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HPV High-Risk Screen with HPV Genotype Reflex

Human Papillomavirus, HPV, HPV DNA, high-risk HPV, HPV genotype 16, HPV genotype 18, HPV genotype 45, HPV high-risk other genotype, cervical cancer screening, ASCUS, co-testing
NOTE: This test is for HPV DNA detection in clinician-collected cervical specimens.

Test Codes

EPIC: LAB1231770, Beaker: HPVWREFLEX

Department

Molecular Pathology

Instructions

This test is for HPV DNA detection in clinician-collected cervical specimens in a healthcare setting.

For clinician-collected vaginal specimens, refer to HPV High-Risk Screen with HPV Genotype Reflex – Vaginal Source (LAB1231772)

For self-collected vaginal specimens, refer to Self-Collect HPV High-Risk Screen with HPV Genotype Reflex (LAB1231853)

NOTE: STI orders cannot be added on once specimen has reached the lab.

Specimen Collection Criteria

Collect: A clinician-collected cervical sample using an endocervical brush/spatula, followed by transport into ThinPrep^® PreservCyt® solution.

Acceptable Source: Clinician-collected cervical sample.

Collection Device: Endocervical brush/spatula.

Container: ThinPrep^® PreservCyt^® Solution.

Refer to the following instructions:
Specimen Collection Manual: Collecting ThinPrep^® Paps for CytologyLab Test | Corewell Health Laboratory.

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.
• Bloody or dark-brown specimens.
• Specimens received in Qiagen/Digene collection kits or specimen transport medium systems.
• Clinician-collected vaginal specimens. Refer to HPV High-Risk Screen with HPV Genotype Reflex – Vaginal Source (LAB1231772).
• Self-collected vaginal specimens. Refer to Self-Collect HPV High-Risk Screen with HPV Genotype Reflex (LAB1231853).

In-Lab Processing

Maintain cervical specimens at room temperature (20-26°C or 68-79°F).

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

Royal Oak Clinical 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 Alinity m HR HPV test on the Alinity m 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,  HPV genotype 45, HPV genotype 31/33/52/58, and HPV genotype 35/39/51/56/59/66/68.

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 Alinity m HR HPV assay is a qualitative, in vitro diagnostic test for the detection of human papillomavirus (HPV) DNA in cervical specimens collected by a health care professional using an endocervical collection brush/spatula placed in ThinPrep^® PreservCyt^® Solution.

This test identifies high-risk (HR) HPV types 16, 18, 45, while reporting the concurrent detection of the other HR genotypes (31/33/52/58) and (35/39/51/56/59/66/68). Alinity m HR HPV is indicated for use in routine cervical cancer screening as per professional medical guidelines, including triage of ASC-US cytology, co-testing (adjunctive screening) with cytology, and HPV primary screening of women to assess the risk for cervical pre-cancer and cancer. This test aids in the detection of high-risk HPV infection associated with the development or progression of invasive cervical carcinoma. 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

CPT code: 87626
Order LOINC: 82675-0

Component LOINC:
- HPV Probe/Screen:  59420-0
- HPV 16:  61372-9
- HPV 18:  61373-7
- HPV 45 = 95536-9
- HPV 31/33/52/58 = 104170-6
- HPV 35/39/51/56/59/66/68 = 106051-6

Contacts

Last Updated

6/3/2025