New Methodology for HPV Testing - Dahl Chase Pathology Associates

April 2015
NEW METHODOLOGY FOR HPV TESTING
Dahl-Chase is pleased to announce that, beginning May 4, 2015, we will be performing Human
Papillomavirus (HPV) testing utilizing PCR (Polymerase Chain Reaction) technology on the Cobas®
4800 System using the SurePath® vial. Our in house analytic validation of this new method shows
99.1% sensitivity and 99.4% specificity for the detection of high risk HPV types.
HPV Genotype Results:

With this new platform, we will have the ability to specifically identify HPV types 16 and 18, while
concurrently detecting 12 additional high risk types (31,33,35,39,45,51,52,56,58,59,66 and 68).
The HPV results will continue to be reported with the pap results, but will now also include
genotype results for HPV 16/18 at no additional cost to the patient (cost of the HPV test remains
the same). Please see sample reports on the reverse side of this newsletter.
Specimen Collection:
The HPV Test will be run off of the SurePath® vial along with the pap. There is no need to collect a
second specimen for the HPV test. If you have any of the HC2 DNA Cervical Sampler devices (Digene
cervical sampler tubes) in your office that you previously used for "HPV Only" orders, we would ask
that you please discard them on May 4, 2015 as we will no longer be utilizing that methodology for
HPV. If you currently use the HC2 DNA Cervical Sampler devices (Digene cervical sampler tubes) in
your office for sending Chlamydia and Gonorrhea testing to Dahl-Chase, you may continue to use
these for GC/CT testing unless we notify you otherwise.
Requisition Forms and FAX back orders:
Until updated requisition forms become available, please use the current requisition form and disregard
the HC2 DNA cervical sampler requirement for "HPV Only" requests beginning May 4, 2015, because
all HPV tests will be run off of the SurePath® vial. See sample requisition form on reverse side. Fax
back orders may be submitted up to 14 days from the date of collection.
Dahl-Chase Diagnostic Services’ state-of-the-art laboratory is located in Bangor, Maine, but serves physicians, hospitals,
laboratories, and clinics throughout northern New England, with research-related work that draws from across the United States and
Europe. Dahl-Chase Diagnostic Services is fully accredited by the College of American Pathologists (CAP), with CLIA certification.
We offer cytopathology, including human papilloma virus (HPV) screening, surgical pathology, hematopathology, molecular
diagnostics, and extensive flow cytometry testing. Dahl-Chase is a national leader in flow cytometric testing for paroxysmal
nocturnal hemoglobinuria (PNH), a rare but serious blood disorder. Dahl-Chase Diagnostic Services is a subsidiary of Dahl-Chase
Pathology Associates, P.A., northern New England’s leading provider of pathology services. Our board-certified pathologists cover
the breadth of subspecialty pathology
Technical Information Contact:
Andrea Illingworth, M.S.
(207) 941-8282
Scientific Information Contact:
Mayur Movalia, M.D.
(207) 941-8200
Collection/Submission Contact:
Lisa Grant
(207) 561-2415
Sample of Positive HPV Report
HPV RESULTS:
HPV 16:
Positive
HPV 18:
Negative
Other HR HPV: Negative
HPV COMMENTS:
High Risk HPV detection was performed using the Roche cobas® HPV PCR methodology which tests for the presence of
HPV types 16,18, 31,33,35,39,45,51,52,56,58,59,66 and 68. A negative result does not preclude the presence of HPV
infection because results depend on adequate specimen collection, absence of inhibitors and sufficient DNA to be
detected.
The HPV assay has been cleared by the FDA for use with ThinPrep cervical/vaginal specimen only. Its analytic performance characteristics with SurePath has been
validated by Dahl-Chase Diagnostic Services. Any results of this test should be interpreted in the context of complete medical history and are not intended to be used as
the sole means for clinical diagnosis or patient management decisions.
Sample of Negative HPV Report
HPV RESULTS:
HPV 16:
Negative
HPV 18:
Negative
Other HR HPV: Negative
HPV COMMENTS:
High Risk HPV detection was performed using the Roche cobas® HPV PCR methodology which tests for the presence of
HPV types 16,18, 31,33,35,39,45,51,52,56,58,59,66 and 68. A negative result does not preclude the presence of HPV
infection because results depend on adequate specimen collection, absence of inhibitors and sufficient DNA to be
detected.
The HPV assay has been cleared by the FDA for use with ThinPrep cervical/vaginal specimen only. Its analytic performance characteristics with SurePath has been
validated by Dahl-Chase Diagnostic Services. Any results of this test should be interpreted in the context of complete medical history and are not intended to be used as
the sole means for clinical diagnosis or patient management decisions.
Sample of Pap / HPV Requisition Form
Submit SurePath sample