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The SensiTox B. anthracis Toxin Test for use with the MultiPath Analyzer, is a qualitative immunofluorescence assay to aid in the diagnosis of inhalation anthrax. The test is intended for the rapid, qualitative detection of lethal factor, a biomarker associated with Bacillus anthracis). The test can be used with whole blood collected with dipotassium EDTA anticoagulant by venipuncture. This testing samples from individuals who have signs and symptoms consistent with inhalation anthrax and a likelihood of exposure to B. anthracis. A positive SensiTox B. anthracis Toxin Test result is presumptively diagnostic for B. anthracis infection. Diagnosis of B. anthracis infection must be made in conjunction with medical history, likelihood of exposure, signs, and symptoms of disease, as well as other laboratory evidence. The definitive identification of B. anthracis from blood samples additional testing and confirmation procedures in consultation with public health or other authorities for whom reports are required. Testing should be performed and reported in accordance with current guidelines provided by the appropriate public health authorities. The level of lethal factor present in blood from individuals with early systemic infection is unknown. 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. Laboratories performing the SensiTox B. anthracis Toxin Test must have the appropriate biosafety equipment, personal protective equipment (PPE), containment facilities, and personnel trained in the safe handling of clinical specimens potentially containing B. anthracis. The SensiTox B. anthracis Toxin Test is for prescription use only. This assay is not FDA-cleared or approved for testing blood or plasma donors.

The SensiTox B. anthracis Toxin Test, run on the MultiPath Analyzer, detects lethal factor in venous whole blood samples using an immunofluorescence assay and the proprietary MultiPath detection technology. A whole blood specimen, collected in dipotassium EDTA, from individuals with signs and symptoms consistent with inhalation anthrax and a likelihood of exposure, is used for the test. The blood sample is added directly to the SensiTox B. anthracis Cartridge, a single use consumable that contains all the reagents required to run the test. The Cartridge is loaded onto the MultiPath Analyzer for processing through the steps of the assay. Once loaded onto the Analyzer, the barcodes on the cartridge that identify the test type and associated test specific information (manufacturer installed barcode) and sample (laboratory affixed barcode) are read. The cartridge is moved to the fluidics station where it is first heated to 35°C. The sample is then split into 3 equal aliquots in 3 distribution wells within the cartridge. The sample aliquots flow from the distribution wells to the reagent wells containing target-specific antibody conjugated fluorescent and magnetic particles in the form of lyophilized beads. Upon contact with the sample, the lyophilized beads rehydrate and the reaction mixtures flow into the imaging wells, the bottoms of which are coated with a dye cushion reagent. Upon contact with the reagents, the dye-cushion dissolves forming a dense opaque aqueous layer that separates the sample and reagents from the bottom optical surface of the Imaging Well. In the upper assay layer, the toxins, if present, bind to the magnetic and fluorescent particles tethering them together. The cartridge is incubated for 12 minutes to allow the reaction to take place and then is moved to the magnetics station. At the magnetics station, the imaging well is placed over permanent magnets that draw the magnetic particles and any fluorescent particles that are tethered to them via the target molecules through the dye-cushion layer, depositing them on the bottom imaging surface. The captured fluorescent particles are imaged and quantified using nonmagnified digital imaging. The Analyzer can be run in batch mode or by random access. Up to 20 cartridges can be loaded onto the Analyzer in parallel. The first result is reported in approximately 21 minutes of loading the cartridge onto the Analyzer with subsequent results being reported in 2.5-minute increments. The results are interpreted using the MultiPath applications software as valid or invalid, and if valid, the results are reported as Lethal Factor detected. Results are displayed on the instrument touch screen and can be printed.