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Negative HPV Test Results on Infinity/GeneXpert® With the Presence of a Late Amplification Signal: What Does This Mean ? (PaPCR)

RECRUITINGSponsored by University Hospital, Brest
Actively Recruiting
SponsorUniversity Hospital, Brest
Started2025-03-01
Est. completion2025-08-31
Eligibility
SexFEMALE
Healthy vol.Accepted

Summary

The aim of this retrospective, single-center, observational study is to improve the diagnosis and interpretation of cervical cancer by better detection of epithelial lesions in the case of a late HPV PCR amplification signal rendered negative by routine laboratory testing using GeneXpert® technology. The various evaluation criteria are : * Presence or absence of lesions on cytological control following a negative HPV test with a late amplification signal on cervico-uterine and anal smear samples from patients seen in consultation at Brest University Hospital from 01/01/2022 to 30/06/2024 (after conventional PCR and genotyping). * Comparison of the GeneXpert® technique with the results of another conventional pan-genotypic Papillomavirus PCR test.

Eligibility

Sex: FEMALEHealthy volunteers accepted
Inclusion Criteria:

* Patients whose cervico-uterine swab was initially rendered negative by the GeneXpert® system when a late Ct signal (\>35) was present in the raw result.

Exclusion Criteria:

* Patients with a positive cervico-uterine swab for Papillomavirus.
* Patients with a negative test with no amplification signal.
* Patients who have expressed opposition to inclusion in the study.
* Patients under legal protection (guardianship, curatorship, etc.).

Conditions4

CancerCervical CancersPapillomavirus InfectionsPapillomavirus Type 16/18 Infection

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