Prevalence of Human Papillomavirus in Self-Taken Samples from Screening Nonattenders

Lam, Janni Uyen Hoa; Ejegod, Ditte Møller; Pedersen, Helle; Rygaard, Carsten; Lynge, Elsebeth; Harder, Elise; Thomsen, Louise T.; Kjær, Susanne K.; Bonde, Jesper

doi:10.1128/jcm.00550-17

Cited by 18 publications

(18 citation statements)

References 28 publications

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“…The higher DNA copy amount in vaginal self‐samples is consistent with the results of our previous study using the same device and HPV analysis . Recently, Lam et al also showed a higher amount of human DNA when performing self‐sampling as compared to samples collected by physicians from the same women …”

Section: Discussionsupporting

confidence: 90%

Randomised study of HPV prevalence and detection of CIN2+ in vaginal self‐sampling compared to cervical specimens collected by medical personnel

Gustavsson

Aarnio

Berggrund

et al. 2018

Intl Journal of Cancer

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We conducted a randomised study to compare vaginal self-sampling with assisted sampling by medical personnel on the cervix for HPV testing in primary screening. The first aim was to determine if the HPV prevalence is independent of sampling location (vagina versus cervix) and the person performing the sampling. The second aim was to evaluate if the two sampling strategies differed in the detection rate of CIN2+. In total, 19,523 women were randomised into two groups, with 9926 invited to perform self-sampling (SS arm) using the Rover VIBA-brush and 9597 offered assisted sampling using the cytobrush (AS arm). All samples were applied to the indicating FTA elute card and analysed for high-risk HPV using the hpVIR real-time PCR assay. The outcome for the first aim was HPV prevalence and for the second aim the number of CIN2+ based on histology. In the SS arm, 52.7% of invited women participated in the study, as compared to 34.2% in the AS arm. All samples contained sufficient amount of nuclear DNA for a valid HPV result, with vaginal samples having a higher DNA amount than cervical samples (p < 4.62 × 10 ). HPV prevalence was 4.6% in the SS arm and 4.1% in the AS arm (p = 5.5 × 10 ), and the distribution of HPV types similar between arms. There was no difference in the prevalence of CIN2+ per 1000 women screened between arms (p = 0.86). The results show that vaginal self-sampling is an equivalent alternative to sampling by medical personnel for HPV typing and identification of CIN2+.

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Section: Discussionsupporting

confidence: 90%

Randomised study of HPV prevalence and detection of CIN2+ in vaginal self‐sampling compared to cervical specimens collected by medical personnel

Gustavsson

Aarnio

Berggrund

et al. 2018

Intl Journal of Cancer

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“…Both studies transferred the swab directly into the cobas PCR media at the point of collection, and as such there are currently no data on the stability of a swab transported dry to a laboratory before being resuspended into this media. BD diluent has been used as buffer, but only in an ad hoc method rather than using the commercially available diluent tubes [57].…”

Section: Pre-analytic Considerationsmentioning

confidence: 99%

Self-Collection for Cervical Screening Programs: From Research to Reality

Hawkes

Keung

Huang

et al. 2020

Cancers

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In 2018, there were an estimated 570,000 new cases of cervical cancer globally, with most of them occurring in women who either had no access to cervical screening, or had not participated in screening in regions where programs are available. Where programs are in place, a major barrier for women across many cultures has been the requirement to undergo a speculum examination. With the emergence of HPV-based primary screening, the option of self-collection (where the woman takes the sample from the vagina herself) may overcome this barrier, given that such samples when tested using a PCR-based HPV assay have similar sensitivity for the detection of cervical pre-cancers as practitioner-collected cervical specimens. Other advantages of HPV-based screening using self-collection, beyond the increase in acceptability to women, include scalability, efficiency, and high negative predictive value, allowing for long intervals between negative tests. Self-collection will be a key strategy for the successful scale up of cervical screening programs globally in response to the WHO call for all countries to work towards the elimination of cervical cancer as a public health problem. This review will examine self-collection for HPV-based cervical screening including the collection devices, assays and possible routine laboratory processes considering how they can be utilized in cervical screening programs.

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“…The Roche cobas 4800 HPV test (Roche Molecular Systems, Pleasanton, CA) (12,13) provides HPV16 and HPV18 genotyping and reports 12 other high-risk HPVs (types 31,33,35,39,45,51,52,56,58,59, 66, and 68) as a pooled result (12) (The inclusion of HPV66 in cervical screening tests is based on a now corrected International Agency for Research on Cancer (IARC) evaluation, but HPV66 was incorporated into HPV testing, and given the difficulty in changing test formats, it remains.) Onclarity identifies six genotypes individually (types 16,18,31,45, 51, and 52), and the remaining eight HPV genotypes are reported in three channels (types 33/58, 56/59/66, and 35/39/68); this test has recently been FDA approved for clinical use to identify types 16, 18, and 45. cobas and Onclarity are the only two tests approved by the FDA for primary HPV screening (without the need for a cytologic component for cotesting).…”

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confidence: 99%

“…Previously reported performance data based on research studies and clinical use in Europe suggest that Onclarity might become a useful HPV test in the United States in the years ahead (6,(14)(15)(16)(17)(18)(19)(20)(21)(22). This analysis aimed to validate BD Onclarity further by assessing (i) the association of Onclarity types/channels with precancer/cancer (classified as cervical intraepithelial neoplasia grade 3ϩ [CIN3ϩ], with secondary consideration of CIN2), (ii) hierarchical and nonhierarchical HPV type/channel agreement (HPV16, HPV18, and 12 other high-risk types) between Onclarity and cobas results, and (iii) Onclarity typing for all types/channels compared to a linear array (LA).…”

mentioning

confidence: 99%

Validation of a Human Papillomavirus (HPV) DNA Cervical Screening Test That Provides Expanded HPV Typing

et al. 2018

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As cervical cancer screening shifts from cytology to human papillomavirus (HPV) testing, a major question is the clinical value of identifying individual HPV types. We aimed to validate Onclarity (Becton Dickinson Diagnostics, Sparks, MD), a nine-channel HPV test recently approved by the FDA, by assessing (i) the association of Onclarity types/channels with precancer/cancer; (ii) HPV type/channel agreement between the results of Onclarity and cobas (Roche Molecular Systems, Pleasanton, CA), another FDA-approved test; and (iii) Onclarity typing for all types/channels compared to typing results from a research assay (linear array [LA]; Roche). We compared Onclarity to histopathology, cobas, and LA. We tested a stratified random sample ( = 9,701) of discarded routine clinical specimens that had tested positive by Hybrid Capture 2 (HC2; Qiagen, Germantown, MD). A subset had already been tested by cobas and LA ( = 1,965). Cervical histopathology was ascertained from electronic health records. Hierarchical Onclarity channels showed a significant linear association with histological severity. Onclarity and cobas had excellent agreement on partial typing of HPV16, HPV18, and the other 12 types as a pool (sample-weighted kappa value of 0.83); cobas was slightly more sensitive for HPV18 and slightly less sensitive for the pooled high-risk types. Typing by Onclarity showed excellent agreement with types and groups of types identified by LA (kappa values from 0.80 for HPV39/68/35 to 0.97 for HPV16). Onclarity typing results corresponded well to histopathology and to an already validated HPV DNA test and could provide additional clinical typing if such discrimination is determined to be clinically desirable.

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Prevalence of Human Papillomavirus in Self-Taken Samples from Screening Nonattenders

Cited by 18 publications

References 28 publications

Randomised study of HPV prevalence and detection of CIN2+ in vaginal self‐sampling compared to cervical specimens collected by medical personnel

Randomised study of HPV prevalence and detection of CIN2+ in vaginal self‐sampling compared to cervical specimens collected by medical personnel

Self-Collection for Cervical Screening Programs: From Research to Reality

Validation of a Human Papillomavirus (HPV) DNA Cervical Screening Test That Provides Expanded HPV Typing

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