Analytical and Clinical Sample Performance Characteristics of the Onclarity Assay for the Detection of Human Papillomavirus

Abstract

Objective: To determine result reproducibility, and performance of the BD Onclarity™ HPV Assay (Onclarity) on the BD Viper™ LT platform using both contrived and clinical specimens. Methods: Reproducibility was assessed in BD SurePath™ LBC media (SurePath) using contrived panels (HPV16+, 18+, or 45+) or clinical specimens (HPV16+, 18+, 31+, 33/58+, 45+, 52+, or HPV-). 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. Results: Contrived specimens showed >95% concordance with expected results and pooled clinical specimens had standard deviation and coefficient of variation values ranging from 0.87 to 1.86 and 2.9% to 5.6%, respectively. For pre-cytology and post-cytology aliquot analyses, specimens showed >98.0% overall agreement and mean differences in Ct score 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. Conclusions: Onclarity results are reproducible and reliable, regardless of sample collection before or after the cytology aliquot. Onclarity performs well regardless of the method of specimen collection (Cervex-brush or Cytobrush/spatula) for cervical cancer screening.

Evaluation of the Onclarity HPV assay on the high-throughput COR system

“…This was a migration study to test both the reproducibility and the agreement of Onclarity HPV results, in three different specimen types (SurePath, PreservCyt, and CBD), when performed on a new high-throughput system, COR, compared to results on Viper LT. The reproducibility results observed here for the Onclarity assay regarding [20], the greatest variation on COR for both contrived and clinical specimens was seen within assay runs. LBC specimens are inherently non-homogenous as they are comprised of exfoliated sheaths of fixed cells.…”

“…The analytical sensitivity of Onclarity on COR was evaluated by confirming previously established LODs for Onclarity on Viper LT. Clinical specimens in SurePath LBC, PreservCyt LBC, or CBD media were screened for all 14 high-risk HPV targets using Onclarity on COR or Viper LT systems and found to be negative for HPV 16, 18, and 45 genotypes. LODs for HPV 16, 18, and 45 were determined as described previously on Viper LT [20]. Serial dilution of HPV positive cell lines, SiHa (HPV 16 positive), HeLa (HPV 18 positive), and MS751 (HPV 45 positive) spiked into SurePath and PreservCyt clinical specimens, and Onclarity specimen diluent for CBD specimens.…”

Utility of Extended HPV Genotyping as Primary Cervical Screen in an Unscreened Population With High HIV Co-Infection Rate

“…The assay performs well in the laboratory and results have been found to be reproducible and reliable in a large quality control study. 6 The test performance was good, independent of sample collection before or after cytology aliquoting. The test performed well in different cytology preservation media.…”

Concordance between the BD Onclarity and Roche cobas assays for detection of HPV DNA in a Chinese population

“…Cytology or HPV testing is recommended in most countries for triage management in HPV+ individuals, and colposcopy referral or immediate treatment is determined based on the results of triage. HPV DNA testing is now used as a triage test to determine whether a woman with atypical squamous cells of undetermined significance (ASC‐US) needs immediate colposcopic evaluation, and as an adjunct to cervical cytology called “cotesting” for cervical cancer screening in women aged 30 years or older 8–10 …”

“…HPV DNA testing is now used as a triage test to determine whether a woman with atypical squamous cells of undetermined significance (ASC-US) needs immediate colposcopic evaluation, and as an adjunct to cervical cytology called "cotesting" for cervical cancer screening in women aged 30 years or older. [8][9][10] The main disadvantage of HPV DNA detection methods in clinical Both cobas and Onclarity have been approved by the US Food and Drug Administration for use in cervical cancer screening. Prior peer-reviewed publications have reported comparable sensitivity and specificity performance parameters for Onclarity and cobas.…”