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Test Code LABHPVRFLX Human Papilloma Virus (HPV) Screen and Genotyping w/ Reflex to Thin Prep PAP Test

Important Note

Endocervical specimen, generates HPVA accession label

Vaginal specimen, generates HPVAV accession label

Infectious

Specimen and Container/Tube

Specimen Type: Endocervical, vaginal

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: 

Endocervical:

  1. Prepare the speculum
  2. For patients without physical or psychological need for lubricant, use lukewarm water to warm and lubricate the speculum
    • Water lubrication has the fewest risks to the quality of the PAP sample collected.
  3. When necessary, sparingly apply carbomer-free lubricant on the exterior of the speculum blades.
  4. If lubricant is necessary due to patient discomfort or the use of a plastic speculum, sparingly apply a thin film of carbomer-free lubricant on the speculum’s surface, avoiding the tip. Do not use an excessive amount of lubricant jelly to lubricate the speculum.
  5. Remove excess mucus or other discharge present before taking the sample. This should be gently removed with ring forceps holding a folded gauze pad.
    • The excess cervical mucus is essentially devoid of meaningful cellular material and when present in the sample vial, may yield a slide with little or no diagnostic material present.
  6. Remove inflammatory exudate from the cervical canal before taking the sample. Remove by placing a dry 2-by-2-inch piece of gauze over the cervix and peeling it away after it absorbs the exudate or by using a dry procto swab or scopette swab.
    • The excess inflammatory exudate is essentially devoid of diagnostic cellular material and, when present in the sample vial, may yield a slide with little or no diagnostic material present
  7. The cervix should not be cleaned by washing with saline or it may result in a relatively acellular specimen.
  8. The sample should be obtained before the application of acetic acid.

 

Specimen Transport: Immediate

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.

Reference Values

Negative

Critical Values

NA

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

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

 

CPT Codes

87626

LOINC Codes

#

Test Components

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).

Synonyms/Search Keywords

HPV, Human papillomavirus, Primary HPV, Reflex PAP, PAP smear

Last Reviewed Date

09/28/2026