|Test||HUMAN PAPILLOMAVIRUS (HPV) - HIGH RISK ONLY|
|Methodology||cobas® 4800 HPV High-Risk test with 16/18 Genotype by Polymerase Chain Reaction (PCR).|
|Description||The Roche cobas® HPV test is designed to specifically identify HPV 16 and HPV 18 genotypes, while concurrently detecting 12 other high risk HPV types (31, 33, 35, 39, 45, 51, 52. 56, 58, 59, 66 and 68) as one group. Women who are HPV 16 and/or 18 positive have a significantly higher risk of harboring a high grade squamous lesion than women with non-16 or 18 high risk viral subtypes, regardless of cytology results.(2) The cobas® HPV test is intended to enhance existing methods for the detection of cervical disease and should be used in conjunction with clinical information derived from other diagnostic and screening tests, physical examinations, and full medical history in accordance with appropriate patient management procedures.(1)
|Specimen||THIN PREP® COLLECTION METHOD
1. Collect specimen as directed in the Thin Prep® package insert.
2. Place the specimen directly into a liquid medium PreservCyt® vial and mix vigorously to release material. PreservCyt® vial is supplied by NorDx.
3. Forward promptly to laboratory at ambient temperature only.
|Analytic Time||2 Days; Maximum Laboratory Time - 6 Days|
|Day(s) Test Set Up||2 -3 times per week|