AOAC RI ERP Final Action Recommendations eBook

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EXPERT REVIEW PANEL (ERP) FOR MICROBIOLOGY FOR FOOD AND ENVIRONMENTAL SURFACES

AOAC Final Action Recommendations for OMA Methods 2012.01, 2013.01, 2013.02, 2013.09, 2013.10, 2013.11, and 2013.14

Prepared February 5, 2016

The Official Methods of Analysis SM (OMA) program is AOAC INTERNATIONAL's premier methods program and is administered through the AOAC Research Institute.

AOAC INTERNATIONAL Official Methods of Analysis SM (OMA) AOAC First Action Methods Recommended for AOAC Final Action Status

TABLE OF CONTENTS

EXPERT REVIEW PANEL FOR MICROBIOLOGY FOR FOODS AND ENVIRONMENTAL SURFACES I. Expert Review Panel Chair Reports

a. Expert Review Panel Chair Report (March, 2013) ............................................................................... 6 b. Expert Review Panel Chair Report (June, 2013) .............................................................................. 12 c. Expert Review Panel Chair Report (December, 2013) ...................................................................... 18 d. Expert Review Panel Chair Report (March, 2014) ............................................................................ 24

II. AOAC Official Method 2012.02: Gram-Positive Bacteria Identification Kit Name: VITEK® 2 Gram Positive (GP) Biochemical Identification Meth

Company: bioMérieux, Method Status: First Action 2012 ............................................................................. 33 a. Method Developer Final Action Feedback Submission...................................................................... 35

III.

AOAC Official Method 2013.01: Salmonella in a Variety of Foods Kit Name: VIDAS ® UP Salmonella (SPT) Method

Company: bioMérieux, Method Status: First Action 2013 ............................................................................. 39 a. Method Developer Final Action Feedback Submission...................................................................... 43

IV. AOAC Official Method 2013.02: Salmonella Species in a Variety of Foods and Environmental Surfaces Kit Name: BAX ® System Real-Time PCR Assay for Salmonella Company: DuPont Nutrition & Health, Method Status: AOAC First Action 2013 ........................................47 a. Method Developer Final Action Feedback Submission...................................................................... 52 b. ERP Summary of Reviews – First Action............................................................................................. 65 c. ERP Safety Review – First Action........................................................................................................ 77 d. ERP Statistics Review – First Action – N/A ............................................................................................ - e. OMA Collaborative Study Manuscript ............................................................................................... 79 f. OMA Pre-Collaborative Study Manuscript....................................................................................... 123 g. OMA Collaborative Study Protocol .................................................................................................. 161 h. PTM Certification – Modification Report ........................................................................................ 219 i. PTM Certification Report ................................................................................................................. 247 j. Method Safety Checklist .................................................................................................................. 289 Company: 3M Food Safety, Method Status: AOAC First Action 2013, Revised First Action 2014 ............... 297 a. Method Developer Final Action Feedback Submission.................................................................... 297 b. ERP Summary of Reviews – First Action – Primary Reviewer .......................................................... 299 c. ERP Summary of Reviews – First Action – Secondary Reviewer ..................................................... 303 d. ERP Safety Review – First Action ..................................................................................................... 307 e. ERP Statistics Review – First Action ................................................................................................. 309 f. OMA Collaborative Study Manuscript ............................................................................................. 311 g. OMA Collaborative Study Protocol .................................................................................................. 377 h. PTM Certification – Modification Report ........................................................................................ 403 i. PTM Certification Report ................................................................................................................. 459 j. Material Safety Data Sheets............................................................................................................. 489 V. AOAC Official Method 2013.09: Salmonella in Selected Foods Kit Name: 3M™ Molecular Detection Assay (MDA) Salmonella Method

Page 1 of 2

k. Method Safety Checklist .................................................................................................................. 515

VI. AOAC Official Method 2013.10: Listeria species in a Variety of Foods and Environmental Surfaces Kit Name: VIDAS® UP Listeria (LPT) Method

Company: bioMérieux, Method Status: AOAC First Action 2013 ................................................................ 517 a. Method Developer Final Action Feedback Submission.................................................................... 521 b. ERP Summary of Reviews – First Action........................................................................................... 525 c. ERP Safety Review – First Action ..................................................................................................... 533 d. ERP Statistics Review – First Action ................................................................................................. 535 e. OMA Collaborative Study Manuscript/ Pre-Collaborative Study Report ......................................... 537 f. OMA Collaborative Study Protocol- Combined LPT and LMX .......................................................... 641 g. Eurofins AFNOR Validation Summary ............................................................................................. 681 h. AFNOR Validation............................................................................................................................. 739 i. Method Safety Checklist .................................................................................................................. 745 Company: bioMérieux, Method Status: AOAC First Action 2013 ................................................................ 747 a. Method Developer Final Action Feedback Submission.................................................................... 751 b. ERP Summary of Reviews – First Action........................................................................................... 755 c. ERP Safety Review – First Action ..................................................................................................... 763 d. ERP Statistics Review – First Action ................................................................................................. 765 e. OMA Collaborative Study Manuscript ............................................................................................. 767 f. OMA Collaborative Study Protocol .................................................................................................. 835 g. PTM Certification – Modification Report ........................................................................................ 875 h. PTM Certification Report ................................................................................................................. 892 i. Eurofins AFNOR Validation Summary ............................................................................................. 955 j. AFNOR Validation........................................................................................................................... 1035 k. Method Safety Checklist ................................................................................................................ 1047 Company: Neogen Corp., Method Status: AOAC First Action 2013 .......................................................... 1049 a. Method Developer Final Action Feedback Submission.................................................................. 1051 b. ERP Summary of Reviews – First Action......................................................................................... 1063 c. ERP Safety Review – First Action ................................................................................................... 1071 d. ERP Statistics Review – First Action – N/A ........................................................................................... - e. OMA Collaborative Study Manuscript ........................................................................................... 1073 f. OMA Pre-Collaborative Study Report ........................................................................................... 1103 g. OMA Collaborative Study Protocol ................................................................................................ 1135 h. Package Insert/User Guide............................................................................................................. 1179 i. Method Safety Checklist ................................................................................................................ 1185 AOAC Official Method 2013.11: Listeria monocytogenes in a Variety of Foods Kit Name: VIDAS® Listeria monocytogenes Xpress (LMX) Method AOAC Official Method 2013.14: Identification of Salmonella spp. from Colony Picks Kit Name: ANSR® Salmonella Confirmation Test

VII.

VIII.

Page 2 of 2

AOAC RESEARCH INSTITUTE Official Methods of Analysis SM (OMA) Expert Review Panel on Microbiology for Food and Environmental Surfaces ( Salmonella )

METHODS FOR CONSIDERATION Conclusion: The Expert Review Panel reviewed the collaborative study for OMAMAN-01 “ Detection of Salmonella species in a Variety of Foods by the DuPont™ BAX® System Real-Time PCR Assay for Salmonella” . Methods Reviewed: Each method collected by AOAC for consideration by this ERP is reviewed by all members. The decisions of this ERP are reflective of both the submitted method review forms and the in person meeting held on Tuesday, March 12, 2013.

M ETHOD N O .

M ANUSCRIPT TITLE

D ETECTION OF S ALMONELLA SPECIES IN A V ARIETY OF F OODS BY THE D U P ONT ™BAX® S YSTEM R EAL -T IME PCRA SSAY FOR S ALMONELLA : C OLLABORATIVE S TUDY A UTHORS F. M ORGAN W ALLACE , B RIDGET A NDALORO , D AWN F ALLON , N ISHA C ORRIGAN , S TEPHEN V ARKEY , D ANIEL D E M ARCO , A NDREW F ARNUM , M ONICA T ADLER , S TEVEN H OELZER , J ULIE W ELLER , E UGENE D AVIS , J EFFREY R OHRBECK AND G EORGE T ICE , D U P ONT N UTRITION &H EALTH , ESL B UILDING 400, R OUTE 141 &H ENRY C LAY R OAD , W ILMINGTON , D ELAWARE 19880, P ATRICK B IRD , E RIN C ROWLEY , J ONATHAN F LANNERY , K IEL F ISHER , T RAVIS H UFFMAN , M EGAN B OYLE , M. J OSEPH B ENZINGER , J R ., P AIGE B EDINGHAUS , K ATIE G OETZ , W ILLIAM J UDD , J IM A GIN AND D AVID G OINS , Q L ABORATORIES , I NC ., 1400 H ARRISON A VENUE , C INCINNATI , O HIO 45214 C OLLABORATORS D. C LARK ; B. D IECKELMAN ; T. D ONOHUE ; H. E LGAALI ; W. F EDIO ; E. G ALBRAITH ; B. K UPSKI ; K. M C C ALLUM ; G. M C W HORTER ; J. M EYER ; D. S WIFT ; R. R ADCLIFF ; D. R ODGERS ; M. S TEELE ; L. T HOMPSON

OMAMAN-01

ERP DECISION(S)

ERP ACTIONS FOR OTHER & FINAL ACTION REQUIREMENTS

VOTE

DECISION DATE

The following revisions are recommended for the Detection of Salmonella species in a Variety of Foods by the DuPont™ BAX ® System Real-Time PCR Assay for Salmonella : Collaborative Study (revision 2-Redline) as submitted on March 11, 2013: Please refer to next page.

M OTION P ASSED U NANIMOUS Hitchins/Chen M OTION P ASSED UNANIMOUS

Motion to move forward to First Action Official Method Status.

March 12, 2013

Motion to not require a statistics review of the Collaborative Study Protocol.

The ERP recommended that a statistics review maybe required only if there is a modification to an approved Collaborative Study Protocol.

March 12, 2013

Hitchins/Chen

AOAC-RI OMA ERP Chart Chart 03-12-2013

AOAC RESEARCH INSTITUTE Official Methods of Analysis SM (OMA) Expert Review Panel on Microbiology for Food and Environmental Surfaces ( Salmonella )

ERP ACTIONS FOR OTHER & FINAL ACTION REQUIREMENTS

Page No.

Line No.

Section

General Recommendation

Editorial Changes

Move specifics from applicability sections to introduction section. Verify reference method for matrices, frankfurters and orange juice.

Page 2

Lines 23-28

Introduction Section

Page 3

Lines 6-8

Study Design

Test Sample Inoculation and Distribution Test Sample Inoculation and Distribution Test Sample Inoculation and Distribution Test Sample Inoculation and Distribution Test Sample Inoculation and Distribution AOAC Official Method Section Applicability Statement Sample Enrichment/Cream Cheese (25g)

Page 3

Lines 11-37

Add specifics to test sample matrices (i.e., 85% lean).

Page 3

Lines 11-37

Add description on how it is done.

Add table showing stressed matrices.

Page 3

Lines 11-37

Indicate stressed acidifying portion for orange juice.

Page 3

Lines 11-37

Include data that shows heat stress (table stress % injury).

Page 3

Lines 11-37

Page 4

Line 7

Add PTM Certification Number and Date Remove “85% lean”, “12% fat”, and “instant”. Change “22-26 hours” to “12-26 hours” Change “significant differences” to “no detectable variations detected”

Page 4

Lines 10-15

Page 8

Line 7

Page 13

Lines 25-26

Results and Discussion

Page 13

Lines 2-26

Results and Discussion

Add section discussing figures.

Transfer AOAC acronyms from Pre-collaborative Report to Collaborative Report; Tables 1-7 add acronyms so each table can stand on its own.

Pages 15-24

-------

Tables 1 - 7

AOAC-RI OMA ERP Chart Chart 03-12-2013

AOAC RESEARCH INSTITUTE Official Methods of Analysis SM (OMA) Expert Review Panel on Microbiology for Food and Environmental Surfaces ( Salmonella )

OBSERVERS

EXPERT REVIEW PANEL MEMBERS

Name

Company

Name

Company

Patrick Bird Joe Boison Jim Harnly

Q Laboratories

Michael Brodsky, Chair

Brodsky Consultants

CFIA USDA DuPont

Yi Chen

US FDA-CFSAN

Donna Douey Tony Hitchins

CFIA

Steven Hoelzer Ronald Johnson John Szpylka Morgan Wallace

US FDA-CFSAN (retired)

bioMerieux, Inc.

Silliker Inc.

Not Present

DuPont

Wendy McMahon

Silliker, Inc.

Maya Achen

Ohio Dept. of Agriculture ANMAT/Ministry of Health Univ. of Buenos Aires Chair, Committee on Safety Member, Committee on Statistics

Maria C. Fernandez

Below are the recommendations from the voting members of the ERP based upon their submitted method review forms for the ERP adopt this method as an AOAC Official Methods of Analysis (First Action status) .

Dermot Hayes

Robert LaBudde

Thomas Hammack

US FDA-CFSAN

Reviewer

Recommendation

Michael Brodsky, Chair

First Action First Action

Yi Chen

Donna Douey Tony Hitchins

First Action w/revisions

AOAC STAFF

First Action First Action First Action First Action

Jim Bradford, Executive Director

Wendy McMahon

Deborah McKenzie Tien Milor La’Kia Phillips

Maya Achen

Maria C. Fernandez

AOAC-RI OMA ERP Chart Chart 03-12-2013

AOAC RESEARCH INSTITUTE Official Methods of Analysis SM (OMA) Expert Review Panel on Microbiology for Food and Environmental Surfaces ( Listeria spp. & Listeria Monocytogenes )

METHODS FOR CONSIDERATION Conclusion: The Expert Review Panel reviewed the collaborative study for OMAMAN-02 “ Detection of Listeria monocytogenes in a Variety of Foods by the VIDAS® L. monocytogenes Xpress (LMX) Method: Collaborative Study” and OMAMAN-03 “ D etection of Listeria species in a Variety of Foods by the VIDAS® UP Listeria (LPT) Method: Collaborative Study”. Methods Reviewed: Each method collected by AOAC for consideration by this ERP is reviewed by all members. The decisions of this ERP are reflective of both the submitted method review forms and the in person meeting held on Monday, June 24, 2013.

M ETHOD N O .

M ANUSCRIPT TITLE

EVALUATION OF VIDAS  LISTERIA MONOCYTOGENES XPRESS (LMX) FOR THE DETECTION OF LISTERIA MONOCYTOGENES IN A VARIETY OF FOODS: COLLABORATIVE STUDY A UTHORS Erin Crowley, Patrick Bird, Jonathan Flannery, M. Joseph Benzinger, Jr., Kiel Fisher, Megan Boyle, Travis Huffman, Ben Bastin, Paige Bedinghaus, Will Judd, Thao Hoang, James Agin, David Goins, Q Laboratories, Inc., 1400 Harrison Ave, Cincinnati, OH 45214, Ronald L. Johnson, bioMérieux, Inc., 595 Anglum Rd, Hazelwood, MO 63042 C OLLABORATORS J. Mills, P. Rule, B. Howard, N. Rogman, J. Cannon , B. Paul, M. Sala-Rhatigan, S. Josephs, N. Palen, A. Stegmann, B. Perry, R. Hiles, T. Stubblefield, N. Nagassar, Sylvanus Owusu, J. Zimmerman, B. Brahmanda, H. Elgaali, A. Capps, G. Rosario, D. Davis, L. Parker, C. Said, J. Li, K. Klemms, B. May, B. Hand, R. Burkhart, J. Pickett, J. Adams, A. Bollenbacher, K. Wiggins, L. Cesanas, J. Jolly, S. Moore, D. Ebbing, M. Michels, A. Kehres, J. Hirsch

OMAMAN-02

ERP DECISION(S)

ERP ACTIONS FOR OTHER & FINAL ACTION REQUIREMENTS

VOTE

DECISION DATE

M OTION P ASSED

Motion to move forward to First Action Official Method Status.

U NANIMOUS

June 24, 2013

Brodsky/Hitchins

AOAC-RI OMA ERP Chart Chart 06-24-2013

AOAC RESEARCH INSTITUTE Official Methods of Analysis SM (OMA) Expert Review Panel on Microbiology for Food and Environmental Surfaces ( Listeria spp. & Listeria Monocytogenes )

M ETHOD N O .

M ANUSCRIPT TITLE

EVALUATION OF VIDAS  UP LISTERIA ASSAY (LPT) FOR THE DETECTION OF LISTERIA IN A VARIETY OF FOODS AND ENVIRONMENTAL SURFACES: COLLABORATIVE STUDY A UTHORS Erin Crowley, Patrick Bird, Jonathan Flannery, M. Joseph Benzinger, Jr., Kiel Fisher, Megan Boyle, Travis Huffman, Ben Bastin, Paige Bedinghaus, William Judd, Thao Hoang, James Agin, David Goins, Q Laboratories, Inc., 1400 Harrison Ave, Cincinnati, OH 45214, Ronald L. Johnson, bioMérieux, Inc., 595 Anglum Rd, Hazelwood, MO 63042 C OLLABORATORS J. Mills, P. Rule, B. Howard, N. Rogman, J. Cannon, B. Paul, M. Sala-Rhatigan, S. Josephs, N. Palen, A. Stegmann, B. Perry, R. Hiles, T. Stubblefield, N. Nagassar, Sylvanus Owusu , J. Zimmerman, B. Brahmanda, H. Elgaali, A. Capps, G. Rosario, D. Davis, L. Parker, C. Said, J. Li, K. Klemms, B. May, B. Hand, R. Burkhart, J. Pickett, , A. Bollenbacher, K. Wiggins, L. Cesanas, J. Jolly, S. Moore, D. Ebbing, M. Michels, A. Kehres, J. Hirsch

OMAMAN-03

ERP DECISION(S)

ERP ACTIONS FOR OTHER & FINAL ACTION REQUIREMENTS

VOTE

DECISION DATE

M OTION P ASSED

Motion to move forward to First Action Official Method Status.

U NANIMOUS

June 24, 2013

Brodsky/Hitchins

AOAC-RI OMA ERP Chart Chart 06-24-2013

AOAC RESEARCH INSTITUTE Official Methods of Analysis SM (OMA) Expert Review Panel on Microbiology for Food and Environmental Surfaces ( Listeria spp. & Listeria Monocytogenes )

EXPERT REVIEW PANEL MEMBERS

OBSERVERS

Name

Organization

Name

Organization Q Laboratories bioMérieux, Inc. bioMérieux, Inc.

Michael Brodsky, Chair

Brodsky Consultants

Patrick Bird

Yi Chen

US FDA-CFSAN

Ronald Johnson

ANMAT/Ministry of Health Univ. of Buenos Aires

John Mills

Maria C. Fernandez Tony Hitchins Yvonne Salfinger Not Present Wendy McMahon Maya Achen Donna Douey Dermot Hayes Robert LaBudde Thomas Hammack

US FDA-CFSAN (retired)

Ray Turnley

bioMérieux, Inc.

Silliker, Inc.

Below are the recommendations from the voting members of the ERP based upon their submitted method review forms for the ERP adopt this method as an AOAC Official Method of Analysis (First Action status) .

Ohio Dept. of Agriculture

CFIA

Chair, Committee on Safety Member, Committee on Statistics

Recommendation

Reviewer

OMAMAN-02 First Action

OMAMAN-03

US FDA-CFSAN

Michael Brodsky, Chair

First Action w/editorial changes First Action w/data

AOAC STAFF

Yi Chen

First Action

Jim Bradford, Executive Director

Donna Douey

First Action, if concerns are addressed by ERP

First Action, if concerns are addressed by ERP

Deborah McKenzie

Tony Hitchins Maya Achen

First Action First Action First Action

First Action First Action First Action

Tien Milor

La’Kia Phillips

Maria C. Fernandez Yvonne Salfinger

First Action w/minor changes

First Action w/changes

AOAC-RI OMA ERP Chart Chart 06-24-2013

AOAC RESEARCH INSTITUTE Official Methods of Analysis SM (OMA) Expert Review Panel on Microbiology for Food and Environmental Surfaces ( Salmonella spp.)

OFFICIAL CHAIR’S EXPERT REVIEW PANEL REPORT ACKNOWLEDGMENT

The undersigned chair hereby confirms that the following document has been reviewed and constitutes the final revised version of the Official Chair’s Report for the Expert Review Panel on Microbiology for Food and Environmental Surfaces ( Salmonella spp.) held on December 12, 2013.

M.H.Brodsky

________________________________________________________ Michael Brodsky, Expert Review Panel Chair Wendy McMahon, Expert Review Panel Chair

______________________________ Date December 18, 2013

Please sign, date and fax this document to La’Kia Phillips at 301-924-7089.

AOAC-RI OMA ERP Chart Chart 12-12-2013

AOAC RESEARCH INSTITUTE Official Methods of Analysis SM (OMA) Expert Review Panel on Microbiology for Food and Environmental Surfaces ( Salmonella spp.)

METHODS FOR CONSIDERATION Conclusion: The Expert Review Panel reviewed the collaborative study for OMAMAN-07: Evaluation of the ANSR® for Salmonella Assay for Identification of Salmonella spp. from Colony Picks from Selective/Differential Agar Media. Methods Reviewed: Each method collected by AOAC for consideration by this ERP is reviewed by all members. The decisions of this ERP are reflective of both the submitted method review forms and the in person meeting held on Thursday, December 12, 2013.

M ETHOD N O .

M ANUSCRIPT TITLE

EVALUATION OF THE ANSR® FOR SALMONELLA ASSAY FOR IDENTIFICATION OF SALMONELLA SPP. FROM COLONY PICKS FROM SELECTIVE/DIFFERENTIAL AGAR MEDIA A UTHORS Mark Mozola 1 , Oscar Caballero, Nicole Enslin, Preetha Biswas, and Jennifer Rice, Neogen Corp., 620 Lesher Place, Lansing, MI 48912, 1 Corresponding author’s email: mmozola@neogen.com C OLLABORATORS E.S. Adams, H. Alnughaymishi, J.B. Barrett, J. Benzinger, M.E. Berrang, M. Boyle, J. Cannon, D. Clark, A. Copeland, M. Corebello, D.E. Cosby, N.A. Cox, N. Cuthbert, H. Dammann, J. Dyszel, E. Feldpausch, J. Flannery, C. Flores, J.G. Frye, R. Fuller, V. Gill, L.M. Hiott, B. Howard, M. Hudgens, C.R. Jackson, W. Jones, S.W. Knapp, L. Kuepfer, P. Kulkarni, B. Kupski, C. Pidgeon, A. Quenneville, L.L. Rigsby, N. Rogman, E. Sai, A. Scollon, M. Sisemore, J. Stepnitz, J. Van Brunt, M. Vross, D. Waltman, H. Wang, G. Whitbeck, S. York, L. Zhang

OMAMAN-07

ERP DECISION(S)

ERP ACTIONS FOR OTHER & FINAL ACTION REQUIREMENTS

VOTE

DECISION DATE

M OTION P ASSED

Requirements for Final Action:

Motion that this method be adopted for First Action Official Method status.

1. Actively solicit feedback and submit to the Expert Review Panel .

U NANIMOUS

December 12, 2013

Brodsky, Salfinger

AOAC-RI OMA ERP Chart Chart 12-12-2013

AOAC RESEARCH INSTITUTE Official Methods of Analysis SM (OMA) Expert Review Panel on Microbiology for Food and Environmental Surfaces ( Salmonella spp.)

EXPERT REVIEW PANEL MEMBERS

OBSERVERS

Name

Organization

Name

Organization Neogen Corp. Q Laboratories

Michael Brodsky, Chair Wendy McMahon, Chair

Brodsky Consultants

Mark Mozola

Silliker, Inc.

Erin Crowley (OMB Rep.)

Maria C. Fernandez Tony Hitchins Yvonne Salfinger Donna Douey Thomas Hammack

ANMAT/ Univ. of Buenos Aires

US FDA-CFSAN (retired)

CFIA

US FDA-CFSAN

Below are the recommendations from the voting members of the ERP based upon their submitted method review forms for the ERP adopt this method as an AOAC Official Method of Analysis (First Action status) .

Not Present Maya Achen

Ohio Dept. of Agriculture

Reviewer

OMAMAN-07 First Action

Yi Chen

US FDA-CFSAN

Robert LaBudde

Member, Committee on Statistics

Maya Achen

Michael Brodsky, Chair

First Action, if concerns are addressed by ERP First Action, if concerns are addressed by ERP

AOAC STAFF

Donna Douey

Jim Bradford, Executive Director

Maria C. Fernandez Tom Hammack Tony Hitchins Wendy McMahon Yvonne Salfinger

First Action First Action First Action

Deborah McKenzie

Tien Milor

La’Kia Phillips

First Action with Revisions

First Action, if concerns are addressed by ERP .

AOAC-RI OMA ERP Chart Chart 12-12-2013

AOAC Official Method 2012.02 Gram-Positive Bacteria Identification VITEK ® 2 Gram Positive (GP) Biochemical Identification Method First Action 2012 (Applicable to the identification of Gram-positive bacteria, including Listeria and Staphylococcus species.) See Tables 2012.02A and 2012.02B for results of the interlaboratory study supporting acceptance of the method. Claimed Gram-positive species validated in both the precollaborative and collaborative studies: Listeria grayi, Listeria innocua, Listeria ivanovii ssp. Ivanovii, Listeria ivanovii ssp. Londoniensis, Listeria monocytogenes, Listeria seeligeri, Listeria welshimeri, Staphylococcus hyicus, Staphylococcus intermedius, Staphylococcus aureus, Staphylococcus aureus, and Staphylococcus epidermidis . A. Principle The VITEK 2 system is an automated microbial identification system that utilizes the VITEK 2 Gram-positive (GP) identification card for the identification of most significant Gram-positive organisms. The VITEK 2 GP card is based on 43 biochemical tests measuring carbon source utilization, inhibition and resistance, and enzymatic activities. Identification results are available in approximately 8 h or less. B. Apparatus and Reagents ( a )  VITEK 2 system. ( b )  VITEK 2 GP test cards. ( c )  Vortex. ( d )  Incubators .—Set to 30°C and 35–37°C.

Table 2012.02B. Interlaboratory study results for the VITEK 2 GP identification method: Exclusivity isolates

Not tested c Total d

Organism

Misidentified a Unidentified b

3 0 0 0 0 6

27

10 40 20 20 14 20 20 20 20 20 14 20

Bacillus coagulans Citrobacter freundii

0 6 0 0 0

Escherichia coli

Serratia marcescens Aspergillus niger Candida albicans  Total Isolates

( j )  Sterile sticks or swabs. ( k )  Brain Heart Infusion (BHI) slants. ( l )  Culture media .—Columbia agar with 5% sheep blood (CBA), Trypticase soy agar (TSA), or Trypticase soy agar with 5% sheep blood (TSAB) plates. C. General Instructions ( a ) The test cannot be performed without a pure culture. A pure culture may be obtained by streaking out the isolate on CBA, TSA, or TSAB plates. ( b ) Gram stain purified isolate prior to preparing VITEK 2 GP test card to verify presence of Gram-positive organism. 98 140 a  Organism was incorrectly characterized by Gram stain and was improperly tested by the VITEK 2 GP method resulting in misidentification. b  Organism was incorrectly characterized by Gram stain and was improperly tested by the VITEK 2 GP method resulting in no identification. c  Organism was excluded by Gram stain procedure and was not tested on VITEK 2 GP card as per protocol. d  Total numbers represent each strain not tested and strains that were misidentified and unidentified. e  Total number of isolates incorrectly tested by the VITEK 2 GP method after erroneous Gram stain result. 9 e 33 e

( e )  VITEK 2 DENSICHEK kit. ( f )  DENSICHEK calibrator . ( g )  VITEK 2 cassette .

( h )  Sterile saline .—Aqueous 0.45 to 0.50% NaCl, pH 4.5 to 7.0. ( i )  Disposable test tubes .—12 × 75 mm clear plastic (polystyrene).

Table 2012.02A. Interlaboratory study results for the VITEK 2 GP identification method: Claimed isolates Organism Correct Misidentified Unidentified Not tested a

Total b AOAC Research Institute Expert Review Panel Use Only

60 60 60 60 60 57 60 60 60 60 57 60

0 0 0 0 0 0 0 0 0 0 0 0 0

0 0 0 0 0 0 0 0 0 0 0 0 0

0 0 0 0 0 3 0 0 0 0 3 0 6

60 60 60 60 60 60 60 60 60 60 60 60

Listeria grayi

Listeria innocua

Listeria ivanovii ssp. Ivanovii Listeria ivanovii ssp. Londoniensis

Listeria monocytogenes

Listeria seeligeri Listeria welshimeri

Staphylococcus hyicus

Staphylococcus intermedius Staphylococcus aureus Staphylococcus aureus Staphylococcus epidermidis

 Total isolates

714

720

a  Organism was incorrectly characterized by Gram stain and was not tested on VITEK 2 GP card. b  Total numbers represent isolates analyzed on the three recommended culture media: CBA, TSA, and TSAB.

© 2012 AOAC INTERNATIONAL

( c )  Caution : Dispose of all reagents and other contaminated materials by acceptable procedures for potentially biohazardous materials. All microbial cultures are potentially infectious and should be treated with universal precautions. ( d ) Store VITEK 2 GP cards at 2–8°C. ( e ) Do not freeze test cards. ( f ) Bring reagents to room temperature before inserting them into the VITEK 2 instrument. ( g ) Return unused cards to 2–8°C immediately after use. Note :  A Gram stain should be performed to determine a pure culture’s Gram reaction and morphology prior to selecting which VITEK 2 identification card to inoculate. Interpretation of test results requires the judgment and skill of a person proficient in Gram staining and knowledgeable in the interpretation of the Gram reaction and morphology of microorganisms. D. Preparation of Test Suspension ( a ) Aseptically transfer 3.0 mL sterile saline (aqueous 0.45 to 0.50% NaCl, pH 4.5–7.0) into polystyrene test tubes (12×75 mm). Do not use glass tubes. ( b ) Using a sterile stick or swab, transfer a sufficient number of colonies from a 24 h culture on recommended culture medium to the saline tube to achieve a density equivalent to McFarland 0.50 to 0.63 with the VITEK 2 DENSICHEK. ( c ) Test the cultures by the VITEK 2 GP method within 30 min of preparation of the suspended culture. ( d ) Insert the culture tube and the VITEK 2 GP card into the VITEK 2 cassette and refer to the User Manual (to be provided with the instrument) for instructions on use of the instrument. ( e ) Report identification results from the VITEK 2 system. ( f ) As indicated in theVITEK 2 GPproduct information provided to end-users, slashline or low discrimination identifications are acceptable results for the VITEK 2 GP method that require supplemental tests to further resolve the organism identification. E. Results and Interpretation The results are interpreted by the VITEK 2 system. Printed results will indicate a high probability match to a single species if a unique identification pattern is recognized. If a unique pattern is not recognized, the system will suggest supplemental tests to distinguish between two or three closely related organisms, or indicate the result as an unidentified organism (either >3 organisms can exhibit the observed pattern, or the biopattern is very atypical and is not represented in the database). It is recommended that hemolysis on blood agar is reviewed for any identification of Listeria innocua. If b -hemolysis is observed, further testing must be performed to exclude Listeria monocytogenes. Reference: J. AOAC Int. 95 , 1425(2012)

Table 2012.02C. Biochemical tests included in the VITEK 2 GP card Well Test Abbreviation 2 D-Amygdalin AMY 4 Phosphatidylinositol phospholipase C PIPLC 5 D-Xylose dXYL 8 Arginine dihydrolase 1 ADH1 9 b -Galactosidase BGAL 11 a -Glucosidase AGLU 13 Ala Phe Pro arylamidase APPA 14 Cyclodextrin CDEX 15 L-Aspartate arylamidase AspA 16 b -Galactopyranosidase BGAR 17 a -Mannosidase AMAN 19 Phosphatase PHOS 20 Leucine arylamidase LeuA 23 L-Proline arylamidase ProA 24 b -Glucaronidase BGURr 25 a -Galactosidase AGAL 26 L-Pyrrolidonyl-arylamidase PyrA 27 b -Glucaronidase BGUR 28 Alanine arylamidase AlaA 29 Tyrosine arylamidase TyrA 30 D-Sorbitol dSOR 31 Urease URE 32 Polymixin B resistance POLYB 37 D-Galactose dGAL 38 D-Ribose dRIB 39 L-Lactate alkalinization ILATk 42 Lactose LAC 44 N -Acetyl-D-glucosamine NAG 45 D-Maltose dMAL 46 Bacitracin resistance BACI 47 Novobiocin resistance NOVO 50 Growth in 6.5% NaCl NC6.5 52 D-Mannitol dMAN 53 D-Mannose dMNE 54 Methyl-B-D-glucopyranoside MBdG 56 Pullulan PUL 57 D-Raffinose dRAF 58 O/129 Resistance (comp.vibrio.) O129R 59 Salicin SAL 60 Saccharose/sucrose SAC 62 D-Trehalose dTRE 63 Arginine dihydrolase 2 ADH2s 64 Optochin resistance OPTO

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AOAC EXPERT REVIEW PANEL FOR MICROBIOLOGY FOR FOODS AND ENVIRONMENTAL SURFACES AOAC Expert Review Panel Final Action Feedback

AOAC OFFICIAL METHOD 2012.02

AOAC OFFICIAL METHOD 2012.02 GRAM-POSITIVE BACTERIA IDENTIFICATION, VITEK® 2 GRAM POSITIVE (GP) BIOCHEMICAL IDENTIFICATION METHOD

MANUSCRIPT INFORMATION VITEK ® 2 Gram Positive (GP) Biochemical Identification Method First Action 2012

o Manuscript publication reference, if available. J. AOAC Int. 95, 1425 (2012) o OMA methods have manuscripts unless otherwise noted in the OMA. Author(s) name(s), Journal Name, Volume number, Issue number (if applicable), Page numbers (if applicable). J. AOAC Int. 95, 1425 (2012)

Evaluation of the VITEK® 2 Gram Positive (GP) Microbial Identification Test Card: Collaborative Study

Erin Crowley, Patrick Bird, Kiel Fisher, Katherine Goetz, Megan Boyle, M. Joseph Benzinger, Jr., Marc Juenger, James Agin, David Goins Q Laboratories, Inc., 1400 Harrison Ave, Cincinnati, OH 45214

Ronald L. Johnson bioMérieux, Inc., 595 Anglum Rd, Hazelwood, MO 63042

Collaborators: J. Mills, J. Colon-Reveles, M. Murphy, J. Glover, R. Daugherty, L. Robertson, S. Kim, M. Coakley, J. Canale, G. Parra, H. Wang, T. Sidebottom, C. Elems, L. Johnson, B. Shaw, D. Cherney, J. Rueble, M. Hayman, A. Garza, S. Montez, J. Finnigan, P. Wikoff, P. Dombroski, K. Wilson, S. Robeson, A. Miller, J. Dyer, U. Patel, M. Kingsley, A. Saldana, D. Toney, M. Segarra, G. Fraser, Y. Salfinger, S. Kim, P. Hanson, E. High, M. Kelly, M. McDonough METHOD APPLICABILITY o In your experience using the method, does the method perform according to the method's applicability as written? yes o Does the applicability of the method need to be improved, such as potential method scope expansions or are there potential points of concern? no SAFETY CONCERNS o In your experience with the method, are there any safety concerns that were identified while using or regarding use of the method? no

o All safety concerns identified during the 2-year evaluation period must be addressed.

Page 1 of 3

AOAC EXPERT REVIEW PANEL FOR MICROBIOLOGY FOR FOODS AND ENVIRONMENTAL SURFACES AOAC Expert Review Panel Final Action Feedback

o Guidance and support can be obtained from the AOAC Safety Committee.

Safety committee approved the method before the collaborative study was initiated. Microbiological safety precautions are addressed in the OMA manuscript and in the method package insert, both of which were reviewed and approved by the AOAC reviewers. REFERENCE MATERIALS o Document efforts undertaken to locate reference materials. Methods may still progress to Final Action even if reference materials are not available. NA SINGLE-LABORATORY VALIDATION o Data demonstrating response linearity, accuracy, repeatability, LOD/LOQ, and matrix scope must be present. Experimental designs to collect this data may vary with the method protocol and the intended use of the method. This method was independently validated by AOAC RI and AOAC OMA involving both single multi-laboratory evaluations and meeting statistical acceptance criteria for each validation organization. REPRODUCIBILITY/UNCERTAINTY AND PROBABILITY OF DETECTION o Do you have any information that supports regarding the reproducibility of this method as written? If so, please specify and submit information. This method was independently validated by AOAC RI and AOAC OMA involving both single and multi-laboratory evaluations and meeting the statistical acceptance criteria for approval from each validation organization. ADDITIONAL FEEDBACK FROM USERS OF METHOD o Based on your experience with the method, are there any recommended changes to the AOAC First Action method as written? no o Document positive and negative feedback from users of the method during the trial period regarding the apparatus and reagents, general instructions, enrichment, results and interpretation, confirmation, etc. see below o Resources can be identified by the AOAC Statistics Committee. NA

o Feedback from users demonstrating method ruggedness should be documented. o Access to the future availability of vital equipment, reference materials, and supplies.

VITEK® 2 GP is a proprietary bioMérieux test kit that is commercially available worldwide. VITEK® 2 Gram Positive (GP) Identification card for use with the VITEK® 2 automated microbial identification system is used in both clinical and industry laboratories worldwide. It has been extensively tested in FDA clinical trials. The method is approved for use in the USDA/FSIS MLG. The VITEK 2 GP method has received independent 3 rd party approvals from AOAC RI and AOAC OMA demonstrating reproducibility, repeatability, robustness and overall reliability in both single independent laboratory testing and in an

Page 2 of 3

AOAC EXPERT REVIEW PANEL FOR MICROBIOLOGY FOR FOODS AND ENVIRONMENTAL SURFACES AOAC Expert Review Panel Final Action Feedback extensive 20 laboratory collaborative study representing government, industry and private testing laboratories throughout the United States. AOAC Performance Tested Method: PTM # 120702 The VITEK 2 GP method was certified by the AOAC Research Institute Performance Tested Method SM (PTM) program after the completion of a single laboratory study and an independent laboratory study. These studies included an evaluation of the following parameters: inclusivity, exclusivity, robustness, lot- to-lot/stability and method comparison. AOAC Official Method: 2012.02 The VIDAS LMX method was adopted as an AOAC Official Method of Analysis (OMA), First Action status after the completion of a multi-laboratory method comparison study.

Page 3 of 3

( g )  Master lot entry (MLE) card. —One card providing specifications for the factory master data required to calibrate the test. ( h )  Package insert . ( i )  Disposable pipet to dispense appropriate volumes. ( j )  VIDAS Heat and Go. —Available from bioMérieux, Inc. ( k )  Water bath (95–100°C) or equivalent system. ( l )  Stomacher ® -type bag with filter. ( m )  Stomacher. —Stomacher Lab Blender 400, available from Seward Medical (London, UK); Smasher, bioMérieux, Inc., or equivalent. ( n )  BPW. —Available from bioMérieux, Inc. ( o )  Salmonella supplement. —Available from bioMérieux, Inc. ( p )  Incubators. —Capable of maintaining 42±1°C and 35±1°C. ( q )  Diagnostic reagents. —Necessary for culture confirmation of assays. See 967.27 ( see 17.9.03). ( r )  IBISA chromogenic agar. —Necessary for cultural confirmation as an alternative to selective agar required by appropriate reference method. Available from bioMérieux, Inc. ( s )  ASAP chromogenic agar. —Necessary for cultural confirmation as an alternative to selective agar required by appropriate reference method. Available from bioMérieux, Inc. ( t )  Vancomycin. —Available from bioMérieux, Inc. C. General Instructions ( a ) Components of the kit are intended for use as integral unit. Do not mix reagents or disposables of different lot numbers. ( b ) Store VIDAS SPT kits at 2–8°C. ( c ) Do not freeze reagents. ( d ) Bring reagents to room temperature before inserting them into the VIDAS instrument. ( e ) Mix standard, controls, and heated test portions well before using. ( f ) Include one positive and one negative control with each group of tests. ( g ) Return unused components to 2–8°C immediately after use. ( h )  See safety precautions in the VIDAS SPT package insert (refer to the following sections in the package insert: Warnings and Precautions and Waste Disposal). D. Preparation of Test Suspension ( a )  Pre-enrichment.— Pre-enrich test portion in BPW using filter Stomacher bags to initiate growth of Salmonella. For 25 g test portions, add 225 mL BPW to each test portion and homogenize thoroughly for 2 min. For 375 g test portions, prewarm BPW to 42±1°C, add 1125 mL to each test portion, and homogenize thoroughly for 2 min. ( b ) After homogenization add Salmonella supplement to each test portion. For 25 g test portions, add 1 mL of Salmonella supplement, mix samples manually, and incubate for 18–24 h at 42±1°C. For 375 g test portions, add 5 mL of Salmonella supplement, mix samples manually, and incubate for 22–26 h at 42±1°C. ( c ) After incubation, homogenize samples manually. If a water bath is used, transfer 2–3 mL enrichment broth into a tube. Seal the tube. Heat for 5±1 min at 95–100°C. Cool the tube. Mix the boiled broth and transfer 0.5 mL into the sample well of the VIDAS SPT reagent strip. If the VIDAS Heat and Go is used, transfer 0.5 mL of the enrichment broth into the sample well of the VIDAS SPT reagent strip. Heat for 5±1 min ( see VIDAS Heat and Go User’s

AOAC Official Method 2013.01 Salmonella in a Variety of Foods VIDAS ® UP Salmonella (SPT) Method First Action 2013

[Applicable to detection of Salmonella in raw ground beef (25 and 375 g), processed American cheese (25 g), deli roast beef (25 g), liquid egg (25 g), peanut butter (25 g), vanilla ice cream (25 g), cooked shrimp (25 g), raw cod (25 g), bagged lettuce (25 and 375 g), dark chocolate (375 g), powdered eggs (25 g), instant nonfat dry milk (25 and 375 g), ground black pepper (25 g), dry dog food (375 g), raw ground turkey (375 g), almonds (375 g), chicken carcass rinsates (30 mL), and stainless steel, plastic, and ceramic environmental surfaces.] See Tables 2013.01A and B for a summary of results of the interlaboratory study. For detailed results of the interlaboratory study, see Tables A–F in Appendix 1 on J. AOAC Int. website, http://aoac.publisher.ingentaconnect.com/content/aoac/jaoac). A. Principle The VIDAS SPT method is for use on the automated VIDAS instrument for the detection of Salmonella receptors using the enzyme-linked fluorescent assay. The solid-phase receptacle (SPR) serves as the solid phase, as well as the pipetting device. The interior of the SPR is coated with proteins specific for Salmonella receptors. Reagents for the assay are ready-to-use and predispensed in the sealed reagent strips. The instrument performs all the assay steps automatically. The reaction medium is cycled in and out of the SPR several times. An aliquot of enrichment broth is dispensed into the reagent strip. The Salmonella receptors present will bind to the interior of the SPR. Unbound components are eliminated during the washing steps. The proteins conjugated to the alkaline phosphatase are cycled in and out of the SPR and will bind to any Salmonella receptors, which are themselves bound to the SPR wall. A final wash step removes unbound conjugate. During the final detection step, the substrate (4-methylumbelliferyl phosphate) is cycled in and out of the SPR. The conjugate enzyme catalyzes the hydrolysis of the substrate into a fluorescent product (4-methylumbelliferone), the fluorescence of which is measured at 450 nm. At the end of the assay, results are automatically analyzed by the instrument which calculates a test value for each sample. This value is then compared to internal references (thresholds) and each result is interpreted as positive or negative. B. Apparatus and Reagents Items ( a )–( h ) are available as the VIDAS SPT assay kit from bioMérieux Inc., Hazelwood, MO. ( a )  VIDAS or miniVIDAS automated immunoassay system. ( b ) SPT reagent strips. —60 polypropylene strips of 10 wells, each strip covered with a foil seal and label. The 10 wells contain the reagents in Table 2013.01C . ( c )  SPR. —60 SPRs coated with proteins specific for Salmonella receptors . ( d )  Standard. —One vial (6 mL). Contains purified and inactivated Salmonella receptors + preservative + protein stabilizer. ( e )  Positive control solution. —One vial (6 mL). Contains purified and inactivated Salmonella receptors + preservative + protein stabilizer. ( f )  Negative control solution. —One vial (6 mL). Contains Tris- buffered saline (150 mmol/L)–Tween pH 7.6 + preservative.

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Candidate confirmed positive/total samples analyzed 0/144 143/144 144/144 0/144 143/144 144/144 0/144 143/144 144/144 Candidate confirmed POD (CC) 0.00 (0.00, +0.03) 0.99 (+0.96, +1.00) 1.00 (+0.97, +1.00) 0.00 (0.00, +0.03) 0.99 (+0.96, +1.00) 1.00 (+0.97, +1.00) 0.00 (0.00, +0.03) 0.99 (+0.96, +1.00) 1.00 (+0.97, +1.00) s r 0.00 (0.00, +0.16) 0.08 (+0.07, +0.16) 0.00 (0.00, +0.16) 0.00 (0.00, +0.16) 0.08 (+0.07, +0.16) 0.00 (0.00, +0.16) 0.00 (0.00, +0.16) 0.08 (+0.07, +0.16) 0.00 (0.00, +0.16) s L 0.00 (0.00, +0.16) 0.00 (0.00, +0.03) 0.00 (0.00, +0.16) 0.00 (0.00, +0.16) 0.00 (0.00, +0.03) 0.00 (0.00, +0.16) 0.00 (0.00, +0.16) 0.00 (0.00, +0.03) 0.00 (0.00, +0.16) s R 0.00 (0.00, +0.22) 0.08 (+0.08, +0.10) 0.00 (0.00, +0.22) 0.00 (0.00, +0.22) 0.08 (+0.08, +0.10) 0.00 (0.00, +0.22) 0.00 (0.00, +0.22) 0.08 (+0.08, +0.10) 0.00 (0.00, +0.22) P -value 1.0000 0.4368 1.0000 1.0000 0.4368 1.0000 1.0000 0.4368 1.0000

Positive reference samples/total samples analyzed 0/144 84/144 138/144 0/144 84/144 138/144 0/144 84/144 138/144 Reference POD 0.00 (0.00, +0.03) 0.58 (+0.50, +0.67) 0.96 (+0.91, +0.98) 0.00 (0.00, +0.03) 0.58 (+0.50, +0.67) 0.96 (+0.91, +0.98) 0.00 (0.00, +0.03) 0.58 (+0.50, +0.67) 0.96 (+0.91, +0.98) s r 0.00 (0.00, +0.16) 0.50 (+0.45, +0.52) 0.19 (+0.17, +0.22) 0.00 (0.00, +0.16) 0.50 (+0.45, +0.52) 0.19 (+0.17, +0.22) 0.00 (0.00, +0.16) 0.50 (+0.45, +0.52) 0.19 (+0.17, +0.22) s L 0.00 (0.00, +0.16) 0.00 (0.00, +0.18) 0.06 (+0.02, +0.13) 0.00 (0.00, +0.16) 0.00 (0.00, +0.18) 0.06 (+0.02, +0.13) 0.00 (0.00, +0.16) 0.00 (0.00, +0.18) 0.06 (+0.02, +0.13) s R 0.00 (0.00, +0.22) 0.50 (+0.45, +0.52) 0.20 (+0.18, +0.24) 0.00 (0.00, +0.22) 0.50 (+0.45, +0.52) 0.20 (+0.18, +0.24) 0.00 (0.00, +0.22) 0.50 (+0.45, +0.52) 0.20 (+0.18, +0.24) P -value 1.0000 0.6298 0.0179 1.0000 0.6298 0.0179 1.0000 0.6298 0.0179 0.41 0.04 0.00 0.41 0.04 0.00 0.41 0.04 0.01 0.00 0.00 0.01 0.00 0.00 0.01 0.00

Table 2013.01A. Summary of results for the detection of Salmonella spp. in raw ground beef (25 g) Method a VIDAS SPT with traditional confirmation on BGSA and XLT4 VIDAS SPT with traditional confirmation on IBISA and ASAP b Inoculation level Uninoculated Low High Uninoculated Low High Uninoculated Low High Candidate presumptive positive/total samples analyzed 0/144 144/144 144/144 0/144 144/144 144/144 0/144 144/144 144/144 Candidate presumptive POD (CP) 0.00 (0.00, +0.03) 1.00 (+0.97, +1.00) 1.00 (+0.97, +1.00) 0.00 (0.00, +0.03) 1.00 (+0.97, +1.00) 1.00 (+0.97, +1.00) 0.00 (0.00, +0.03) 1.00 (+0.97, +1.00) 1.00 (+0.97, +1.00) s r d 0.00 (0.00, +0.16) 0.00 (0.00, +0.16) 0.00 (0.00, +0.16) 0.00 (0.00, +0.16) 0.00 (0.00, +0.16) 0.00 (0.00, +0.16) 0.00 (0.00, +0.16) 0.00 (0.00, +0.16) 0.00 (0.00, +0.16) s L e 0.00 (0.00 +0.16) 0.00 (0.00, +0.16) 0.00 (0.00, +0.16) 0.00 (0.00, +0.16) 0.00 (0.00, +0.16) 0.00 (0.00, +0.16) 0.00 (0.00, +0.16) 0.00 (0.00, +0.16) 0.00 (0.00, +0.16) s R f 0.00 (0.00, +0.22) 0.00 (0.00, +0.22) 0.00 (0.00, +0.22) 0.00 (0.00, +0.22) 0.00 (0.00, +0.22) 0.00 (0.00, +0.22) 0.00 (0.00, +0.22) 0.00 (0.00, +0.22) 0.00 (0.00, +0.22) P -value 1.0000 1.0000 1.0000 1.0000 1.0000 1.0000 1.0000 1.0000 1.0000 VIDAS SPT with alternative confirmation on IBISA and ASAP c

(–0.03, +0.03)

(+0.01, +0.09)

(–0.02, +0.04)

(+0.32, +0.49)

(–0.03, +0.03)

(–0.03, +0.03)

(–0.03, +0.03)

(+0.01, +0.09)

(–0.02, +0.04)

(+0.32, +0.49)

(–0.03, +0.03)

(–0.03, +0.03)

(0.01, +0.09)

(–0.03, +0.03)

(+0.32, +0.49) AOAC Research Institute Expert Review Panel Use Only (–0.02, +0.04)

dLPOD (candidate vs reference) 0.00 (–0.03, +0.03)

dLPOD (candidate presumptive vs candidate confirmed) 0.00 (–0.03, +0.03)

a  Results include 95% confidence intervals. b  Traditional confirmation on ASAP/IBISA = secondary enrichments streaked onto IBISA and ASAP. c  Alternative confirmation = direct streak of the primary enrichment onto IBISA and ASAP. d  Repeatability standard deviation. e  Among-laboratory standard deviation. f  Reproducibility standard deviation.

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