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Jun 12, 2017

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Clinical Hub,Tools & Resources,UWHC Lab Test Directory,Molecular Diagnostics

Human Papilloma (HPV) Genotyping

Human Papilloma (HPV) Genotyping (HCHPVGEN) Molecular Diagnostics Lab Test

Name: Human Papilloma (HPV) Genotyping

Test Name: Human Papilloma (HPV) Genotyping

Health Link Test Code: HCHPVGEN

LIS Test Code: HPVGEN

CPT Code(s): 87625

Methodology: Aptima

Clinical Information:

The Aptima HPV 16 18/45 genotype assay is an in vitro nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) of human papillomavirus (HPV) types 16,18 and 45 in cervical specimens. The Aptima HPV 16 18/45 genotype assay can differentiate HPV 16 from HPV 18 and/or HPV 45, but does not differentiate between HPV 18 and HPV 45.

 

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

Days Performed: Once a week.

In-Lab Turnaround Time: 10 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 initial High Risk HPV testing.

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 HPV 16, 18 or 45, or any other high risk HPV type (31,33,35,39,51,52,56,58,59,66,68).  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. 

 

Virus quantitation is not possible due to the nature of the specimen.

Additional Information:

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.