Abstract
The objective of this study was to determine the result reproducibility and performance of the BD Onclarity human papillomavirus (HPV) assay (Onclarity) on the BD Viper LT platform using both contrived and clinical specimens. Reproducibility was assessed in BD SurePath liquid-based cytology (LBC) medium (SurePath) using contrived panels (HPV genotype 16 [HPV16] positive, HPV18 positive, or HPV45 positive) or clinical specimens (HPV16, -18, -31, -33/58, -45, or -52 positive or HPV negative). In addition, specimens from 3,879 individuals from the Onclarity trial were aliquoted prior to or following cytology processing and tested for HPV. Finally, specimens were collected using either the Cervex-Brush or Cytobrush (or Cytobrush/spatula) for comparison of HPV results. Contrived specimens showed >95% concordance with the expected results, and pooled clinical specimens had standard deviations and coefficients of variation ranging from 0.87 to 1.86 and 2.9% to 5.6%, respectively. For precytology and postcytology aliquot analyses, specimens showed >98.0% overall agreement and mean differences in cycle threshold (CT ) scores for HPV ranging from -0.07 to 0.31. Positivity rates were close between the Cervex-Brush and Cytobrush/spatula for all age groups tested. Onclarity results are reproducible and reliable, regardless of sample collection before or after cytology aliquoting. Onclarity performs well regardless of the method of specimen collection (Cervex-Brush or Cytobrush/spatula) for cervical cancer screening.
Highlights
The objective of this study was to determine the result reproducibility and performance of the BD Onclarity human papillomavirus (HPV) assay (Onclarity) on the BD Viper LT platform using both contrived and clinical specimens
Onclarity is FDA approved for reporting HPV genotype 16 (HPV16) and HPV18 during HPV primary screening and HPV16, -18, and -45 during atypical squamous cells of undetermined significance (ASCUS) triage and cotesting; in addition, it is CE in vitro diagnostics (IVD) marked for the detection of 14 high-risk HPV genotypes [14,15,16]
30,489 women characterized as negative for intraepithelial lesions or malignancies (NILM) cytology, 1,960 women identified with atypical squamous cells of undetermined significance (ASCUS) cytology, and 1,122 women identified with ϾASCUS cytology were included in the baseline data from the Onclarity trial
Summary
The objective of this study was to determine the result reproducibility and performance of the BD Onclarity human papillomavirus (HPV) assay (Onclarity) on the BD Viper LT platform using both contrived and clinical specimens. Onclarity performs well regardless of the method of specimen collection (Cervex-Brush or Cytobrush/spatula) for cervical cancer screening. Onclarity is FDA approved for reporting individual genotype results for HPV16, -18, -31, -45, -51, and -52 and grouped results for HPV33/58, -35/29/68, and -56/59/66 in order to facilitate risk-based screening for cervical cancer and precancer. The Onclarity assay is performed on samples obtained from liquid-based cytology (LBC) specimens collected using a Cervex-Brush or Cytobrush (or Cytobrush/spatula) device. Sites utilizing HPV primary screening with cytology triage will perform HPV testing from an initial LBC aliquot (precytology) and use the remaining vial/specimen for cytology. Sites employing a screening program with primary cytology testing and HPV triage testing will perform cytology testing first, followed by HPV testing from the specimen after cytology processing (postcytology aliquot). It is important to establish that the performance of the HPV assay is unaffected by the order in which the aliquot is taken
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