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Self-Collect HPV High-Risk Screen with HPV Genotype Reflex

Human Papillomavirus, HPV, HPV DNA, high-risk, genotype 16, genotype 18, high-risk other genotype, HPV Self Collect, Vaginal Collection
NOTE: This test is for HPV DNA detection in patient-collected vaginal specimens in a healthcare setting only. STI and PAP co-testing is unavailable for these specimens.

Test Codes

EPIC:  LAB1231853, Beaker: HPVHR

Department

Molecular Pathology

Instructions

This test is for HPV DNA detection in patient-collected vaginal specimens in a healthcare setting. 

For Clinician-collected cervical specimens, refer to HPV High Risk Screen with HPV Genotype Relex LAB1231770

For Clinicial-collected vaginal specimens, refer to HPV High Risk Screen with HPV Genotype Reflex-Vaginal Source LAB1231772

NOTE: STI testing and PAP Test cannot be ordered on self-collected specimens.

Specimen Collection Criteria

Collect: A patient-collected vaginal sample using a Rovers^® Evalyn^® Brush, followed by transport into ThinPrep^® PreservCyt^® solution by a healthcare staff member.

Patient’s must a Rovers^® Evalyn^® Brush in a healthcare setting to self-collect a vaginal specimen following the Evalyn Brush collection instructions (Evalyn Brush Self-Collection Instructions). A trained healthcare staff member must immediately suspend the Evalyn Brush into a vial of ThinPrep^® PreservCyt^® solution following transport instructions (HPV Self-Collect Transport Instructions). The ThinPrep^® PreservCyt^® vial must then be transported to the lab at 2 to 30°C.

Physician Office/Draw Specimen Preparation

Maintain specimens in ThinPrep^® 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: ThinPrep^® 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.
• Patient-collected specimens that are collected outside of a healthcare setting.
• Receipt of Rovers^® Evalyn^® Brush instead of the ThinPrep^® PreservCyt^® vial.
• Clinician-collected cervical specimens  (refer to HPV High Risk Screen with HPV Genotype Relex LAB1231770).
• Clinician-collected vaginal specimens (refer to HPV High Risk Screen with HPV Genotype Reflex-Vaginal Source LAB1231772).

In-Lab Processing

Maintain specimens at room temperature (20-26°C or 68-78.8°F). 

Storage

Specimen Stability for Testing:

Room Temperature (20-26°C or 68-78.8°F): 6 months
Refrigerated (2-8°C or 36-46°F): 6 months
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

Royal Oak Molecular Pathology Laboratory

Performed

Monday – Friday
Results available within 7-10 business days.

Reference Range

Not detected.

Test Methodology

Nucleic acid amplification and detection using the FDA-approved Roche cobas^® HPV test on the Roche cobas^® 4800 system.

Interpretation

A positive result indicates the presence of one or more of the following 14 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 as follows: HPV genotype 16, HPV genotype 18 , and HPV genotype HR Other.

This test includes an internal control (human β-globin) to ensure adequate specimen cellularity. Samples lacking detectable internal control will be reported as “INVALID” and a new sample should be collected, if testing is clinically indicated. 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

The cobas® HPV Test is a qualitative in vitro test for the detection of high-risk human papillomavirus. This test detects the high-risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 in cervical and vaginal specimens.

The cobas® HPV Test is indicated for use for routine cervical cancer screening as per professional medical guidelines, including triage of ASC-US cytology, co-testing (or adjunctive screen) with cytology, and HPV primary screening of individuals with a cervix to assess the risk for cervical precancer and cancer. Persistent infection with HR HPV is the principal cause of cervical cancer and its precursor cervical intraepithelial neoplasia (CIN). Although persistent infection with high-risk (HR) HPV is a necessary cause of cervical cancer and its precursor lesions, a very small percentage of infections progress to these disease states. Sexually transmitted infection with HPV is extremely common, with estimates of up to 75% of all women experiencing exposure to HPV at some point9. However, almost all of infected women will mount an effective immune response and clear the infection within 2 years without any long-term health consequences. An infection with any HPV type can produce cervical intraepithelial neoplasia (CIN) although this also usually resolves once the HPV infection has been cleared. Patients should be followed-up in accordance with professional medical guidelines, results from prior screening, medical history, and other risk factors.

The use of this test has not been evaluated for the management of women with prior ablative or excisional therapy, or who are pregnant.

The cobas^® HPV Test is NOT intended:

• For use in determining the need for treatment (i.e., excisional or ablative treatment of the cervix) in the absence of high-grade cervical dysplasia. Patients who are HPV16/18 positive should be monitored carefully for the development of high-grade cervical dysplasia according to current practice guidelines.
• For women who have undergone hysterectomy.
• For use with samples other than those collected by a clinician using an endocervical brush/spatula or a cervical broom and placed in the ThinPrep Pap Test PreservCyt^® Solution.
• For use with samples other than those collected by a clinician using a cervical broom and placed in the SurePath™ Preservative Fluid.
• For use with self-collected vaginal samples other than those collected with collection devices specifically FDA-approved or cleared for use with the cobas^® HPV. 

CPT Codes

CPT code: 87626
Order LOINC: 71432-9

Component LOINC:
- HPV 16:  61372-9
- HPV 18:  61373-7
- HPV Other:  71431-1

Contacts

Last Updated

6/3/2025