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Gustinucci D, Ciccocioppo L, Coppola L, et al. Multicentre Evaluation of Hepika Test Clinical Accuracy in Diagnosing HPV-Induced Cancer and Precancerous Lesions of the Uterine Cervix. Diagnostics (Basel). 2021;11(4)doi: 10.3390/diagnostics11040619.
Gustinucci, D., Ciccocioppo, L., Coppola, L., Negri, G., Zannoni, G., Passamonti, B., Cesarini, E., Ianzano, C., Andreano, T., Pireddu, A., & Giorgi-Rossi, P. (2021). Multicentre Evaluation of Hepika Test Clinical Accuracy in Diagnosing HPV-Induced Cancer and Precancerous Lesions of the Uterine Cervix. Diagnostics (Basel, Switzerland), 11(4), . https://doi.org/10.3390/diagnostics11040619
Gustinucci, Daniela, et al. "Multicentre Evaluation of Hepika Test Clinical Accuracy in Diagnosing HPV-Induced Cancer and Precancerous Lesions of the Uterine Cervix." Diagnostics (Basel, Switzerland) vol. 11,4 (2021). doi: https://doi.org/10.3390/diagnostics11040619
Gustinucci D, Ciccocioppo L, Coppola L, Negri G, Zannoni G, Passamonti B, Cesarini E, Ianzano C, Andreano T, Pireddu A, Giorgi-Rossi P. Multicentre Evaluation of Hepika Test Clinical Accuracy in Diagnosing HPV-Induced Cancer and Precancerous Lesions of the Uterine Cervix. Diagnostics (Basel). 2021 Mar 30;11(4). doi: 10.3390/diagnostics11040619. PMID: 33808260; PMCID: PMC8066214.
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Diagnostics (Basel). 2021 Mar 30;11(4). doi: 10.3390/diagnostics11040619.

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

Diagnostics (Basel, Switzerland)

Daniela Gustinucci, Lucia Ciccocioppo, Luigi Coppola, Giovanni Negri, Gianfranco Zannoni, Basilio Passamonti, Elena Cesarini, Ciro Ianzano, Tiziana Andreano, Anjuta Pireddu, Paolo Giorgi-Rossi

Affiliations

  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. Department of Woman, Child and Public Health Sciences, Gynecopathology and Breast Pathology Unit, Catholic University of Sacred Hearth, 00168 Rome, Italy.
  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.

PMID: 33808260 PMCID: PMC8066214 DOI: 10.3390/diagnostics11040619

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.

Keywords: CIN; HPV; Hepika; cancer; carcinoma; precancerous lesion; tumor biomarker; uterine cervix

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