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Test Code LABHPVSELFCOLLECT Human Papilloma Virus (HPV) Screen and Genotyping, Self Collect

Important Note

Vaginal specimen, generates HPVAV accession label

Infectious

Specimen and Container/Tube

Specimen Type: Self-collected vaginal specimens using FLOQSwab® or Evalyn® brush

Preferred Specimen: Thin Prep vials containing PreservCyt® Solution

Volume

Minimum Volume: 20 mL

Specimen Stability

Storage Temperature

Stability

(2 - 30°C)

6 months

Frozen

(-20°C)

Not acceptable

Collection Instructions

Instructions for Copan FLOQSwabs® for vaginal self-collection are displayed under the "Resources" heading in the sidebar.

 

Instructions for Rovers Evalyn® Brush Sample suspension are displayed under the "Resources" heading in the sidebar.

 

Specimen Collection: 

Vaginal: Wipe clean of vaginal secretions and mucus. Using a speculum with no lubricant, collect the sample. . Please use the PreservCyt ThinPrep Pap test vials for all HPV tests, even when a cytologic exam is not requested. This test can be performed on the same sample collected for liquid-based ThinPrep Pap test.
 

Specimen Transport: Immediate, no refrigeration.
 

 

Specimen Handling and Transport Instructions

UCMC Onsite Instructions: Collect specimen per standard collection procedure and send to laboratory immediately. 

 

UCMC Offsite and UC MedLab Outreach Instructions: Collect specimen per standard collection procedure and send to laboratory immediately. Transportation of HPV specimens must comply with country, federal, state and local regulations for the transport of etiologic agents.

Rejection Criteria

  • Common specimen rejected situations include: incorrect specimen type, insufficient volume, incorrect collection container, missing or incomplete specimen identifiers, incorrect specimen transport, or specimens outside stability limits. 
  • Frozen specimens will be rejected.
  • Specimens with preservatives or additives will be rejected.
  • Specimens not in a PreservCyt solution/container will be rejected

Turnaround Time

Turnaround times are relative to the time the specimen is received in the test laboratory. 

STAT Turnaround Time: TAT in hours/days

Routine Turnaround Time: TAT in hours/days

Testing Schedule: Monday - Friday

Clinical Indications

The cobas® HPV Test on the cobas® 4800 system is a qualitative in vitro diagnostic test for the detection of Human Papillomavirus in cervical specimens collected by a clinician using an endocervical brush/spatula and placed in the ThinPrep Pap Test PreservCyt®. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis. The test specifically identifies types HPV16 and HPV18 while concurrently detecting the rest of the high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68).

Methodology

Roche cobas® 4800 automated PCR

Test Components

The assay detects high-risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68 but does not discriminate among the types.

CPT Code

87626

LOINC Codes

#

Synonyms/Key Search Words

HPV, Self-Collect HPV, Human papillomavirus, Primary HPV, Reflex PAP, Gen-Probe Aptima

Last Reviewed Date

09/28/2026

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