HPV testing in cervical cancer formalin-fixed paraffin embedded tissues: Reliability of the Xpert HPV test and high-risk HPV genotypes distribution in Tunisia.
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.
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.
Authors
Ben Taher Ben Taher, Ben Rekaya Ben Rekaya, Romdhane Romdhane, Miladi Miladi, Bel Hadj Kacem Bel Hadj Kacem, Med H'mayada Med H'mayada, Ben Mansour Ben Mansour, Sassi Sassi, Chelbi Chelbi, Tangour Tangour, Blel Blel, Rammeh Rammeh
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