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. 2021 Mar 30;11(4):619.
doi: 10.3390/diagnostics11040619.

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 , Gianfranco Zannoni  5 , Basilio Passamonti  1 , Elena Cesarini  1 , Ciro Ianzano  2 , Tiziana Andreano  6 , Anjuta Pireddu  7 , Paolo Giorgi-Rossi  8
Affiliations

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

Daniela Gustinucci et al. Diagnostics (Basel). .

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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Conflict of interest statement

The other authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
Samples of the study and relative testing results. (Abbreviations: HG: high grade; LG: low grade).
Figure 2
Figure 2
Mean size of residual liquid by histology.
Figure 3
Figure 3
Estimated mean values of total cells by histology.
Figure 4
Figure 4
Distribution of atypical cells based on histology and Hepika test result. Data are presented in boxes and whiskers’ style, which represents the medians and ranges of the data. (Abbreviations: CC: carcinoma; CIN: cervical intraepithelial neoplasia (grade 1, 2, and 3); HK: Hepika (positive: +; negative: −); n: number of cases).
Figure 5
Figure 5
Distribution of atypical cells by Hepika test result. Data are presented in boxes and whiskers’ style, which represents the medians and ranges of the data. (Abbreviations: POS: positive; NEG: negative).
Figure 6
Figure 6
Distribution of complexes E6#p53 and E7#pRb optical density in relation to Hepika test result. Data are presented in boxes and whiskers’ style, which represents the medians and ranges of the data. (Abbreviations: POS: positive; NEG: negative).
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