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Test Code HPV Geno HPV Genotype 16 18/45 Assay

Useful For

In women 21 years and older with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results the Aptima HPV 16 18/45 genotype assay can be used to test samples from women with Aptima HPV assay positive results to assess the presence or absence of high-risk genotypes 16, 18, and/or 45. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy.

In women 30 years and older, the Aptima HPV 16 18/45 genotype assay can be used to test samples from women with Aptima HPV assay positive results. The assay results will be used in combination with cervical cytology to assess the presence or absence of high-risk HPV genotypes In women 30 years and older, the Aptima HPV 16 18/45 genotype assay can be used to test samples from women with Aptima HPV assay positive results. The assay results will be used in combination with cervical cytology to assess the presence or absence of high-risk HPV genotypes

Patient Preparation

No special preparations required

Special Collection Instructions

Collect cervical specimens in ThinPrep Pap Test vials containing PreservCyt Solution with broom-type or cytobrush/spatula collection devices according to the manufacturer’s instructions.

Collection Method

  • Collect cervical specimens in ThinPrep Pap Test vials containing PreservCyt Solution with broom-type or cytobrush/spatula collection devices according to the manufacturer’s instructions.
  • Prior to or after cytology processing with the ThinPrep 200 System, transfer 1mL of the ThinPrep liquid cytology specimen into an Aptima Specimen transfer tube according to the instructions in the Aptima Specimen Transfer Kit package insert.

Minimum Volume

1 mL PreservCyt solution in an APTIMA specimen transport tube.

Container

APTIMA Specimen Transport Tube

Preferred Specimen

APTIMA PreservCyte sample in APTIMA specimen transport tube

Acceptable Specimens

Aptima Specimen Transfer Tube

Reference or Target Ranges

Negative

Reportable Units

Negative, Positive, Invalid

Critical Value

Not established for this assay.

Reasons for Rejection

Reject if collected in inappropriate specimen container.

 

Specimen Stability

Ambient Specimen in PreservCyt Solution  30 Days
Ambient Specimen in APTIMA specimen transfer tube  14 Days
Refrigerated 2-8 ̊C Specimen in APTIMA specimen transfer tube  30 Days

 

Performance Information

Days and Times Performed Daily, Monday-Friday
 
Expected TAT 1-7 days
Stat Availability Not available STAT
Performing Lab Section Molecular Pathology
Routing/Bench EF Panther
Instrument Hologic Panther

Special Handling

Avoid cross-contamination during the specimen handling steps. Ensure that specimen containers do not contact one another, and discard used materials without passing over open containers. Change gloves if they come in contact with specimen.

Additional Information/Important Notes

This assay is not intended for use in determining the need for treatment (i.e. excisional or ablative treatment of the cervix) in the absence of highgrade cervical intraepithelial neoplasia (CIN). Women who are HPV 16/18/45 positive should be monitored carefully for the development of high-grade CIN according to current practice guidelines.

The Aptima HPV 16 18/45 genotype assay is not intended for use as a stand-alone assay. The assay should be performed only as a follow-up to an Aptima HPV assay positive results, and should be interpreted in conjunction with cervical cytology test results.

CPT Codes

87625

Methodology/Method Description

The Aptima HPV Assay 16 18/45 genotype assay is an in vitro nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) of human papillomavirus (HPV) types 16, 18, and 48 in cervical specimens from women with Aptima HPV assay positive results. The Aptima HPV 16 18/45 genotype assay does can differentiate HPV 16 from HPV 18 and/or HPV 45, but does not differentiate between HPV 18 and HPV 45.

Panel Components

N/A

Reflex Testing

N/A