INTRODUCTION: Testing for high-risk types of human papillomavirus (HPV) has been consistently more sensitive than cervical cytology for high-grade precancers and cancers of the cervix (cervical intraepithelial neoplasia grade 2 or higher) but less specific. New assays are being developed to improve on the overall accuracy of molecular testing. The Gen-Probe APTIMA HPV assay (AHPV) is a multiplex assay that qualitatively detects 14 HPV types in a single tube. Because the AHPV targets HPV-E6/E7 messenger RNA transcripts, it should theoretically have a greater specificity than HPV assays that detect HPV DNA. The objective of this study was to compare the sensitivity and the specificity of the Gen-Probe AHPV with those of the Qiagen Hybrid Capture 2 assay (HC2) and liquid-based cytologic examination for cervical cancer screening. METHODS: A total of 2098 unscreened or poorly screened women 25 to 59 years of age were recruited in the city of Shenzhen, China. Two cervical specimens were collected: 1 in SurePath liquid for cytologic examination and 1 in PreservCyt for HPV testing by HC2 and the AHPV. The testing was performed by blinded technicians according to the manufacturer's instructions. Women who had atypical squamous cells of undetermined significance or worse cytologic diagnosis and/or were HPV positive by either assay were asked to return for colposcopy and biopsy. RESULTS: Overall, 2095 women had complete data. Overall, 16.5% of the women were positive on HC2, 10.1% were positive on the AHPV, 5.45% had atypical squamous cells of undetermined significance or greater on cytologic examination, and 1.4% had histologically confirmed cervical disease: cervical intraepithelial neoplasia grade 2 or higher. The sensitivity values of liquid-based cytologic examination, HC2, and the AHPV were 66.7%, 88.9%, and 100%, respectively. The specificity values were 95.5%, 84.5%, and 91.2%, respectively. The AHPV was significantly more accurate by receiver operating characteristic curve comparison (P = 0.005). CONCLUSIONS: The low false-positive rate (high specificity) and the high sensitivity of the AHPV makes this assay suitable for use as a primary assay for detecting cervical disease in a screening setting.
INTRODUCTION: Testing for high-risk types of human papillomavirus (HPV) has been consistently more sensitive than cervical cytology for high-grade precancers and cancers of the cervix (cervical intraepithelial neoplasia grade 2 or higher) but less specific. New assays are being developed to improve on the overall accuracy of molecular testing. The Gen-Probe APTIMA HPV assay (AHPV) is a multiplex assay that qualitatively detects 14 HPV types in a single tube. Because the AHPV targets HPV-E6/E7 messenger RNA transcripts, it should theoretically have a greater specificity than HPV assays that detect HPV DNA. The objective of this study was to compare the sensitivity and the specificity of the Gen-Probe AHPV with those of the Qiagen Hybrid Capture 2 assay (HC2) and liquid-based cytologic examination for cervical cancer screening. METHODS: A total of 2098 unscreened or poorly screened women 25 to 59 years of age were recruited in the city of Shenzhen, China. Two cervical specimens were collected: 1 in SurePath liquid for cytologic examination and 1 in PreservCyt for HPV testing by HC2 and the AHPV. The testing was performed by blinded technicians according to the manufacturer's instructions. Women who had atypical squamous cells of undetermined significance or worse cytologic diagnosis and/or were HPV positive by either assay were asked to return for colposcopy and biopsy. RESULTS: Overall, 2095 women had complete data. Overall, 16.5% of the women were positive on HC2, 10.1% were positive on the AHPV, 5.45% had atypical squamous cells of undetermined significance or greater on cytologic examination, and 1.4% had histologically confirmed cervical disease: cervical intraepithelial neoplasia grade 2 or higher. The sensitivity values of liquid-based cytologic examination, HC2, and the AHPV were 66.7%, 88.9%, and 100%, respectively. The specificity values were 95.5%, 84.5%, and 91.2%, respectively. The AHPV was significantly more accurate by receiver operating characteristic curve comparison (P = 0.005). CONCLUSIONS: The low false-positive rate (high specificity) and the high sensitivity of the AHPV makes this assay suitable for use as a primary assay for detecting cervical disease in a screening setting.
Authors: Thomas Iftner; Sven Becker; Klaus-Joachim Neis; Alejandra Castanon; Angelika Iftner; Barbara Holz; Annette Staebler; Melanie Henes; Katharina Rall; Juliane Haedicke; Claus Hann von Weyhern; Andreas Clad; Sara Brucker; Peter Sasieni Journal: J Clin Microbiol Date: 2015-05-27 Impact factor: 5.948
Authors: Maria Paraskevaidi; Simon J S Cameron; Eilbhe Whelan; Sarah Bowden; Menelaos Tzafetas; Anita Mitra; Anita Semertzidou; Antonis Athanasiou; Phillip R Bennett; David A MacIntyre; Zoltan Takats; Maria Kyrgiou Journal: EBioMedicine Date: 2020-09-25 Impact factor: 8.143
Authors: D A M Heideman; A T Hesselink; F J van Kemenade; T Iftner; J Berkhof; F Topal; D Agard; C J L M Meijer; P J F Snijders Journal: J Clin Microbiol Date: 2013-08-28 Impact factor: 5.948
Authors: Cornelis Johannes Jacobus Huijsmans; Willemina Rosalia Rita Geurts-Giele; Cindy Leeijen; Hendrikus Lambertus Cornelius Maria Hazenberg; Jenneke van Beek; Carola de Wild; Johannes Cornelis van der Linden; Adrianus Johannes Christiaan van den Brule Journal: BMC Cancer Date: 2016-11-28 Impact factor: 4.430
Authors: J Cuzick; L Cadman; D Mesher; J Austin; L Ashdown-Barr; L Ho; G Terry; S Liddle; C Wright; D Lyons; A Szarewski Journal: Br J Cancer Date: 2013-01-31 Impact factor: 7.640