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HPV

Alinity m HR HPV AMP Kit

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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.

Intended Use

The Alinity m High Risk (HR) HPV assay is a qualitative in vitro test for use with the automated Alinity m System for the detection of DNA from 14 high-risk human papillomavirus (HPV) genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68 in clinical specimens. The assay specifically identifies HPV genotypes 16, 18, and 45 while reporting the concurrent detection of the other high-risk genotypes (31/ 33/ 52/ 58) and (35/ 39/ 51/ 56/ 59/ 66/ 68) at clinically relevant infection levels. The Alinity m HR HPV assay is intended for the following uses:

  • To screen patients with ASC-US (atypical squamous cells of undetermined significance) cervical cytology test 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 genotype.
  • 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.

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.

To learn more about Alinity m HR HPV Assay please visit: https://www.molecular.abbott/int/en/products/infectious-disease/alinity-m-hr-hpv-assay

ALINITY m HR HPV ASSAY PERFORMANCE
TechnologyRT-PCR
Time to first result<115 min
Probe DesignSingle stranded probes
Target RegionL1 Region
Specimen type*Cervical specimens collected in liquid-based cytology media:
• ThinPrep® PreservCyt® Solution (Hologic, Inc.)
• SurePath™ Preservative Fluid (BD) and post-gradient cell pellet dilution
Cervical specimens collected with the Alinity m Cervi-Collect Specimen Collection Kit
High Risk (HR) Genotypes
Detected		14 High Risk (HR) Genotypes detected: 16, 18, 31, 33, 35,39, 45,51, 52, 56, 58, 59, 66, and 68
Result Reporting16, 18, 45 while reporting concurrent detection of other HR genotypes in (31/33/52/58) and
(35/39/51/56/59/66/68)
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.
Carryover0.0%
Clinical SensitivityASC-US population: 96.8% (95% CI: 83.8–99.4)
Screening population (age ≥ 30 years): 100.0% (95% CI: 94.7–100.0)
Clinical SpecificityScreening population (age ≥ 30 years): 93.2.0% (95% CI: 92.2 -94.0)
Screening population with normal cytology (age ≥ 30 years): 92.8% (95% CI: 91.8, 93.7)
ReproducibilityIntra-laboratory reproducibility: 97.9% (95% CI: 96.4 -98.8); k= 0.95
Inter-laboratory reproducibility: 97.5% (95% CI: 95.8 -98.5); k= 0.94
Clinically validated for:Primary screening: fulfills the International Consensus Guidelines 1
ASC-US triage, adjunct to cervical cytology, HPV 16 and HPV 18 genotyping
Sample input volume400μL
Abbott Collection DeviceAlinity m cervi-collect specimen collection kit
ControlsPositive Control, Negative Control
Cellular Control (CC)Human β-globin gene (DNA). True cellular internal control to ensure sample cellularity and control
the efficiency of nucleic acid extraction and amplification

1. Meijer et al. Guidelines for human papillomavirus DNA test requirements for primary cervical cancer screening in women of 30 years and older. Int J Cancer. 2009 Feb 1; 124(3): 516-520. doi:10.1002/ijc.24010.

 

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ASR Analyte Specific Reagent (Analytical and performance characteristics are not established)
GPR General Purpose Reagent
IVD In Vitro Diagnostics (Rx Only)
RUO Research Use Only (Not for Diagnostic Use)
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