Comparison of Analytical and Clinical Performance of HPV 9G DNA Chip, PANArray HPV Genotyping Chip, and Hybrid-Capture II Assay in Cervicovaginal Swabs

BACKGROUND: Human papillomavirus (HPV) infection can be detected by using several molecular methods, including Hybrid-Capture II (HC2) assay and variable HPV DNA chip tests, although each method has different sensitivities and specificities. METHODS: We performed HPV 9G DNA Chip (9G) and PANArray HPV Genotyping Chip (PANArray) tests on 118 cervicovaginal swabs and compared the results with HC2, cytology, histology, and direct sequencing results. RESULTS: The overall and high-risk HPV (HR-HPV) positivity rates were 62.7% and 44.9% using 9G, and 61.0% and 30.5% using PANArray, respectively. The positivity rates for HR-HPV with these two chips were significantly lower than 55.1% when HC2 was used. The sensitivity of overall HPV positivity in detecting histologically confirmed low-grade cervical squamous intraepithelial lesions or higher was 88.7% for all three tests. The specificity was 58.5% for 9G and 61.5% for PANArray, which was significantly lower than the 72.3% for HC2. With the HR-HPV+ genotype threshold, the sensitivity decreased to 75.5% for 9G and 52.8% for PANArray, which was significantly lower than the 88.7% for HC2. Comparison of the two chips showed concordant results in 55.1% of the samples, compatible results in 16.9%, and discordant results in 28.0%, exhibiting poor agreement in detecting  certain HPV genotypes. Compared with direct sequencing, 9G yielded no discordant results, whereas PANArray yielded 31 discordant results (26.7%). CONCLUSIONS: Compared with HC2, the HPV genotyping tests showed lower sensitivity in histologic correlation. When the two chips were compared, the 9G was more sensitive and accurate for detecting HR-HPV than the PANArray.

Detection of high risk human papillomavirus cervical infections by the hybrid capture in Asunción, Paraguay

Cervical cancer is the most frequent malignant tumour of women in Latin America being human papillomavirus (HPV) the main cause. The aim of this study was to increase the knowledge about the cervical infections with oncogenic HPV types (HR-HPV) in Asuncion, Paraguay. Two hundred and seventy-two cervical samples were analyzed using hybrid capture II assay (HCA II) for HR-HPV. The frequency of HR-HPV in the study group was 44 percent. HR-HPV was detected in 25 percent of the women negative for squamous intraepithelial lesions (NSIL), 72 percent with atypical squamous cells of undetermined significance (ASCUS), 68 percent with low SIL and 78 percent with high SIL. A moderate concordance was observed between HCA II assay and cytology (kappa: 0.43 IC95 percent 0.3 - 0.5). It was detected a high frequency of HR-HPV in women from 11 to 30 years old and in those over 60 years old. The data obtained in this study showed a high frequency of HR-HPV in woman with NSIL and ASCUS, which corroborate that the use of cytology together with HCA II assay for HR-HPV could improve remarkably the efficiency of screening programs of cervical cancer in Paraguay. Furthermore, these findings point out the need for the periodical follow-up of HR-HPV infections in older women.