Next Generation Blood Screening Platform Workshop下一代血液筛查平台研讨会.pptVIP

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Next Generation Blood Screening Platform Workshop下一代血液筛查平台研讨会.ppt

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Next Generation Blood Screening Platform Workshop下一代血液筛查平台研讨会

TaqScreen West Nile Virus Program - Roche Update James L. Gallarda, Ph.D. Roche Molecular Diagnostics Critical Milestones (Update from March BPAC) IND filed - April 21, 2003 Approved to allow sites to begin as test of record Phase I Training, Installation (5 sites - US and Canada) Initiated studies (completed May, 2003) Unlinked studies focused on workflow, training Phase II Training, Installation (completed June 14) Safety and effectiveness in detecting WNV First Fully Automated System in North America - TaqScreen? WNV Non-Clinical Performance Studies Capacity Analysis Non-Clinical Performance Studies Clinical specificity - 400 random volunteer samples from WNV low- and high- prevalence areas Analytical specificity studies with non-WNV microorganisms Limit of detection studies with CDC WNV lysate Analytical sensitivity studies with IMPATH/BCP WNV Lineage 1 isolate Analytical sensitivity studies with BBI WNV Lineage 2 (QWN701) Isolate Reactivity to Japanese encephalitis serocomplex members Clinical specificity - 400 random volunteer samples from WNV low- and high- prevalence areas Analytical specificity studies with non-WNV microorganisms Human T-cell leukemia virus (HTLV I/II) Hepatitis B virus (HBV) Human immunodeficiency virus Type I (HIV-1) Hepatitis C virus (HCV) Cytomegalovirus (CMV) Hepatitis A virus (HAV) Adenovirus Herpes simplex virus (HSV) Human papilloma virus (HPV) Varicella virus Chlamydia trachomatis Proprionibacterium acnes Staphylococcus aureus Staphylococcus epidermidis Neisseria gonorrhoeae Candida albicans Analytical specificity studies with non-WNV microorganisms Each of the 125 samples positive for these microorganisms tested negative in the TaqScreen WNV assay - no false-positive test results were observed. All associated Armored Internal Controls were positive for each sample tested. Limit of detection studies with CDC WNV lysate Analytical sensitivity studies with IMPATH/BCP WNV Lineage 1 isolate* Analytical sensitivity studies