FDA-approved test and platform for primary HPV screening in individuals ≥25 years of age with a cervix. FDA-approved test for routine cervical cancer screening in combination with cervical cytology (Pap smear) in individuals ≥30 years of age with a cervix. Follow-up test for abnormal cytology results in individuals ≥21 years of age with a cervix.
Qualitative Polymerase Chain Reaction
New York DOH Approval Status
Cervical, anal, or vaginal specimen with brush or spatula from ThinPrep kit and place in PreservCyt Media
Mix well. Transfer 3 mL to an ARUP Standard Transport Tube. (Min 1.5 mL). If test is being used for primary screening, submit specimen aliquot and retain the original specimen at the client site.
Bloody or dark brown specimens. Specimens in any media other than indicated above.
Specimen source required.
Ambient: 6 months; Refrigerated: 6 months; Frozen: Unacceptable
This test amplifies DNA of HPV16, HPV18 and 12 other high-risk HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) associated with cervical cancer and its precursor lesions. Sensitivity may be affected by specimen collection methods, stage of infection, and the presence of interfering substances. Results should be interpreted in conjunction with other available laboratory and clinical data. A negative high-risk HPV result does not exclude the presence of other high-risk HPV types, the possibility of future cytologic abnormalities, underlying CIN2-3, or cancer.
HPV testing should not be used for screening or management of atypical squamous cells of undetermined significance (ASCUS) in women under age 21.
|Component Test Code*||Component Chart Name||LOINC|
|2011935||HPV Genotype 16 by PCR||77399-4|
|2011936||HPV, Other High Risk by PCR||82675-0|
|2011941||HPV Genotype 18 by PCR||77400-0|
- HPV High Risk
- HPV HR ThinPrep
- HPV Primary screening
- Human papilloma virus