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 high-risk HPV detection in individuals 25 years of age or older with a cervix. FDA-approved test for routine cervical cancer screening in combination with cervical cytology (Pap smear) in individuals 30 years of age or older with a cervix. Follow-up test for abnormal cytology results in individuals 21 years of age or older with a cervix.

If a cervical specimen cannot be obtained by a healthcare provider, a patient-collected vaginal specimen collected using the vaginal self-collect kit is acceptable. For primary HPV testing with reflex to cytology, refer to HPV Primary Screen by PCR With Reflex to Cytology (3016636).

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation
Collect

Provider-collected cervical or anal specimen with broom, brush or spatula from ThinPrep collection kit. (ARUP supply #41785 ThinPrep (Vial and Broom) or #51369 ThinPrep (Vial, Brush and Spatula).

Patient-collected vaginal specimen, obtained in a healthcare setting, using the FLOQSwab in Vaginal Self-Collect Kit (ARUP supply # 64594).
Collection supplies available online through eSupply using ARUP Connect™ or contact ARUP Client Services at 800-522-2787.

Specimen Preparation

Cervical or anal specimen with brush or spatula from ThinPrep kit: Swirl the collection device vigorously in the PreservCyt Media.

Patient-collected vaginal swab: Release cells from FLOQswab by fully immersing in Preservcyt media and swirl along the inner vial wall for at least 20 seconds. Draw swab up, draining all fluid from swab into container. Discard swab.

Storage/Transport Temperature

Refrigerated.

Unacceptable Conditions

Bloody or dark brown specimens. Dry swab or specimens in any media other than ThinPrep Preservecyt.

Remarks

Specimen source required.

Stability

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

Methodology

Qualitative Polymerase Chain Reaction (PCR)

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

Depends on Specimen/Source/Method

Note

Hotline History

View Hotline History

 

Hotline History

Date of Change
Test Name Change
Methodology
Performance/Reported Schedule
Specimen Requirements
Reference Interval
Interpretive Data
Note
CPT Code
Component Change
Other Interface Change
New Test
Inactive
04/21/2025
X
X
X
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

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