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    cobas® HPV Test

    Risk matters. Deliver 3 results in 1 test for accuracy that your clinical partners expect and that patients deserve      

The cobas® HPV Test offers testing flexibility in the lab workflow.

Choose from two test result options with the cobas® HPV Test. 

The cobas® HPV Test is the only IVD high-risk HPV test with the flexibility to offer two test options, all in one run, from one patient sample:

  • Detection of 12 high-risk genotypes in a pooled result with simultaneous reporting of HPV 16 & HPV 18 
  • Detection of 14 high-risk genotypes as a pooled result 


Use the cobas® HPV Test pre-cytology or post-cytology.

 

The cobas® HPV Test also has the flexibility to be used either pre-cytology or post-cytology. It is the only HPV test that offers the primary vial post-cytology testing for both the ThinPrep®, 1 T2000 and T3000 processors. In addition, it is the only molecular test that has been FDA-approved for use after T3000 processing.

Labs can directly load primary vials onto the cobas® 4800 System post-cytology to process the cobas® HPV Test, eliminating the need for alliquoting a patient’s sample into a secondary vial.  

The removal of a secondary vial reduces costs and biohazardous waste, in addition to saving the time and effort used to label the tube and aliquot the sample. As a result, the primary vial method decreases repetitive motions in the lab that may lead to fatigue and human error.  

Primary Vial Post-Cytology Testing

Labs can use the same ThinPrep Pap Test vial post-cytology for direct loading into the cobas® 4800 System for high-risk HPV testing.


Choose the test that has proven reliability and performance.

The cobas® HPV Test performs reliably and consistently on primary vial specimens, regardless if cytology has been previously performed, providing confidence in the results. 

 

During clinical testing, the overall percentage agreement (OPA) in the entire population seen in samples that were tested from both a secondary vial (pre-cytology) and a primary vial was 98.8% when using the T2000 and 97.7% for the T3000 system.2

 

In addition, cytology processing using the T2000 or the T3000 system showed no evidence of cross-contamination when using the primary vial post-cytology method.2  


Based on these results, the primary vial post-cytology testing option offers the lab flexibility in its workflow, while still providing accurate patient reportables.

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T2000 PPA NPA OPA
ASC-US 99.5 96.3 96.0
NILM 86.2 99.8 98.0
Combined 92.2 99.6 98.8
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T3000  
ASC-US 95.6 91.5 93.5
NILM 84.2 99.1 98.1
Combined 85.8 99.1 97.7

Reduce pipetting time and labor.

 

The primary vial post-cytology method decreases repetitive motions in the lab, such as pipetting, that may lead to fatigue and human error.  

With the primary vial post-cytology method, labs will benefit from:

  • Decreased processing time and labor  
  • Decreased aliquoting and labeling 
  • Decreased repetitive motions that lead to fatigue 
  • Decreased risk of errors due to fatigue 
  • Decreased biohazardous waste production

LAB INSIGHTS

"Any time you skip a step in a laboratory you improve efficiency; you decrease potential for mistakes; and you basically streamline your process."

Dr. Mirna Z. Knight

Mirna Z. Knight, DO, PhD

Director of Molecular Pathology, Metropolitan Pathologists PC

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  • Acronyms:

References:

1. ThinPrep is a registered trademark of Hologic, Inc. Copyright 2012. All rights reserved.

2. Rao A, Young S, Krevolin M, Sun R, Purner MB, Sharma A, Behrens CM. 2012 Cancer Cytopathol. Jun 20. Vol120(3).