HPV mRNA E6/E7, Rectal with Reflex to Genotypes 16, 18/45
Use
This test detects the presence of HPV E6/E7 messenger RNA from high‑risk HPV types in anal‑rectal specimens; if positive, reflex testing for HPV genotypes 16 and 18/45 is performed, allowing identification of specific high‑risk strains. This offers improved specificity over DNA testing and supports more informed clinical management of anal‑rectal HPV infection. Quest’s Infectious Disease laboratory has validated anal‑rectal specimen use in PreservCyt® ThinPrep® vials, aligning with the Aptima® HPV mRNA testing method.
Special Instructions
Anal‑rectal samples must be collected using a Dacron or polyester swab placed into 3 mL PreservCyt® transport medium (ThinPrep® vial) or Aptima® specimen transfer tube. Clinicians should avoid cotton or wooden‑shaft swabs and specimens grossly contaminated with feces. Reflex to genotyping occurs only if initial E6/E7 mRNA is detected.
Limitations
Not all high‑risk HPV genotypes are individually identified—only types 16 and 18/45 are specifically genotyped upon reflex. The test may detect E6/E7 transcription from other high‑risk HPV types that are not distinguished. Reflex genotyping incurs additional CPT coding (87625) and cost. Performance was validated for anal‑rectal specimens in PreservCyt® medium only.
New York Approved
Methodology
Other
Biomarkers
LOINC Codes
- 74763-4
- 77396-0
Result Turnaround Time
Not provided.
Related Documents
For more information, please review the documents below
Specimen
Rectal Swab
Volume
Not provided
Minimum Volume
1.5 mL
Container
ThinPrep® vial with 3 mL PreservCyt® or Aptima® specimen transfer tube
Collection Instructions
Collect with Dacron/Polyester swab into 3 mL PreservCyt® or Aptima® transfer tube; avoid cotton/wood swab or fecal contamination.
Causes for Rejection
Cotton swab on a wooden stick; swabs grossly contaminated with feces.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 30 days |
| Refrigerated | 30 days |
| Frozen | Undetermined |