Search Results

NP Screen is a semi-quantitative in vitro diagnostic test that uses real-time PCR to determine the level of Epstein-Barr Virus Nuclear Antigen-1 (EBNA-1) DNA in nasopharyngeal cellular specimens collected using the NP Screen Trans-Oral Nasopharyngeal Brush. The test is intended for use in conjunction with endoscopy and other clinical information to assess the likelihood that EBV-associated nasopharyngeal carcinoma (NPC) is present. The test is indicated for use in adults of Chinese descent with signs and symptoms of nasopharyngeal carcinoma.

NP Screen is a semi-quantitative in vitro test for the detection of Epstein-Barr Virus Nuclear Antigen-1 gene (EBNA-1) in nasopharyngeal epithelial specimens are collected by the clinician, using the NP Screen Trans-Oral Collection Brush, and placed into the Transport Medium for shipping. The test is performed in a single laboratory, Primex Clinical Laboratories, Inc. Total nucleic acid is extracted from the specimen and the dsDNA is then quantitated. If the amount of extracted DNA does not meet the minimum required for testing, the specimen is rejected, and a new specimen must be collected. Extracted specimen DNA that meets the specification is normalized to a pre-defined concentration. The standardized DNA is tested in duplicate using real-time Polymerase Chain Reaction (real-time PCR) and nucleic acid hybridization for the detection of target EBV EBNA-1 DNA. Simultaneous amplification and detection of human RNAse P DNA serves as the internal control for assessing all steps of the NP Screen assay. Low and High Positive External Controls are included with each run.