Worldwide Distribution - USA including AZ, CA, FL, GA, IA, IL, IN, KY, MA, MD, MN, MO, MT, NC, NE, NJ, NY, OH, OR, PA, TX, UT, VA, WA, WI, OH and Internationally to Bulgaria, Germany, Italy, Japan, South Korea, and Spain.
Descripción del producto
The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection. The following virus types and subtypes are identified using the RV+: Influenza A, Influenza A subtype H1, Influenza A subtype H3, 2009 H1N1, Influenza B, Respiratory Syncytial Virus (RSV) subtype A, and RSV subtype B. The test is not intended to detect Influenza C virus. Detecting and identifying specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection, if used in conjunction with other clinical and laboratory findings. || Negative results for Influenza A, Influenza B, or RSV do not preclude influenza virus or RSV infection and should not be used as the sole basis for diagnosis, treatment, or patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. || Performance characteristics for Influenza A Virus were established when Influenza A/H3, A/H1, and 2009 H1N1 were the predominant Influenza A viruses circulating. These characteristics may vary when other Influenza A viruses are emerging. || If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions used specifically for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
Worldwide Distribution:US (Nationwide) including states of: AZ, CA, FL, IL, KY, MD, MN, MT, OH, PA, TN, TX, VA, WA, WI; and countries of: Belgium, China, and Saudi Arabia.
Descripción del producto
Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Cartridges; are qualitative multiplexed in vitro diagnostic tests for simultaneous detection and identification of selected gram-positive (BC-GP) and gram-negative (BC-GN) bacteria and resistance markers.
Nationwide Distribution including CA, CO, IA, MT, OH, OK, OR, TX, and UT
Descripción del producto
Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges. Each Test Cartridge comes preloaded with all required reaction solutions, including wash solutions, oligonucleotide probe solution and signal amplification solutions required to generate a test result. BC-GN is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial bloodstream infections; however, is not used to monitor these infections.
Nanosphere Verigene || Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigene CDF Amplification Reagent Kit. || The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). Presumptive identification of the PCR ribotype 027 strain of C. difficile is by detection of the binary toxin (cdt) gene sequence and the single base pair deletion at nucleotide 117 in the tcdC gene. The tcdC gene encodes for a negative regulator in C. difficile toxin production. The test is performed on the Verigene System and utilizes automated specimen preparation and polymerase chain reaction (PCR) amplification, combined with a nanoparticle-based array hybridization assay to detect the toxin gene sequences associated with toxin-producing C. difficile. The CDF test is indicated for use as an aid in the diagnosis of CDI. Detection of PCR ribotype 027 strains of C. difficile by the CDF test is solely for epidemiological purposes and is not intended to guide or monitor treatment for C. difficile infections. Concomitant culture is necessary only if further typing or organism recovery is required.
Worldwide Distribution - USA including AZ, CA, FL, GA, IA, IL, IN, KY, MA, MD, MN, MO, MT, NC, NE, NJ, NY, OH, OR, PA, TX, UT, VA, WA, WI, OH and Internationally to Bulgaria, Germany, Italy, Japan, South Korea, and Spain.
Descripción del producto
The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers. BC-GN is performed directly on blood culture media using blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram negative bacteria as determined by gram stain.