HPV testing in cervical cancer formalin-fixed paraffin embedded tissues: Reliability of the Xpert HPV test and high-risk HPV genotypes distribution in Tunisia

TL;DR

This study evaluated the Xpert HPV test for detecting and genotyping high-risk HPV in cervical cancer tissues in Tunisia, finding it highly accurate and identifying a common HPV 16 prevalence.

Contribution

The study provides new evidence on the reliability of the Xpert HPV test in FFPE tissues and reports HR-HPV genotype distribution in Tunisia.

Findings

The Xpert HPV test showed 99.16% sensitivity and 100% specificity for HR-HPV detection.

HPV 16 was the most prevalent genotype (71%), followed by HPV 31 (8%) and HPV 18 (5%).

The test demonstrated strong agreement with multiplex PCR for both detection and genotyping.

Abstract

This study aims to assess the performance of the Xpert HPV test for the detection and genotyping of high-risk HPVs (HR-HPV) on FFPE cervical cancer (CC) tissues and to determine the distribution of HR-HPV genotypes in a CC Tunisian series.

The Xpert HPV test was conducted on purified DNA from 134 FFPE CC tissues. A single-tube multiplex polymerase chain reaction (PCR) served as a comparator assay to evaluate Xpert HPV performance in detecting and genotyping HR-HPVs. Discordant cases were tested using uniplex PCR.

The Xpert HPV test generated valid results in 131/134 (97.8%) samples. Sensitivity, specificity, positive and negative predictive values of Xpert HPV for HR-HPV detection among valid samples were 99.16%, 100%, 100%, and 92.31%, respectively. Agreement between Xpert HPV and multiplex PCR for HPV detection was observed in 131/134 cases (97.8%), with a kappa value of 0.892. Agreement between Xpert HPV and Multiplex PCR for HR-HPV genotyping was 96.6%. Combining assays results and after confirmation with uniplex PCR, HR-HPVs were detected in 119/134 (88.8%) samples and 11 HR-HPV genotypes were detected with a predominance of HPV 16 (71%), followed by HPV 31 (8%) and HPV 18 (5%).

This study demonstrated a high accuracy of the Xpert-HPV test for HR-HPVs detection and genotyping in FFPE CC tissues and revealed a distinct distribution of HR-HPVs in Tunisia.

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