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1st Area Medical Laboratory Participation in the FDA Specificity Evaluation of the JBAIDS Influenza A/H5 Detection System. SSG Edward Loudenclos IV NCOIC, Bio/Endemic Disease Section. AGENDA. Evaluation Abstract Background: A/H5 influenza Background: the JBAIDS analyzer H5 Project Overview

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1st Area Medical Laboratory Participation in the FDA Specificity Evaluation of the JBAIDS Influenza A/H5 Detection System

SSG Edward Loudenclos IV

NCOIC, Bio/Endemic Disease Section


Agenda
AGENDA

  • Evaluation Abstract

  • Background: A/H5 influenza

  • Background: the JBAIDS analyzer

  • H5 Project Overview

  • The 1st AML?

  • Sample Processing and Testing

  • THE EXPERIENCE!

  • Results and Summary

  • Acknowledgements and References


Evaluation abstract
Evaluation Abstract

  • The possibility of an emerging A/H5 pandemic is cause for great concern. Historically, influenza pandemics have killed countless millions. Fast and early detection impacts treatment and quarantine, and is CRITICAL!



Background a h5 influenza
BACKGROUND: for A/H5 by the CDC.A/H5 Influenza


A h5 influenza avian flu
A/H5 Influenza (Avian Flu) for A/H5 by the CDC.

  • Primarily infects birds, but can infect humans.

  • Infected birds have been reported in at least 40 different countries.

  • Human cases reported in at least 15 different countries.

  • Mortality rate is approximately 61%! Death toll world-wide would exceed 1918 pandemic.


H5 maps
H5 Maps for A/H5 by the CDC.




ABI 7500 FAST


Abi 7500 fast real time pcr using cdc flu panel
ABI 7500 FAST Real Time PCR using CDC Flu Panel Characterization panel (rRT-PCR Flu Panel).

Pros

Cons

Size

Not mobile

Consumables (temperature issues)

Operator Training

  • CDC Validated

  • FDA Cleared

  • Reliable Results

  • Sensitivity

How do we address these problems?


Background the jbaids analyzer
BACKGROUND: Characterization panel (rRT-PCR Flu Panel).The JBAIDS Analyzer


Jbaids joint biological agent identification and diagnostic systems
JBAIDS Characterization panel (rRT-PCR Flu Panel).Joint Biological Agent Identification and Diagnostic Systems

  • DoD accepted Platform for both identification and diagnostic confirmation of biological agents and pathogens of concern.

  • Can operate in fixed medical facilities, or deployed mobile units.

  • Developed by Idaho Technology, Inc.


Jbaids specifications
JBAIDS: Characterization panel (rRT-PCR Flu Panel).Specifications

  • Approximately 36 lbs packed.

  • 110/220v power switching capability.

  • Rugged, carbon fiber case. 1-meter drop test.

    • Meets MILSTD 810F requirements

  • Easy user-level maintenance, replacement parts issued with instrument.

  • 32-sample capacity

  • Includes “Tough-book” laptop and software.

  • Real-time PCR for both DNA and RNA.

  • Cycle times vary (40 minutes for DNA, 70 minutes for RNA due to RT step)


Jbaids extraction
JBAIDS: Characterization panel (rRT-PCR Flu Panel).Extraction

  • ITI produces Extraction kits for use with the JBAIDS analyzer:

    • SWIPE: Nasal Swabs (DNA), Surface Swabs (DNA and RNA), live culture (DNA and RNA), Powder (DNA and RNA) Pus swabs, lymph node aspirates.

    • VIBE: Whole Blood (RNA), Nasal Swabs (RNA), Sputum (DNA and RNA).

    • SCOOP: Stool and Soil samples.

    • QFLOW DNA: Whole Blood(DNA), Air in PBC (DNA), Water, Milk, Salad, Ground Beef, Tuna Salad, Gastric Washings.

    • QFLOW RNA: Air in PBS(RNA).

    • PLATINUM PATH: All Sample Types, can extract DNA and RNA simultaneously (Uses Mag-Bead Technology).


Jbaids reagents
JBAIDS: Characterization panel (rRT-PCR Flu Panel).Reagents

  • Vaccinia (Orthopox)

  • Yersina pestis (Plague)

  • Bacillus anthracis (Anthrax)

  • Francisella tularensis

  • Brucella melitensis

  • Rickettsia prowazekii

  • Burkholderia spp.

  • Variola (Smallpox)

  • Coxiella burnetii

  • Ebola

  • Marburg

  • Eastern, Western, and Venezuelan equine encephalitis

  • FDA Cleared Reagents:

    • Anthrax IVD

    • Plague IVD

    • Tularemia IVD

  • Kits are freeze-dried, lyophilized reagents. Can be stored at Room Temp.


Jbaids h5 project overview
JBAIDS H5 Project Overview Characterization panel (rRT-PCR Flu Panel).


Overview clinical testing locations
Overview: Characterization panel (rRT-PCR Flu Panel).Clinical Testing Locations

  • 3 Tests Sites:

Naval Health Research Center

San Diego, CA

Brooke Army Medical Center

San Antonio, TX

Tripler Army Medical Center

Honolulu, HI


Overview sample criteria
Overview: Characterization panel (rRT-PCR Flu Panel).Sample Criteria

  • 600-950 Specimens

  • Two sample types:

    • Throat Swabs

    • Nasopharyngeal Swabs

  • 0.6mL-1.5mL sample volume

  • Specimens previously tested using standard diagnostic methods

  • De-identified (no Personally Identifiable Information)


Overview sample flow
Overview: Characterization panel (rRT-PCR Flu Panel).Sample Flow

Sick. Flu-like Symptoms

Samples obtained

Lab results negative for Flu

Samples De-identified

Sample aliquots for extraction


Overview extraction
Overview: Characterization panel (rRT-PCR Flu Panel).Extraction

  • De-identified Specimens split 3 ways to be extracted using the following kits:

    • IT 1-2-3 VIBE Extraction Kit (on JBAIDS)

    • IT 1-2-3 Platinum Path Extraction Kit (on JBAIDS)

    • Qiagen QIAamp RNA mini Kit (on ABI 7500 FAST)

  • Positive and Negative extraction controls are processed with every specimen batch.

  • All extracted samples must be sent to analysis the day of extraction.


Overview results
Overview: Characterization panel (rRT-PCR Flu Panel).Results

  • Specimens were tested against 3 targets:

    • 2 targets specific to A/H5 (Asian Lineage)

    • Control target Human RNase P gene (functioned as Extraction and Inhibition control)

  • ALL results from the processed specimens must match regardless of extraction method and PCR analyzer used.


Here comes the 1 st area medical laboratory
Here comes the Characterization panel (rRT-PCR Flu Panel).1st Area Medical Laboratory!


How the 1 st aml got involved
How the 1 Characterization panel (rRT-PCR Flu Panel).st AML got involved

  • Tripler Army Medical Center.

    • Small number of people JBAIDS trained.

    • Staff had multiple duties.

  • Clinical Mission >Research Mission.

  • Time requirements for extraction and testing necessitated Full-time staffing.

  • Oh, and…



Sample processing and testing
Sample Processing and Testing through Pat Craig at JPEO-CBMS.


Extraction
Extraction through Pat Craig at JPEO-CBMS.


Reagent prep
Reagent Prep through Pat Craig at JPEO-CBMS.


Analysis
Analysis through Pat Craig at JPEO-CBMS.


Results
Results through Pat Craig at JPEO-CBMS.


The hawaiian experience
The Hawaiian Experience! through Pat Craig at JPEO-CBMS.


The results
The Results! through Pat Craig at JPEO-CBMS.


  • Total number of samples evaluated: through Pat Craig at JPEO-CBMS.986

    • 518 Throat Swabs

    • 468 Nasopharyngeal Swabs

  • JBAIDS Influenza A/H5 Detection Kit resulted with a Clinical Specificity of 99% and with a 95% confidence. (This met target goals!)

  • All findings, results, and data were submitted to the FDA for review on: 29 JAN 2010


Future goals
Future Goals through Pat Craig at JPEO-CBMS.

  • The JBAIDS Program Office is currently working on taking the full Influenza test panel (A,B, seasonal A/H1, season A/H3, swine A and 2009 A/H1 assays) through 510(k)

  • Anticipated FDA clearance is 2nd or 3rd Quarter 2011.


Summary
Summary through Pat Craig at JPEO-CBMS.

  • A/H5 Avian Flu could pose a grave pandemic threat.

  • Rapid diagnostic testing necessary to help prevent spread of infection.

  • Real-time PCR is set as standard for testing.

  • ITI’s H5 Flu kit can provide same level of sensitivity and confidence as currently accepted methods.


Acknowledgements
Acknowledgements through Pat Craig at JPEO-CBMS.

  • Tripler Army Medical Center:

    • LTC Hamilton, CPT Barrera, Mr. and Miss. Eberly

  • Idaho Technology, Inc:

    • Sean Phipps, Beth Lingenfelter, Sarah Jeffs

  • JPEO-CBMS and JBAIDS Program Office:

    • Pat Craig, James Karaszkiewicz, Jennifer McLaughlin

  • 1st Area Medical Laboratory:

    • COL Freund, SGM Krueger, LTC Pell, CPT Pierson


References
References through Pat Craig at JPEO-CBMS.

  • Beigel, J.H., et al., Avian influenza A (H5N1) infection in humans. N Engl J Med, 2005. 353(13): p. 1374-85.

  • WHO, Avian Influenza Update.http://www.who.int/csr/disease/avian_influenza/en/, 2008.

  • CDC, Key Facts About Avian Influenza (Bird Flu) and Avian Influenza A (H5N1) Virus.http://www.cdc.gov/flu/avian/gen-info/facts.htm, 2007.



Questions
QUESTIONS? through Pat Craig at JPEO-CBMS.


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