IVDT_In Vitro Diagnostics Technology

IVD Technology, November/December 2012

Issue link: http://dc.cn.ubm-us.com/i/92152

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Page 23 of 43

MOLECULAR DIAGNOSTICS amplify more slowly at lower input amounts of target DNA because of mutations under the primer sequence. As is seen in Figure 5, assay results are similar for blood cultures tested directly (108 CFU/mL) or for those diluted 1/100 into negative blood culture (106 CFU/mL). Th is is signifi - cant as the LOD necessary for detec- tion of positive blood cultures requires this range of performance.16 We have plans to initiate clinical validation of this test in planned stud- ies upcoming on both of the major we are developing a cartridge that can process two samples at a time, leverag- ing the same blister packs. Also, Great Basin has developed a test for detect- ing rpoB gene mutation in Mycobac- terium tuberculosis on a further simpli- fi ed device that is consistent with the ASSURED goals for developing world diagnostic test requirements.1 In the future, there is a signifi cant market opportunity for CLIA-waived tests to be performed directly in the physician's offi ce (POL) setting. Th is includes rapid test-and-treat indica- In the future, there is a signifi cant market opportunity for CLIA-waived tests to be performed directly in the physician's offi ce setting. blood culture instrument platforms, the BACTEC system (Becton Dick- inson) and the BacTAlert system (BioMérieux). Currently Great Basin is developing a suite of products designed to detect pathogens present in positive blood culture bottles with plans to migrate some of these tests to detection of pathogens directly from the blood stream. We have successfully devel- oped a panel that can identify seven clinically signifi cant Candida species directly from positive blood cultures and we also are developing broader multiplex panels for gram positive and gram negative organisms along with drug-resistance-gene detection. Fur- ther, expansion of the content of our FDA-approved toxigenic C. diffi cille assay to detect hypervirulent strains that are associated with increased rate of relapse of infection is in develop- ment; identity of multiple ribotypes, not just 027, will be included. Currently a single cartridge process- ing instrument is available. A multiple cartridge processor is also in develop- ment. As another approach to increase throughput and lower cost per test, Product Pipeline tions such as viral and bacterial respi- ratory pathogens as well as women's health indications such as detection of pathogens that cause bacterial vaginosis and vaginitis and sexually transmitted disease pathogens, includ- ing Chlamydia trachomitis and Neiserria gonorrhea. Th e cost/speed profi le of our test platform makes it attractive for the point-of-care setting, where highly specifi c and sensitive rapid detection can direct appropriate therapy before the patient leaves the offi ce. References 1. Ao W, Aldous S, Woodruff E, et al., "Rapid detection of rpoB gene mutations conferring rifampin reistance in Mycobacterium tuberculosis," Journal of Clinical Microbiology, 50: 2433-2440, 2012. 3. Ginocchio CC, Zhang F, Manji R, et al., "Eval- uation of multiple test methods for the detec- tion of the novel 2009 infl uenza A (H1N1) during the New York City outbreak," Journal of Clinical Virology 45: 191-195, 2009. 2. Hicke B, Pasko C, Groves B, et al., "Auto- mated detection of toxigenic Clostridium diffi cile in clinical samples: Isothermal tcdB amplifi ca- tion coupled to array-based detection," Journal of Clinical Microbiology, 50: 2681-2687, 2012. 6. Silva HL, Strabelli TM, Cuhna ER, et al., "Nosocomial coagulase-negative staphylococci bacteremia: fi ve year prospective data collection," Journal of Infectious Diseases, 4: 271-274, 2000. care units: current data and interpretations," Wien Klin Wochenschr, 115: 99-103, 2003. 8. Ibrahim EH, Sherman G, Ward S, et al., "Th e infl uence of inadequate antimicrobial treatment of bloodstream infections on patient outcomes in the ICU setting," Chest, 118: 146-155, 2000. 7. Shorr AF, Micek ST, et al., "Inappropriate ther- apy for methicillin-resistant Staphylococcus aureus: resource utilization and cost implications," Criti- cal Care Medicine, 36: 2335-2340, 2008. 11. Schweizer ML, Furuno JP, Harris AD, et al., "Comparative eff ectiveness of nafcillin or cefazolin versus vancomycin in methicillin-sus- ceptible Staphylococcus aureus bacteremia," BMC Infectious Diseases, 11: 279, 2011. 12. Hall KK and Lyman JA, "Updated review of blood culture contamination," Clinical Microbi- ology Reviews, 19: 788-802, 2006. 9. Pittet D, Tarar D, and Wenzel R P, "Nosocomial bloodstream infection in critically ill patients: excess length of stay, extra costs, and attributable mortality," JAMA, 271: 1598-1601, 1999. 10. Stamper PD, Cai M, Howard T, et al., "Clinical validation of molecular BD GeneOhm StaphSR assay for direct detection of Staphylococcus aureus and methicillin-resistant Staphylococcus aureus in positive blood cultures," Journal of Clinical Micro- biology, 45: 2191-2196, 2007. 13. Forrest GN, Mehta S, Weekes E, et al., "Impact of rapid in situ hybridization on coagulase-negative staphylococci positive blood cultures," Journal of Antimicrobial Chemotherapy, 58: 154-158, 2006. 14. Weinstein M, "Blood culture contamination: persisting problems and partial progress,"Journal of Clinical Microbiology, 41: 2275-2278, 2003. 16. Marlowe EM, Gibson L, Hogan J, et al., "Conventional and molecular methods for veri- fi cation of results obtained with BacT/Alert nonevent blood culture bottles," Journal of Clin- ical Microbiology, 41: 1266-1269, 2003. IVD Larry Rea is senior vice president, opera- tions, at Great Basin Corp., West Valley City, Utah. Brian Hicke is director, research, at Great Basin Corp., West Valley City, Utah. Wes Lindsey is director, product develop- ment, at Great Basin Corp., West Valley City, Utah. Michael McMahon is senior hardware systems engineer at Great Basin Corp., West Valley City, Utah. 4. Centers for Disease Control and Prevention. "National Nosocomial Infections Surveillance (NNIS) system report, data summary January 1992-June 2001, issued August 2001," American Journal of Infection Control, 29: 404-421, 2001. 5. Gastmeier P, Geff ers C, Sohr D, et al., "Sur- veillance of nosocomial infections in intensive 24 IVD TECHNOLOGY | NOVEMBER/DECEMBER 2012 Charles Owen is director, engineering, at Great Basin Corp., West Valley City, Utah. Robert Jenison is chief technology offi cer at Great Basin Corp., West Valley City, Utah. He can be reached at rjenison@ gbscience.com. ivdtechnology.com 15. Pasko C, Hicke B, Dunn J, et al., "Staph ID/R: a rapid method for determining Staphylococcus species identity and detecting the mecA gene directly from positive blood culture," Journal of Clinical Microbiology, 50: 810-817, 2012.

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