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The GeneSTAT.MDx Coccidioides Assay is a qualitative real-time polymerase chain reaction (PCR) in vitro diagnostic test for the detection of nucleic acids from Coccidioides immitis and Coccidioides posadasii. The assay does not differentiate between these two species. The assay is performed on bronchial alveolar lavage (BAL) or bronchial wash (BW) specimens from patients presenting with respiratory signs and symptoms consistent with coccidioidomycosis. The GeneSTAT.MDx Coccidioides Assay is intended to be used along with clinical findings and other laboratory results as an aid in the diagnosis of coccidioidomycosis in patients with possible or probable exposure to Coccidioides immitis or Coccidioides posadasii.

The GeneSTAT.MDx Coccidioides Assay is a qualitative real-time PCR-based assay to detect target Coccidioides spp. DNA from bronchial alveolar lavage (BAL) or bronchial wash (BW) samples. The sample is prepared by a lysis and extraction process, with the extracted DNA then tested with the GeneSTAT.MDx Coccidioides assay on the GeneSTAT System. The GeneSTAT System is a real-time PCR nucleic acid testing platform. The GeneSTAT system consists of: - The single-use, disposable, assay-specific Test Module cartridge that contains the real-time PCR reagents, internal control, reaction wells, and test parameters. The single-use cartridge contains all the necessary reagents for amplification and detection of the Coccidioides target DNA as well as a human DNA control sequence that is used to monitor the presence of inhibitors in the PCR reaction and to ensure that the sample preparation process is adequate. All information to run the assay as well as lot number and expiration date is contained on the Radio-Frequency Identification (RFID) tag on the cartridge. The cartridge contains two PCR reaction wells. One well contains PCR reagents for amplification and detection of Coccidioides DNA and the human gene internal control (Reaction Well 1). The second well (Reaction Well 2) contains the same reagents for amplification/detection of Coccidioides DNA as used in Reaction Well 1 but does not contain the PCR reagents to detect the internal control. - The GeneSTAT Analyzer instrument that performs the mechanical, optical, and fluidic actions upon the Test Module to perform the PCR reactions. The instrument generates, analyzes, and transmits results to a connected pre-configured computer for presentation to the user. One single-use Test Module can be tested at a time in each GeneSTAT Analyzer. Up to four GeneSTAT Analyzers can be connected to single computer. - A MS Windows based laptop computer - The associated software and firmware required to run the test, analyze the results, and present the results to the user. - The Performance Verification Test Cartridges (PVT) that are used to periodically verify that the analyzer is functioning within acceptable limits. A successful PVT run is required to activate the analyzer. The PVT should be run at minimum every six months, and it is recommended that a PVT should be run monthly.