Abstract
This study describes a validation of the BD Onclarity HPV (Onclarity) assay using the international guidelines for HPV test requirements for cervical cancer screening of women 30 years old and older using Danish SurePath screening samples. The clinical specificity (0.90, 95% confidence interval [CI] = 0.88 to 0.91) and sensitivity (0.97, 95% CI = 0.87 to 1.0) of the Onclarity assay were shown to be not inferior to the reference assay (specificity, 0.90 [95% CI = 0.88 to 0.92]; sensitivity, 0.98 [95% CI = 0.91 to 1.0]). The intralaboratory reproducibility of Onclarity was 97%, with a lower confidence bound of 96% (kappa value, 0.93). The interlaboratory agreement was 97%, with a lower confidence bound of 95% (kappa value, 0.92). The BD Onclarity HPV assay fulfills all the international guidelines for a new HPV test to be used in primarily screening. This is the first clinical validation of a new HPV assay using SurePath screening samples, and thus the Onclarity HPV assay is the first HPV assay to hold an international validation for both SurePath and ThinPrep.
Highlights
We present validation data on Onclarity with SurePath-collected samples in accordance with the international criteria for use in primary HPV screening
Test performance was compared to Hybrid Capture 2 (HC2) for clinical specificity and sensitivity on samples from Danish women undergoing screening and follow-up in the organized Danish Screening program
The samples were derived from women diagnosed with histologically confirmed CIN2ϩ detected by cervical screening on the basis of an abnormal liquid-based cytology (ՆASCUS) and/or a positive hrHPV HC2 result
Summary
We present validation data on Onclarity with SurePath-collected samples in accordance with the international criteria for use in primary HPV screening. Test performance was compared to Hybrid Capture 2 (HC2) for clinical specificity and sensitivity on samples from Danish women undergoing screening and follow-up in the organized Danish Screening program. This validation has the added impact of being the first validation of a commercial HPV assay on SurePath-collected cytology samples. SurePath is the predominantly used cytology medium in the Danish screening program, accounting for ca. 85% of the 450,000 routine cervical cancer screening samples taken annually SurePath is the predominantly used cytology medium in the Danish screening program, accounting for ca. 85% of the 450,000 routine cervical cancer screening samples taken annually
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