Performance of the APTIMA HPV assay as compared to Hybrid Capture-II on cytologically and histologically defined specimens
Abstract number: P992
Dockter J., Joo S., Schroeder A., Eaton B., Getman D., Giachetti C.
Objectives: The APTIMA HPV Assay detects HPV E6/E7 mRNA from 14 high-risk types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) in liquid Pap specimens. It utilises Gen-Probe's target capture, Transcription-Mediated Amplification, and Hybridisation Protection Assay technologies, incorporates an internal control, and can be run on both the semi-automated Direct Tube Sampling (DTS) instruments and the fully automated TIGRIS DTS System (TIGRIS). In this study, the performance of the APTIMA assay was evaluated in residual Cytyc PreservCyt liquid-based cytology samples from US and France referral populations, including samples determined to contain atypical squamous cells (ASC), and samples classified as CIN 13.
Methods: PreservCyt samples (n = 367) were diluted 1/4 in APTIMA specimen transport media and tested on TIGRIS. Samples were also tested using the Digene Hybrid Capture 2 (HC2) assay following its standard assay procedure.
Results: The APTIMA assay detected 259 of the 367 samples tested (70.6%) and the HC2 assay detected 260 (70.8%). The reactivity rate for the APTIMA assay in ASC samples was 69.1%. For these same samples the HC2 assay reactivity rate was 81.8%. For samples determined to be CIN-1, -2, or -3 (n = 375), APTIMA assay reactivity rates were 76.8%, 95.5%, and 96%, respectively, while HC2 assay reactivity rates were 76.8%, 93.2%, and 92%, respectively. For samples determined to be CIN 2 or -3 (n = 319), the APTIMA assay achieved 95.8% reactivity, while HC2 assay reactivity was 92.4%. Inter-assay concordance was 87.5% overall, 80% for the ASC samples, and 95% for the CIN-2 or -3 samples.
Conclusion: The APTIMA HPV assay exhibited lower reactivity than the HC2 assay in samples with ASC cytology, and higher reactivity than the HC2 assay in disease-positive (CIN-2 or -3) samples. Concordance between the APTIMA and HC2 assays was 95% in histologically disease-positive specimens.
|Session name:||18th European Congress of Clinical Microbiology and Infectious Diseases|
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