Intended Use
The Xpert HPV test is a qualitative in vitro test for the detection of the E6/E7 region of the viral DNA genome from high risk Human Papillomavirus (HPV) in patient specimens.
Specimen Required
Cervical, anal or vaginal specimens with SurePath collection kit and place in SurePath media.
Patient Preparation
- Sample Collection: Cervical specimens collected in SurePath Solution have been validated for use with the Xpert HPV test.
- Storage/Transport Temperature: Cervical specimens collected in SurePath Solution may be transported and stored at 2–30 °C.
- Unacceptable Conditions: Specimens in any media other than indicated above.
- Remarks: Specimen source required.
- Stability: Ambient: 1 month; Refrigerated: 6 months; Frozen: Unacceptable.
Methodology
The test is performed using qualitative real time PCR on Cepheid GeneXpert Instrument Systems.
Sample Received to Report Turnaround Time (TAT)
Twice in a Week (Scheduled Test)
Reference Interval
Negative
Interpretive Data
This test amplifies DNA of HPV16, HPV18 and 12 other high-risk HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) associated with cervical cancer and its precursor lesions. HPV testing should not be used for screening or management of atypical squamous cells of undetermined significance (ASCUS) in women under age 21.
Resources
- Additional Technical Information
- Test Request Form
Sample Reports
- Enhanced Report
- See report