Sign in →

Test Code DHPVR Human Papillomavirus (HPV) Type 16 with Type 18, 31, 33, and 35 Reflex, Droplet Digital PCR, Blood


Ordering Guidance


This test should be used as an initial pre-diagnostic screen to detect and quantify circulating cell free DNA from 5 high-risk human papillomavirus genotypes, including HPV-16, -18, -31, -33 & -35. This test is specific for HPV-16 which accounts for 90% of HPV associated head and neck squamous cell carcinomas. This test should be used as a pre-diagnostic screen without prior knowledge of HPV genotype. If the HPV genotype is known, specific tests for HPV-16 (DHPVA / Human Papillomavirus [HPV] Type 16, Droplet Digital PCR, Blood) or HPV-18, -31, -33 & -35 (DHPVB / Human Papillomavirus [HPV] Types 18, 31, 33, and 35, Droplet Digital PCR, Blood) should be ordered individually for monitoring purposes, as appropriate.

 

For routine cervical cancer screening, order VHPV / Human Papillomavirus (HPV) Vaginal Detection with Genotyping for High-Risk Types by PCR.



Specimen Required


Supplies: Streck Tan Top Tube Kit (T715)

Container/Tube: Streck Cell-Free DNA blood collection kit

Specimen Volume: Two 10-mL Streck Cell-Free DNA blood collection tubes

Additional Information: Only blood collected in Streck Cell-Free DNA tubes will be accepted.


Useful For

Aid in the diagnosis of cancers caused by human papillomavirus (HPV) high-risk genotypes 16, 18, 31, 33, and 35

 

Pre-diagnostic screening (ie, prior to confirmation of an HPV-related cancer through traditional biopsy)

 

This test should not be used to screen asymptomatic patients.

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
DHPVB HPV-18/31/33/35, cfDNA, ddPCR, B Yes No

Testing Algorithm

If testing is positive for the human papillomavirus (HPV)-16 genotype, no further testing is performed. If negative for HPV-16, reflex testing for the less frequently encountered HPV-18, -31, -33 and -35 genotypes is performed at an additional charge.

Method Name

Droplet Digital Polymerase Chain Reaction (ddPCR)

Reporting Name

High Risk HPV ddPCR, Reflex

Specimen Type

Whole blood

Specimen Minimum Volume

One 10 mL Streck Cell-Free DNA blood collection tube

Specimen Stability Information

Specimen Type Temperature Time
Whole blood Ambient (preferred) 7 days
  Refrigerated  7 days

Reject Due To

Specimen collected in tube other than Streck Cell-Free DNA collection tube Reject
  All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.

Reference Values

Not detected

Day(s) Performed

Varies

Report Available

5 to 10 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

87799

LOINC Code Information

Test ID Test Order Name Order LOINC Value
DHPVR High Risk HPV ddPCR, Reflex In Process

 

Result ID Test Result Name Result LOINC Value
623293 HPV-16 ddPCR Result w/ Reflex 61372-9
623294 HPV-16 ddPCR Quant w/ Reflex In Process