CDC DENV-1-4 : real-time RT-PCR assay for detection and serotype identification of dengue virus : instructions for use package insert

Details

• Corporate Authors:
  National Center for Emerging and Zoonotic Infectious Diseases (U.S.). Division of Vector-Borne Diseases.Dengue Branch.
• Description:
  The CDC DENV-1-4 Real-Time RT-PCR Assay is intended for use on an Applied Biosystems (ABI) 7500 Fast Dx Real-Time PCR Instrument: ; • For the diagnosis of dengue in serum or plasma collected from patients with signs and symptoms consistent with dengue (mild or severe) during the acute phase; ; • For the identification of dengue virus serotypes 1, 2, 3 or 4 from viral RNA in serum or plasma (sodium citrate) collected from human patients with dengue during the acute phase; ; • To provide epidemiologic information for surveillance of circulating dengue viruses. ; Testing of clinical blood specimens (serum or plasma) with the CDC DENV-1-4 Real-Time RT-PCR Assay should not be performed unless the patient meets clinical and/or epidemiologic criteria for testing suspect dengue cases. ; The CDC DENV-1-4 Real-Time RT-PCR Assay is not FDA cleared or approved for the screening of blood or plasma donors. ; Negative results obtained with this test do not preclude the diagnosis of dengue and should not be used as the sole basis for treatment or other patient management decisions.
• Subjects:
  • Dengue/diagnosis
  • Dengue/genetics
  • Dengue Virus/isolation & purification
  • Real-Time Polymerase Chain Reaction
  • Reverse Transcriptase Polymerase Chain Reaction/methods
• Document Type:
  Pamphlet (or booklet)
• Pages in Document:
  53 numbered pages
• Download URL:
  https://stacks.cdc.gov/view/cdc/31035/cdc_31035_DS1.pdf
• File Type:
  [PDF - 1.84 MB]
• Collection(s):
  Stephen B. Thacker CDC Library
• Main Document Checksum:
  urn:sha256:c871db2c12eaaacbd5e6189644041c04e4361037a6c3c00cff3a02d41bb52dc1