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Jun 12, 2017

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Human Papilloma (HPV), High Risk with Reflex to Genotyping if indicated

Human Papilloma (HPV), High Risk with Reflex to Genotyping if indicated (HCHPVDNA) Molecular Diagnostics Lab Test

Name: Human Papilloma (HPV), High Risk with Reflex to Genotyping if indicated

Test Name: Human Papilloma (HPV), High Risk with Reflex to Genotyping if indicated

Health Link Test Code: HCHPVDNA

LIS Test Code: HPVDNA

CPT Code(s): 87624

Methodology: Aptima

Clinical Information:

The Aptima HPV assay is an in vitro nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) from 14 high-risk  types of human papillomavirus (HPV) in cervical specimens. The high-risk types detected by the assay include: 16,18,31,33,35,39,45,51,52,56,58,59,66, and 68. The Aptima assay does not discriminate between the 14 high-risk types.

 

If HPV is requested with a Pap, it must only be ordered within the Pap order as a reflex test. Current ASCCP HPV triage recommendations are based on reflexing HPV off of the Pap result and patient's age. Our lab staff triage for HPV ordering based on your order request within the Pap order and the ASCCP criteria. See Pap and HPV Testing FAQ's.

 

An HPV add-on option is available in Health link for providers wishing to add HPV testing after Pap has been collected and resulted, within 3 weeks of the collect date.

 

HPV as normal or office collect status can be ordered when there is insufficient material for HPV testing after the Pap is resulted. Recollect specimen in Thin Prep vial; send to main lab with work station order. Do not reorder Pap.

Days Performed: Mon-Fri.

In-Lab Turnaround Time: 2 - 3 days.

Collection Container: ThinPrep PreservCyt Solution Vial 20 mL

Collection Instructions:

See instructions for Cytology, ThinPrep Pap Test.

Collection Volume: 20 mL

Stability Ambient:

18 weeks. Note: Specimens are retained only 3 weeks following cytology.

Testing Volume: 6 mL

Specimen Transport:

Place specimen inside a biohazard bag with the request form in the outside pocket of the bag. Transport specimen to Laboratory.

Unacceptable Criteria:

Failure to tighten the cap on the PreservCyt vial may cause loss of the specimen.

Interpretation:

Report provides interpretation.

Test Limitations:

A Not Detected result does not exclude the possibility of infection with a high risk HPV type.  Virus quantitation is not possible due to the nature of the specimen.

Additional Information:

A positive result (Detected) indicates the presence of one or more of the following high risk HPV types: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68.  This assay does not genotype the virus.  A negative result does not exclude the possibility of infection with a high risk HPV type.  False negative results may be due to low levels of HPV infected cells, inhibitory substances, inappropriate or inadequate sampling, or insufficient cellular material.  Inadequate specimen collection, processing and storage may invalidate test results. 

 

This test should not be used as the only criterion to form a clinical conclusion; instead, results should be correlated with other test results, patient symptoms and clinical presentation. 

 

This test is approved by the U.S. Food and Drug Administration.