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The AOAC International Rapid Methods Validation Process

The AOAC International Rapid Methods Validation Process. Ronald Johnson bioM é rieux, Inc. Chair, AOAC Research Institute Board of Directors Board of Director AOAC International. Scott Coates Managing Director AOAC Research Institute. York College-CUNY/FDA workshop Jamaica, NY

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The AOAC International Rapid Methods Validation Process

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  1. The AOAC International Rapid Methods Validation Process Ronald Johnson bioMérieux, Inc. Chair, AOAC Research Institute Board of Directors Board of Director AOAC International Scott Coates Managing Director AOAC Research Institute York College-CUNY/FDA workshop Jamaica, NY Presented May 29, 2008

  2. AOAC Validation Programs • AOAC International • Official Methods of Analysis • AOAC Research Institute • Performance Tested Methods • Harmonized Program

  3. AOAC International • non-profit organization • established in 1874 • review, validation and publication of analytical methods • best known in food and agriculture • chemistry and microbiology methods • international membership • staff of approx. 40 in Gaithersburg, Maryland, USA

  4. AOAC Research Institute • Incorporated in December 1991 as a subsidiary of AOAC INTERNATIONAL • Non-profit, international, scientific organization • Provides rapid entry point into the AOAC validation process and provides a rapid approval process • Provides an independent third-party review of test kit performance claims • Chemistry and microbiology methods • Staff with industry experience

  5. Method Validation Guidelines For Microbiology: • AOAC Guidelines For Validation Of Qualitative And Quantitative Food Microbiological Official Methods Of Analysis published J. Assoc. Off. Anal. Chem. 85, 1187-1203 (2002) • ISO 16140: Protocol for the validation of alternative methods For Chemistry: • "Guidelines for Collaborative Study of Procedure to Validate Characteristics of a Method of Analysis," J. Assoc. Off. Anal. Chem. 72, 694-704(1989) • Used by ISO, AOAC, NMKL, and many others Used when applicable by both AOAC validation programs

  6. Official Methods of Analysis • Published in Official Methods of Analysis of AOAC INTERNATIONAL • Published in Journal of AOAC INTERNATIONAL • Cited in U.S. Code of Federal Regulations • Two Phase Validation – Pre-Collaborative and Collaborative • Number of Collaborative Labs Required: • Quantitative method: 8 laboratories minimum • Qualitative method: 10 laboratories minimum • Data Review by Appropriate Committee and GR • Validation Time: 12-18 Months Minimum to First Action • Final Action can be obtained two years after First Action

  7. Performance Tested Methods • List of Performance Tested Methods published on the internet at http://www.aoac.org/testkits/testedmethods.html • Companies licensed to use certification mark in advertisements and packaging for one year increments – annual reviews • Two-part Validation – Internal Studies and Independent Study • One Independent Laboratory required – contracted by AOAC RI • Data review by two Expert Reviewers and GR • Validation Time: can be less than 6 months

  8. Pre-Collaborative Studies Inclusivity Exclusivity Method Comparison 15-20 foods USDA or FDA reference methods Collaborative Study Method Comparison 8-10 labs 6 foods USDA or FDA reference methods Official Methods of Analysis Validation Study Design

  9. Method Comparison Study • Determines matrices that can be claimed to be validated • A method can NOT be validated for all foods (except for Salmonella OMA methods) • Qualitative methods: • PCS and PTM studies require 20 replicates at each inoculation level and 5 uninoculated controls or 20 replicates of naturally contaminated • CS requires 6 replicates at each inoculation level and 6 uninoculated controls per laboratory • MUST obtain fractionally positive results • Quantitative methods require five replicates at each of three inoculated levels and five uninoculated controls or 3 lots of naturally contaminated foods

  10. Internal Studies Inclusivity Exclusivity Method Comparison 10 foods for “Variety of Foods” choice of reference methods Ruggedness Stability Lot-to-Lot Variation Independent Study Method Comparison 1 laboratory 1-2 foods Performance Tested Methods Validation Study Design

  11. Harmonized Program • Administered through AOAC RI • PTM studies are equivalent to the OMA Pre-Collaborative Study • Obtain Certification Mark first • Continue on to Collaborative Study to obtain OMA First Action

  12. Harmonization Overview 2 AOAC approvals and 2 published studies in Journal of AOAC, ILM article Use of Certification Mark

  13. Inclusivity rate Exclusivity rate Sensitivity rate Specificity rate False Positive rate False Negative rate Repeatability Reproducibility Method Agreement or McNemar’s Chi-Square Limit of Detection or Limit of Quantitation Relative Standard Deviation Performance Indicators

  14. Several laboratories to choose from. Submits a bid for the study based upon approved testing protocol Contracted with AOAC RI, the lab performs evaluation based upon protocol and kit package insert. Report submitted to Research Institute Independent Laboratoriesfor PTM Program

  15. AOAC General Referee Approves all testing protocols and reviews the final Validation Report Two Expert Reviewers 50% of Expert Reviewers are from outside of the US Reviews Validation Report Expert Reviewers for PTM program

  16. Sponsor Compiles validation report of internal report and independent laboratory information Reply to reviewers’ comments and/or suggestions Reviewers Review validation report for technical and editorial criteria and package insert Provide commentary on report and/or insert Performance TestedSM status granted upon consensus Review Processfor PTM program

  17. Review & respond to all Certification documentation Inside Laboratory Management Article J of AOAC publication of study List on website databases License Agreement and Use of the Mark Annual Renewal Certification for PTM program

  18. List of Approved Performance Tested Methodssm

  19. Survey ofPerformance Tested Methodssm • Survey is not all inclusive • Intended to provide a snap-shot of approved kits • Approved methods come and go • Visit the AOACRI website to find out if a kit is PTM approved • http://www.aoac.org/testkits/testedmethods.html

  20. BioControl Systems, Inc • SimPlate for TPC (Total Plate Count) • Assurance GDS for Salmonella • Assurance GDS™ for Listeria spp. • Assurance GDS™ for L. monocytogenes

  21. BD Diagnostics • BBLTM CHROMagarTM • Salmonella • Listeria • O157 • Staph aureus

  22. bioMérieux, sa • VIDAS® • VIDAS®Listeria (LIS)Assay • VIDAS®E. coli O157 (ECO) Test with O157:H7 ID Agar: 8 Hour and 24 Hour  Methods • VIDAS® Staph enterotoxin II (SET2) • VIDAS®Listeria species Xpress (LSX) with Ottaviani Agosti Agar (OAA) 0157:H7 ID OAA

  23. bioMérieux, sa • TEMPO® • TVC (Total Viable Count) Method • EC ( E. coli ) Test • CC (Coliform Count) • EB (Enterobacteriaceae)

  24. bioMérieux, Inc • VITEK® 2 • VITEK® 2 GP (Gram-Positive Identification Card) • VITEK® 2 GN (Gram-Negative Identification Card)

  25. Bio-Rad Laboratories • RAPID’chromogenic media • RAPID’E.coli O157:H7 Agar • RAPID’E. coli 2 Agar • RAPID’Staph Agar • RAPID’Listeria spp. Agar • RAPID’L.Mono Agar • RAPID’Salmonella Agar

  26. Bio-Rad Laboratories • iQ-Check Listeria spp. Real-Time PCR Test Kit

  27. Chisso Corporation • Sanita-kun Total Plate Count • Sanita-kun Coliforms

  28. Centrus International / FOSS A/S • Soleris/ MicroFoss Coliform Test

  29. Matrix MicroScience Ltd • PATHATRIX • Salmonella species Pooling Test System • Listeria species Test System • Listeria species Pooling Test System • Listeria/Salmonella species • Salmonella species • E.coli O157 Test System 

  30. Merck KGaA • Singlepath® • E. coli O157 Lateral Flow Assay • Salmonella Lateral Flow Assay • Campylobacter Lateral Flow Assay • Duopath® Verotoxin Lateral Flow Assay

  31. Neogen Corporation • Reveal • Salmonella spp. • Listeria Test System • GENE TRAK • Salmonella DLP Assay • Listeria DLP Assay

  32. Neogen Corporation • GeneQuence • Salmonella Microwell assay  • Listeria Microwell Test • Listeria monocytogenes Test

  33. Nissui Pharmaceutical Co. • Compact Dry • Total Count • Compact Dry YM • Compact Dry CF • Compact Dry EC

  34. Qualicon, Inc. • BAX® System with Automated Detection PCR Assay for: • Screening L. monocytogenes  • Screening Listeria genus • Screening for Salmonella • E. coli O157:H7 Kit • Screening E. coli O157:H7 MP • Campylobacter jejuni / coli / lari

  35. Qualicon, Inc. • DuPont Lateral Flow System • Listeria Test Kit • E. coliO157 Test Kit • Salmonella Test Kit

  36. Raisio Diagnostics AB • Transia Plate for: • Salmonella Gold • E. coliO157 • Transia Card for: • E. coli O157

  37. Strategic Diagnostics Inc. • RapidCheck for: • E. coli O157 (including H7) Lateral Flow Assay • Salmonella Lateral Flow Assay • Select ™ Salmonella Test • Listeria species Lateral Flow Test • Listeria species Media

  38. 3M Microbiology • 3M Petrifilm Environmental Listeria Plate

  39. Survey of Performance Tested Methodssm • Approved methods come and go. • Visit the AOACRI website to find out if a kit is PTM approved • http://www.aoac.org/testkits/testedmethods.html

  40. Survey ofOfficial Methods of Anlaysis Rapid microbiobiology methods granted Official Methods of Anlaysis since 2000

  41. BioControl Systems, Inc 2002.07 SimPlate® Total Plate 2002.11 SimPlate® Yeast and Mold Color Indicator (Y&M-CI) 2005.03 Simplate® Coliform and E. coli

  42. BioControl Systems, Inc 2005.04 Assurance GDSTM for E. coli O157:H7 • 2005.05 Assurance GDSTM for Shigatoxin Genes

  43. bioMérieux, Inc • 2001.07 VIDAS® Immuno‑Concentration Salmonella Assay (ICS) in Combination with Salmonella Selective Plating Media: SMID/BS/HE • 2001.08 VIDAS® Immuno‑Concentration Salmonella Assay (ICS) in Combination with Salmonella Selective Plating Media: XLD/BS/HE • 2001.09 Salmonella in Foods, VIDAS® Immuno‑Concentration Salmonella (ICS) in Combination with VIDAS (SLM) Salmonella Method

  44. bioMérieux, Inc • 2004.02 VIDAS® Listeria monocytogenes II (LMO2) Immunoassay Method • 2004.03 VIDAS® Salmonella (SLM) Immunoassay • 2004.06 VIDAS® Listeria species (LIS) Immunoassay Method

  45. Dupont Qualicon • 2003.09 • BAX® System for the Detection of Salmonella • 2003.12 BAX® Automated System for the Detection of Listeria monocytogenes

  46. Neogen Corp. • 2000.13 • REVEAL for Escherichia coli O157:H7 Screening Test • 2007.02 • GeneQuenceTMSalmonella

  47. Tecra • 2000.07 TECRA Unique Salmonella Test • 2002.09 TECRA Listeria Visual Immunoassay (modification)

  48. 3M Petrifilm™ 2000.15 Rapid Enumeration of Coliforms 2001.05 Rapid S. aureus Count Plate

  49. 3M Petrifilm™ 2003.01 Enterobacteriaceae Count Plate 2003.07, 2003.08 & 2003.11 Staph Express Count Plate

  50. AOAC Validation Completed ThankYou www.aoac.org

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