Clinical Evaluation of Human Papillomavirus Detection by careHPV<sup>TM</sup>Test on Physician-Samples and Self-Samples using The Indicating FTA Elute® Card

Wang, Shaoming; Hu, Shangying; Chen, Feng; Chen, Wen; Zhao, Fanghui; Zhang, Yuqing; Ma, Xin−Ming; Qiao, You‐Lin

doi:10.7314/apjcp.2014.15.17.7085

Cited by 17 publications

(8 citation statements)

References 16 publications

(19 reference statements)

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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

507

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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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

507

731

View full text Add to dashboard Cite

show abstract

“…The scenario of completing the self-collection at home by women themselves followed by specimens travelling would be another option for the women. Feasibility and acceptability of using dry samples versus liquid transport media have been explored previously 13 and will be further validated in the future study.…”

Section: Discussionmentioning

confidence: 99%

Comparative performance evaluation of different HPV tests and triaging strategies using self‐samples and feasibility assessment of thermal ablation in ‘colposcopy and treat’ approach: A population‐based study in rural China

Zhao

Duan

et al. 2020

Intl Journal of Cancer

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Human papillomavirus (HPV) test, self-sampling and thermal ablation for cervical intraepithelial neoplasia (CIN) have been developed separately to increase screening coverage and treatment compliance of cervical cancer screening programmes. A large-scale study in rural China screened 9,526 women with their combinations to explore the optimal cervical cancerscreening cascade in the real-world. Participants received careHPV and polymerase chain reaction (PCR) HPV tests on selfcollected samples. Women positive on either HPV test underwent colposcopy, biopsy and thermal ablation in a single visit. Samples positive on either HPV test were retested for genotyping. Absolute and relative performance of HPV tests, triage strategies, 'colposcopy and thermal ablation' approach were statistically evaluated. PCR HPV test detected 33.3% more CIN grade two or worse (CIN2+) at a cost of 28.1% more colposcopies compared to careHPV. Sensitivities of PCR HPV and careHPV tests to detect CIN2+ were 96.7 and 72.5%. Specificities for the same disease outcome were 82.1 and 86.0%. Triaging HPV-positive women with HPV16/18 genotyping considerably improved the positive predictive value for CIN2+ (4.8-5.0 to 18.2-19.2%). Ninety-six women positive on HPV and having abnormal colposcopy were eligible for thermal ablation and all accepted same-day treatment, contributing to 64.6% being treated appropriately (CIN1+ on histopathology), which reached up to 84.8% among women positive on HPV 16/18 triage. No serious side-effects/ complications were reported. The combination of PCR HPV test followed by HPV 16/18 triaging on self-collected samples and colposcopy of triage positive women followed by immediate thermal ablation might be the appropriate screening cascade for rural China.

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“…However, for field samples the sensitivity was 89% (95% CI: 77.35-95.03) for serum, 100% (95% CI: 80-100) for lung sample and 45% (95% CI: 19.97-73.01) for oral fluids respectively. Wang et al (2014) observed higher specificity (79%) in FTA ® card as compared to liquid sample carrier (71.6%) collected from patients with human papilloma virus infection.…”

Section: Discussionmentioning

confidence: 79%

Evaluation of a specialized filter-paper matrix for transportation of extended bovine semen to screen for bovine herpesvirus-1 by real-time PCR

Sarangi

Naveena

Rana

et al. 2018

Journal of Virological Methods

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The extended frozen semen (EFS) batches produced from infectious bovine rhinotracheitis (IBR) sero-positive cattle and buffalo bulls housed in various semen stations in India are transported to the testing laboratory in liquid nitrogen (LN) for screening bovine herpesvirus-1 (BoHV-1). This procedure is laborious and poses LN related hazards. An alternative logistics for transportation of samples was investigated. Use of Flinders Technology Associates (FTA) elute card was evaluated for transportation of extended bovine semen to screen BoHV-1 DNA by real-time PCR targeting gB gene and the method was compared with the OIE approved Chelex resin based method. A protocol for extraction of BoHV-1 DNA from FTA card spotted with extended semen was optimized. The viral DNA was found to be stable on FTA card for at least 28 days when the cards are stored at 4°-37 °C. The analytical sensitivity for the assay was determined using variable dilutions of BoHV-1 spiked semen and positive plasmid harbouring gB gene (97bp) spotted onto FTA card and it was found to be 10 TCID/ml or 100 copies respectively in real-time PCR. The test could detect as low as 10 TCID/ml or 1 copy of positive plasmid when more number of replicates (n = 6) of the same sample were tested. This sensitivity was found to be comparable to Chelex method and both the methods demonstrated a very strong correlation (r = 0.9774; 95% CI: 0.9620-0.9860) in terms of Ct value (p < 0.0001). The diagnostic sensitivity and specificity of the FTA method in comparison to the Chelex method was 83.08% (95% CI: 71.73%-91.24%) and 93.23% (95% CI: 89.38%-96.01%) respectively when 316 samples were screened by both the methods. The degree of agreement between these two tests was good (Kappa value: 0.738; 95% CI: 0.646-0.829). The method was found to be robust and highly repeatable in inter-assay and intra-assay precision testing. The result suggests that the FTA card holds promise as an alternative system for transportation of EFS for downstream screening of BoHV-1 DNA.

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Clinical Evaluation of Human Papillomavirus Detection by careHPV^TMTest on Physician-Samples and Self-Samples using The Indicating FTA Elute® Card

Cited by 17 publications

References 16 publications

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

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

Comparative performance evaluation of different HPV tests and triaging strategies using self‐samples and feasibility assessment of thermal ablation in ‘colposcopy and treat’ approach: A population‐based study in rural China

Evaluation of a specialized filter-paper matrix for transportation of extended bovine semen to screen for bovine herpesvirus-1 by real-time PCR

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Clinical Evaluation of Human Papillomavirus Detection by careHPVTMTest on Physician-Samples and Self-Samples using The Indicating FTA Elute® Card

Cited by 17 publications

References 16 publications

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

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

Comparative performance evaluation of different HPV tests and triaging strategies using self‐samples and feasibility assessment of thermal ablation in ‘colposcopy and treat’ approach: A population‐based study in rural China

Evaluation of a specialized filter-paper matrix for transportation of extended bovine semen to screen for bovine herpesvirus-1 by real-time PCR

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Clinical Evaluation of Human Papillomavirus Detection by careHPV^TMTest on Physician-Samples and Self-Samples using The Indicating FTA Elute® Card