Abstract
Objective
Early screening and intervention are crucial for the prevention and treatment of cervical
cancer. TruScreen is a real-time, intelligent, pathological diagnostic technology
designed for cervical cancer screening. The aim of this study was to evaluate the
clinical value of TruScreen in screening for cervical lesions.
Study design
A total of 458 women aged between 25 and 65 years were recruited to receive cervical
cancer screening, including human papillomavirus (HPV) testing, cytological testing
using the ThinPrep cytology test (TCT), and TruScreen from December 2018 to January
2020. The clinical performance of TruScreen, alone and in combination with HPV testing,
was evaluated to detect cervical intraepithelial neoplasia grade 2 or worse (CIN2+
or CIN3+).
Results
For detection of CIN2+, the sensitivity and specificity of TruScreen were 83.78% and
78.86%, respectively. The specificity of TruScreen was significantly higher than those
of HPV testing (50.59%, P < 0.001) and TCT (55.58%, P < 0.001). In high-risk HPV-positive
women, the specificity of HPV testing combined with TruScreen was significantly higher
than that of HPV testing combined with TCT (50% vs 39.9%, P = 0.004). The sensitivity
of HPV testing combined with TruScreen was comparable to that of HPV testing combined
with TCT (93.94% vs 87.88%, P = 0.625). Similar patterns were also observed for CIN3+
cases.
Conclusion
TruScreen has the potential for screening high-grade cervical precancerous lesions
and may replace cytological tests as a cervical cancer screening method in China to
avoid subjectivity in the interpretation of cytological tests and requirements by
pathologists.
Keywords
Abbreviations:
ASCUS (atypical squamous cells of undetermined significance), CIN (cervical intraepithelial neoplasia), CIN2+ (CIN grade 2 or worse), CIN3+ (CIN grade 3 or worse), HPV (human papillomavirus), HR-HPV (high-risk HPV), HSIL (high-grade squamous intraepithelial lesion), LSIL (low-grade squamous intraepithelial lesion), NILM (negative intraepithelial lesion or malignancy), NPV (negative predictive value), PPV (positive predictive value), TCT (ThinPrep cytology test)To read this article in full you will need to make a payment
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Article info
Publication history
Published online: September 27, 2021
Accepted:
September 26,
2021
Received in revised form:
September 2,
2021
Received:
June 25,
2021
Identification
Copyright
© 2021 Elsevier B.V. All rights reserved.
