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HPV Genotypes 16, 18
Test CodeLab3016
Alias/See Also
Human Papilloma Virus (HPV)
CPT Codes
87624
Preferred Specimen
Cervical specimen in ThinPrep Pap test PreservCyt Solution. (Use endocervical brush/spatula or PAPETTE (broom))
Minimum Volume
1 mL
Transport Container
ThinPap Vial
Transport Temperature
Ambient
Specimen Stability
Ambient – 3 months
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Inadequate volume
Vaginal swab
Specimen received frozen
Specimen in other collection device will be forwarded to reference laboratory
Vaginal swab
Specimen received frozen
Specimen in other collection device will be forwarded to reference laboratory
Methodology
Cobas® HPV test, by RT-PCR (Real-Time PCR)
Setup Schedule
Tuesday and Thursday
Reference Range
Not detected
Clinical Significance
This test is for the detection of Human Papilloma Virus (HPV) in patient specimens.
The test is indicated:
• To screen patients 21 years and older with ASC-US (Atypical squamous cells of undetermined significance) cervical cytology test results to determine the need for referral to colposcopy.
• For use in patients 21 years or older with ASC-US cervical cytology results, to assess the presence or absence of high-risk HPV genotypes 16 and 18 as well as 12 other high-risk genotypes. These results together with a physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent woman from proceeding to colposcopy.
The test is indicated:
• To screen patients 21 years and older with ASC-US (Atypical squamous cells of undetermined significance) cervical cytology test results to determine the need for referral to colposcopy.
• For use in patients 21 years or older with ASC-US cervical cytology results, to assess the presence or absence of high-risk HPV genotypes 16 and 18 as well as 12 other high-risk genotypes. These results together with a physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent woman from proceeding to colposcopy.
Performing Laboratory
Meritus Molecular Diagnostics – Microbiology
