Abbott RealTime High Risk HPV

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PRODUCT NAME	UNIT SIZE	ORDER NUMBER	GTIN

The Abbott RealTime High Risk (HR) HPV assay detects 14 high-risk HPV genotypes with simultaneous identification of HPV 16 and HPV 18. (02N09-90)

02N09-92 has the following additional intended use:

To screen patients with ASC-US (atypical squamous cells of undetermined significance) cervical cytology results to determine the need for referral to colposcopy. The results of this test are not intended to prevent women from proceeding to colposcopy.
To be used with cervical cytology to adjunctively screen to assess the presence or absence of high risk HPV genotypes.
To be used as a first-line primary screening test to identify women at increased risk for the development of cervical cancer or the presence of high-grade disease.
To assess the presence or absence of HPV genotypes 16 and 18 to identify women at increased risk for the development of cervical cancer or the presence of high-grade disease with or without cervical cytology.

ABBOTT REALTIME HIGH RISK HPV
Instrumentation	Extraction: m2000sp, m24; Amplification and Detection: m2000rt
Kit Configuration	4 x 24 tests/kits
Technology	Multiplex real-time PCR
Assay Performance	Clinical Sensitivity and Specificity in Referral Population: High Risk HPV Detection Clinical Sensitivity: 97.5%; Clinical Specificity: 99.4%
HPV High Risk Detection	16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68
HPV Genotyping	HPV 16, HPV 18
Sample Type	ThinPrep® PreservCyt® Solution (Hologic, Inc.) SurePath® Preservative Fluid® (Becton, Dickinson and Company) and post-gradient cell pellet dilution Abbott Cervi-Collect Specimen Collection Kit
Input Volume	400 ul
Internal Control	An endogenous human beta globin sequence in detected as sample validity control for cell adequacy, sample extraction and amplification efficiency
External Controls	Negative control; Positive control
Reported Results	Qualitative detection of 14 High Risk HPV types, typing of HPV 16 and/or HPV 18, single and mixed infections

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