2011940
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Human Papillomavirus (HPV), High Risk with 16 and 18 Genotype by PCR, ThinPrep

TP HPV1618
Example Reports
Negative
Positive

Ordering Recommendation

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.

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation
Collect

Cervical, anal, or vaginal specimen with brush or spatula from ThinPrep kit and place in PreservCyt Media

Specimen Preparation

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.

Storage/Transport Temperature

Refrigerated.

Unacceptable Conditions

Bloody or dark brown specimens. Specimens in any media other than indicated above.

Remarks

Specimen source required.

Stability

Ambient: 6 months; Refrigerated: 6 months; Frozen: Unacceptable

Methodology

Qualitative Polymerase Chain Reaction

Performed

Tue-Sat

Reported

1-5 days

Reference Interval

Negative

Interpretive Data

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.

Compliance Category

FDA

Note

Hotline History

N/A

CPT Codes

87626

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Components

Component Test Code* Component Chart Name LOINC
0060752 HPV Source 31208-2
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
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

  • Human papilloma virus
  • HPV High Risk
  • HPV HR ThinPrep
  • HPV Primary screening
Human Papillomavirus (HPV), High Risk with 16 and 18 Genotype by PCR, ThinPrep