ArticleDiagnostics (Basel, Switzerland)2021
Multicentre Evaluation of Hepika Test Clinical Accuracy in Diagnosing HPV-Induced Cancer and Precancerous Lesions of the Uterine Cervix.
Article in Diagnostics (Basel, Switzerland), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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Who cites it
3 citing papers in PubMed, 2 citations in OpenAlex.
- Recent advancement in inflammatory biomarkers for cervical cancer diagnosis and therapy.Frontiers in oncology · 2026Review
- Diagnostic Value of Spiral CT and Magnetic Resonance Imaging Scanning in Gastric Cancer and Precancerous Lesions.Scanning · 2022Article
- Detection and Outcome of Endocervical Atypia in Cytology in Primary HPV Screening Programme.Diagnostics (Basel, Switzerland) · 2021Article
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Authors and funding
11 authors at 6 institutions in 1 country.
Funding
Abstract
objectiveTo evaluate the clinical accuracy of Hepika test to identify cancer/precancerous lesions of the uterine cervix. MATERIALS AND
methodsA 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.
resultsPositive 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%).
conclusionThe 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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