HPV Qualitative DNA Test - Vietnam Registration 2401179ĐKLH/BYT-HTTB

The NeuMoDx™ HPV Assay, performed on the NeuMoDx™ 96 Molecular System and NeuMoDx™ 288 Molecular System ((c) NeuMoDx™ Systems), is a real-time PCR-based nucleic acid amplification test for the rapid, automated, qualitative detection of DNA of high-risk types of human papillomavirus (HPV) in cervical cytology specimens. The test specifically identifies HPV16 and HPV18, and simultaneously detects other high-risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 67 and 68) at clinically relevant levels of infection. Cervical cytology specimens that can be tested with the NeuMoDx™ HPV Assay include clinical cervical cytology specimens collected by the clinician using a brush/cytobrush device and preserved in liquid cell culture medium based on PreservCyt (HOLOGIC) and SurePath (BD). The test is used as a primary screening test to assess the risk of (pre)cancer in women 21 years of age and older, to determine the need for referral to colposcopy or other monitoring procedures, and as a monitoring test for women with atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL) cytology results to determine the need for referral to colposcopy or other monitoring procedures. The information, together with the clinician's cytologic history, other risk factors and clinical judgment, can be used to guide patient management. This product is intended for use by professional users, such as laboratory technicians and laboratory personnel, who are trained in in vitro diagnostic techniques and molecular biology techniques.