Abstract
Objectives
The main objective of this prospective observational study was to investigate the
diagnostic performance of the p16/Ki-67 dual stain technique (DST) for detecting CIN
2+ in a LLETZ referral setting. Test performances were compared with HR-HPV testing
and Pap cytology.
Methods
All patients referred for a LLETZ procedure were candidates for participation in this
trial. A total of 110 patients were enrolled between October 2016 and March 2017.
From each participant, a cervical cytology sample was obtained before the onset of
the LLETZ procedure. On each sample, the dual stain technique (Roche CINtec PLUS ®
test), Pap cytology and an HPV DNA assay (identifying 17 different HPV types) were
performed.
Results
The overall disease prevalence of CIN 2+ was 56%. The mean age was 41 years, with
38% of patients being younger than 35 years.
The overall sensitivity and specificity of the dual stain technique for detecting
CIN 2+ was 94% (95% CI: 84.30–98.21%) and 58% (95% CI: 43.21–72.93%) respectively
with a PPV of 74% (95% CI: 67.34–80.31%) and a NPV of 88% (95% CI: 72.48–94.90%).
HR-HPV testing results in a similar sensitivity of 92% (95% CI: 82.17–97.33%) but
considerable lower specificity of 21% (95% CI: 11.17–33.35%) compared to the dual
stain technique.
At an ASCUS or worse threshold, Pap cytology had the lowest sensitivity of 89% (95%
CI 78.11–95.34%) compared to dual staining and HR-HPV testing. Specificity was better
(48% with 95% CI of 33.29–62.81%) than that of HR-HPV testing but not as good as the
DST.
Conclusion
p16/Ki-67 dual staining provides high sensitivity and improved specificity compared
to HR-HPV testing and Pap cytology for detecting CIN 2+, making it an interesting
tool for identifying relevant disease in patients referred for a LLETZ procedure.
Keywords
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Article info
Publication history
Published online: June 21, 2018
Accepted:
June 12,
2018
Received:
April 27,
2018
Identification
Copyright
© 2018 Elsevier B.V. All rights reserved.
