Human Papillomavirus (HPV) Detection by Nucleic Acid Amplification

Human Papillomavirus (HPV) High-Risk, Hybrid Capture ll®
DataValue
Method Nucleic Acid Amplification Test (NAAT);  Transcription-mediated amplification
CPT Code 87624
Preferred Specimen ThinPrep liquid cytology, SurePath cytology or Aptima Cervical Specimen Collection specimens
Minimum Specimen Volume
Specimen Container Vial with PreservCyt® solution, ThinPrep® or SurePath-recommended container;  ThinPrep specimens must be tranferred to an Aptima Specimen tube within 105 days of collection.  SurePath specimens must be transferred to an Aptima Specimen tube within 7 days of collection.
Specimen Identification Label sample container with patient’s first name, last name and DOB include date and time of collection.
Collection Collect according to the liquid-based cytology specimen preparation guidelines. 
Special Instructions Positive specimens that show evidence of ASCUS will be evaluated for the presence of high-risk human Papillomavirus DNA sequences (type 16 and 18) only as requested.  Evaluation for HPV 16/18 is a send-out test.
Use To aid in the diagnosis of sexually-transmitted HPV infections with HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68, which are associated with squamous intraepithelial lesions of all types, including high-grade squamous intraepithelial (HSIL) lesions and invasive cancers of the cervix.  Positive specimens are sent to additional laboratory for genotyping.
Shipping Requirements ThinPrep and Aptima specimens must be stored between 2 and 30 degrees Celsius for up to 60 days.  For longer storage, specimens must be frozen at -20 degrees Celsius or lower, for a maximum of 24 months.  SurePath specimens must be kept between 2 and 25 degrees Celsius and must be transferred to an Aptima vial within 7 days of collection.
Limitations Detects the 14 most common high-risk HPV types
Sample Rejection Criteria
  • Improper collection medium
  • Specimen more than 21 days old in liquid-based preservative
Turn-around-time 7 Business days