| 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 |
N/A |
| 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 high-risk HPV types (specifically 16, 18 and 31), 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 |
24-48 hours (M-F) |