Recommendations for Use of p16/Ki67 Dual Stain for Management of Individuals Testing Positive for Human Papillomavirus

for the Enduring Consensus Cervical Cancer Screening and Management Guidelines Committee

doi:10.1097/LGT.0000000000000802

Recommendations for Use of p16/Ki67 Dual Stain for Management of Individuals Testing Positive for Human Papillomavirus

for the Enduring Consensus Cervical Cancer Screening and Management Guidelines Committee

Pathology

Research output: Contribution to journal › Article › peer-review

4 Scopus citations

Abstract

Objectives The Enduring Consensus Cervical Cancer Screening and Management Guidelines Committee developed recommendations for dual stain (DS) testing with CINtec PLUS Cytology for use of DS to triage high-risk human papillomavirus (HPV)-positive results. Methods Risks of cervical intraepithelial neoplasia grade 3 or worse were calculated according to DS results among individuals testing HPV-positive using data from the Kaiser Permanente Northern California cohort and the STudying Risk to Improve DisparitiES study in Mississippi. Management recommendations were based on clinical action thresholds developed for the 2019 American Society for Colposcopy and Cervical Pathology Risk-Based Management Consensus Guidelines. Resource usage metrics were calculated to support decision-making. Risk estimates in relation to clinical action thresholds were reviewed and used as the basis for draft recommendations. After an open comment period, recommendations were finalized and ratified through a vote by the Consensus Stakeholder Group. Results For triage of positive HPV results from screening with primary HPV testing (with or without genotyping) or with cytology cotesting, colposcopy is recommended for individuals testing DS-positive. One-year follow-up with HPV-based testing is recommended for individuals testing DS-negative, except for HPV16- and HPV18-positive results, or high-grade cytology in cotesting, where immediate colposcopy referral is recommended. Risk estimates were similar between the Kaiser Permanente Northern California and STudying Risk to Improve DisparitiES populations. In general, resource usage metrics suggest that compared with cytology, DS requires fewer colposcopies and detects cervical intraepithelial neoplasia grade 3 or worse earlier. Conclusions Dual stain testing with CINtec PLUS Cytology is acceptable for triage of HPV-positive test results. Risk estimates are portable across different populations.

Original language	English (US)
Pages (from-to)	124-130
Number of pages	7
Journal	Journal of lower genital tract disease
Volume	28
Issue number	2
DOIs	https://doi.org/10.1097/LGT.0000000000000802
State	Published - Apr 1 2024

Funding

N.B. has served as a consultant for Dysis. M.E. has served as a consultant for Papivax, Merck, BD, and PDS. R.G. has served as a consultant for Inovio. D.H. has served as a consultant for Roche. W.H. has served as a consultant for Roche, SeeGene, and AstraZeneca. R.N. has participated in an educational meeting supported by Roche. D.C. has received stipends from ABOG and Medscape and is currently receiving project funding from ACOG. The other authors have declared they have no conflicts of interest.

Keywords

cervical cancer
dual stain
human papillomavirus
recommendations
screening
triage

ASJC Scopus subject areas

Obstetrics and Gynecology

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1097/LGT.0000000000000802

Cite this

@article{9a93520aaa4441438c14c2bd7ae30690,

title = "Recommendations for Use of p16/Ki67 Dual Stain for Management of Individuals Testing Positive for Human Papillomavirus",

abstract = "Objectives The Enduring Consensus Cervical Cancer Screening and Management Guidelines Committee developed recommendations for dual stain (DS) testing with CINtec PLUS Cytology for use of DS to triage high-risk human papillomavirus (HPV)-positive results. Methods Risks of cervical intraepithelial neoplasia grade 3 or worse were calculated according to DS results among individuals testing HPV-positive using data from the Kaiser Permanente Northern California cohort and the STudying Risk to Improve DisparitiES study in Mississippi. Management recommendations were based on clinical action thresholds developed for the 2019 American Society for Colposcopy and Cervical Pathology Risk-Based Management Consensus Guidelines. Resource usage metrics were calculated to support decision-making. Risk estimates in relation to clinical action thresholds were reviewed and used as the basis for draft recommendations. After an open comment period, recommendations were finalized and ratified through a vote by the Consensus Stakeholder Group. Results For triage of positive HPV results from screening with primary HPV testing (with or without genotyping) or with cytology cotesting, colposcopy is recommended for individuals testing DS-positive. One-year follow-up with HPV-based testing is recommended for individuals testing DS-negative, except for HPV16- and HPV18-positive results, or high-grade cytology in cotesting, where immediate colposcopy referral is recommended. Risk estimates were similar between the Kaiser Permanente Northern California and STudying Risk to Improve DisparitiES populations. In general, resource usage metrics suggest that compared with cytology, DS requires fewer colposcopies and detects cervical intraepithelial neoplasia grade 3 or worse earlier. Conclusions Dual stain testing with CINtec PLUS Cytology is acceptable for triage of HPV-positive test results. Risk estimates are portable across different populations.",

keywords = "cervical cancer, dual stain, human papillomavirus, recommendations, screening, triage",

author = "{for the Enduring Consensus Cervical Cancer Screening and Management Guidelines Committee} and Clarke, {Megan A.} and Nicolas Wentzensen and Perkins, {Rebecca B.} and Francisco Garcia and Deborah Arrindell and David Chelmow and Cheung, {Li C.} and Darragh, {Teresa M.} and Didem Egemen and Richard Guido and Warner Huh and Alexander Locke and Lorey, {Thomas S.} and Ritu Nayar and Carolann Risley and Debbie Saslow and Smith, {Robert A.} and Unger, {Elizabeth R.} and Massad, {L. Stewart}",

note = "Publisher Copyright: {\textcopyright} Lippincott Williams & Wilkins.",

year = "2024",

month = apr,

day = "1",

doi = "10.1097/LGT.0000000000000802",

language = "English (US)",

volume = "28",

pages = "124--130",

journal = "Journal of lower genital tract disease",

issn = "1089-2591",

publisher = "Lippincott Williams and Wilkins",

number = "2",

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TY - JOUR

T1 - Recommendations for Use of p16/Ki67 Dual Stain for Management of Individuals Testing Positive for Human Papillomavirus

AU - for the Enduring Consensus Cervical Cancer Screening and Management Guidelines Committee

AU - Clarke, Megan A.

AU - Wentzensen, Nicolas

AU - Perkins, Rebecca B.

AU - Garcia, Francisco

AU - Arrindell, Deborah

AU - Chelmow, David

AU - Cheung, Li C.

AU - Darragh, Teresa M.

AU - Egemen, Didem

AU - Guido, Richard

AU - Huh, Warner

AU - Locke, Alexander

AU - Lorey, Thomas S.

AU - Nayar, Ritu

AU - Risley, Carolann

AU - Saslow, Debbie

AU - Smith, Robert A.

AU - Unger, Elizabeth R.

AU - Massad, L. Stewart

PY - 2024/4/1

Y1 - 2024/4/1

N2 - Objectives The Enduring Consensus Cervical Cancer Screening and Management Guidelines Committee developed recommendations for dual stain (DS) testing with CINtec PLUS Cytology for use of DS to triage high-risk human papillomavirus (HPV)-positive results. Methods Risks of cervical intraepithelial neoplasia grade 3 or worse were calculated according to DS results among individuals testing HPV-positive using data from the Kaiser Permanente Northern California cohort and the STudying Risk to Improve DisparitiES study in Mississippi. Management recommendations were based on clinical action thresholds developed for the 2019 American Society for Colposcopy and Cervical Pathology Risk-Based Management Consensus Guidelines. Resource usage metrics were calculated to support decision-making. Risk estimates in relation to clinical action thresholds were reviewed and used as the basis for draft recommendations. After an open comment period, recommendations were finalized and ratified through a vote by the Consensus Stakeholder Group. Results For triage of positive HPV results from screening with primary HPV testing (with or without genotyping) or with cytology cotesting, colposcopy is recommended for individuals testing DS-positive. One-year follow-up with HPV-based testing is recommended for individuals testing DS-negative, except for HPV16- and HPV18-positive results, or high-grade cytology in cotesting, where immediate colposcopy referral is recommended. Risk estimates were similar between the Kaiser Permanente Northern California and STudying Risk to Improve DisparitiES populations. In general, resource usage metrics suggest that compared with cytology, DS requires fewer colposcopies and detects cervical intraepithelial neoplasia grade 3 or worse earlier. Conclusions Dual stain testing with CINtec PLUS Cytology is acceptable for triage of HPV-positive test results. Risk estimates are portable across different populations.

AB - Objectives The Enduring Consensus Cervical Cancer Screening and Management Guidelines Committee developed recommendations for dual stain (DS) testing with CINtec PLUS Cytology for use of DS to triage high-risk human papillomavirus (HPV)-positive results. Methods Risks of cervical intraepithelial neoplasia grade 3 or worse were calculated according to DS results among individuals testing HPV-positive using data from the Kaiser Permanente Northern California cohort and the STudying Risk to Improve DisparitiES study in Mississippi. Management recommendations were based on clinical action thresholds developed for the 2019 American Society for Colposcopy and Cervical Pathology Risk-Based Management Consensus Guidelines. Resource usage metrics were calculated to support decision-making. Risk estimates in relation to clinical action thresholds were reviewed and used as the basis for draft recommendations. After an open comment period, recommendations were finalized and ratified through a vote by the Consensus Stakeholder Group. Results For triage of positive HPV results from screening with primary HPV testing (with or without genotyping) or with cytology cotesting, colposcopy is recommended for individuals testing DS-positive. One-year follow-up with HPV-based testing is recommended for individuals testing DS-negative, except for HPV16- and HPV18-positive results, or high-grade cytology in cotesting, where immediate colposcopy referral is recommended. Risk estimates were similar between the Kaiser Permanente Northern California and STudying Risk to Improve DisparitiES populations. In general, resource usage metrics suggest that compared with cytology, DS requires fewer colposcopies and detects cervical intraepithelial neoplasia grade 3 or worse earlier. Conclusions Dual stain testing with CINtec PLUS Cytology is acceptable for triage of HPV-positive test results. Risk estimates are portable across different populations.

KW - cervical cancer

KW - dual stain

KW - human papillomavirus

KW - recommendations

KW - screening

KW - triage

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JO - Journal of lower genital tract disease

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ER -

Recommendations for Use of p16/Ki67 Dual Stain for Management of Individuals Testing Positive for Human Papillomavirus

Abstract

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Keywords

ASJC Scopus subject areas

UN SDGs

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