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MDPI
Diagnostics
,  volume 11 ,  issue 4 ,  pages 619

Multicentre Evaluation of Hepika Test Clinical Accuracy in Diagnosing HPV-Induced Cancer and Precancerous Lesions of the Uterine Cervix

Daniela Gustinucci 1
, 
Lucia Ciccocioppo 2
, 
Luigi Coppola 3
, 
Giovanni Negri 4
, 
Gian Franco Zannoni 5
, 
Basilio Passamonti 1
, 
Elena Cesarini 1
, 
Ciro Ianzano 2
, 
Tiziana Andreano 6
, 
Anjuta Pireddu 7
, 
Giorgi Rossi Paolo 8
1
 
Laboratorio Unico di Screening USL Umbria 1, 06124 Perugia, Italy | 
2
 
Cytopathology Unit, Renzetti Hospital, 66034 Lanciano, Italy | 
3
 
Pathology Unit, San Filippo Neri Hospital, 00135 Rome, Italy | 
4
 
Pathology Unit, Central Hospital Bolzano, 39100 Bolzano, Italy | 
5
 
6
 
Pathology Unit, Renzetti Hospital, 66034 Lanciano, Italy | 
7
 
Pathology Unit, USL Umbria 1, 06012 Città di Castello, Italy | 
8
 
Epidemiology Unit, Azienda Unità Sanitaria Locale—Istituto di Ricovero e Cura a Carattere Scientifico di Reggio Emilia, 42123 Reggio Emilia, Italy | 
Publication type: Journal Article
Publication date: 2021-03-30
MDPI
scimago Q2
wos Q1
SJR: 0.773
CiteScore: 5.9
Impact factor: 3.3
ISSN: 20754418
Clinical Biochemistry
Abstract

Objective: To evaluate the clinical accuracy of Hepika test to identify cancer/precancerous lesions of the uterine cervix. Materials and Methods: A multicentre retrospective study was carried out in 2018 and included 330 liquid-based cytology samples from three Italian centres of women aged 25–64 who had been tested for the human papillomavirus (HPV) and whose histology or follow-up outcome was known. Hepika is an enzyme-linked immunosorbent assay (ELISA) targeting the protein complexes E6#p53 and E7#pRb. After excluding samples without sufficient residual material, the clinical accuracy of Hepika test was evaluated in 274 samples: adenocarcinoma (ADC) (4), squamous cell carcinoma (SCC) (7), adenocarcinoma in situ (AIS) (1), cervical intraepithelial neoplasia (CIN) grade 3 (60), CIN2 (51), CIN1 (34), and negative histology (117). Association, sensitivity, and specificity for carcinoma, CIN3+ and CIN2+ are reported. Results: Positive Hepika test was associated with a high probability of carcinoma (odds ratio (DOR) = 33.68, 95% confidence interval (CI) 7.0–163.1); sensitivity was 81.8%, specificity, 88.2%. A positive Hepika test showed a weaker association with CIN3+ lesions (DOR = 3.5; 95% CI 1.75–6.99) and lower sensitivity (27.8%). Conclusion: The Hepika test was found to be an accurate biomarker for HPV-induced cervical carcinoma. Population-based prospective studies are needed to confirm the clinical usefulness of the Hepika test in the differential diagnosis of HPV-induced invasive lesions.

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GOST Copy
Gustinucci D. et al. Multicentre Evaluation of Hepika Test Clinical Accuracy in Diagnosing HPV-Induced Cancer and Precancerous Lesions of the Uterine Cervix // Diagnostics. 2021. Vol. 11. No. 4. p. 619.
GOST all authors (up to 50) Copy
Gustinucci D., Ciccocioppo L., Coppola L., Negri G., Zannoni G. F., Passamonti B., Cesarini E., Ianzano C., Andreano T., Pireddu A., Paolo G. R. Multicentre Evaluation of Hepika Test Clinical Accuracy in Diagnosing HPV-Induced Cancer and Precancerous Lesions of the Uterine Cervix // Diagnostics. 2021. Vol. 11. No. 4. p. 619.
RIS |
Cite this
RIS Copy
TY - JOUR
DO - 10.3390/diagnostics11040619
UR - https://doi.org/10.3390/diagnostics11040619
TI - Multicentre Evaluation of Hepika Test Clinical Accuracy in Diagnosing HPV-Induced Cancer and Precancerous Lesions of the Uterine Cervix
T2 - Diagnostics
AU - Gustinucci, Daniela
AU - Ciccocioppo, Lucia
AU - Coppola, Luigi
AU - Negri, Giovanni
AU - Zannoni, Gian Franco
AU - Passamonti, Basilio
AU - Cesarini, Elena
AU - Ianzano, Ciro
AU - Andreano, Tiziana
AU - Pireddu, Anjuta
AU - Paolo, Giorgi Rossi
PY - 2021
DA - 2021/03/30
PB - MDPI
SP - 619
IS - 4
VL - 11
PMID - 33808260
SN - 2075-4418
ER -
BibTex |
Cite this
BibTex (up to 50 authors) Copy
@article{2021_Gustinucci,
author = {Daniela Gustinucci and Lucia Ciccocioppo and Luigi Coppola and Giovanni Negri and Gian Franco Zannoni and Basilio Passamonti and Elena Cesarini and Ciro Ianzano and Tiziana Andreano and Anjuta Pireddu and Giorgi Rossi Paolo},
title = {Multicentre Evaluation of Hepika Test Clinical Accuracy in Diagnosing HPV-Induced Cancer and Precancerous Lesions of the Uterine Cervix},
journal = {Diagnostics},
year = {2021},
volume = {11},
publisher = {MDPI},
month = {mar},
url = {https://doi.org/10.3390/diagnostics11040619},
number = {4},
pages = {619},
doi = {10.3390/diagnostics11040619}
}
MLA
Cite this
MLA Copy
Gustinucci, Daniela, et al. “Multicentre Evaluation of Hepika Test Clinical Accuracy in Diagnosing HPV-Induced Cancer and Precancerous Lesions of the Uterine Cervix.” Diagnostics, vol. 11, no. 4, Mar. 2021, p. 619. https://doi.org/10.3390/diagnostics11040619.