Evaluation of novel assays for the detection of human papilloma virus in self-collected samples for cervical cancer screening

Chen, Q; Du, Hongwu; R, Zhang; Jian-Gao, Zhao; Qc, Hu; Wang, C; Wang, Guoxiu; Tang, Jih-Luh; Rf, Wu

doi:10.4238/gmr.15027896

Cited by 6 publications

(4 citation statements)

References 13 publications

(12 reference statements)

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“…Our study shows that BMRT-HPV, as the primary screening algorithm for cervical cancer, has similar sensitivity to Cobas, which is similar to the result of the Chen's study [17] This suggests BMRT is worthy of clinical promotion as a primary screening assay for cervical cancer.…”

Section: Discussionsupporting

confidence: 87%

The application of BMRT-HPV viral load to secondary screening strategies for cervical cancer

Duan

Wang

et al. 2020

PLoS ONE

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Objective Evaluate the significance of BMRT HPV assay viral load and its performance for secondary screening. Methods BMRT-HPV reports type-specific viral loads/10,000 cells. We tested 1,495 physician collected, stored specimens from Chinese Multiple-center Screening Trial (CHIMUST), that were positive by Cobas, SeqHPV, and/or Cytology (�LSIL); and 2,990 age matched, negatives in a nested case control study. We explored the relationship between BMRT HR-HPV viral load and cervical lesions, determined alternative CIN2+ cut-points by ROC curve, and evaluated BMRT HR-HPV for primary / secondary cervical cancer screening. Results The viral loads of HPV16/18, 12 other subtypes HR-HPV and 14 HR-HPV were statistically different in all grades of cervical lesions (P<0.05, among which HPV16, 33 and 58 showed the strongest relationship (P<0.01). The viral load of HR-HPV also increased with the grade of cervical lesions (P<0.05). The sensitivity for CIN2+ and CIN3+ of BMRT was comparable to Cobas (92.6% vs 94.3%, 100% vs 100%, P>0.05), specificity was higher than Cobas (84.8% vs 83.3%, 83.5% vs 82.0%, P<0.001). When using HPV16/18 viral load(log cutpoint �3.2929), plus the viral-load of 12 other subtypes (log cut-point �3.9625) as

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Section: Discussionsupporting

confidence: 87%

The application of BMRT-HPV viral load to secondary screening strategies for cervical cancer

Duan

Wang

et al. 2020

PLoS ONE

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“…The most likely explanation for the slight difference in sensitivity is that a sample obtained by vaginal self-sampling contains fewer representative cells for diagnosis than a sample obtained by clinician-based cervical sampling as reflected by the difference in mean Ct levels in CIN3+ cases. This is supported by diagnostic studies with Cobas PCR testing showing relative sensitivities for CIN3+ between 0·92 and 0·98 [20] , [21] , [22] , [23] . Similar findings were observed for other hrHPV tests [7] .…”

Section: Discussionmentioning

confidence: 73%

Clinical performance of high-risk HPV testing on self-samples versus clinician samples in routine primary HPV screening in the Netherlands: An observational study

Inturrisi

Aitken

Melchers

et al. 2021

The Lancet Regional Health - Europe

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Background High-risk human papillomavirus (hrHPV) testing on self-collected samples has potential as a primary screening tool in cervical screening, but real-world evidence on its accuracy in hrHPV-based screening programmes is lacking. Methods In the Netherlands, women aged 30–60 years invited for cervical screening can choose between sampling at the clinician's office (Cervex Brush) or self-sampling at home (Evalyn Brush). HrHPV testing is performed using Roche Cobas 4800. We collected screening test results between January 2017 and March 2018 and histological follow-up until August 2019. The main outcome measures were mean cycle threshold (Ct) value, cervical intraepithelial neoplasia (CIN) grade 3 or cancer (CIN3+) and CIN grade 2 or worse (CIN2+). Findings 30,808 women had a self-collected and 456,207 had a clinician-collected sample. In hrHPV-positive women with adequate cytology, Ct values were higher for self-collection than clinician-collection with a mean Ct difference of 1·25 (95% CI 0·98–1·52) in women without CIN2+, 2·73 (1·75–3·72) in CIN2 and 3·59 (3·03–4·15) in CIN3+. The relative sensitivity for detecting CIN3+ was 0·94 (0·90–0·97) for self-collection versus clinician-collection and the relative specificity was 1·02 (1·02–1·02). Interpretation The clinical accuracy of hrHPV testing on a self-collected sample for detection of CIN3+ is high and supports its use as a primary screening test for all invited women. Because of the slightly lower sensitivity of hrHPV testing on a self-collected compared to a clinician-collected sample, an evaluation of the workflow procedure to optimise clinical performance seems warranted. Funding National Institute for Public Health and the Environment (the Netherlands) and the European Commission.

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“…This update contains 19 new reports containing 22 diagnostic studies and nine new randomized participation trials, 26 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 which were added to the 34 accuracy studies and to the 16 participation trials already included in the previous meta-analyses. 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 The updated meta-analyses finally comprised 56 diagnostic test accuracy studies a...…”

Section: Resultsmentioning

confidence: 99%

Detecting cervical precancer and reaching underscreened women by using HPV testing on self samples: updated meta-analyses

Arbyn

Smith

Temin

et al. 2018

BMJ

554

731

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ObjectiveTo evaluate the diagnostic accuracy of high-risk human papillomavirus (hrHPV) assays on self samples and the efficacy of self sampling strategies to reach underscreened women.DesignUpdated meta-analysis.Data sourcesMedline (PubMed), Embase, and CENTRAL from 1 January 2013 to 15 April 2018 (accuracy review), and 1 January 2014 to 15 April 2018 (participation review).Review methodsAccuracy review: hrHPV assay on a vaginal self sample and a clinician sample; and verification of the presence of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) by colposcopy and biopsy in all enrolled women or in women with positive tests. Participation review: study population included women who were irregularly or never screened; women in the self sampling arm (intervention arm) were invited to collect a self sample for hrHPV testing; women in the control arm were invited or reminded to undergo a screening test on a clinician sample; participation in both arms was documented; and a population minimum of 400 women.Results56 accuracy studies and 25 participation trials were included. hrHPV assays based on polymerase chain reaction were as sensitive on self samples as on clinician samples to detect CIN2+ or CIN3+ (pooled ratio 0.99, 95% confidence interval 0.97 to 1.02). However, hrHPV assays based on signal amplification were less sensitive on self samples (pooled ratio 0.85, 95% confidence interval 0.80 to 0.89). The specificity to exclude CIN2+ was 2% or 4% lower on self samples than on clinician samples, for hrHPV assays based on polymerase chain reaction or signal amplification, respectively. Mailing self sample kits to the woman’s home address generated higher response rates to have a sample taken by a clinician than invitation or reminder letters (pooled relative participation in intention-to-treat-analysis of 2.33, 95% confidence interval 1.86 to 2.91). Opt-in strategies where women had to request a self sampling kit were generally not more effective than invitation letters (relative participation of 1.22, 95% confidence interval 0.93 to 1.61). Direct offer of self sampling devices to women in communities that were underscreened generated high participation rates (>75%). Substantial interstudy heterogeneity was noted (I2>95%).ConclusionsWhen used with hrHPV assays based on polymerase chain reaction, testing on self samples was similarly accurate as on clinician samples. Offering self sampling kits generally is more effective in reaching underscreened women than sending invitations. However, since response rates are highly variable among settings, pilots should be set up before regional or national roll out of self sampling strategies.

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Evaluation of novel assays for the detection of human papilloma virus in self-collected samples for cervical cancer screening

Cited by 6 publications

References 13 publications

The application of BMRT-HPV viral load to secondary screening strategies for cervical cancer

The application of BMRT-HPV viral load to secondary screening strategies for cervical cancer

Clinical performance of high-risk HPV testing on self-samples versus clinician samples in routine primary HPV screening in the Netherlands: An observational study

Detecting cervical precancer and reaching underscreened women by using HPV testing on self samples: updated meta-analyses

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