HPV Assay Test

Human Papillomavirus (HPV), High Risk with 16 and 18 Genotype by Liquid-Based Pap Test and Hologic Thin Prep

Ordering Recommendation

This FDA-approved test and platform is designed for primary HPV screening in individuals aged 25 and older with a cervix. It is also FDA-approved for routine cervical cancer screening in combination with cervical cytology (Pap smear) for those aged 30 and older. Additionally, it serves as a follow-up test for abnormal cytology results in individuals aged 21 and older.

Mnemonic

Methodology

Qualitative Polymerase Chain Reaction

Performed

Mon-Sat

Reported

Within 1-5 days

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 a Standard Transport Tube. (Min 1.5 mL). For primary screening purposes, please submit a specimen aliquot and keep 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

Reference Interval

Negative

Interpretive Data

This test detects the DNA of HPV16, HPV18, and 12 other high-risk HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are linked to cervical cancer and its precursor lesions. The accuracy of the results may be influenced by specimen collection methods, the infection stage, and the presence of interfering substances. It's crucial to interpret these results alongside other laboratory and clinical data. A negative high-risk HPV result does not rule out the presence of other high-risk HPV types, potential future cytologic abnormalities, underlying CIN2-3, or cancer.

HPV testing is not recommended for the screening or management of atypical squamous cells of undetermined significance (ASCUS) in women under 21 years of age.

Human Papillomavirus (HPV), High Risk with 16 and 18 Genotype by Liquid-Based Pap Test and Hologic Thin Prep

Ordering Recommendation

Mnemonic

Methodology

Qualitative Polymerase Chain Reaction

Performed

Mon-Sat

Reported

Within 1-5 days

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 a Standard Transport Tube. (Min 1.5 mL). For primary screening purposes, please submit a specimen aliquot and keep 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

Reference Interval

Negative

Interpretive Data

Note

CPT Code

87624

Components

Component Chart Name

Component Test Code

LOINC

HPV Source

0060752

31208-2

2011935

HPV Genotype 16 by PCR

77399-4

2011936

2011941

HPV, Other High Risk by PCR

82675-0

HPV Genotype 18 by PCR

77400-0

Aliases