HPV
Testing
Methodology:
Roche cobas®
4800 System
Principle:
The cobas HPV Test is an automated test run on the cobas® 4800
System which is used to identify human papillomavirus (HPV) DNA from 14
high-risk genital HPV types that are commonly associated with cervical cancer.
The test specifically identifies types HPV 16 and HPV 18 while concurrently
detecting the rest of the high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58,
59, 66 and 68). DNA is isolated from a scrape of cells from a woman's cervix
and is subsequently mixed in reaction wells with primers and probes that
specifically recognize and amplify HPV DNA. This reaction produces
fluorescence, which is then measured to determine the presence of HPV in the
cervical sample. ß-globin from cellular input is used as an internal
control to assess specimen quality and identify specimens containing factors
that inhibit the amplification process.
Specimen
Requirements:
HPV testing
is performed using the original SurePath vial as long as the test is ordered
within 2 weeks of the collection date. For FDA approval, the
cervical broom MUST be in the SurePath vial. A brush and/or spatula
may be used in addition to the cervical broom if desired.
Ordering
HPV Testing
For recommended guidelines for ordering HPV, please visit the ASCCP
website at www.asccp.org
1. Reflexive
testing based on age recommendations: HPV testing may be ordered on the
pap requisition by checking the box for the reflex criteria for HPV
testing.
2. Adding on
HPV testing through "Faxback": If the provider wishes to add on
HPV testing after the pap result has been finalized, the provider may do this
by faxing an order to add HPV testing to the SurePath vial within 2
weeks of collection. The provider must provide the patient name, date of
the SurePath pap collection and the "G" number from the Pap report
(see HPV faxback form). We will fax this form back to you as a confirmation of
receipt of the order.
Ordering
an "HPV only":
If the provider wants only HPV testing, the provider will need to
specify on the requisition that this test is for "HPV
ONLY". This way, the patient will not be charged for a SurePath
pap in addition to the HPV. This should be collected in a SurePath
vial.
Reporting:
Positive or negative for HPV16, 18 and/or other HR HPV genotypes (31, 33,
35, 39, 45, 51, 52, 56, 58, 59, 66 and 68).
