The Abbott RealTime High Risk (HR) HPV assay is a qualitative in vitro polymerase chain reaction (PCR) assay that utilizes homogeneous target amplification and detection technology for the detection of high risk human papillomavirus (HPV) DNA in cervical cells collected in liquid cytology media. The Abbott RealTime HR HPV assay is intended to detect 14 high risk HPV genotypes: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68 and to partially genotype 16, 18 from other 12 high risk genotypes.
The Abbott RealTime High-Risk HPV assay is designed for the detection of high-risk HPV genotypes in cervical specimens from women with precancerous lesions of the cervix uteri (≥ CIN2) and cervical cancer to provide clinically meaningful results in cervical cancer screening.
Clinically Validated According to International Consensus Guidelines
|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||PreservCyt Solution (Hologic, Inc.)
SurePath Preservative Fluid (TriPath Imaging)
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|
Qualitative detection of 14 High Risk HPV types, typing of HPV 16 and/or HPV 18, single and mixed infections
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