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Alinity m high risk HPV assay delivers timely and clinically relevant information on 14 high risk HPV genotypes which combined with uniquely matched outstanding workflow efficiency while meeting the needs of the clinicians and laboratories.
• Integrated evidence based risk stratification by separately reporting HPV genotypes 16, 18, 45 and two pools of HR HPV genotypes in ONE single reaction
• Multiplex detection of 14 high risk genotypes for the general and vaccinated population by enabling clinical practice for the future through next level risk stratification
• Built in cellular control provides diagnostic confidence in negative results by ensuring sample adequacy, which in turn helps guide patient management.
The results from the Alinity m HR HPV, together with the physician’s assessment of cytology, history, other risk factors, and professional guidelines, may be used to guide patient management.
ALINITY m HR HPV ASSAY PERFORMANCE | |
Target Region |
L1 Region |
Limit of Detection (LoD) | The LOD was defined as a concentration having a ≥95% detection rate with all higher concentrations having a ≥95% detection rate. |
Carryover | 0.0% |
External Control | Positive Control, Negative Control |
Cellular Control | Detects the endogenous human beta globin, (BG) sequence as Cellular Control (CC) signal to evaluate cell adequacy, sample extraction and amplification efficiency |
Collection Device | Alinity m cervi-collect specimen collection kit |
Sample Input Volume |
400 μL |
Specimen Types |
Cervical specimen collected in Alinity m Cervi-Collect Specimen Collection Cervical specimen collected in ThinPrep PreservCyt Solution and SurePath Preservative Fluid |
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