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The Great Basin Stool Bacterial Pathogens Panel is a multiplexed, qualitative test for the detection and identification of DNA targets of enteric bacterial pathogens. The Stool Bacterial Pathogens Panel detects nucleic acids from: - · Campylobacter (C. coli/C. jejuni) - · Salmonella - · Shiga toxin 1 (stx1) - Shiga toxin 2 (stx2) - · Escherichia coli serotype 0157 - Shigella Shiga toxin genes are found in Shiga toxin-producing strains of E. coli (STEC/EHEC/VTEC) and Shigella dysenteriae. The E. coli O157 test result is only reported if a Shiga toxin gene (stx1 and/or stx2) is also detected. The Stool Bacterial Pathogens Panel is performed directly from Cary Blair or C&S Medium preserved stool specimens from symptomatic patients with suspected acute gastroenteritis, or colitis and is performed on the Portrait™ Analyzer. The test is intended for use as an aid in the diagnosis of gastrointestinal illness in conjunction with clinical and epidemiological information; however, it is not to be used to monitor these infection . Positive results do not rule out co-infection with other organisms and may not be the definitive cause of patient illness. Negative test results in the setting of clinical illness compatible with gastroenteritis 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. Concomitant culture is necessary if organism recovery or further typing of bacterial agents is desired.

The Great Basin Stool Bacterial Pathogens Panel on the PA500 Portrait™ System utilizes automated, hot-start PCR amplification technology to amplify specific nucleic acid sequences that are then detected using hybridization probes immobilized on a modified silicon chip surface, in a single-use, self-contained test cartridge. An aliquot of the specimen (stool preserved in stool transport media) is first processed using the Sample Preparation Device (SPD). An aliquot of the eluate obtained from the SPD is loaded into the sample port of the SBPP Test Cartridge. Genomic DNA is extracted from microbial cells and diluted to reduce potential inhibitors of the PCR. During the PCR process, biotin-labeled primers direct the amplification of specific nucleic acid sequences within a conserved region for identification of: a bacterial sample processing control (SPC), Campylobacter coli/Campylobacter jejuni, Salmonella spp., Shiga toxin 1, Shiqa toxin 2, and E. coli serotype 0157. Following PCR, biotin-labeled, amplified target DNA sequences are hybridized to sequence specific probes immobilized on the silicon chip surface, and incubated with antibody conjugated to the horseradish peroxidase enzyme (HRP). The unbound conjugate is washed away, and tetramethylbenzidine (TMB) is added to produce a colored precipitate at the location of the probe/target sequence complex. The resulting signal is detected by the automated Portrait™ Optical Reader within the PA500 Portrait™ Analyzer System. The SPC undergoes the same extraction, amplification, and detection steps as the sample in order to inhibitory substances, as well as process inefficiency due to instrument or reagent failure. No operator intervention is required once the sample is loaded into the sample port, and the Stool Bacterial Pathogens Panel cartridge is loaded into the Portrait™ Analyzer. The PA500 Portrait™ Analyzer System is a fully automated system that includes: the Portrait™ Analyzer, single-use Stool Bacterial Pathogen Panel Cartridges, and the Portrait™ Data Analysis Software Program. The Portrait™ System is designed to perform automated sample preparation, PCR, and optical chip-based detection with integrated data analysis in less than two hours.

The Great Basin Bordetella Direct Test is a qualitative in vitro diagnostic test for the detection of Bordetella pertussis DNA from nasopharyngeal swab specimens obtained from patients suspected of having a respiratory tract infection attributable to B. pertussis. The Bordetella Direct Test is performed on the PA500 Portrait Analyzer and utilizes PCR amplification of the insertion sequence IS481. The IS481 sequence is also found in other organisms including Bordetella holmesii or Bordetella bronchiseptica. Respiratory infection with B. pertussis, B. holmesii ot B. bronchiseptica may yield positive test results with IS481 assays. B. holmesii infection may cause clinical illness similar to B. pertussis, and mixed outbreaks involving both B. pertussis and B. holmesii infection have been reported. Additional testing should be performed if necessary to differentiate B. holmesii and B. pertussis. B. bronchiseptica is a rare cause of infection in humans. When clinical factors suggest that B. pertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the Great Basin Bordetella Direct Test do not preclude B. pertussis infection and positive results do not rule out co-infection with other respiratory pathogens. Results from the Great Basin Bordetella Direct Test should be used in conjunction with information obtained during the patient's clinical evaluation as an aid in diagnosis of Bordetella pertussis infection and should not be used as the sole basis for treatment or other patient management decisions.

The Great Basin Bordetella Direct Test on the PA500 Portrait™ Analyzer System utilizes automated hot-start PCR technology to target and amplify the IS481 insertion sequence of B. pertussis. Genomic DNA is extracted from microbial cells and diluted to reduce potential inhibitors of PCR. During PCR, double-stranded DNA is separated and the target nucleic acid sequence is amplified by thermal cycling using biotin-labeled primers that target the IS481 sequence for identification of B. pertussis. Following PCR, biotin-labeled amplicon is hybridized to sequence-specific capture probes immobilized on the silicon chip surface, then incubated with anti-biotin antibody conjugated to the horseradish peroxidase enzyme (HRP). The unbound conjugate is washed away and tetramethylbenzidine (TMB) is added to produce a visible precipitate at the location of the probe/target sequence complex. The resulting signal is detected by the automated Portrait™ Optical Reader within the PA500 Portrait™ Analyzer System. The Specimen Processing Control (SPC), undergoes the extraction, and detection steps to monitor for inhibitory substances as well as process inefficiency due to instrument or reagent failure. No operator intervention is necessary once the clinical sample is loaded into the sample port and the Bordetella Direct Test cartridge is loaded into the Portrait Analyzer. The PA500 Portrait™ Analyzer System is a fully automated system that includes: The Portrait™ Analyzer, single-use Bordetella Direct Test Cartridges, and the Portrait™ Data Analysis Software Program. The Portrait™ System is designed to perform automated sample preparation, PCR, and optical chip-based detection with integrated data analysis in less than two hours.

The Great Basin Staph ID/R Blood Culture Panel is a qualitative, multiplex, nucleic acid-based in vitro diagnostic assay intended for the simultaneous identification of nucleic acid from Staphylococcus lugdumensis and various Staphylococcus species to the genus level and the detection of the mecA gene for methicillin resistance directly from patient positive blood culture specimens. The test utilizes automated hot-start enabled polymerase chain reaction (PCR) for the amplification of specific DNA targets detected by hybridization probes immobilized on a silicon chip surface. The assay is performed directly on positive blood culture specimens identified as positive by continuous monitoring blood culture system that demonstrates the presence of organisms as determined by Gram stain to contain gram-positive cocci in clusters (GPCC) or gram-positive cocci in singles (GPC). The test may be performed using blood culture bottles. The Staph ID/R Blood Culture Panel identifies Staphylococcus aureus (SA), and Staphylococcus lugdunensis, and detects other Staphylococcus species without identification to species level. The Portrait Staph ID/R Blood Culture Panel is indicated for use in conjunction with other clinical or laboratory findings to aid in the diagnosis of bacterial bloodstream infections; however, it is not used to monitor these infections. Subculturing positive blood cultures is necessary to recover viable organisms for further identification, susceptibility testing, or epidemiological typing to identify organisms in the blood culture that are not detected by the Great Basin Staph ID/R Blood Culture Panel. If detected, mecA may or may not be associated with Staphylococcus spp. detected or the agent responsible for the disease. Negative results for mecA antimicrobial resistance gene assays do not always indicate susceptibility, as other mechanisms of resistance to methicillin exist.

The Great Basin PA500 Portrait™ Analyzer System is a fully automated system that includes the Portrait Analyzer, single-use Staph ID/R Blood Culture Panel Test Cartridges, and the Portrait data analysis software. The PA500 Portrait Analyzer System is designed to perform automated sample preparation, PCR, and optical chip-based detection with integrated data analysis in approximately 110 minutes.

The Great Basin Shiga Toxin Direct Test performed on the Portrait™ Analyzer is an automated, in vitro diagnostic assay for the qualitative detection of Shiga toxin 1 (stxl) / Shiga toxin 2 (stx2) genes and specific identification of a conserved genetic region of the E. coli O157 serogroup. Shiga toxin genes are found in Shiga toxin-producing strains of E. coli (STEC) and Shigella dysenteriae. The E. coli 0157 test result is reported only if a Shiga toxin gene is also detected. The test is performed directly from Cary-Blair or C&S Medium preserved stool specimens from symptomatic patients with suspected acute gastroenteritis, or colitis in hospital laboratories. The assay is intended for use in conjunction with clinical presentation as an aid in the diagnosis of STEC infections. Positive results do not rule out oninfection with other organisms, and may not be the definitive cause of patient illness. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Shiga Toxin Direct Test negative results in the setting of clinical illness compatible with gastroenteritis 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 Portrait System is a fully automated system that includes the Portrait Analyzer, single-use Great Basin Shiga Toxin Direct Test cartridges, and the Portrait System data analysis software. The Portrait System is designed to perform automated sample preparation, PCR, and optical chip-based detection with integrated data analysis in approximately 2 hours. The single-use Test Cartridge contains blister packs, fluidic channels, processing chambers, a waste chamber, and an assay chip coated with an array of sequence-specific detection probes. All reagents are contained within the integrated blister packs with the exception of the amplification reagents and SPC, which are dried into the Amplification Chamber and SPC Chambers of the Cartridge, respectively. The appropriate specimen for use in the Test Cartridge is an aliquot of stool from symptomatic patients preserved in Cary-Blair or C&S transport media. A preserved stool specimen is placed into the sample port of the Test Cartridge for processing. Multiple fluidic channels move reagents from integrated blister packs to chambers where reagent mixing and sample processing occur. A waste chamber, self-contained and segregated within the Test Cartridge, collects and stores reagent waste.