plus
Safaeian et al. (2007)⁴⁰	Comparability of Self-Collected Vaginal Swabs and Physician-Collected Cervical Swabs for Detection of Human Papillomavirus Infections in Rakai, Uganda	2002–2003	Uganda	Community	Digene sampler kit (with Dacron swab)	Digene sampler kit (with Dacron swab)
Senkomago et al. (2018)⁴¹	High-Risk HPV-RNA Screening of Physician- and Self-Collected Specimens for Detection of Cervical Lesions Among Female Sex Workers in Nairobi, Kenya	2009–2013	Kenya	Community	Does not state	Does not state
Taku et al. (2020)⁴³	Acceptability of Self- Collection for Human Papillomavirus Detection in the Eastern Cape, South Africa	September 2017–March 2019	South Africa	Community	Viba-Brushes	Viba-Brushes
Toliman et al. (2016)⁴⁴	Field Evaluation of Xpert HPV Point-of-Care Test for Detection of Human Papillomavirus Infection by Use of Self-Collected Vaginal and Clinician-Collected Cervical Specimens	October 2014–October 2015	Papua New Guinea	Community	Vaginal cytobrush	Cervical cytobrush
Vega Crespo et al. (2022)⁴⁵	Role of Self-Sampling for Cervical Cancer Screening: Diagnostic Test Properties of Three Tests for the Diagnosis of HPV in Rural Communities of Cuenca, Ecuador	May 2021–August 2021	Ecudaor	Community	Evalyn Brush	Hybribio cervical brush
Wong et al. (2018)⁴⁶	Can Human Papillomavirus DNA Self-Sampling be an Acceptable and Reliable Option for Cervical Cancer Screening in Female Sex Workers?	November 3, 2009–May 4, 2010	China	Community	Dacron swab	Dacron swab
Wright Jr et al. (2000)⁴⁷	HPV DNA Testing of Self-Collected Vaginal Samples Compared with Cytologic Screening to Detect Cervical Cancer	January 1998–April 1999	South Africa	Community	Dacron	Special conically shaped brush

CSCT, Cervical Specimen Collection and Transport; HC2, hybrid capture 2; HPV, human papillomavirus.

Quality analysis

The full quality analysis of all the 36 included studies using the NIH Quality Assessment Tool for Observational Cohort and Cross-sectional Studies is available in Supplementary Table S1.

For each included study, the questions on time frame and exposure were marked as “high” according to guidelines for cross-sectional studies. Cross-sectional studies are conducted where the exposure and outcomes are measured at the same time, thus cross-sectional analyses inherently provide weaker evidence than regular cohort studies regarding a potential causal relationship between exposures and outcomes. For the time frame, since cross-sectional analyses involve the exposures and outcomes being assessed at the same time, they do not allow time to see an effect.

Excluding the exposure and time frame categories, all the studies were robust. Eight studies had a higher risk of bias with three or more categories marked as high risk for bias. The majority of studies had overall low–moderate risk of bias.

Detection rate

The rate of HPV detection in self-collected and clinician-collected samples is reported in Table 2. The rate of HPV detection ranged from 4.7% to 63% in self-collected samples and from 3.7% to 62% in clinician-collected samples. Values varied widely across studies; thus, averages were not calculated; furthermore, the methodology for collection was heterogeneous, making reliability and interpretation of a meta-analysis poor.

Table 2.

Detection Rates, Concordance, and Kappa of Final Included Articles

Study	Self-collected HPV detection rate (%)	n	Clinician-collected HPV detection rate (%)	n	Concordance (%)	Kappa
Aftab et al. (2006)¹²	43	135	45	135	83	0.66
Agorastos et al. (2005)¹³	4.7	379	3.7	379	96.3	0.54
Ajenifuja et al. (2018)¹⁴	9.8	194	6.2	194	93.8	0.47
Aranda Flores et al. (2021)¹⁵	22.8	505	19.2	505	78.2	0.34
Boa et al. (2021)¹⁶	25.1	375	16.3	375	86.8	0.72
Boggan et al. (2015)¹⁷	21.4	1836	18.6	1836	91.4	0.73
Cerigo et al. (2012)¹⁸	38.2	89	28.1	89	85.4	0.67
Des Marais et al. (2018)¹⁹	12.4	193	11.4	193	92.7	0.66
Dijkstra et al. (2012)²⁰	63	135	62	135	86	0.7
Du et al. (2021)²¹	13.8	10,399	10.8	10,399	95.13	0.77
Gage et al. (2011)²²	18.4	406	20.2	406	88.2	0.611
Guan et al. (2013)²³	30	174	32	174	91	0.8
Haguenoer et al. (2014)²⁴	25.5	722	20.9	722	90.2	0.72
Holanda et al. (2006)²⁵	33.9	878	28.6	878	84.6	0.7
Howard et al. (2006)²⁶	9.9	152	8.6	152	89.5	0.37
Ilardo et al. (2022)²⁷	20.4	157	21.0	157	96.8	0.9
Johnson et al. (2014)²⁸	6.5	261	7.7	261	85.82	0.62
Jones et al. (2007)²⁹	41	222	37.8	222	81.5	0.61
Katanga et al. (2021)³⁰	13.8	464	19.0	464	90.5	0.66
Latiff et al. (2015)³¹	22.6	226	27	226	86.2	0.6
Lim et al. (2022)³²	20.0	300	21.0	300	92.3	0.77
Madhivanan et al. (2021)³³	10.1	119	12.6	119	94.1	0.735
McLarty et al. (2019)³⁴	15.3	59	13.5	163	93.2	0.71
Nilyanimit (2014)³⁵	40.6	101	40.6	101	91	0.58
Nutthachote et al. (2019)³⁶	10	400	7.5	400	95.5	0.73
Ortiz et al. (2013)³⁷	35.1	97	38.4	99	96.9	0.56
Pilotto et al. (2018)³⁸	39.4	94	33	112	85.1	0.68
Prado et al. (2017)³⁹	10.9	201	10.4	201	94.5	0.71
Reisner et al. (2018)⁴²	13	131	16	131	93.9	0.75
Safaeian et al. (2007)⁴⁰	15	505	15.6	505	93	0.75
Senkomago et al. (2018)⁴¹	28.5	344	29.9	344	82.8	0.55
Taku et al. (2020)⁴³	27.9	413	26.4	413	86.9	0.669
Toliman et al. (2016)⁴⁴	16.5	1005	12.3	1005	93.4	0.74
Vega Crespo et al. (2022)⁴⁵	21.0	120	15.0	120	92.5	0.74
Wong et al. (2018)⁴⁶	39.7	68	36.8	68	85.3	0.69
Wright Jr et al. (2000)⁴⁷	21.1	1415	21.3	1415	81.6	0.45
Total, N		23,328		23,328
Range	4.7–63	—	3.7–62	—	78.2–96.9	0.34–0.9

n, number of studies.

Kappa/concordance

The concordance between self-collected and clinician-collected samples and the kappa for the comparative detection rates are reported in Table 2. The concordance ranged between 78.2% and 96.9% for all the included studies. The kappa values for all the included studies ranged from 0.34 to 0.90. The kappa results between 0.01 and 0.20 are classified as none to slight agreement, 0.21–0.40 as fair, 0.41–0.60 as moderate, 0.61–0.80 as substantial, and 0.81–1.00 as almost perfect agreement.¹¹ Among the 36 included studies, 2 studies had fair agreement, 7 had moderate agreement, 26 had substantial agreement, and 1 study has almost perfect agreement.

Discussion

This systematic review identifies the validity and accuracy of self- versus clinician-obtained primary HPV testing to fill the knowledge gap presented by the USPSTF. There was high concordance between the self-collected and clinician-collected samples, with ranges between 78.2% and 96.9%; the kappa values varied, but the majority of studies (26/36) had substantial agreement. Primary HPV detection through self-collection is a reliable and accurate screening method for cervical cancer screening.

The studies included in this analysis were conducted with robust protocols, specimens were obtained in an easy-to-understand method, tools are commercially available, and results are reproducible from study to study. Based on these findings, it is plausible and appropriate to use self-collected HPV in U.S. settings. Findings from qualitative research have demonstrated that self-collection is generally accepted and or even preferred by patients for self-collection compared with clinician-collection.⁴⁸

Clinician-collected primary HPV testing has been recommended by the USPSTF for nearly 5 years yet has not been routinely used.⁴⁹ As such, it is important to consider how self-collection would be implemented into practice. Studies analyzed in this systematic review offered several options for testing: clinic-based self-collection during which a nurse or staff member provided education, home self-collection with swabs and instructions provided by a study team or clinic staff, and home self-collection with mailed swabs and instructions. It is feasible to suggest a similar approach to widespread adoption where multiple testing options are offered, as one single method may not work for all clinics.

The exclusion criteria of this study bring forth points of applicability to the general population. Many available studies reviewed were excluded due to study participant characteristics. Studies were excluded if the majority of participants were not in the USPSTF-defined age group of women 30–65 years old who are appropriate for HPV testing. In addition, studies were excluded if the majority of participants had high-risk characteristics that would not be prevalent in the majority of women in the regular screening population (i.e., HIV-positive women, those with atypical squamous cells of undetermined significance, or seen in a colposcopy clinic). Thus, the populations included in this evaluation are generalizable to the U.S. screening population. A limitation of using these exclusion criteria is that our concordance range does not have external validity to those with history of HPV+ or abnormal cytology. Further research is needed to compare the concordance in high-risk populations compared with general screening populations to elucidate if significant differences exist between concordances.

Another possible limitation of the study is the varying methodologies used to obtain cervical samples. As reflected in Table 1, the device used to collect samples varied. Studies included devices such as cytobrushes, cotton swabs, Dacron swabs, and spatulas—common in U.S. clinical practice. We excluded non-cervicovaginal swab methods such as tampons, sanitary pads, and urine samples as they are not standardized, validated instruments used in the United States. Further research is needed to assess validity of these methods compared with typical clinician-collected samples using cervicovaginal swabs.

It is reasonable to provide self-collected primary HPV screening options as a method for screening for cervical cancer. The quality of samples provided by patients is equivalent to that of clinician-collection. To optimally and equitably implement self-collection, commercial testing kits should be made available, clinicians should be coached on discussing this with patients, and public health messaging should include this as an option to remain up-to-date with cancer screenings.

Footnotes

Acknowledgments

The authorship team would like to thank the Virginia Commonwealth University Department of Family Medicine and Population Health for their support of this research.

Authors' Contributions

S.B.: Conceptualization, formal analysis, investigation, methodology, project administration, visualization, writing—original draft, writing—review and editing. J.W.C.: Methodology, formal analysis, software, writing—review and editing. A.N.H.: Conceptualization, data curation, formal analysis, methodology, resources, supervision, visualization, writing (original and review and editing).

Author Disclosure Statement

No competing financial interests exist.

Funding Information

The authorship team did not receive any funding for the work or publication of this article. Covidence access was sponsored by the C. Kenneth and Dianne Wright Center for Clinical and Translational Research (CTSA Award No. UL1TR002649 from the National Center for Advancing Translational Sciences).

Supplementary Material

Supplementary Table S1

Supplementary Appendix SA1

References

Cancer of the Cervix Uteri—Cancer Stat Facts. SEER. Available from: https://seer.cancer.gov/statfacts/html/cervix.html [Last accessed: December 19, 2022 ].

US Preventive Services Task

Force

, Curry

, Krist

, et al. Screening for cervical cancer: US preventive services task force recommendation statement. JAMA, 2018; 320(7):674; doi: 10.1001/jama.2018.10897

Vesco

, Whitlock

, Eder

, et al. Screening for Cervical Cancer: A Systematic Evidence Review for the U.S. Preventive Services Task Force. (U.S. Preventive Services Task Force Evidence Syntheses, formerly Systematic Evidence Reviews). Agency for Healthcare Research and Quality (US): Rockville, MD, USA; 2011.Available from: www.ncbi.nlm.nih.gov/books/NBK66099/ [Last accessed: December 19, 2022].

Bouvard

, Wentzensen

, Mackie

, et al. The IARC perspective on cervical cancer screening. N Engl J Med, 2021; 385(20):1908–1918; doi: 10.1056/NEJMsr2030640

Mitchell

, Lothamer

, Garcia

, et al. Acceptability and feasibility of community-based, lay navigator-facilitated at-home self-collection for human papillomavirus testing in underscreened women. J Womens Health, 2020; 29(4):596–602; doi: 10.1089/jwh.2018.7575

Aarnio

, Östensson

, Olovsson

, et al. Cost-effectiveness analysis of repeated self-sampling for HPV testing in primary cervical screening: A randomized study. BMC Cancer, 2020; 20(1):645; doi: 10.1186/s12885-020-07085-9

Malone

, Barnabas

, Buist

DSM

, et al. Cost-effectiveness studies of HPV self-sampling: A systematic review. Prev Med, 2020; 132:105953; doi: 10.1016/j.ypmed.2019.105953

Buskwofie

, David-West

, Clare

. A review of cervical cancer: Incidence and disparities. J Natl Med Assoc, 2020; 112(2):229–232; doi: 10.1016/j.jnma.2020.03.002

Huffstetler

. The positive impact of primary hrHPV self-testing. J Womens Health, 2020; 29(7):894–895; doi: 10.1089/jwh.2020.8432

10.

Study Quality Assessment Tools. NHLBI, NIH. Available from: https://www.nhlbi.nih.gov/health-topics/study-quality-assessment-tools [Last accessed December 19, 2022 ].

11.

McHugh

. Interrater reliability: The kappa statistic. Biochem Med (Zagreb), 2012; 22(3):276–282.

12.

Aftab

, Saint-Jean

, Mendez

, et al. Detection of carcinogenic human papillomavirus in specimens collected with a novel self-sampling device. J Clin Microbiol, 2006; 44(6):2158–2159; doi: 10.1128/JCM.02358-05

13.

Agorastos

, Dinas

, Lloveras

, et al. Self-sampling versus physician-sampling for human papillomavirus testing. Int J STD AIDS, 2005; 16(11):727–729; doi: 10.1258/095646205774763225

14.

Ajenifuja

, Ikeri

, Adeteye

, et al. Comparison between self sampling and provider collected samples for Human Papillomavirus (HPV) Deoxyribonucleic acid (DNA) testing in a Nigerian facility. Pan Afr Med J, 2018; 30:110; doi: 10.11604/pamj.2018.30.110.14321

15.

Aranda Flores

, Gomez Gutierrez

, Ortiz Leon

, et al. Self-collected versus clinician-collected cervical samples for the detection of HPV infections by 14-type DNA and 7-type mRNA tests. BMC Infect Dis, 2021; 21(1):504; doi: 10.1186/s12879-021-06189-2

16.

Boa

, Saidu

, Denny

, et al. Performance of Xpert HPV on self-collected vaginal samples for cervical cancer screening among women in South Africa. J Low Genit Tract Dis, 2021; 25(1):15–21; doi: 10.1186/s12879-021-06189-2

17.

Boggan

, Walmer

, Henderson

, et al. Vaginal self-sampling for human papillomavirus infection as a primary cervical cancer screening tool in a Haitian population. Sex Transm Dis, 2015; 42(11):655–659; doi: 10.1097/OLQ.0000000000000345

18.

Cerigo

, Coutlee

, Franco

, et al. Dry self-sampling versus provider-sampling of cervicovaginal specimens for human papillomavirus detection in the Inuit population of Nunavik, Quebec. J Med Screen, 2012; 19(1):42–48; doi: 10.1258/jms.2012.012011

19.

Des Marais

, Zhao

, Hobbs

, et al. Home self-collection by mail to test for human papillomavirus and sexually transmitted infections. Obstet Gynecol, 2018; 132(6):1412–1420; doi: 10.1097/AOG.0000000000002964

20.

Dijkstra

, Heideman

DAM

, van Kemenade

, et al. Brush-based self-sampling in combination with GP5+/6+-PCR-based hrHPV testing: High concordance with physician-taken cervical scrapes for HPV genotyping and detection of high-grade CIN. J Clin Virol, 2012; 54(2):147–151; doi: 10.1016/j.jcv.2012.02.022

21.

, Duan

, Liu

, et al. Evaluation of cobas HPV and SeqHPV Assays in the Chinese multicenter screening trial. J Low Genit Tract Dis, 2021; 25(1):22–26; doi: 10.1097/LGT.0000000000000577

22.

Gage

, Partridge

, Rausa

, et al. Comparative performance of human papillomavirus DNA testing using novel sample collection methods. J Clin Microbiol, 2011; 49(12):4185–4189; doi: 10.1128/JCM.01254-11

23.

Guan

, Gravitt

, Howard

, et al. Agreement for HPV genotyping detection between self-collected specimens on a FTA cartridge and clinician-collected specimens. J Virol Methods, 2013; 189(1):167–171; doi: 10.1016/j.jviromet.2012.11.010

24.

Haguenoer

, Giraudeau

, Gaudy-Graffin

, et al. Accuracy of dry vaginal self-sampling for detecting high-risk human papillomavirus infection in cervical cancer screening: A cross-sectional study. Gynecol Oncol, 2014; 134(2):302–308; doi: 10.1016/j.ygyno.2014.05.026

25.

Holanda

Jr , Castelo

, Veras

TMCW

, et al. Primary screening for cervical cancer through self sampling. Int J Gynaecol Obstet, 2006; 95(2):179–184; doi: 10.1016/j.ijgo.2006.07.012

26.

Howard

, Kaczorowski

, Sellors

, et al. Vaginal self sampling versus physician cervical sampling for HPV among younger and older women. Sex Transm Infect, 2006; 82(4):337–339; doi: 10.1136/sti.2005.019430

27.

Ilardo

, Marguerettaz

, Breton

, et al. Performance and pre-analytical stability of self-collected samples versus clinician cervical samples for the detection of HPV16, HPV18 and a pool of 12 other HPV types on the Roche Cobas 8800 System. New Microbiol, 2022; 45(2):111–114. PMID: 35699559

28.

Johnson

, Bhatta

, Smith

, et al. Assessment of high-risk human papillomavirus infections using clinician- and self-collected cervical sampling methods in rural women from far western Nepal. PLoS One, 2014; 9(6):e101255; doi: 10.1371/journal.pone.0101255

29.

Jones

, Allan

, van de Wijgert

JHHM

, et al. Agreement between self- and clinician-collected specimen results for detection and typing of high-risk human papillomavirus in specimens from women in Gugulethu, South Africa. J Clin Microbiol, 2007; 45(6):1679–1683; doi: 10.1128/JCM.02369-06

30.

Katanga

, Rasch

, Manongi

, Pembe

, Mwaiselage

, Kjaer

. Concordance in HPV detection between self-collected and health provider-collected cervicovaginal samples using careHPV in Tanzanian women. JCO Glob Oncol, 2021; 7:985–991; doi: 10.1200/GO.20.00598

31.

Latiff

, Ibrahim

, Pei

, et al. Comparative assessment of a self-sampling device and gynecologist sampling for cytology and HPV DNA detection in a rural and low resource setting: Malaysian experience. Asian Pac J Cancer Prev, 2015; 16(18):8495–8501; doi: 10.7314/apjcp.2015.16.18.8495

32.

Lim

, Chan

MFG

, Win

PPT

, Shen

, Arunachalam

, Ng

SYJ

, et al. Self-sampling HPV DNA test for cervical cancer screening in Singapore: A prospective study. Ann Acad Med Singap, 2022; 51(11):733–735; doi: 10.47102/annals-acadmedsg.2022133

33.

Madhivanan

, Nishimura

, Ravi

, et al. Acceptability and concordance of self- versus clinician-sampling for HPV testing among rural south Indian women. Asian Pac J Cancer Prev, 2021; 22(3):971–976; doi: 10.31557/APJCP.2021.22.3.971

34.

McLarty

, Loyd

, Williams

, et al. Cervical human papillomavirus testing with two home self-collection methods compared with a standard clinically Collected sampling method. Sex Transm Dis, 2019; 46(10):670–675; doi: 10.1097/OLQ.0000000000001045

35.

Nilyanimit

. Comparison of detection sensitivity for human papillomavirus between self-collected vaginal swabs and physician-collected cervical swabs by electrochemical DNA chip. Asian Pac J Cancer Prev, 2014; 15(24):10809–10812.

36.

Nutthachote

, Oranratanaphan

, Termrungruanglert

, 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. Taiwan J Obstet Gynecol, 2019; 58(4):477–481; doi: 10.1016/j.tjog.2019.05.008

37.

Ortiz

, Romaguera

, Perez

, et al. Human papillomavirus infection in women in Puerto Rico: Agreement between physician-collected and self-collected anogenital specimens. J Low Genit Tract Dis, 2013; 17(2):210–217; doi: 10.1097/LGT.0b013e318260e312

38.

Pilotto

, Rodrigues

LLS

, Sahasrabuddhe

, et al. Cervico-vaginal self-collection in HIV-infected and uninfected women from Tapajos region, Amazon, Brazil: High acceptability, hrHPV diversity and risk factors. Gynecol Oncol, 2018; 151(1):102–110; doi: 10.1016/j.ygyno.2018.08.004

39.

Prado

, Caceres

, Bellot

, et al. Self-sampling for human papillomavirus DNA detection: A preliminary study of compliance and feasibility in BOLIVIA. BMC Womens Health, 2017; 17(1):135; doi: 10.1186/s12905-017-0490-z

40.

Safaeian

, Kiddugavu

, Gravitt

, et al. Comparability of self-collected vaginal swabs and physician-collected cervical swabs for detection of human papillomavirus infections in Rakai, Uganda. Sex Transm Dis, 2007; 34(7):429–436; doi: 10.1097/01.olq.0000243623.67673.22

41.

Senkomago

, Ting

, Kwatampora

, et al. High-risk HPV-RNA screening of physician- and self-collected specimens for detection of cervical lesions among female sex workers in Nairobi, Kenya. Int J Gynecol Obstet, 2018; 143(2):217–224; doi: 10.1002/ijgo.12628

42.

Reisner

, Deutsch

, Peitzmeier

, et al. Test performance and acceptability of self- versus provider-collected swabs for high-risk HPV DNA testing in female-to-male trans masculine patients. PLoS One, 2018; 13(3):e0190172; doi: 10.1371/journal.pone.0190172

43.

Taku

, Meiring

, Gustavsson

, et al. Acceptability of self-collection for human papillomavirus detection in the Eastern Cape, South Africa. PLoS One, 2020; 15(11):e0241781; doi: 10.1371/journal.pone.0241781

44.

Toliman

, Badman

, Gabuzzi

, et al. Field evaluation of Xpert HPV point-of-care test for detection of human papillomavirus infection by use of self-collected vaginal and clinician-collected cervical specimens. J Clin Microbiol, 2016; 54(7):1734–1737; doi: 10.1128/JCM.00529-16

45.

Vega Crespo

, Neira

, Ortiz Segarra

, et al. Role of self-sampling for cervical cancer screening: Diagnostic test properties of three tests for the diagnosis of HPV in rural communities of Cuenca, Ecuador. Int J Environ Res Public Health, 2022; 19(8):12; doi: 10.3390/ijerph19084619

46.

Wong

ELY

, Cheung

AWL

, Huang

, et al. Can human papillomavirus DNA self-sampling be an acceptable and reliable option for cervical cancer screening in female sex workers?. Cancer Nurs, 2018; 41(1):45–52; doi: 10.1097/NCC.0000000000000462

47.

Wright Jr

, Kuhn

, Pollack

, et al. HPV DNA testing of self-collected vaginal samples compared with cytologic screening to detect cervical cancer. J Am Med Assoc, 2000; 283(1):81–86; doi: 10.1001/jama.283.1.81

48.

Nishimura

, Yeh

, Oguntade

, et al. HPV self-sampling for cervical cancer screening: A systematic review of values and preferences. BMJ Glob Health, 2021; 6(5):e003743; doi: 10.1136/bmjgh-2020-003743

49.

MacLaughlin

, Jacobson

, St. Sauver JL, et al. Awareness and support of clinician- and patient-collected human papillomavirus testing for cervical cancer screening among primary care clinicians. Womens Health Rep (New Rochelle), 2022; 3(1):10–19; doi: 10.1089/whr.2021.0074

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