3016636
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HPV Primary Screen by PCR With Reflex to Cytology

HPV PRMRY
Example Reports
Negative
Positive

Ordering Recommendation

FDA-approved test for routine cervical cancer screening in individuals 25 years and older with a cervix.

New York DOH Approval Status

This test is not New York state approved. Alternative testing that is New York approved is available. See Ordering Recommendations.

Specimen Required

Patient Preparation
Collect

Cervical or endocervical specimen with brush or spatula from ThinPrep kit collection kit.
(ARUP supply #41785 ThinPrep (Vial and Broom) or #51369 ThinPrep (Vial, Brush and Spatula)) available online through eSupply using ARUP Connect or contact ARUP Client Services at 800-522-2787.

Specimen Preparation

Place collection device in corresponding ThinPrep media vial.

Storage/Transport Temperature

Refrigerated

Unacceptable Conditions

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

Remarks
Stability

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

Methodology

Qualitative Polymerase Chain Reaction (PCR)

Performed

Tue-Sat

Reported

Within 24 hours
If reflexed, add 1-7 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

For cervical sources, a negative high-risk HPV result does not exclude the possibility of future cytologic abnormalities, underlying CIN2-3, or cancer.

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
08/19/2024
X
X
02/20/2024
X
N/A

CPT Codes

87626; if reflexed, add 88142; if reviewed by pathologist, add 88141

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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
3016637 HPV Genotype 18 by PCR 77400-0
3016638 HPV Media
3016759 HPV Other High Risk by PCR Primary Scrn 82675-0
* 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 ThinPrep
  • HPV High Risk
  • HPV HR with Cytology
  • HPV Primary Screening
  • HPV Typing
  • HPV 16 18
  • Human papilloma virus
HPV Primary Screen by PCR With Reflex to Cytology