Cytoactiv – HPV L1 detection
Scientific publications (commented)
E. Y. Ki et al., 2019
Utility of human papillomavirus L1 capsid protein and HPV test as prognostic markers for cervical intraepithelial neoplasia 2+ in women with persistent ASCUS / LSIL cervical cytology.
International Journal of Medical Sciences, Vol. 16, p. 1096
Absence of HPV L1 capsid expression and presence of HPV type 16 or 18 infection are reliable predictors of progression to CIN2+. Only 4.1% of Cytoactiv-positive LSIL and 13.8% of Cytoactiv-positive ASCUS progressed. 89% of progressive cases were HPV16/18 positive. Only 1.5% of non-HPV16/18, L1-positive cases progressed.
F. Carozzi et al., 2018
Molecular Cytology Applications on Gynecological Cytology. In: Schmitt F. (eds) Molecular Applications in Cytology.
Springer
Chapter 8.3.1 “Biomarkers of the Productive Phase of the HPV-Induced Carcinogenesis” provides an overview of Cytoactiv HPV L1 detection.
Y.-J. Choi et al., 2018
E2/E6 ratio and L1 immunoreactivity as biomarkers to determine HPV16-positive high-grade squamous intraepithelial lesions (CIN2 and 3) and cervical squamous cell carcinoma.
Journal of Gynecologic Oncology
Validation of HPV L1 capsid protein expression combined with decreased HPV E2/E6 ratio as predictive markers of ≥CIN2 lesions. Using 226 ThinPrep slides, Cytoactiv was shown to be effective in combination with HPV integration markers. Combined AUC was 0.87.
G. Mehlhorn et al., 2014
HPV16-L1-specific Antibody Response Is Associated with Clinical Remission of High-risk HPV-positive Early Dysplastic Lesions.
Anticancer Research 34: 5127–5132
Detection of HPV16-L1-specific antibodies strongly correlates with clinical remission. The risk of progression to CIN3 in L1 antigen and HPV16-L1 antibody double-positive women is extremely low (approx. 6%).
S.-J. Lee et al., 2014
Clinicopathological Implications of HPV L1 Capsid Protein Immunoreactivity in HPV16-Positive Cervical Cytology.
International Journal of Medical Sciences, 11(1):80–86
HPV L1 expression is low in advanced dysplasia. Absence of L1 in HPV16-positive ASCUS and LSIL is strongly associated with high-grade histopathology (≥CIN3).
G. Mehlhorn et al., 2013
HPV L1 detection discriminates cervical precancer from transient HPV infection: a prospective international multicenter study.
Modern Pathology, 26: 967–974
Prospective multicenter study (n=908) confirmed that only ~20% of L1-positive cases progressed to CIN3, whereas 84% of L1-negative cases progressed. Cytoactiv reliably distinguishes transient from progressive HPV infections.
S. W. Byun et al., 2013
Immunostaining of p16INK4a/Ki-67 and L1 Capsid Protein on Liquid-based Cytology Specimens from ASC-H and LSIL-H Cases.
International Journal of Medical Sciences
Combined analysis of p16INK4a, Ki-67 and L1 capsid protein improves prediction of high-risk precursor or invasive cervical lesions.
R. Hilfrich, 2013
HPV L1 Detection as a Prognostic Marker for Management of HPV High Risk Positive Abnormal Pap Smears.
InTech – Human Papillomavirus
Comprehensive summary of scientific data supporting Cytoactiv as a prognostic marker in abnormal Pap smear management.
I. Norman et al., 2013
High-risk HPV L1 capsid protein as a marker of cervical intraepithelial neoplasia in HR-HPV-positive women with minor abnormalities.
Oncology Reports 30
Loss of L1 expression predicts CIN2+. L1-positive ASCUS/LSIL lesions have low malignant potential and support a “wait and see” strategy.
Ch. A. Brown et al., 2012
Role of Protein Biomarkers in the Detection of High-Grade Disease in Cervical Cancer Screening Programs.
Journal of Oncology, Volume 2012
Review of protein biomarkers including Ki-67, p16INK4a, BD ProEx C and Cytoactiv HPV L1.
L. Benerini-Gatta et al., 2011
Diagnostic Implications of L1, p16, and Ki-67 Proteins in Low-grade Cervical Intraepithelial Neoplasia.
International Journal of Gynecological Pathology
Malignant transformation correlated with L1– / p16+ cases (100% of CIN2/3 and SCC). Approximately 23% of CIN1 cases showed malignant transformation.
G. Böhmer, Th. Weyerstahl, 2011
Management of abnormal results of the cervix uteri during cervical cancer screening.
Thieme Gynaecology up2date
Review of current management recommendations; Cytoactiv clearly distinguished as a prognostic marker.
S. J. Lee et al., 2011
Correlation between HPV L1 immunocytochemistry and behavior of low-grade cervical cytology.
Journal of Obstetrics and Gynaecology Research
Positive predictive value of HPV L1-positive cases for non-progression was 91.7%.
M. T. Galgano et al., 2010
Using Biomarkers as Objective Standards in the Diagnosis of Cervical Biopsies.
American Journal of Surgical Pathology
Cytoactiv showed superior specificity (96.7%) and highest reproducibility compared to p16 and Ki-67.
Y. S. Choi et al., 2010
HPV L1 Capsid Protein and HPV16 as Prognostic Markers in CIN1.
International Journal of Gynecological Cancer
HPV L1 protein expression is closely related to spontaneous regression in CIN1.
H. Griesser et al., 2009
HPV vaccine protein L1 predicts disease outcome of HR-HPV+ early dysplastic lesions.
American Journal of Clinical Pathology
Progression occurred in only 20% of L1-positive cases versus 97% of L1-negative cases.
Th. Scheidemantel et al., 2008
Expression pattern of HPV L1 capsid protein in PAP tests.
Abstract, American Society of Cytopathology
None of the Cytoactiv-positive patients progressed to cervical cancer.
G. Negri et al., 2008
p16 and HPV immunohistochemistry in low-grade dysplastic lesions.
American Journal of Surgical Pathology
Confirms prognostic value of Cytoactiv and benefit of combination with p16 and HPV testing.
R. Hilfrich, J. Hariri, 2008
Prognostic relevance of HPV L1 detection combined with p16.
Analytical and Quantitative Cytology and Histology
Progression in 83.9% of L1-negative cases versus 27.5% of L1-positive cases; Cytoactiv specificity 100%.
D. Rauber et al., 2008
Prognostic significance of HPV L1 detection in mild to moderate dysplasia.
European Journal of Obstetrics & Gynecology and Reproductive Biology
Progression rate of L1-positive cases was only 12.3%.
H. Griesser et al., 2004
Correlation of HPV L1 detection with regression of HR-HPV positive dysplasia.
Analytical and Quantitative Cytology and Histology
First Cytoactiv publication demonstrating strong prognostic value of HPV L1 detection.


