Research on west nile virus published by A. Pai et al
December 1st, 2008
2008 DEC 1 -- "The cobas TaqScreen West Nile virus (WNV) test (Roche Molecular Systems) was licensed by the Food and Drug Administration (FDA) in August 2007 for detecting WNV RNA in pools of six or in individual donations (IDs). A series of studies established the performance characteristics of the assay and test system before FDA licensure," scientists writing in the journal Transfusion report.
"Analytic sensitivity was determined by probit analysis using multiple source materials. Clinical sensitivity was determined by testing a panel of 315 known WNV RNA-positive specimens. A large clinical specificity study was conducted by five laboratories during months when WNV activity was not expected. The 95 percent limit of detection for ID testing using the Lineage 1 Health Canada WNV reference standard was 40.3 copies per mL (95% individual donation, 35.1-47.8 copies per mL). Clinical sensitivity was 100 percent (95% confidence interval [CI], 98.8%-100%) for ID testing and 97.5 percent (95% CI, 95.1-98.9%) for minipool (MP) testing. Clinical specificity, when resolved to the ID, was 100 percent for both formats and was 99.986 percent at the MP level," wrote A. Pai and colleagues.
The researchers concluded: "The cobas TaqScreen WNV test performed on the cobas s 201 system is a fully automated test system with excellent clinical sensitivity and specificity that offers the benefits of automated sample preparation and a secure environment for donor testing information."
Pai and colleagues published their study in Transfusion (Performance characteristics of the Food and Drug Administration-licensed Roche Cobas TaqScreen West Nile virus assay. Transfusion, 2008;48(10):2184-2189).
Additional information can be obtained by contacting J. Saldanha, Roche Molecular Systems, 4300 Hacienda Dr., Pleasanton, CA 94588, USA.
The publisher of the journal Transfusion can be contacted at: Blackwell Publishing, 9600 Garsington Rd., Oxford OX4 2DQ, Oxon, England.
Keywords: United States, Pleasanton, Blood Transfusion, FDA, Infectious Disease, Medical Device, Parasitic Disease, Regulatory Actions, Transfusion Medicine, U.S. Food and Drug Administration, Vectors, West Nile Fever, West Nile Virus, Zoonoses.
This article was prepared by Biotech Business Week editors from staff and other reports. Copyright 2008, Biotech Business Week via NewsRx.com.
