# Presentation: 037623

## 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 - TaqScreenTM  WNV

- COBAS AmpliPrep

- COBAS TaqMan

- Hamilton Pipettor

## 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* 

- 95% LOD estimated to be _<_ 5 copies/mL

## Analytical sensitivity studies with BBI WNV Lineage 2 (QWN701) Isolate* 

- 95% LOD (PROBIT) = 7.41 copies/mL (95% CI: 4.78 – 16.13)

## Reactivity to Japanese Encephalitis serocomplex members

- Additional WNV isolate  (ATCC VR-1267)
- St Louis encephalitis virus (ATCC VR-1265)
- Murray Valley encephalitis virus (ATCC VR-77)

- All isolates detected

## Phase I Capacity Analysis(Gulf Coast Regional Blood Center)

- Start pooling 0630 hrs (average pooling time 19.5 minutes)
- First extractions on COBAS AmpliPrep begin 0649 hrs
- First amplifications begin 0900 hrs
- Total throughput with 2 FTE operating 2 systems = 1728 samples in 11 1⁄2 hours
- Conservative extrapolation (one shift of 8 hours with “reporting” in the last 3 1⁄2 hours) estimates ~500,000 samples per 2 FTE operating 2 system per year.

## Current Status & Issues

- All 11 US sites and 3 Canadian sites are installed and prepared for linked testing on or before July 1
- Potential expansion to other sites
- Assisting public health lab diagnostic needs
- Dissemination of prevalence data through REDS
- USDA permit requirements to ship WNV panels
- Standardization of WNV panel
- Capital, training, and support costs are substantial to execute multi-site IND

## Roche Diagnostics - Commitment to West Nile Response

**Branchburg**
**& Belleville, NJ**
- Manufacturing & Quality
- IT/SAP

_**Alameda, CA**_
- Legal/Licensing
- Research
- Roche *Genetics*

_**Rotkreuz, SW**_
- Engineering
- Manufacturing

_**Penzberg, GmbH**_
- Development
- Regulatory
- Marketing

_**Pleasanton, CA**_
- Development
- Marketing
- Regulatory/Clinical
- Finance & Admin.

_**Laval, Que, Canada**_
- Distribution
- Customer Support
- Regulatory
- Clinical Trial Support

_**Indianapolis, IN**_
- Distribution
- Customer Support