The performance characteristics of HPV testing using the SurePath sample medium were determined by ARUP Laboratories in a validation study. The FDA has not approved the SurePath sample medium for HPV testing. Specimens collected in SurePath sample medium may produce false-negative results under certain conditions, e.g., when specimens exceed stability requirements. For HPV results using an FDA-approved test, laboratories should collect and transport specimens according to the instructions of FDA-approved kits (e.g., ThinPrep medium or HPV Digene collection kits).
This test detects the high-risk HPV genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68 associated with cervical cancer and its precursor lesions. However, cross-reactions with other genotypes may occur. Results should be correlated with cytologic and histologic findings. Sensitivity may be affected by cellularity of specimen.
This test is intended for medical purposes only and is not valid for the evaluation of suspected sexual abuse or for other forensic purposes.
HPV testing should not be used for screening or management of atypical squamous cells of undetermined significance (ASCUS) in women under age 21.
See Compliance Statement B: www.aruplab.com/CS
||Condyloma (Human Papillomavirus (HPV) DNA Probe, High Risk Surepath® (AutoCyte))
, Genital Warts (Human Papillomavirus (HPV) DNA Probe, High Risk Surepath® (AutoCyte))