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HPV DNA, High Risk
MessageSendout, Mayo test code: SHPV
Test Code
LAB5210706
Alias/See Also
High Risk HPV
HPV (Human Papillomavirus) PCR
Huamn Papillomavirus (HPV) Genotyping
SHPV
HPV (Human Papillomavirus) PCR
Huamn Papillomavirus (HPV) Genotyping
SHPV
CPT Codes
87624, G0476 (if appropriate)
Preferred Specimen
3 mL of SurePath™ specimen
Minimum Volume
1 mL of SurePath™ specimen
Instructions
1. Aliquot 3 mL SurePath specimen into Cobas PCR Media Tube w/Cap tube.
2. Bag specimens individually as they have a tendency to leak during transport.
3. Place labels on the vial and on the bag.
2. Bag specimens individually as they have a tendency to leak during transport.
3. Place labels on the vial and on the bag.
Transport Container
Cobas PCR Media Tube (T945)
Transport Temperature
Ambient
Specimen Stability
Ambient: 42 days
Refrigerated: 42 days
Refrigerated: 42 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
SurePath enriched cell pellet
Methodology
Real-Time Polymerase Chain Reaction (PCR)
FDA Status
Approve
Setup Schedule
Monday through Saturday
Report Available
3 to 6 days
Limitations
The cobas human papillomavirus (HPV) test is US Food and Drug Administration (FDA)-approved for cervical/endocervical samples collected in PreservCyt (ThinPrep) media. Other sample types (eg, vaginal) collected in media, such as SurePath, are not considered FDA-approved sources; however, verification studies have been completed in compliance with CLIA-regulations by Mayo Clinic Laboratories.
Prolonged storage (>42 days) of clinical samples in SurePath media may impact the detection of high-risk (HR) HPV, especially if the amount of nucleic acid present in the sample is initially at a low concentration. Therefore, samples should be submitted for testing as soon as possible following collection.
Cervical specimens often show visibly detectable levels of whole blood as a pink or light brown coloration. These specimens are processed normally on the cobas systems. If concentrations of whole blood exceed 10% (dark-red or brown coloration) in PreservCyt solution, there is a likelihood of obtaining a false-negative result.
The cobas HPV test performance has been validated with PreservCyt specimens that have been treated with up to 5% glacial acetic acid for removal of red blood cells. Addition of glacial acetic acid over 5% in PreservCyt specimens prior to HPV testing would invalidate the cobas HPV Test results.
Human beta-globin amplification and detection is included in cobas HPV to differentiate HPV negative specimens from those that do not exhibit HPV signal due to insufficient cell mass in the specimen. All HPV negative specimens must have a valid beta-globin signal within a pre-defined range to be identified as valid negatives.
The cobas HPV test detects DNA from high-risk genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. This test does not detect DNA of low-risk HPV types (eg, 6, 11, 42, 43, 44), which are not associated with invasive cervical cancer and its precursor lesions. Low-risk HPV types are associated with noninvasive genital warts and laryngeal papillomatosis.
Prevalence of HPV infection in a population may affect performance. Positive predictive values decrease when testing populations with low prevalence or individuals with no risk of infection.
Infection with HPV is not an indicator of cytologic high grade intraepithelial lesion (HSIL) or high-grade cervical intraepithelial neoplasia (CIN), nor does it indicate that a high-grade intraepithelial lesion (eg, HSIL or CIN2-3) or cancer will develop. Most women infected with 1 or more HR HPV types do not develop CIN2-3 or cancer.
A negative HR HPV result does not exclude the possibility of a patient developing a high-grade intraepithelial lesion (eg, HSIL or CIN2-3) or cancer in the future.
Prolonged storage (>42 days) of clinical samples in SurePath media may impact the detection of high-risk (HR) HPV, especially if the amount of nucleic acid present in the sample is initially at a low concentration. Therefore, samples should be submitted for testing as soon as possible following collection.
Cervical specimens often show visibly detectable levels of whole blood as a pink or light brown coloration. These specimens are processed normally on the cobas systems. If concentrations of whole blood exceed 10% (dark-red or brown coloration) in PreservCyt solution, there is a likelihood of obtaining a false-negative result.
The cobas HPV test performance has been validated with PreservCyt specimens that have been treated with up to 5% glacial acetic acid for removal of red blood cells. Addition of glacial acetic acid over 5% in PreservCyt specimens prior to HPV testing would invalidate the cobas HPV Test results.
Human beta-globin amplification and detection is included in cobas HPV to differentiate HPV negative specimens from those that do not exhibit HPV signal due to insufficient cell mass in the specimen. All HPV negative specimens must have a valid beta-globin signal within a pre-defined range to be identified as valid negatives.
The cobas HPV test detects DNA from high-risk genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. This test does not detect DNA of low-risk HPV types (eg, 6, 11, 42, 43, 44), which are not associated with invasive cervical cancer and its precursor lesions. Low-risk HPV types are associated with noninvasive genital warts and laryngeal papillomatosis.
Prevalence of HPV infection in a population may affect performance. Positive predictive values decrease when testing populations with low prevalence or individuals with no risk of infection.
Infection with HPV is not an indicator of cytologic high grade intraepithelial lesion (HSIL) or high-grade cervical intraepithelial neoplasia (CIN), nor does it indicate that a high-grade intraepithelial lesion (eg, HSIL or CIN2-3) or cancer will develop. Most women infected with 1 or more HR HPV types do not develop CIN2-3 or cancer.
A negative HR HPV result does not exclude the possibility of a patient developing a high-grade intraepithelial lesion (eg, HSIL or CIN2-3) or cancer in the future.
Reference Range
Included with report
Clinical Significance
Detection of high-risk (HR) genotypes associated with the development of cervical cancer
An aid in triaging women with abnormal Pap smear test results
Individual genotyping of human papillomavirus (HPV)-16 and/or HPV-18, if present
This testing is intended for use in clinical monitoring and management of patients. It is not intended for use in medical-legal applications.
An aid in triaging women with abnormal Pap smear test results
Individual genotyping of human papillomavirus (HPV)-16 and/or HPV-18, if present
This testing is intended for use in clinical monitoring and management of patients. It is not intended for use in medical-legal applications.
Performing Laboratory
Mayo Clinic Laboratories, Rochester, Minnesota
Additional Information
Human Papillomavirus (HPV) DNA Detection with Genotyping, High-Risk Types by PCR, SurePath, Varies
