| Test
395H - HPV DNA (High Risk only) Assay by Hybrid
Capture® II
|
| Method |
Hybrid Capture®
II |
| Specimen
Requirements |
ThinPrep Solution:
4.0 ml (2.0 ml), SurePath Solution: 1.0 ml (0.5 ml) cell
suspensions in PreservCyt medium. Store at room temperature
up to 21 days; Cervical Brush: Use Digene
Cytology Brush Specimen Collection Kit, available from
Genetic Assays. Store specimen at 2-30ºC for up to 14
days and indefinitely at -20ºC. Cervical brush
should be collected prior to the application of acetic
acid if colposcopic examination is being performed;
Cervical Biopsy: Cervical biopsies should
be fresh tissue. Use Digene Cytology Brush Specimen Collection
Kit, available from Genetic Assays. Remove and discard
cytology brush and suspend fresh tissue in media within
the collection tube. Biopsies should be frozen at -20ºC
until they are shipped. Cervical biopsies processed
with histological fixatives cannot be tested. |
| Collection
& Transport |
ThinPrep or SurePath
Solution and Digene Cytology Brush Specimen Collection
Kit at room temperature, ship ambient; Digene Cytology
Brush Specimen Collection Kit frozen, ship on dry ice;
Biopsies, frozen in Styrofoam cooler with dry ice. |
| Causes
for Rejection |
<2.0
ml ThinPrep‘ or <0.5 ml SurePath‰ Solution
and/or exceeds 21 day limit; Digene Cytology Brush Specimen
Collection Kit received without a cervical brush; cervical
brush collected after the application of acetic acid;
cervical biopsy processed with histological fixatives. |
| Specimen
Stability |
ThinPrep
or SurePath Solution solution stable up to 21 days at
room temperature; Digene Cytology Brush Specimen Collection
Kit stable up to 14 days at room temperature and indefinitely
at -20ºC; cervical biopsies stable indefinitely at -20ºC. |
| Reference
Range |
Not Detected |
| TAT |
24-48
hours |
| CPT
Code |
87621,
papillomavirus human, amplified probe technique (high
risk) |
|
HPV
is a family of over 70 viruses of which 18 are associated
with anogenital lesions, representing a spectrum of
disease ranging from common genital warts to cervical
cancer. The HPV DNA test is used for clarification and
confirmation of cytologic diagnosis and may be used
in triaging patients for possible referral for colposcopy.
The HPV DNA assay is extremely useful in cases involving
ASCUS (atypical squamous cells of undetermined significance)
since the Pap Smear is incapable of providing information
about the risk profile of HPV if present. This FDA approved
test will detect all 13 anogenitally important HPV High
Risk types. The hybrid capture assay utilizes two DNA
probes to distinguish between HPV types associated with
low grade squamous intraepithelial lesions (LSIL) and
those types associated with high-grade squamous intraepithelial
lesions (HSIL) and invasive cancer of the cervix. |
