Medical Necessity Documentation:
Client Notes:
Patient Preparation:
Specimen Requirements:
5 mL Liquid Cytology (PreservCyt®) Preservative (ThinPrep®) collected in an APTIMA® transport tube
Collection Instructions:
Labs performing cytology: Aliquot PreservCyt® solution before or after performance of liquid based cytology testing.
PreservCyt®: Transfer 1 mL of PreservCyt® solution into APTIMA® Vaginal Collection tube (orange label) or APTIMA® Specimen Transfer tube (green label). Ship to lab.
Minimum Volume:
1.0 mL Liquid Cytology
Transport & Storage: Temperature/Stability:
30 days Ambient (transport)
90 days Refrigerated
Rejection Criteria:
Cervical swabs in Digene® HC Cervical Sampler • Digene® vials • Vaginal swabs • SurePath® vials • Received frozen
Reference Range:
| HPV mRNA E6/E7 |
Not detected |
Critical Ranges:
Test Comments:
This test was performed using the APTIMA® HPV Assay (Gen-Probe Inc.).
This assay detects E6/E7 viral messenger RNA (mRNA) from 14 high-risk HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68).
If HPV mRNA E6/E7 is detected, HPV Genotypes 16, 18/45 will be performed at an additional charge (CPT Code(s): 87625).
Methodology:
Transcription-Mediated Amplification (TMA)
Clinical Significance:
The presence of E6/E7 messenger RNA from 14 high risk HPV types indicates incorporation of HPV DNA into the host cells. Proteins expressed from E6/E7 polycistronic mRNA alter cellular p53 and retinoblastoma protein functions, leading to disruption of cell-cycle check points and cell genome instability. This information, together with the physician's assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. This assay detects E6/E7 viral messenger RNA (mRNA) from 14 high-risk HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68).
Documentation:
Custom Panel:
No
PRODUCTION SCHEDULE
Turn Around Time:
2 to 3 days
Days Performed:
Monday, Wednesday, Friday
Sites Performed:
Quest - Chantilly
PHL Test Code:
HPVRE
EPIC Test Code:
LAB2952
Send Out Test Code:
90942
Alternate Test Names:
E6/E7; Hologic; TMA w/ Reflex
Included Tests:
CPT Coding:
87624