RE: [Histonet] HPV Final Report Using Ventana

From:"Zummak Melissa"

I have been using this method for about 3 years now and our reports read
for diagnosis: The result for HPV testing by in-situ hybridization for
this patient was (either "detected",or "not detected", or we also use
"determined equivocal").

The CAP checklist has some suggestions for the disclaimer, we use "This
test was developed and its performance characteristics determined by
(your lab name).  It has not been cleared or approved by the U.S. FDA.
The FDA has determined that such clearance or approval is not necessary.
This test is used for clinical purposes.  It should not be regarded as
investigational or for research.  This laboratory is regulated under
CLIA 88 as qualified to perform high complexity clinical testing.

Melissa Zummak 

-----Original Message-----
[] On Behalf Of Shirley
Sent: Tuesday, January 30, 2007 12:52 PM
Subject: [Histonet] HPV Final Report Using Ventana

Hello All,
  I was wondering if anyone knew what kind of diagnosis wording would
work best for reporting HPV results from the Ventana system?  The
Ventana guys also mentioned a disclaimer that should be included on the
final report due to its status as an ASR.  Any help would be greatly
  Tom Ward M.S. CT(ASCP)
  Harrisonburg Cytology Services
  (540) 289-7558

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