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HelpTest 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 |
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.
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 | ||||||
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
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