1 / 28

USAF JBAIDS/M1M Proficiency Test Program

USAF JBAIDS/M1M Proficiency Test Program. Ketan Patel, Ph.D. SAFMLS Feburary 11, 2008. Points of Interest for USAF PT Program FY08. JBAIDS PT Program Details Submitting Results for JBAIDS PT JBAIDS PT Failures M1M Proficiency Test AFIP support. JBAIDS PT: Program Details.

judah-greene
Download Presentation

USAF JBAIDS/M1M Proficiency Test Program

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. USAF JBAIDS/M1M Proficiency Test Program Ketan Patel, Ph.D. SAFMLS Feburary 11, 2008

  2. Points of Interest for USAF PT Program FY08 • JBAIDS PT Program Details • Submitting Results for JBAIDS PT • JBAIDS PT Failures • M1M Proficiency Test • AFIP support

  3. JBAIDS PT: Program Details • Approximately 53 Sites • Testing Format • 2 Unknowns (multiple simulated matrices) • 4 Organisms (B.a (2 targets), F.t (1), Y.p (2), Orthopox(1)) • 4 Runs per sample (PTC, NTC, Unk1, Unk2; pos, neg, and unks ran in dup) • 4 Extraction Procedures • QFlow • Scoop • Vibe • Swipe

  4. JBAIDS PT: Program Details • Three PT events per fiscal year • Supplies • Unknown samples (2) • DNA or heat-killed bacteria • Variety of matrices • Sterility reports kept on file at AFIP • Provided by AFIP • Shipped via FEDEX • Notification of receipt of samples required from HLDs

  5. JBAIDS PT: Program Details • Reagents • Extraction Kits (QFLOW, Scoop, VIBE, and Swipe) • Provided by individual sites • JBAIDS Assay Targets • Lyophilized reagents require reconstitution • Reconstitution water provided in assay kit • Reconstitution buffer provided in assay kit • Provided by individual sites

  6. JBAIDS PT: Program Details • RT-PCR Using JBAIDS Platform • Unknown sample QC done by AFIP • Pre-shipment QC • Post-shipment QC • Results submitted to PT Coordinator • Due 10 business days from the time of receipt of PT samples by HLD

  7. Changes With The JBAIDS PT & Instrumentation • Sites provide their own reagents for PT • JBAIDS software differs from RAPID • User-friendly • Specific positioning of samples • Automatically makes result calls • Notifies user of failed QCs • Produces a “combined call” based on QC results and individual sample results

  8. Changes With The JBAIDS PT & Instrumentation (cont.) • Multiple extraction protocols for different matrices • QFlow (replaced Flow in Fall 07) • Scoop • Swipe • VIBE

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

  10. Scoop & Vibe Extractions • Matrices for Scoop Extraction • Soil (DNA) • Stool (DNA) • Matrices for Vibe Extraction • Whole Blood (DNA) • Nasal Swab (RNA) • Sputum (DNA/RNA)

  11. Swipe Sample Extraction • Matrices • Nasal/Pus Swab • Surface Swab • Powder • Culture Samples

  12. Phases of JBAIDS Extractions • Reconstitution of samples • Sample lysis • Bead Beating • DNA/RNA Bound to filter • Buffer 1 • DNA/RNA Washed of inhibitors • Buffer 2 • DNA/RNA Eluted from the filter • Buffer 3

  13. Submitting Results • Fax Result Forms to AFIP • Fax Conditions & Progress Logs to AFIP • Fax JBAIDS report to AFIP • Forward JBAIDS run files (.ixo) to AFIP • Evaluation of PT • Grades will be determined based on: • JBAIDS report • Result form responses • >80% constitute passing grade for PT

  14. Failures • JBAIDS Failure policy • (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 AFIP PT Coordinator • (Poor) Less than 80% in two out of three consecutive PT periods requires: • The discontinuation of testing until MAJCOM approves resumption • Investigation of failure

  15. 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

  16. 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

  17. Current Status of JBAIDS PT ‘08 • PT events prior to ’08 were educational challanges • JBAIDS PT ‘08 #1 • Shipped on January 4, 2008 • Awaiting final report

  18. Common errors from Past PTs • Common errors • Failure to follow OI • Failure to detect DNA (technical) • Blanks left on result form (clerical)

  19. Common Errors for JBAIDS PT • Failure to follow SOP • Running Target 2 with Target 1 • Target 2 should be ran only when Target 1 is positive • Using wrong extraction kit • Transcription errors • Switching answers • Skipping answers (leaving results blank)

  20. Current • Changes for fall of 2007 • Introduction of inhibition controls for each assay • Introduction of extraction controls for each extraction • Sites will stock the following assays only • Ba target #1 and #2 • Yp target #1 and #2 • F. tularensis • Orthopox • Smallpox

  21. M1M Proficiency Testing • Approximately 27 participants • Testing Format • One unknown • Three target toxins • M1M Test Menu for HLD • Ricin • Bot A • SEB (Staphylococcus enterotoxin B)

  22. M1M Proficiency Test(Cont.) • Supplies • Unknowns • Non-infectious, lyophilized material • Provided by AFIP • Reagents and Instrument supplies • Provided by individual sites • Frequency and Delivery Methods • Three times per fiscal year • M1M PT will be delivered with JBAIDS PT • M1M PT will be scored independently of JBAIDS PT

  23. M1M Proficiency Test (Cont.) • Submitting results • Fax result form to AFIP • Fax conditions and progress logs to AFIP • 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%

  24. Common Errors with M1M PTs • Problems that occurred • Lack of package inserts with controls • Lack of OI • Lack of “key” to coded reagents • Error in reconstitution directions for PT material

  25. AFIP Support • AFIP PT Coordinator • 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

  26. AFIP Proficiency Testing Team

  27. AFIP Contact Information • Dr. Robert Crawford • (202)782-1825 • crawfordr@afip.osd.mil • Dr. Ketan Patel • (202) 782-2847 • patelk@afip.osd.mil • Major Patrick Kennedy • (202) 782-1863 • kennedyp@afip.osd.mil • Dr. Stephen Francesconi • (202)782-1834 • francesconis@afip.osd.mil • Ms. Ellen LaMorena • (202) 782-1861 • dnicuolam@afip.osd.mil

  28. Questions? Comments?

More Related