| HPV REPORTING EXAMPLES: |
| Example 1: |
HPV RESULTS: POSITIVE FOR HIGH RISK HPV |
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Type will be listed here |
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Note: The analytical and performance characteristics of this laboratory-developed test (LDT) were determined by Physicians Laboratory pursuant to Clinical Laboratory Improvement Amendments (CLIA 88) requirements. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not a requirement prior to use for clinical purposes.
Gel interpretation was performed by Access Genetics.
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| HPV Reporting Change |
As Physicians Laboratory transitions its methodologies to FDA approved technologies for determining HPV, we are reclassifying several HPV types as 'low risk' that we formerly reported as 'high risk'. Additional reclassification will come with the new methodology. All HPV types formerly classified as 'unknown risk' are reclassified as 'low risk'; types 53, 81, 82, 83, and 62 are reclassified as 'low risk' effective 1 May 2010.
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| Use of Lubricants during Pap testing |
The use of lubricant during Pap test collection can increase the risk of contaminating or obscuring the cellular sample with both conventional Pap smears and all liquid based methods, including ThinPreps. Because of this, Physicians Laboratory strongly recommends that likewarm water be used to lubricate and warm the speculum. Lubricant can cause difficulties with cell adherance on the slide as well as obscure cellular detail. |
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