Clinical utility of CINtec® PLUS triage in equivocal cervical cytology and HPV primary screening

Andrew McDowell, Mary McMenamin, Michael McKenna

Research output: Contribution to journalArticle

Abstract

OBJECTIVES:
While cervical cytology is accepted triage for human papillomavirus (HPV)-positive women, the efficiency of cervical screening could be improved by exploiting disease markers with higher specificity.
METHODS:
CINtec PLUS triage alone and combined with HPV 16/18 genotyping was performed on Thin Prep samples from HPV-positive women. Clinical performance and the potential to reduce or expedite colposcopy referrals were evaluated.
RESULTS:
The 2-year sensitivity and specificity for cervical intraepithelial neoplasia grade 3 or worse (CIN3+) were 90% and 42%, respectively. Specificity was improved over HPV testing in equivocal cytology and could cut the referral rate by about 40%. When combined with HPV 16/18 genotyping, CINtec PLUS triage of the 12 other high-risk HPV genotypes generally demonstrated better sensitivity for CIN3+ than separate triage of non-type-specific HPV-positive women. This strategy could reduce colposcopy referrals by 31%.
CONCLUSIONS:
These findings highlight the potential of CINtec PLUS to improve management pathways in HPV-positive women. CINtec PLUS cytology represents a sensitive and efficient triage in HPV-positive women. The clinical performance of the dual-stain was most notable in women younger than 25 years and could potentially improve management pathways.
LanguageEnglish
Number of pages10
JournalAmerican Journal of Clinical Pathology
Early online date29 Aug 2018
Publication statusE-pub ahead of print - 29 Aug 2018

Fingerprint

Triage
Cell Biology
Human papillomavirus 18
Colposcopy
Referral and Consultation
Human papillomavirus 16
Cervical Intraepithelial Neoplasia
Coloring Agents
Genotype
Sensitivity and Specificity

Keywords

  • CINtec PLUS cytology; Equivocal cytology; HPV triage; HPV primary screening

Cite this

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title = "Clinical utility of CINtec{\circledR} PLUS triage in equivocal cervical cytology and HPV primary screening",
abstract = "OBJECTIVES:While cervical cytology is accepted triage for human papillomavirus (HPV)-positive women, the efficiency of cervical screening could be improved by exploiting disease markers with higher specificity.METHODS:CINtec PLUS triage alone and combined with HPV 16/18 genotyping was performed on Thin Prep samples from HPV-positive women. Clinical performance and the potential to reduce or expedite colposcopy referrals were evaluated.RESULTS:The 2-year sensitivity and specificity for cervical intraepithelial neoplasia grade 3 or worse (CIN3+) were 90{\%} and 42{\%}, respectively. Specificity was improved over HPV testing in equivocal cytology and could cut the referral rate by about 40{\%}. When combined with HPV 16/18 genotyping, CINtec PLUS triage of the 12 other high-risk HPV genotypes generally demonstrated better sensitivity for CIN3+ than separate triage of non-type-specific HPV-positive women. This strategy could reduce colposcopy referrals by 31{\%}.CONCLUSIONS:These findings highlight the potential of CINtec PLUS to improve management pathways in HPV-positive women. CINtec PLUS cytology represents a sensitive and efficient triage in HPV-positive women. The clinical performance of the dual-stain was most notable in women younger than 25 years and could potentially improve management pathways.",
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Clinical utility of CINtec® PLUS triage in equivocal cervical cytology and HPV primary screening. / McDowell, Andrew; McMenamin, Mary; McKenna, Michael.

In: American Journal of Clinical Pathology, 29.08.2018.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Clinical utility of CINtec® PLUS triage in equivocal cervical cytology and HPV primary screening

AU - McDowell, Andrew

AU - McMenamin, Mary

AU - McKenna, Michael

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Y1 - 2018/8/29

N2 - OBJECTIVES:While cervical cytology is accepted triage for human papillomavirus (HPV)-positive women, the efficiency of cervical screening could be improved by exploiting disease markers with higher specificity.METHODS:CINtec PLUS triage alone and combined with HPV 16/18 genotyping was performed on Thin Prep samples from HPV-positive women. Clinical performance and the potential to reduce or expedite colposcopy referrals were evaluated.RESULTS:The 2-year sensitivity and specificity for cervical intraepithelial neoplasia grade 3 or worse (CIN3+) were 90% and 42%, respectively. Specificity was improved over HPV testing in equivocal cytology and could cut the referral rate by about 40%. When combined with HPV 16/18 genotyping, CINtec PLUS triage of the 12 other high-risk HPV genotypes generally demonstrated better sensitivity for CIN3+ than separate triage of non-type-specific HPV-positive women. This strategy could reduce colposcopy referrals by 31%.CONCLUSIONS:These findings highlight the potential of CINtec PLUS to improve management pathways in HPV-positive women. CINtec PLUS cytology represents a sensitive and efficient triage in HPV-positive women. The clinical performance of the dual-stain was most notable in women younger than 25 years and could potentially improve management pathways.

AB - OBJECTIVES:While cervical cytology is accepted triage for human papillomavirus (HPV)-positive women, the efficiency of cervical screening could be improved by exploiting disease markers with higher specificity.METHODS:CINtec PLUS triage alone and combined with HPV 16/18 genotyping was performed on Thin Prep samples from HPV-positive women. Clinical performance and the potential to reduce or expedite colposcopy referrals were evaluated.RESULTS:The 2-year sensitivity and specificity for cervical intraepithelial neoplasia grade 3 or worse (CIN3+) were 90% and 42%, respectively. Specificity was improved over HPV testing in equivocal cytology and could cut the referral rate by about 40%. When combined with HPV 16/18 genotyping, CINtec PLUS triage of the 12 other high-risk HPV genotypes generally demonstrated better sensitivity for CIN3+ than separate triage of non-type-specific HPV-positive women. This strategy could reduce colposcopy referrals by 31%.CONCLUSIONS:These findings highlight the potential of CINtec PLUS to improve management pathways in HPV-positive women. CINtec PLUS cytology represents a sensitive and efficient triage in HPV-positive women. The clinical performance of the dual-stain was most notable in women younger than 25 years and could potentially improve management pathways.

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M3 - Article

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JF - American Journal of Clinical Pathology

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