HPV test provides information to clinicians on a patients risk for developing cervical cancer. There are currently five FDA-approved HPV assays that are detecting high-risk (HR) genital HPV types that are commonly associated with cervical cancer. Hybrid Capture 2 High Risk HPV DNA Test (Digene, Qiagen) detects 13 HR-HPV types; Cervista ¢ „ ¢ HPV HR (Third Wave Technologies, Hologic) detects 14 HR genital HPV types; Cervista HPV 16/18 identifies DNA types 16 and 18; Cobas HPV Test (Roche) specifically identifies types HPV 16 and HPV 18 while concurrently detecting the rest of the high risk types. These four tests detect HPV viral DNA in cervical cells collected during the liquid-based Pap test ( "pap smear " ¯). APTIMA HPV assay with the TIGRIS DTS System (Gen-Probe) is the first FDA-approved assay that detects the messenger RNA of two HPV viral oncogenes, E6 and E7. Although HPV infection is very common, and usually self-resolving, if HPV RNA is present, the patient is in a higher risk category for developing cervical cancer than if HPV is not detected.
Use
Guidelines for cervical cancer screening that include HPV DNA testing issued by the American Society for Colposcopy and Cervical Pathology (ASCCP), the Centers for Disease Control and Prevention, and the American College of Obstetricians and Gynecologists recommend that
HPV molecular testing is not used for evaluation of women younger than 21 years " ”most HPV infections in this age group are transient and will be cleared by the immune system.
HPV molecular testing is performed as a reflex test for women older than 21 with atypical cells of undetermined significance (ASC-US) Pap test result,
HPV molecular testing is performed concurrently with a Pap test for women 30 years and older.
Limitations
Test results may be affected by improper specimen collection, storage, or specimen processing.
Cervista ¢ „ ¢ HPV HR HPV tests, Cobas HPV Test, and TIGRIS DTS detect high-risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 (with exception of Hybrid Capture 2 HR HPV), and 68 but not HPV low-risk types.
Testing of alternate specimen types (rectal and oropharyngeal) is not currently FDA approved; however, some laboratories have conducted validation studies to offer testing.