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The Genetic Signatures EasyScreen™ Gastrointestinal Parasite Detection Kit is a rapid in vitro nucleic acid amplification assay for the qualitative detection of pathogenic gastrointestinal parasite nucleic acid from the stool of patients with signs and/or symptoms of gastroenteritis. The test, based on real-time PCR, detects the nucleic acid of the following organisms: - · Cryptosporidium spp. - · Giardia intestinalis - Dientamoeba fragilis - · Entamoeba histolytica - Blastocystis hominis - · Enterocytozoon bieneusi - · Encephalitozoon intestinalis - · Cyclospora cayetanensis The kit is compatible with stool specimens that are unpreserved or frozen or in transport media including Cary Blair or C&S media from symptomatic patients with suspected gastroenteritis. It is required that the stool is first processed using the EasyScreen™ Sample Processing Kit. Nucleic acid extraction and real-time PCR set up are performed on the automated Genetic Signatures GS1 platform. This device is an in vitro diagnostic (IVD) intended to be used by trained personnel in clinical, pathology or hospital laboratories as an aid in the diagnosis of gastrointestinal illness. This test is intended for use, in conjunction with clinical presentation, laboratory findings, and epidemiological information, as an aid in the differential diagnosis of infections by Dientamoeba fragilis, Blastocystis hominis, Enterocytozoon bieneusis, Entamoeba histolytica, Encephalitozoon intestinalis, Cryptosporidium spp. (including C. parvum), and Giardia intestinalis. Results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decision. Positive results do not rule out co-infection with other organisms that are not detected by this test, and may not indicate the sole or definitive cause of patient illness. Negative results in the setting of clinical illness compatible with gastroenteritis and/or colitis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.

The EasyScreen™ Gastrointestinal Parasite Detection Kit (EP005) is designed to simultaneously identify 8 potential pathogens of the gastrointestinal tract, from human stool samples. The device is only compatible with nucleic acids prepared using an EasyScreen™ Sample Processing Kit (SP008B). A stool sample from a patient suspected of having gastroenteritis (usually liquid or soft stool) is collected and transported to the testing laboratory. A portion of the stool material is taken using a swab or pipette and processed with the EasyScreen™ Sample Processing Kit (SP008B), which lyses cells and converts the nucleic acid to a 3base™ form. An aliquot of purified eluate is then added to the PCR reagents supplied in the EP005 kit, which selectively amplify the genetic targets of Cryptosporidium spp., Giardia intestinalis, Entamoeba Dientamoeba fragilis, Blastocystis hominis, Enterocytozoon histolytica. bieneusi. Encephalitozoon intestinalis and Cyclospora cayetanensis. The reaction mix is manufactured to detect an Extraction Control (EC) and features an incorporated Internal Positive Control (IPC) to determine the reliability of the extracted nucleic acid and to detect the presence of any inhibitors after extraction from the primary sample. Amplified targets are detected with probes labeled with fluorophores as detected by the real-time PCR platform. The PCR amplification takes approximately 150 minutes, depending on the PCR platform used. A positive control is included to ascertain that the detection reagents and analyzer are functioning correctly. The amplified nucleic acid targets are detected by probes labeled with fluorophores, as detected by the real-time PCR platform. If no amplification occurs for a given target, then there will not be any significant increase in fluorescence. Each probe fluoresces at a given wavelength and the signals are measured and distinguished from each other by the real-time PCR platform. The realtime PCR software interprets all data collection and provides the information for automated or manual result analysis. The assay is semi-automated.