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The BD Onclarity™ HPV Assay detects 14 high-risk genotypes and provides additional individual results beyond 16 and 18 in a single sample-to-result run, positioning the laboratory to adapt to evolving screening guidelines and to provide timely, comprehensive data to clinicians.
The BD Onclarity™ HPV Assay, which is FDA approved for use with the BD SurePath™ collection vial1, offers genotyping for HPV primary screening, co-testing, and cytology primary with ASCUS reflex screening paradigms.
Individual genotype reporting for types 16, 18 and 45
Offers an important tool to help stratify risk and guide patient management.
Individual (31, 51, 52) or concurrent (33/58, 35/39/68 and 56/59/66) detection of remaining types
A positive or negative pooled result for these remaining high-risk genotypes (non-16, 18, 45).
Does not require additional processing, reagents or hands-on-time to get genotype results1.
Unique multiplexed design
Uses genotype-specific primers and probes to detect single and mixed genotype HPV infections1.
Internal cellular control
Ensures a sample is present, minimizing false-negative results1.
E6/E7 viral genome target
Targets the E6/E7 genomic region that, different from the L1 region targeted in other assays, is not deleted during HPV DNA integration; minimizing another source of false-negative results4.
No cross-reactivity with low-risk HPV types
Reduced risk of false-positive results due to lack of cross-reactivity with low-risk HPV types.1
Ready to use reagents
No refrigeration needed and no waiting time for the reagents to reach room temperature to begin testing.
|441990||BD Onclarity™ HPV Assay Reagent Pack|
|444087||BD Viper™ PCR Extraction Reagent Troughs|
|444088||BD Onclarity™ HPV Control Set|
|444089||BD FOX PCR Extraction Tubes|
|443837||BD Onclarity™ HPV LBC Diluent Tubes|
|441354||BD Onclarity™ Neutralization Pouch|
|441996||BD Viper™ LT Pipette Tips|
|443747||HPV Key Card|
|442957||BD Viper™ LT PCR Tube / Tray Kit|
|442967||BD Viper™ LT System PCR Accessory Kit|
|442393||BD Totalys™ Aliquot Tube|
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