HPV mRNA E6/E7 with Reflex to HPV Genotypes 16, 18/45
Also known as: Hologic, E6/E7, TMA with Reflex
Use
The Aptima HPV mRNA test detects E6/E7 mRNA transcripts from 14 high-risk HPV genotypes, providing higher specificity to reduce false-positive results and unnecessary invasive procedures such as colposcopy or biopsy. The E6/E7 oncoprotein transcripts are associated with elevated risk of cervical intraepithelial neoplasia and cervical cancer, and reflex genotyping for HPV types 16, 18/45 enables further risk stratification for the most carcinogenic subtypes.
Special Instructions
Specimens should be collected as liquid cytology (ThinPrep® PreservCyt®) using APTIMA® vaginal or multitest collection kits (orange label) or APTIMA® transfer tubes (green label). Aliquoting from PreservCyt® vial may be done either before or after cytology testing. Transport at room temperature; ship per instructions.
Limitations
Frozen specimens are unacceptable. The assay has not been evaluated in certain populations including HPV‑vaccinated women, pregnant women, post‑hysterectomy patients (unless specific validated test code), or those with prior ablative or excisional therapies. Regular cervical cytology remains necessary; this test does not replace routine screening.
New York Approved
Methodology
Other
Biomarkers
LOINC Codes
- 69002-4
- 77399-4
- 75694-0
Result Turnaround Time
Not provided.
Related Documents
For more information, please review the documents below
Specimen
Other
Volume
5 mL
Minimum Volume
1 mL
Container
APTIMA® vaginal collection kit or multitest collection kit (orange label), or APTIMA® specimen transfer tube (green label)
Collection Instructions
Aliquot PreservCyt® solution before or after cytology testing; transfer 1 mL of PreservCyt® solution into APTIMA® tube; ship to lab.
Causes for Rejection
Frozen specimens; cervical swabs in Digene® HC cervical sampler; Digene® vials; SurePath™ vials; swabs
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 30 days |
| Refrigerated | 90 days |
| Frozen | Unacceptable |