rss
07-01-2015, 03:53 AM
CorGENIX ReEBOV Antigen Rapid Test Kit approved by WHO for emergencies
http://cdn.medgadget.com/wp-content/uploads/2015/06/reebov.pngFor the past year and a half, the Ebola virus has affected thousands, claiming*over 11,000 lives to date. The disease is **w considered contained, and Liberia has been free of cases for seven weeks, until a new case emerged this morning (http://www.bbc.com/news/world-africa-33323664). The need to employ constant vigilance and surveillance remains high.
Testing for the virus is mostly*done through nucleic acid testing, which requires highly trained personnel and expensive equipment and resources. The WHO has reviewed the*CorGENIX ReEBOV Antigen Rapid Test Kit,*a point-of-care screening test to rapidly check a patient’s blood for presence of the virus. The review followed the*Emergency Assessment and Use procedure, which sets the minimum quality, safety, and performance requirements for diag**stic devices for*the Ebola emergency. As such, the product is listed only for procurement, and **t prequalified yet.
The CorGENIX ReEBOV Antigen Rapid Test Kit is a dipstick that works by capturing EBOV VP40 antigen present in a sample of patient blood. The dipstick is striped with EBOV VP40-specific antibodies conjugated to gold na**particles, which, in the presence of antigen, form a complex that’s carried to the reagent site, and forms a pink line that correlates to the concentration of*EBOV VP40 antigen in the sample. You can imagine it as being similar to how a pregnancy test works, but using blood instead of urine. In their report in The Lancet, the researchers compared the ReEBOV fingerstick testing to RT-PCR (a nucleic acid test, used as a reference) in 106 patients, and found a sensitivity and specificity of 100% and 92%, respectively.
CorGENIX will continue to conduct post-market surveillance of the safety and efficacy of its test, and the WHO will also be monitoring its performance in the field.
WHO:*First Antigen Rapid Test for Ebola through Emergency Assessment and Eligible for Procurement… (http://www.who.int/medicines/ebola-treatment/1st_antigen_RT_Ebola/en/)
The Lancet: ReEBOV Antigen Rapid Test kit for point-of-care and laboratory-based testing for Ebola virus disease: a field validation study… (http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)61042-X/abstract)
Link: ReEBOV Antigen Rapid Test fact sheet… (ftp://ftp.corgenix.com/Intra/ReEBOV/14039.pdf)
The post CorGENIX ReEBOV Antigen Rapid Test Kit approved by WHO for emergencies (http://www.medgadget.com/2015/06/corgenix-reebov-antigen-rapid-test-kit-approved-emergencies.html) appeared first on Medgadget (http://www.medgadget.com).
http://feeds.feedburner.com/~ff/Medgadget?d=yIl2AUoC8zA (http://feeds.feedburner.com/~ff/Medgadget?a=4wk8BtFLdfo:1Vapsni1DIA:yIl2AUoC8zA) http://feeds.feedburner.com/~ff/Medgadget?d=qj6IDK7rITs (http://feeds.feedburner.com/~ff/Medgadget?a=4wk8BtFLdfo:1Vapsni1DIA:qj6IDK7rITs) http://feeds.feedburner.com/~ff/Medgadget?i=4wk8BtFLdfo:1Vapsni1DIA:gIN9vFwOqvQ (http://feeds.feedburner.com/~ff/Medgadget?a=4wk8BtFLdfo:1Vapsni1DIA:gIN9vFwOqvQ)
http://feeds.feedburner.com/~r/Medgadget/~4/4wk8BtFLdfo
http://cdn.medgadget.com/wp-content/uploads/2015/06/reebov.pngFor the past year and a half, the Ebola virus has affected thousands, claiming*over 11,000 lives to date. The disease is **w considered contained, and Liberia has been free of cases for seven weeks, until a new case emerged this morning (http://www.bbc.com/news/world-africa-33323664). The need to employ constant vigilance and surveillance remains high.
Testing for the virus is mostly*done through nucleic acid testing, which requires highly trained personnel and expensive equipment and resources. The WHO has reviewed the*CorGENIX ReEBOV Antigen Rapid Test Kit,*a point-of-care screening test to rapidly check a patient’s blood for presence of the virus. The review followed the*Emergency Assessment and Use procedure, which sets the minimum quality, safety, and performance requirements for diag**stic devices for*the Ebola emergency. As such, the product is listed only for procurement, and **t prequalified yet.
The CorGENIX ReEBOV Antigen Rapid Test Kit is a dipstick that works by capturing EBOV VP40 antigen present in a sample of patient blood. The dipstick is striped with EBOV VP40-specific antibodies conjugated to gold na**particles, which, in the presence of antigen, form a complex that’s carried to the reagent site, and forms a pink line that correlates to the concentration of*EBOV VP40 antigen in the sample. You can imagine it as being similar to how a pregnancy test works, but using blood instead of urine. In their report in The Lancet, the researchers compared the ReEBOV fingerstick testing to RT-PCR (a nucleic acid test, used as a reference) in 106 patients, and found a sensitivity and specificity of 100% and 92%, respectively.
CorGENIX will continue to conduct post-market surveillance of the safety and efficacy of its test, and the WHO will also be monitoring its performance in the field.
WHO:*First Antigen Rapid Test for Ebola through Emergency Assessment and Eligible for Procurement… (http://www.who.int/medicines/ebola-treatment/1st_antigen_RT_Ebola/en/)
The Lancet: ReEBOV Antigen Rapid Test kit for point-of-care and laboratory-based testing for Ebola virus disease: a field validation study… (http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)61042-X/abstract)
Link: ReEBOV Antigen Rapid Test fact sheet… (ftp://ftp.corgenix.com/Intra/ReEBOV/14039.pdf)
The post CorGENIX ReEBOV Antigen Rapid Test Kit approved by WHO for emergencies (http://www.medgadget.com/2015/06/corgenix-reebov-antigen-rapid-test-kit-approved-emergencies.html) appeared first on Medgadget (http://www.medgadget.com).
http://feeds.feedburner.com/~ff/Medgadget?d=yIl2AUoC8zA (http://feeds.feedburner.com/~ff/Medgadget?a=4wk8BtFLdfo:1Vapsni1DIA:yIl2AUoC8zA) http://feeds.feedburner.com/~ff/Medgadget?d=qj6IDK7rITs (http://feeds.feedburner.com/~ff/Medgadget?a=4wk8BtFLdfo:1Vapsni1DIA:qj6IDK7rITs) http://feeds.feedburner.com/~ff/Medgadget?i=4wk8BtFLdfo:1Vapsni1DIA:gIN9vFwOqvQ (http://feeds.feedburner.com/~ff/Medgadget?a=4wk8BtFLdfo:1Vapsni1DIA:gIN9vFwOqvQ)
http://feeds.feedburner.com/~r/Medgadget/~4/4wk8BtFLdfo