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Adenovirus R-gene® US Assay is a Real Time PCR in vitro diagnostic test for the rapid and qualitative detection of Adenovirus viral DNA isolated and purified from nasopharyngeal swab or nasopharyngeal wash/aspirate specimens obtained from individuals exhibiting signs and symptoms of acute respiratory infection. The intended use for this test is to aid in the diagnosis of respiratory Adenovirus infection in humans in conjunction with other clinical and laboratory findings. The test detects, but does not differentiate, Adenovirus species (A, B, C, D, E, F and G). Negative results do not preclude Adenovirus infection and should not be used as the sole basis for treatment or other patient management decisions.

The ADENOVIRUS R-gene® US Assay is a Taqman based Real Time PCR Assay that enables detection of human Adenovirus DNA and Internal Control 2. An overview of the procedure is as follows: 1. Collect nasopharyngeal specimens from symptomatic patients. Two transport media may be used UTM or M4RT (not provided with kit). 2. Add an Internal Control 2 (IC2) to every sample and to the W0 reagent, to monitor for inhibitors present in the specimens and check the extraction step. 3. Perform extraction and purification of nucleic acids using a NucliSENS® easyMAG™ System (bioMérieux) and the Automated Magnetic Extraction Reagents (bioMérieux). 4. Add purified nucleic acids to the ready to use R*10 amplification premix included in the ADENOVIRUS R-gene® US kit. The R*10 amplification premix contains oligonucleotide primers and target-specific oligonucleotide probes. The primers and probes are complementary to a fragment located in the Hexon gene region and to the internal control 2 DNA sequence. The probes are duallabeled with a reporter dye attached to the 5'-end and a quencher dye attached to the 3'-end. 5. Perform amplification of DNA in a Cepheid SmartCycler® 2.0 instrument. In this process, the probe anneals specifically to the DNA template followed by primer extension and amplification. The 5' - 3' exonuclease activity of the Tag polymerase cleaves the probe separating the reporter dye from the quencher. This generates an increase in fluorescent signal upon excitation from a light source. With each cycle, additional reporter dye molecules are cleaved from their respective probes, further increasing fluorescent signal. The amount of fluorescence at any given cycle is dependent on the amount of amplification products present at that time. Fluorescent intensity is monitored during each PCR cycle by the real-time instrument. 6. Interpretation.