| Test
395 - HPV DNA Assay by Hybrid Capture(r) II |
| Method |
Hybrid
Capture(r) II |
| Specimen
Requirements |
ThinPrep(tm)
or AutoCyte(tm) Solution: 8.0 ml (4.0 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(tm)
or AutoCyte(tm) 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 |
<4.0
ml ThinPrep(tm) or AutoCyte(tm) 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(tm)
or AutoCyte(tm) 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 (low risk)
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 18 anogenitally important HPV 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.
|
