USAF JBAIDS/M1M Proficiency Test Program

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USAF JBAIDS/M1M Proficiency Test Program

• Presented By
• Thomas Shaak, Maj, USAF, BSC
• Deputy Chief, Division of Wound Biology and
  Translational Research
• Armed Forces Institute of Pathology
• Washington, DC

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Purpose of AFPT Program

• AFPT program for the JBAIDS/M1M is a corner stone
  of HSMR-LBDT capability.
• The PT challenges ensure that in the unlikely
  event of Biowarfare (BW)/Toxin attack we can
  accurately indentify the presence of BW agents.

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AFPT Program

• 55 Air Force Sites (Bagram and Moody)
• Biological and Toxin testing Platforms
• JBAIDS proficiency testing
• M1M proficiency testing
• AFIP support

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JBAIDS/M1M

• JBAIDS-uses principles of real-time PCR for
  presumptive identification of biological warfare
  agents
• M1M-uses principles of immuno-based ECL for
  detection of pathogens and toxins in biological,
  environmental and food samples.
• Both systems allow for rapid ID and diagnostic
  confirmation of biological pathogens

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JBAIDS PT Program Details

• 3 PT events per fiscal year
• Real-time PCR platform (JBAIDS)
• Testing Format
• 2 (or more) Unknowns (multiple simulated
  matrices)
• 4 Organisms (B.a (2), F.t (1), Y.p (2),
  Orthopox(1))
• 4 Runs per sample (PTC, NTC, Unk1, Unk2 pos,
  neg, and unknowns run in duplicate)
• Unknown sample QC done by AFIP
• 8 of samples made, tested for QC
• Results submitted to PT Project Manager
• Due 10 business days from the time of receipt of
  PT samples by the HSMR-LBDT sites

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JBAIDS PT Program Details

• Supplies
• Unknown samples (2)
• Inactivated antigen
• Critical Reagent Program
• Variety of matrices
• Provided by AFIP
• Shipped via FEDEX
• Notification of receipt of samples required from
  HSMR-LBDT

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JBAIDS PT Program Details

• Reagents
• JBAIDS Assay Targets
• Lyophilized reagents require reconstitution
• Reconstitution water provided in assay kit
• Reconstitution buffer provided in assay kit
• Provided by AFIP (including inhibition and
  extraction controls)
• Prior provided by individual sites
• Extraction Kits for different matrices (QFLOW,
  Scoop, VIBE, and Swipe)
• Provided by individual sites

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QFlow Sample Extraction

• Matrices
• Whole blood (DNA)
• Food (DNA)
• Water
• Tuna
• Ground Beef
• Salad
• Gastric Wash (DNA)
• Water (DNA)
• Air into PBS (DNA/RNA)

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Scoop Vibe Extractions

• Matrices for Scoop Extraction
• Soil
• Stool
• Sand (new)
• Matrices for Vibe Extraction
• Whole Blood
• Nasal Swab
• Sputum

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Swipe Sample Extraction

• Matrices
• Nasal/Pus Swab
• Surface Swab
• Powder
• Culture Samples

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JBAIDS Results and Scoring

• Submitting Results
• Fax to AFIP
• Result Forms
• Conditions Progress Logs
• JBAIDS report
• Forward JBAIDS run files or paper reports (.ixo)
  to AFIP
• Scoring
• Grades will be determined based on
• JBAIDS report
• Result form responses
• gt80 constitute passing grade for PT

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M1M PT Program Details

• Approximately 47 sites (Bagram)
• Three PT events per fiscal year
• M1M PT will be delivered with JBAIDS PT
• M1M PT will be scored independently of JBAIDS PT
• Immunoassay platform testing format
• One unknown
• Three target toxins
• Ricin
• Bot A
• SEB (Staphylococcus enterotoxin B)

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M1M PT Program Details

• Supplies
• Unknowns
• Non-infectious, lyophilized material
• Provided by AFIP
• Reagents and Instrument supplies
• Provided by individual sites

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M1M Results and Scoring

• Submitting results
• Fax to AFIP
• Result form
• Conditions and progress logs
• Forward to AFIP M1M run files or paper reports
• Grading
• Pass/Fail Scoring
• Based on number of unknowns and assays
• With only 3 possible answers, one incorrect
  result causes the percentage to fall below 80

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AFIP Support

• USAF PT Project Manager (Ellen LaMorena)
• Notification of shipment of PT thru email
• Technical support
• Via email
• Via phone
• Tracking information for shipments will be made
  available upon request
• Distribution of results to individual sites and
  MAJCOM consultants via email
• Limited number of replacement PT samples will be
  available upon request
• AFIP will provide additional testing samples for
  additional training

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AFIP Support

• New
• Site Visits
• Remediation or retraining
• Site request required (notification of Sq/cc)
• E-mail AFIP support to initiate
• Notify Chain of Command of the date
• AFIP provides onsite training, evaluation, report
  and outbrief to site command

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Failures

• (Insufficient) Less than 80 in a PT period
  requires
• Investigation of failure
• Perform any appropriate action to correct problem
• Complete Exception response form
• Return form to AFPT Project Manager
• (Poor) Less than 80 in two out of three
  consecutive PT periods requires
• The discontinuation of testing until MAJCOM
  approves resumption
• Investigation of failure

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Failure (cont.)

• Perform any appropriate action to correct problem
• Complete Exception response form
• Forward completed Exception report including
  investigation results, corrective action
  proposals, etc. to MAJCOM for review and
  signature
• MAJCOM will decide if appropriate action has been
  taken and if testing should resume
• Forward forms to AFIP PT Coordinator after MAJCOM
  approval
• Within three days of resumption of testing
  forward Exception response form to the CCLM
  office

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Failures (cont.)

• (Unsatisfactory) Less than 80 in three out of
  four consecutive PT periods requires
• Complete the steps for poor performance listed
  previously in addition to
• The Director of the CCLM will review
  investigations and other corrective action
  documentation
• The decision to resume testing will be made by
  the Director of the CCLM

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Common Errors for PT

• Failure to follow SOP
• Using wrong extraction kit (JBAIDS)
• False positives/negatives
• In a real scenario-a false positive could create
  an international incident and a false negative
  could lead to unnecessary casualties
• Transcription errors
• Switching answers
• Skipping answers (leaving results blank)

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Results from AFPT-July 2009

• JBAIDS PT
• 54 out of 54 HSMR-LBDT sites participated
• 93 passing (4 out of 54 failed)
• 4 failed sites 4 false negative responses
• 2 sites were second failures
• All sites repeated and did not pass

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Results from AFPT July 2009

• M1M PT
• 46 HLD sites currently have M1M platform
• 36 out of 46 HLD sites participated
• 100 passing (36 out of 36)
• 10 non-participating sites--due to lack of
  reagents or instrument maintenance

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Changes to AFPT Scoring

• No Changes

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Future Direction of PT

• More challenging
• Inhibitors

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Questions???