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The Francisella tularensis Real-time PCR Assay is an in vitro diagnostic test for the qualitative detection of chromosomal DNA sequences from Francisella tularensis. The assay can be used to test whole blood EDTA, pleural fluid, and bacterial culture isolates grown on agar from individuals suspected of having tularemia.

Results generated from direct specimen testing are presumptive for the identification of Francisella tularensis. Results generated from culture isolate testing are used as part of the LRN Francisella tularensis Testing Algorithm. The diagnosis of Francisella tularensis infection must be made based on history, signs, symptoms, exposure likelihood, and other laboratory evidence, in addition to the identification of Francisella tularensis from culture isolates or from clinical specimens.

Negative results do not preclude infection with the biothreat microbial agents targeted by the device and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

Use is limited to Centers for Disease Control and Prevention (CDC) designated laboratories.

The Francisella tularensis Real-time PCR Assay is composed of oligonucleotide primers and dual-labeled hydrolysis probes (Taqman®) for use in real-time PCR reactions. This assay is intended for the in vitro detection of Francisella tularensis in individuals suspected of having tularemia. Extracted DNA samples are tested using the Francisella tularensis Real-time PCR Assay along with an extraction control primer and probe set to demonstrate adequate DNA extraction and isolation, specimen integrity, proper function of common reagents and equipment, and the absence of inhibitory substances.

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