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.
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.
Original language | English |
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Number of pages | 10 |
Journal | American Journal of Clinical Pathology |
Early online date | 29 Aug 2018 |
Publication status | Published online - 29 Aug 2018 |
Keywords
- CINtec PLUS cytology; Equivocal cytology; HPV triage; HPV primary screening