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CDC DENV-1-4 : real-time RT-PCR assay for detection and serotype identification of dengue virus : instructions for use package insert
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04‐12‐2013
[PDF-1.84 MB]
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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.
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