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Test Code HPV Human Papillomovirus, Qualitative

Useful For

To screen women 21 years and older with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results to determine the need for referral to colposcopy.
In women 30 years and older, the Aptima HPV assay can be used with cervical cytology to adjunctively screen to assess the presence or absence of high-risk HPV types. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management.

Patient Preparation

No special patient preparation 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 defined for this assay

Reasons for Rejection

Hemolysis Threshold
 N/A
Icterus Threshold
 N/A
Lipemia Threshold
 N/A
Interfering Subtances/Other
  • Reject if specimen has been repeatedly frozen and thawed
  • Leakage or contamination of specimen, improper collection, container or transport, questionable patient or specimen identification, insufficient quantity

Specimen Stability

Ambient
 Specimen in PreservCyt Solution30 Days
Specimen in APTIMA specimen transfer tube: 14 Days
Refrigerated (4°C to 8°C)
 Specimen in APTIMA specimen transfer tube: 30 Days
Frozen(-70°C to 0°C)
 N/A

Performance Information

Days and Time Performed
 Monday – Friday
Expected Turn Around Time
 1 – 7 Days
Stat Availabilty
 No
Performing Bench
 Molecular Pathology
Methodology/Method Description
 Hologic Panther – Nucleic Acid Amplification

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 as a screening device for women under age 30 with normal cervical cytology.

The Aptima HPV assay is not intended to substitute for regular cervical cytology screening.

CPT Codes

87624

Reflex Testing

Reflex available for HPV Genotype if high risk HPV detected