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

2011933
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Negative
Positive
Ordering Recommendation

FDA-approved test for routine cervical cancer screening for women ≥25 years. Follow-up test for abnormal cytology results in women ≥21 years.

Mnemonic
SP HPV1618
Methodology

Qualitative Polymerase Chain Reaction

Performed

Mon, Wed, Fri

Reported

1-5 days

New York DOH Approval Status
This test is New York DOH approved.
Specimen Required
Patient Preparation
Collect

Cervical specimen with SurePath collection kit and place in SurePath media.

Specimen Preparation

Mix well. Transfer 3 mL to an ARUP Standard Transport Tube. (Min 1.5 mL)

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: 1 month; Refrigerated: 6 months; Frozen: Unacceptable

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.

This test is intended for medical purposes only and is not valid for the evaluation of suspected sexual abuse or for other forensic purposes. 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

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
05/18/2020
N/A
CPT Codes

87624

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Components
Component Test Code* Component Chart Name LOINC
0060752 HPV Source 31208-2
2011934 HPV Genotype 18 by PCR 77400-0
2011935 HPV Genotype 16 by PCR 77399-4
2011936 HPV, Other High Risk by PCR 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 16 18
  • HPV SurePath
  • HPV Typing
  • Human papilloma virus
Human Papillomavirus (HPV), High Risk with 16 and 18 Genotype by PCR, SurePath