|
|
| A B C D E F G H I J K L M N O P Q R S T U V W X Y Z # |
HPV DNA (16, 18, Other High Risk), PCR, Vaginal Self-Collected
Test Code14263
CPT Codes
87626
Preferred Specimen
1 ThinPrep® vial sample collected with COPAN FLOQSwab 552C.RM
Minimum Volume
1.5 mL
Other Acceptable Specimens
1 ThinPrep vial sample collected with Evalyn Brush
Instructions
Patient should follow instructions provided with the self-collection device.
The collection device should be immediately transferred to ThinPrep following provided instructions.
The collection device should be immediately transferred to ThinPrep following provided instructions.
Transport Temperature
Room temperature
Specimen Stability
Room temperature: 30 days
Refrigerated: 30 days
Frozen: Unacceptable
Refrigerated: 30 days
Frozen: Unacceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Copan Swab not suspended in ThinPrep • Evalyn Brush not suspended in ThinPrep • SurePath™ pellet • Samples treated with Acetic Acid • Cervical sources • Samples from patients who have undergone hysterectomy • Swab in vial • Patients less than 21 years of age
Methodology
Polymerase Chain Reaction (PCR)
Setup Schedule
Set up: Mon-Sun; Report available: 2-3 days
Reference Range
| HPV 16 | Not Detected |
| HPV 18 | Not Detected |
| HPV Other | Not Detected |
Clinical Significance
This test is used for the detection of high-risk Human Papillomavirus in self-collected vaginal samples and can be used as part of an HPV primary screening algorithm. The test detects high-risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68, which are reported out as HPV 16, HPV 18, and other high-risk HPV types which includes, but does not differentiate, the remaining 12 high- risk types. Interim guidance supports the use of an HPV primary screening algorithm, where high-risk HPV testing is used as a first line screen, in women ≥25 years of age [1].
In patients for whom cervical sampling is either contraindicated or a cervical sample cannot otherwise be obtained, vaginal samples can be self-collected within a healthcare setting where samples can be processed by trained personnel. Patients should be followed-up in accordance with professional medical guidelines, results from prior screening, medical history, and other risk factors.
1. Huh WK, Ault KA, Chelmow D, et al. Use of primary high- risk human papillomavirus testing for cervical cancer screening: interim clinical guidance. Obstet Gynecol. 2015;125(2):330-337. doi:10.1097/AOG.0000000000000669
In patients for whom cervical sampling is either contraindicated or a cervical sample cannot otherwise be obtained, vaginal samples can be self-collected within a healthcare setting where samples can be processed by trained personnel. Patients should be followed-up in accordance with professional medical guidelines, results from prior screening, medical history, and other risk factors.
1. Huh WK, Ault KA, Chelmow D, et al. Use of primary high- risk human papillomavirus testing for cervical cancer screening: interim clinical guidance. Obstet Gynecol. 2015;125(2):330-337. doi:10.1097/AOG.0000000000000669
