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The JBAIDS Influenza A/H5 (Asian lineage) Detection Kit is intended for use in real-time reverse-transcriptase polymerase chain reaction (rRT-PCR) assays on the Joint Biological Agent Identification and Diagnostic System (JBAIDS) instruments for the in vitro qualitative detection of Influenza A/H5 (Asian lineage) viral RNA in patient nasopharyngeal swab (NPS) or throat swab (TS) specimens for the presumptive laboratory identification of Influenza A/H5 (Asian lineage) virus. Testing with the JBAIDS Influenza A/H5 (Asian lineage) Detection Kit should be in conjunction with other laboratory testing and clinical observations for the following indications: 1. Providing epidemiological information for the surveillance of human infection with Influenza A/H5 (Asian lineage) virus. 2. Identifying patients who may be infected with Influenza A/H5 (Asian lineage) virus based on clinical and epidemiological risk factors. Testing with the JBAIDS Influenza A/H5 (Asian lineage) Detection Kit should not be performed unless the patient meets the most current U.S. Department of Health and Human Services (DHHS) clinical and epidemiologic criteria for testing suspected A/H5 specimens. The definitive identification of influenza A/H5 (Asian lineage) either directly from patient specimens or from virus cultures requires additional laboratory testing, along with clinical and epidemiological assessment in consultation with national influenza surveillance experts. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Use is limited to laboratories with appropriate biosafety equipment and containment procedures. It is intended for use by experienced laboratory personnel who have training in standardized molecular testing procedures and expertise in viral diagnosis, and have received training on the JBAIDS Instrument. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a biosafety laboratory (BSL) 3+ facility is available to receive and culture specimens.

The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Influenza A/H5 (Asian lineage) Detection Kit is a real-time reverse transcriptase polymerase chain reaction (rRT-PCR) test kit, which, when used with the JBAIDS instrument and software, allows the qualitative in vitro detection of Influenza A/H5 (Asian lineage) viral RNA. The kit contains two freeze-dried assays with primer and fluorescent-probe sets for the detection of Influenza A/H5 (Asian lineage) viral RNA. In particular, the two assays specifically target distinct regions of the influenza A hemagglutinin gene of the highly pathogenic H5N1 viruses from the Asian lineage, without detection of other influenza A virus subtypes, including the North American lineage influenza A/H5 viruses. The tests are performed using the previously FDA-cleared JBAIDS instrument and software. A human gene target assay will be used as an inhibition and extraction control.