Negative Xpert HPV Test (Cepheid) With Late Amplification Signals: Is There a Clinical Significance? (the PaPCR...

Area of Science:

• Oncology
• Virology
• Medical Diagnostics

Background:

• Cervical cancer is a leading global cancer in women, particularly in low-resource settings.
• Nucleic acid amplification tests (NAATs) like Xpert HPV rapidly detect high-risk human papillomavirus (HR-HPV).
• The clinical significance of weak/late HPV amplification signals (CT ≥ 38), often deemed negative, is not fully understood.

Purpose of the Study:

• To assess the clinical significance of weak/late HPV amplification signals.
• To compare results with cytological findings and patient history.
• To evaluate the risk of missing HR-HPV infections in routine screening.

Main Methods:

• Retrospective analysis of 45 cervical samples with weak/late Xpert HPV amplification signals.
• Retesting using in-house HPV pangenotypic PCR and genotyping (LiPA).
• Comparison with available cytology results and HPV history.

Main Results:

• Of 44 samples with available cytology, 34.1% showed abnormal results (LSIL/ASC-US).
• 59.5% of 42 retested samples were HPV positive, with 11.9% confirmed as HR-HPV genotypes.
• 73.3% of patients with HPV history showed concordance with previous infections, suggesting persistent HR-HPV.

Conclusions:

• Weak HPV signals, especially with abnormal cytology or history, warrant closer follow-up.
• Cytological triage and patient history review are vital for identifying at-risk patients.
• Further multicenter studies are needed to validate findings and explore viral load correlations.