Test Performance Comparison of Inform HPV and Hybrid Capture 2 High-Risk HPV DNA Tests Using the SurePath Liquid-Based Pap Test as the Collection Method

Davis-Devine, Sharon; Day, Sarah J.; Freund, Gregory G.

doi:10.1309/bfvv-u29h-cc5r-cky5

Cited by 7 publications

(8 citation statements)

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“…The present study demonstrates that both HPV detection techniques work with PS, showing a specificity ranging from 78.3% for HC2 to 92.8% for PCR, with a high detection rate of H-SIL/CIN2+ (85.7% for HC2 and 96.4% for PCR). These results are similar to those published previously, ranging from 82.6% to 93% for HC2 and from 96% to 100% for PCR using various media [14,[19][20][21][22][23][24][25].…”

Section: Discussionsupporting

confidence: 92%

“…The most reliable DNA-based tests now available are the consensus primer PCR assay and the Hybrid Capture II (HC2) microtitre assay, which is a hybridization technique using a single-stranded RNA probe and viral DNA without previous amplification [Hybrid Capture II; Digene Diagnostics, Gaithersburg, MD, USA] [11][12][13]. These techniques have been validated using the Surepath (Tripath Care Technologies, Burlington, NC, USA) [14,15] and Thinprep (Cytyc, Boxborough, MA, USA) [12] systems, but only the latter has been Food and Drug Administration approved for HC2 testing since 2002.…”

Section: Introductionmentioning

confidence: 99%

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Validation of ThermoFisher's Papspin for human papillomavirus detection in cervicovaginal specimens using PCR with GP5+/GP6+ primers and the Hybrid Capture II assay

Weynand

Delvenne²,

Polet

et al. 2010

Clinical Microbiology and Infection

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The present study aimed to validate ThermoFisher's (Thermo Fisher Scientific, Runcorn, Cheshire, UK) Papspin (PS) for human papillomavirus (HPV) testing by in-house PCR and by the Hybrid Capture II (HC2) assay and to compare the results with those obtained using Specimen Transport Medium (STM) (Digene Diagnostics, Gaithersburg, MD, USA). Forty-five patients underwent conization for known lesions ranging from atypical squamous cells of undetermined significance (ASC-US) with high-risk HPV (hr-HPV) to high-grade squamous intraepithelial lesion (H-SIL/CIN2+) or adenocarcinoma. Two negative controls were included: one patient with post-menopausal bleeding and another from whom an inflammatory cervical sample was taken without conization. Prior to conization, a gynaecologist collected two cervical samples, fixed in PS or STM, from each patient. All but four cases were tested for panHPV (GP5+/GP6+) and specific hr-HPV subtypes (HPV16, 18, 31,33) by PCR using both media and all were processed for HC2. This study demonstrates that both HPV detection techniques work with PS, showing a specificity of 78.3% for HC2 and 92.8% for PCR compared to 83.8% for HC2 and 92% for PCR using STM. The efficacy of detecting HPV in PS-preserved H-SIL/CIN2+ was very high (96% for PCR using PS and 86% for HC2 using PS), which was in the same range as for PCR using STM, and which was only slightly lower than for HC2 using STM (96% and 89%, respectively). The differences were not statistically significant. It is concluded that ThermoFisher's PS is a valid liquid-based cytology medium for cervical samples, convenient for HPV testing by PCR with GP5+/GP6+ primers and by the HC2 assay.

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Section: Discussionsupporting

confidence: 92%

Section: Introductionmentioning

confidence: 99%

Validation of ThermoFisher's Papspin for human papillomavirus detection in cervicovaginal specimens using PCR with GP5+/GP6+ primers and the Hybrid Capture II assay

Weynand

Delvenne²,

Polet

et al. 2010

Clinical Microbiology and Infection

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“…There is at present no standardized SurePath HPV protocol that all laboratories use and no literature with sufficient detail to represent an agreed upon standard 6,7,33–36. Furthermore, the manufacturer cannot under current regulations recommend standardized procedures for non-FDA-approved hrHPV testing.…”

Section: Discussionmentioning

confidence: 99%

Limitations of widely used high-risk human papillomavirus laboratory-developed testing in cervical cancer screening

Naryshkin¹,

Austin²

2012

DHPS

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Objective:To increase awareness of the limitations of high-risk human papillomavirus (hrHPV) laboratory-developed testing (LDT) widely used in US cervical cancer screening.Methods and results:A young woman in her 30s was diagnosed and treated for stage 1B1 cervical squamous cell carcinoma in which HPV 16 DNA was detected using polymerase chain reaction testing. Both 1 month before and 42 months before cervical cancer diagnosis, the patient had highly abnormal cytology findings; however, residual SurePath™ (Becton, Dickson and Company, Franklin Lakes, NJ) vial fluid yielded negative Hybrid Capture 2 (HC2; Qiagen NV, Hilden, Germany) hrHPV LDT results from each of the two specimens. This prompted questions to be asked concerning the performance characteristics of hrHPV LDT. A review of the available data indicates that (1) purification of DNA from SurePath specimens requires complex sample preparation due to formaldehyde crosslinking of proteins and nucleic acids, (2) HC2–SurePath hrHPV testing had not been Food and Drug Administration-approved after multiple premarket approval submissions, (3) detectible hrHPV DNA in the SurePath vial decreases over time, and (4) US laboratories performing HC2–SurePath hrHPV LDT testing are not using a standardized manufacturer-endorsed procedure.Conclusion:Recently updated cervical screening guidelines in the US recommend against the use of hrHPV LDT in cervical screening, including widely used HC2 testing from the SurePath vial. The manufacturer recently issued a technical bulletin specifically warning that use of SurePath samples with the HC2 hrHPV test may provide false negative results and potentially compromise patient safety. Co-collection using a Food and Drug Administration-approved hrHPV test medium is recommended for HPV testing of patients undergoing cervical screening using SurePath samples.

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“…Each cervicovaginal sample was collected with a separate endocervical brush. The liquid-based preparation method for collecting cervicovaginal samples was performed according to the manufacturer’s instructions (ThinPrep® and Surepath™) and stored until further analysis [28]. Whole genomic DNA was extracted from each of the 980 sample swabs collected from 912 twins, siblings, and their mothers; to determine the presence of HPV infection, 912 subjects were tested for HPV using two primer sets, MY09/MY11 and GP5+/GP6+, as described in a previous study [18].…”

Section: Methodsmentioning

confidence: 99%

Association of the Vaginal Microbiota with Human Papillomavirus Infection in a Korean Twin Cohort

et al. 2013

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Human papillomavirus (HPV) is the most important causative agent of cervical cancers worldwide. However, our understanding of how the vaginal microbiota might be associated with HPV infection is limited. In addition, the influence of human genetic and physiological factors on the vaginal microbiota is unclear. Studies on twins and their families provide the ideal settings to investigate the complicated nature of human microbiota. This study investigated the vaginal microbiota of 68 HPV-infected or uninfected female twins and their families using 454-pyrosequencing analysis targeting the variable region (V2–V3) of the bacterial 16S rRNA gene. Analysis of the vaginal microbiota from both premenopausal women and HPV-discordant twins indicated that HPV-positive women had significantly higher microbial diversity with a lower proportion of Lactobacillus spp. than HPV-negative women. Fusobacteria, including Sneathia spp., were identified as a possible microbiological marker associated with HPV infection. The vaginal microbiotas of twin pairs were significantly more similar to each other than to those from unrelated individuals. In addition, there were marked significant differences from those of their mother, possibly due to differences in menopausal status. Postmenopausal women had a lower proportion of Lactobacillus spp. and a significantly higher microbiota diversity. This study indicated that HPV infection was associated with the composition of the vaginal microbiota, which is influenced by multiple host factors such as genetics and menopause. The potential biological markers identified in this study could provide insight into HPV pathogenesis and may represent biological targets for diagnostics.

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Test Performance Comparison of Inform HPV and Hybrid Capture 2 High-Risk HPV DNA Tests Using the SurePath Liquid-Based Pap Test as the Collection Method

Cited by 7 publications

References 0 publications

Validation of ThermoFisher's Papspin for human papillomavirus detection in cervicovaginal specimens using PCR with GP5+/GP6+ primers and the Hybrid Capture II assay

Validation of ThermoFisher's Papspin for human papillomavirus detection in cervicovaginal specimens using PCR with GP5+/GP6+ primers and the Hybrid Capture II assay

Limitations of widely used high-risk human papillomavirus laboratory-developed testing in cervical cancer screening

Association of the Vaginal Microbiota with Human Papillomavirus Infection in a Korean Twin Cohort

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