Human Papillomavirus Screen and Typing Non-Cervical
| Sunquest Code: | HPVMD | ||
| Epic Code: | LAB4618 | Epic Name: | HPV Screen with Reflex to Genotype |
| Sunquest Code (non-Epic sites): | MD | ||
| Synonyms: | Molecular; Human Papillomavirus Screen, Cervical Cancer; HPV Screen | ||
| Methodology: | Amplification of DNA, restriction endonuclease digest of PCR product for HPV typing | ||
| Test Includes: | Screening for presence of human papillomavirus virus and typing of all positives. | ||
| Turnaround Time: | Performed Mon-Fri; results are reported within 10 days. | ||
| Special Instructions: | Anal pap smears can be automatically reflexed for this testing by indicating on request form. | ||
| Compliance: | This test was developed and its performance determined by the University of Minnesota Medical Center Molecular Diagnostic Laboratory. 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 necessary. Pursuant to the requirements of CLIA '88, this laboratory has established and verified the test's accuracy and precision. This test is used for clinical purposes. |
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Collection Instructions
| Specimen: | Tissue, fixed tissue, anal pap samples |
| Optimal Volume: | 5 mm x 5 mm x 5 mm fresh tissue; 1 block paraffin embedded tissue (sufficient for 60-100 ten micron sections); anal pap smear collection brushes |
| Minimum\Peds Volume: | 3 mm x 3 mm x 3 mm fresh tissue |
| Container: | See Collection Instructions |
| Collection Instructions: | Fresh tissue and cytobrushes should be delivered to laboratory within 1 hour or placed in RPMI and transported same day at 4° C, or frozen at -70° C (liquid nitrogen or dry ice). Paraffin embedded tissue is also acceptable; indicate fixative used. |
| Causes for Rejection: | Necrotic tissue |
Processing and Shipping
| Specimen Processing: | Fresh tissue should be frozen on dry ice within 1 hour of collection. Store fixed tissue at room temperature. |
| Shipping Instructions: | Ship specimens Mon-Fri to arrive by 1400 on Fri. Ship frozen tissue on dry ice. Paraffin embedded tissue may be shipped at room temperature. |
| Stability: | After hours and weekends, store frozen tissue at -70C (on dry ice); store embedded tissue at room temperature. Store SurePath vials at room temperature. |
| Test Performed at or Referral Lab | Molecular Diagnostics (UMMC-East Bank) |
Interpretive
| Reference Range: | Results are reported as "negative for HPV DNA" or if positive results are "positive for high risk". The specific HPV type(s) is reported for all types. |
| Use: | Diagnose the presence and type of human papilloma virus in tissues. The common use of this test is in the characterization of cellular atypia in samples from the skin, ororespiratory and anogenital tract. |
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