HPV Selfy clinical sensitivity and specificity resulted non-inferior to those of HC2. By analysis of a total of 889 cervical liquid-based cytology samples from a screening population, of which 98 were from women with CIN2+, HPV Selfy showed relative sensitivity and specificity for CIN2+ of 0.98 and 1.00 respectively (non-inferiority score test: P = 0.01747 and P = 0.00414, respectively); the test reached adequate intra- and inter-laboratory reproducibility. Moreover, we demonstrated that the performance of HPV Selfy on self-collected vaginal samples was non-inferior to the performance obtained on clinician-collected cervical specimen (0.97 relative sensitivity and 0.97 relative specificity). Finally, through HPV Selfy genotyping, we were able to describe HPV types prevalence in the study population. Clinical validation of HPV Selfy on self‑collected vaginal samples (VALHUDES) Next, we aimed at evaluating HPV Selfy performance on self-collected samples, as indicated by VALHUDES protocol. Hence, we needed to assess whether HPV testing on vaginal self-samples was as accurate as HPV testing on a cervical sample taken by a clinician. To do so, we identified 119 CIN2+ cases (age 25–65 years) and 791 ≤ CIN1 cases, for which we had available paired cervical specimen and self-collected vaginal samples. HPV Selfy testing in self-collected samples was found similarly sensitive (93/96; relative sensitivity 0.97; 95% CI 0.90–1.04) and specific (722/745; relative specificity 0.97; 95% CI 0.95–0.99) to detect CIN2+ in the total study population (Table 4), in comparison with HPV Selfy performed on paired ThinPrep. Thus, HPV Selfy assay fulfills VALHUDES requirements for use of HR-HPV DNA tests on self-collected samples according to non-inferiority analysis (relative sensitivity > 0.90 with T = 1.70, p = 0.044; relative specificity > 0.95 with T = 1.87, p =0.031). Secondary objectives of VALHUDES protocol include the assessment of the absolute accuracy of HR-HPV DNA test applied according to the sampling device and the proportion of adequate samples as determined by amplification of an internal control (a ubiquitous human gene). HPV Selfy assay provides a human beta-globin internal control, used to evaluate sample quality. In the whole study cohort, mean Ct value for the human beta-globin internal control for the HPV Selfy test on self-collected samples, obtained with the direct analysis on self-collected samples, was 26.1 Ct (median value 25.9 Ct, maximum 30.7 Ct, minimum 16.5 Ct). In the subgroup of women with biopsy-diagnosis of cervical lesions CIN2+, the same analysis resulted in 26.7 Ct (median value 26.5 Ct, maximum 30.7 Ct, minimum 24.2 Ct). This means that all women were able to self-collect a similar amount of specimen, confirming self-collected samples’ quality adequacy and so the easiness of the self-sampling procedure using the FLOQSwabs® (Copan, Brescia, Italy).

Correction: Clinical validation of full HR-HPV genotyping HPV Selfy assay according to the international guidelines for HPV test requirements for cervical cancer screening on clinician-collected and self-collected samples

Avian, Alice;Mauro, Elisabetta;Isidoro, Erica;Di Napoli, Michela;Dudine, Sandra;Giudici, Fabiola;Foschi, Nicola;Mocenigo, Marco;Montrone, Michele;Puzzi, Luca;Sola, Riccardo;Pachetti, Maria;Centonze, Sandro;Gerin, Daniela;Marini, Bruna;Canzonieri, Vincenzo;Zanconati, Fabrizio;
2023-01-01

Abstract

HPV Selfy clinical sensitivity and specificity resulted non-inferior to those of HC2. By analysis of a total of 889 cervical liquid-based cytology samples from a screening population, of which 98 were from women with CIN2+, HPV Selfy showed relative sensitivity and specificity for CIN2+ of 0.98 and 1.00 respectively (non-inferiority score test: P = 0.01747 and P = 0.00414, respectively); the test reached adequate intra- and inter-laboratory reproducibility. Moreover, we demonstrated that the performance of HPV Selfy on self-collected vaginal samples was non-inferior to the performance obtained on clinician-collected cervical specimen (0.97 relative sensitivity and 0.97 relative specificity). Finally, through HPV Selfy genotyping, we were able to describe HPV types prevalence in the study population. Clinical validation of HPV Selfy on self‑collected vaginal samples (VALHUDES) Next, we aimed at evaluating HPV Selfy performance on self-collected samples, as indicated by VALHUDES protocol. Hence, we needed to assess whether HPV testing on vaginal self-samples was as accurate as HPV testing on a cervical sample taken by a clinician. To do so, we identified 119 CIN2+ cases (age 25–65 years) and 791 ≤ CIN1 cases, for which we had available paired cervical specimen and self-collected vaginal samples. HPV Selfy testing in self-collected samples was found similarly sensitive (93/96; relative sensitivity 0.97; 95% CI 0.90–1.04) and specific (722/745; relative specificity 0.97; 95% CI 0.95–0.99) to detect CIN2+ in the total study population (Table 4), in comparison with HPV Selfy performed on paired ThinPrep. Thus, HPV Selfy assay fulfills VALHUDES requirements for use of HR-HPV DNA tests on self-collected samples according to non-inferiority analysis (relative sensitivity > 0.90 with T = 1.70, p = 0.044; relative specificity > 0.95 with T = 1.87, p =0.031). Secondary objectives of VALHUDES protocol include the assessment of the absolute accuracy of HR-HPV DNA test applied according to the sampling device and the proportion of adequate samples as determined by amplification of an internal control (a ubiquitous human gene). HPV Selfy assay provides a human beta-globin internal control, used to evaluate sample quality. In the whole study cohort, mean Ct value for the human beta-globin internal control for the HPV Selfy test on self-collected samples, obtained with the direct analysis on self-collected samples, was 26.1 Ct (median value 25.9 Ct, maximum 30.7 Ct, minimum 16.5 Ct). In the subgroup of women with biopsy-diagnosis of cervical lesions CIN2+, the same analysis resulted in 26.7 Ct (median value 26.5 Ct, maximum 30.7 Ct, minimum 24.2 Ct). This means that all women were able to self-collect a similar amount of specimen, confirming self-collected samples’ quality adequacy and so the easiness of the self-sampling procedure using the FLOQSwabs® (Copan, Brescia, Italy).
2023
26-gen-2023
Pubblicato
https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-023-03882-5
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9878793/
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11368/3040278
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