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HPV DNA Test

Human Papillomavirus, HPV, HPV DNA, high risk, genotype 16, genotype 18, cervical cancer screening, ASCUS, co-testing

Test Codes

EPIC: LAB6847, SOFT: HPVO/HPHHR

Department

Molecular Pathology

Specimen Collection Criteria

Collect:

ThinPrep^® PreservCyt® vial: Cervical Swab or brush.

Physician Office/Draw Specimen Preparation

Maintain specimens in PreservCyt^® solution, refrigerated (2-8°C or 36-46°F) or at room temperature (20-26°C or 68-78.8°F).

Preparation for Courier Transport

Transport: PreservCyt^® vial, at room temperature (20-26°C or 68-78.8°F) or refrigerated (2-8°C or 36-46°F).

Rejection Criteria

• Unlabeled specimens.
• Specimens received in Qiagen/Digene collection kits or specimen transport medium systems.

In-Lab Processing

Maintain cervical specimens refrigerated (2-8°C or 36-46°F) until testing.

Storage

Specimen Stability for Testing:

Room Temperature (20-26°C or 68-78.8°F): 6 weeks
Refrigerated (2-8°C or 36-46°F): 6 weeks
Frozen (-20°C/-4°F or below): Unacceptable

Specimen Storage in Department Prior to Disposal:

Room Temperature (20-26°C or 68-78.8°F): 6 weeks

Laboratory

Dearborn Clinical Molecular Pathology Laboratory
Royal Oak Clinical Molecular Pathology Laboratory

Performed

Monday – Friday.
Results available within 1-3 business days. 

Reference Range

Negative.

Test Methodology

Nucleic Acid Amplification (FDA Approved). Roche Cobas^® HPV Test.

Interpretation

Qualitative detection of fourteen high-risk HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) associated with the development or progression of invasive cervical carcinoma. This test provides genotype-specific reporting at no additional cost as follows: HPV genotype 16, HPV genotype 18 and Other HPV High Risk.

This test includes an internal control (human β-globin) to ensure adequate specimen cellularity. Samples lacking detectable internal control will be reported inadequate. A negative result does not exclude the possibility of HPV infection. Very low levels of infection may cause a false-negative result. Bloody specimens may give false-negative results. 

Clinical Utility

This test aids in the detection of high risk HPV infection associated with the development or progression of invasive cervical carcinoma. It serves as an adjunct to the Pap smear in the identification of women who may be at increased risk for cervical intraepithelial neoplasia. Genotype-specific reporting of HPV types 16 and 18 also aid in the appropriate management of patients who may need referral to coloscopy.

CPT Codes

87624
LOINC: HPV Genotype 16  61372-9, HPV Genotype 18  61373-7 

Contacts

Last Updated

12/7/2021