CERTIFICATION. Certificate No The AOAC Research Institute hereby certifies that the performance of the test kit known as:

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1 CERTIFICATION AOAC Prormanc Tst SM Crtiicat No Th AOAC Rsarch Institut hrby crtiis that th prormanc o th tst kit known as: ANSR or Listria monocytogns manuactur by Nogn Corporation 620 Lshr Plac Lansing, MI USA This mtho has bn valuat in th AOAC Prormanc Tst Mthos SM Program, an oun to prorm as stat by th manuacturr contingnt to th commnts contain in th manuscript. This crtiicat mans that an AOAC Crtiication Mark Licns Agrmnt has bn xcut which authorizs th manuacturr to isplay th AOAC Prormanc Tst SM crtiication mark along with th statmnt - "THIS METHOD'S PERFORMANCE WAS REVIEWED BY AOAC RESEARCH INSTITUTE AND WAS FOUND TO PERFORM TO THE MANUFACTURER'S SPECIFICATIONS" - on th abov mntion mtho or a prio o on calnar yar rom th at o this crtiicat (January 1, 2015 Dcmbr 31, 2015). Rnwal may b grant at th n o on yar unr th ruls stat in th licnsing agrmnt. Dborah McKnzi Dborah McKnzi, Snior Dirctor Signatur or AOAC Rsarch Institut Jun 30, 2015 Dat 2275 Rsarch Blv., St. 300, Rockvill, Marylan, USA Tlphon: Fax: Intrnt -mail: aoacri@aoac.org * Worl Wi Wb Sit:

2 METHOD AUTHORS Oscar Caballro, Susan Alls, Quynh-Nhi L, R. Lucas Gray, Ean Hosking, Lisa Pinkava, Paul Norton, Jrry Tolan, Mark Mozola an Jnnir Ric SUBMITTING COMPANY Nogn Corporation 620 Lshr Plac Lansing, MI KIT NAME(S) ANSR or Listria monocytogns # CATALOG NUMBERS 9824 INDEPENDENT LABORATORY Q Laboratoris, Inc Harrison Avnu, Cincinnati, OH USA AOAC EXPERTS AND PEER REVIEWERS Yi Chn 1, Elliot Rysr 2, Josph Oumru 3 1 USDA FDA CFSAN, Collg Park, MD, USA 2 Michigan Stat Univrsity, East Lansing, MI, USA 3 Univrsity o Gulph, Gulph, Ontario, Canaa APPLICABILITY OF METHOD Targt organism Listria monocytogns Matrics BAM Ch. 10: quso rsco, cantaloup, guacamol, pasturiz liqui gg, sprout irrigation watr MLG 8.09: hot ogs, stainlss stl Prormanc claims - Prormanc quivalnt to that o th U.S. Foo an Drug Aministration Bactriological Analytical Manual (FDA/BAM; 6) or th U.S. Dpartmnt o Agricultur Foo Saty an Inspction Srvic Microbiology Laboratory Guibook (USDA/MLG; 7) rrnc cultur mthos as trmin by probability o tction (POD) analysis. REFERENCE METHOD US FDA (2011) Bactriological Analytical Manual, chaptr 10 (Accss Fbruary, 2015) (8) USDA-FSIS (2014) Microbiology Laboratory Guibook, chaptr 8.09 (Accss January, 2015) (9) PRINCIPLE OF THE METHOD ANSR Listria monocytogns is an isothrmal nuclic aci ampliication assay bas on nicking nzym ampliication raction (NEAR TM ) tchnology (9). Th ampliication mchanism involvs bining o an oligonucloti tmplat to a spciic squnc o targt DNA. Th tmplat contains a rcognition sit or a spciic nonuclas. Th nick stran is rcogniz as amag an rpair by th action o a thrmostabl DNA polymras, isplacing th original stran with th nwly-synthsiz rpair portion. This isplac DNA prouct thn bins to a scon tmplat an th sam ractions la to ormation o a scon prouct. Ampliication proucts ar tct using a spciic molcular bacon prob. A luorscnt signal is gnrat in ral tim, with ampliication an tction complt within 10 minuts. Th ntir assay is conuct at a constant tmpratur o 56 C using a tmpratur-controll luorscnc tction instrumnt. Assay sotwar analyzs th luorscnt signal ovr tim; a ata intrprtation algorithm intrprts rsults as ngativ, positiv, or invali bas on baslin, rat-o-chang, an othr critria. Each ANSR ragnt tub also contains an intrnal positiv control, signaling in a scon luorscnc channl irrspctiv o th prsnc o targt DNA, an inicating propr unctioning o th ampliication ragnts. DISCUSSION OF THE VALIDATION STUDY Th rsults prsnt hr monstrat that ovrall prormanc o th ANSR Listria monocytogns assay is quivalnt to that o ithr th USDA-FSIS/MLG or FDA/BAM rrnc mthos. Bas on intrnal as wll as inpnnt laboratory stuis or hot ogs, Mxican-styl chs, cantaloup, guacamol, pasturiz liqui gg, sprout irrigation watr, an spong sampls rom a stainlss stl surac, ANSR Listria monocytogns is an ctiv procur or tction o L. monocytogns atr 24 h o nrichmnt. Furthr, th ata supports tsting o stainlss stl spong sampls atr only 16 h o nrichmnt. In inclusivity tsting, 96% o L. monocytogns strains tst wr positiv, whil in xclusivity tsting, 100% o strains tst wr ngativ. Rsults o robustnss tsting show that th moii assay can withstan minor librat prturbations to multipl assay paramtrs an still yil accurat rsults. In aition to high snsitivity an spciicity, th ANSR Listria monocytogns mtho ors th avantags o singl-stp nrichmnt, a univrsal nrichmnt mium, minimal labor an assay harwar rquirmnts, an assay rsults within 40 minuts ollowing sampl nrichmnt. Whn us with sampl nrichmnt in LESS Plus broth, th ANSR Listria an ANSR Listria monocytogns assays can b mploy ithr sparatly, or in combination, as part o an icint Listria tsting program. Sampls can b scrn using th Listria spp. assay to provi rsults at an inicator lvl, an thn positivs may b r-tst with th Listria monocytogns assay to provi a rapi an high coninc inication o th prsnc o th pathognic spcis. REFERENCES CITED 1. Caballro, O., Alls, S., L, Q. Gray, R.L., Hosking, E., Pinkava, L., Norton, P., Tolan, J., Mozola, M., an Ric, J., Evaluation o th Valiation o th ANSR Listria monocytogns Mtho or Dtction o Listria monocytogns in Slct Foo an Environmntal Sampls, AOAC Prormanc Tst SM crtiication numbr AOAC Rsarch Institut Valiation Outlin or ANSR Listria monocytogns Mtho or Dtction o Listria monocytogns in Slct Foo an Environmntal Sampls, Approv Jun Mozola, M., Norton, P., Alls, S., Gray, R., Tolan, J., Caballro, O., Pinkava, L., Hosking, E., Luplow, K., & Ric, J. (2013) J. AOAC Intl. 96, Caballro, O., Alls, S., Gray, R., Tolan, J., Mozola, M., & Ric, J. (2014) J. AOAC Intl. 97, Foti, D., Zhang, L., Biswas, P., Mozola, M. & Ric, J. (2014) J. AOAC Intl. 97, Wnor, M., Flpausch, E., Pinkava, L., Luplow, K., Hosking, E., Norton, P., Biswas, P., Mozola, M., & Ric J. (2013) J. AOAC Intl. 96, Mozola, M., Botimr, M., Jagaics, C., Norton, P., Caballro, O., Enslin, N., Biswas, P., & Ric J. (2014) J. AOAC Intl. 97, US FDA (2011) Bactriological Analytical Manual, chaptr 10 (Accss Fbruary, 2015) 9. USDA-FSIS (2014) Microbiology Laboratory Guibook, chaptr 8.09 (Accss January, 2015) 92c-c290ba92/MLG-8.p?MOD=AJPERES 10. AOAC INTERNATIONAL Mthos Committ Guilins or Valiation o Microbiological Mthos or Foo an Environmntal Suracs (2012) Oicial Mthos o Analysis o AOAC INTERNATIONAL, 19th E., Appnix J, AOAC INTERNATIONAL, Gaithrsburg, MD (Accss January, 2015) Van Nss, J., Van Nss, L.K., & Galas, D. (2003) Proc. Natl. Aca. Sci. USA 100, MPN Calculator, accss March, Anrson, G. & Scott, M. (1991) Clin. Chm. 37,

3 Nogn ANSR or Listria monocytogns AOAC Crtiication Numbr Tabl 1. Rsults o inclusivity tsting or th ANSR Listria monocytogns tst using LESS Plus nrichmnt mia Organism Srotyp Strain # Sourc Origin (i known) ANSR Rsult, (~10 6 CFU/mL) L. monocytogns 1/2a GT2669 H. Sligr b Chs Positiv L. monocytogns 1/2a GT1030 H. Sligr Chs Positiv L. monocytogns 1/2b GT1038 H. Sligr Bloo Positiv L. monocytogns 3b GT3396 H. Sligr Chs Positiv L. monocytogns 1/2a GT3727 H. Sligr Bloo Positiv L. monocytogns 1/2a GT4340 CDC c Buttrish Positiv L. monocytogns 1/2a GT4343 CDC Slic ham Positiv L. monocytogns 1/2a GTA194 ATCC a Positiv L. monocytogns 1/2b GT3635 H. Sligr Bloo Positiv L. monocytogns 1/2b GT3728 H. Sligr Chs Positiv L. monocytogns 1/2b GT4341 CDC Buttrish Positiv L. monocytogns 1/2b A195 ATCC Positiv L. monocytogns 1/2c GT3648 H. Sligr Chs Positiv L. monocytogns 1/2c GT2400 H. Sligr Bloo Positiv L. monocytogns 1/2c GT3730 H. Sligr - Positiv L. monocytogns 1/2b GT3741 H. Sligr - Positiv L. monocytogns 1a GT1072 C. Donnlly Raw milk Positiv L. monocytogns 1a GT1082 C. Donnlly Raw milk Positiv L. monocytogns 1a GT1880 J. Lovtt Bri chs Positiv L. monocytogns 1a GT3812 J. Lovtt Chocolat milk Positiv L. monocytogns 1a GT3829 C. Donnlly Raw milk Positiv L. monocytogns 1b GT3784 CDC - Ngativ L. monocytogns 2 A169 ATCC Positiv L. monocytogns 3a GT1035 H. Sligr - Positiv L. monocytogns - GT3147 Nogn Environmntal Positiv L. monocytogns 3a GT3720 H. Sligr Chs Positiv L. monocytogns 3b GT1057 J. Lovtt Bri chs Positiv L. monocytogns 3b GT3715 H. Sligr Bloo Positiv L. monocytogns 3b GT3745 H. Sligr - Positiv L. monocytogns 3b GT3857 J. Lovtt Bri chs Positiv L. monocytogns 3c GT3695 H. Sligr Chs Positiv L. monocytogns 4a GT1046 H. Sligr Human Positiv L. monocytogns 4a A170 ATCC Positiv GT1019 Nogn - Positiv GT1022 CDC Human Positiv GT1081 C. Donnlly - Positiv GT3733 H. Sligr Human Positiv GT3746 H. Sligr Human Positiv GT3957 H. Sligr Chs Positiv GT4342 CDC Sausag Positiv A171 ATCC Human Positiv A207 ATCC Human CSF Positiv L. monocytogns 3b GT3817 H. Sligr Chs Positiv 2

4 Nogn ANSR or Listria monocytogns AOAC Crtiication Numbr GT2402 H. Sligr Bloo Positiv L. monocytogns 6b GT672 H. Sligr Chs Positiv L. monocytogns 7 GT278 H. Sligr - Positiv L. monocytogns 7a GT354 Nogn - Positiv L. monocytogns ATCC Guina pig Ngativ L. monocytogns - GT1013 USDA B Positiv L. monocytogns ATCC Guina pig Positiv a Amrican Typ Cultur Collction, Univrsity Blv., Manassas, VA b Institut o Hygin an Molcular Microbiology, Univrsity o Würzburg, D8700 Würzburg, Grmany. c Cntrs or Disas Control an Prvntion, 1600 Cliton R., Atlanta, GA Dpartmnt o Nutrition an Foo Scincs, Univrsity o Vrmont, Nutrition an Foo Scincs, 355 MLS Carrigan Wing, Burlington, VT U.S. Foo an Drug Aministration, 6751 Stgr Dr., Cincinnati, OH Strains wr conirm by PCR to b lacking th assay targt gn. Tabl 2. Rsults o xclusivity tsting or th ANSR Listria monocytogns tst Organism Strain No. Sourc Origin (i known) ANSR rsult (~10 9 CFU/mL) Cultur conitions a Bacillus crus A208 ATCC Cow ung Ngativ Bacillus mgatrium GT2128 ATCC Ngativ Bacillus subtilis GT4402 ATCC b Grain Ngativ Brochothrix thrmosphacta GT664 ATCC Pork sausag Ngativ BHI Broth, 26 C or 48 h, 5% CO2 Entrococcus urans GT407 ATCC 6056 Human cs Ngativ Entrococcus acalis GT3242 ATCC Ngativ Entrococcus acium GT919 ATCC 6057 Chs Ngativ Entrococcus hira GT923 ATCC Cow ung Ngativ Gobacillus starothrmophilus GT4373 ATCC Ngativ Kocuria varians GT4404 ATCC Milk Ngativ Nutrint Broth, 48 h Kurthia gibsonii GT2129 ATCC Mat Ngativ Kurthia zopii GT1941 ATCC Turky ccum Ngativ Lactobacillus aciophilus GT256 ATCC 4356 Human Ngativ Lactobacillus rmntum GT4063 ATCC Ngativ MRS Broth, 35 C or 48 h, 5% CO2 Lactococcus lactis GT3516 ATCC Ngativ Listria grayi GT4800 Nogn c Environmntal Ngativ Listria grayi A203 ATCC Chinchilla cs Ngativ Listria grayi GT259 Lan O'Laks Dairy plant Ngativ Listria innocua GT1029 H. Sligr Milk Ngativ Listria innocua GT1026 H. Sligr Chs Ngativ Listria innocua GT1042 H. Sligr Chs Ngativ Listria innocua GT1050 H. Sligr Chs Ngativ Listria innocua GT1044 H. Sligr Chs Ngativ Listria innocua GT1052 J. Farbr Milk Ngativ Listria innocua GT3627 H. Sligr Chs Ngativ Listria innocua 3785 ATCC Cow brain Ngativ Listria innocua GT3631 CDC g Chs Ngativ Listria innocua A102 ATCC Cow brain Ngativ Listria ivanovii A140 ATCC Shp Ngativ Listria ivanovii GT1028 H. Sligr Mous brain Ngativ 3

5 Nogn ANSR or Listria monocytogns AOAC Crtiication Numbr Listria ivanovii GT4339 CDC Stu lamb chop Ngativ Listria sligri A201 ATCC Bank vol intstins Ngativ Listria sligri GT3794 J. Lovtt h Bri chs Ngativ Listria sligri GT3821 H. Sligr Sot chs Ngativ Listria wlshimri A199 ATCC Dcaying plant matrial Ngativ Listria wlshimri A200 ATCC Soil Ngativ Listria wlshimri GT3862 C. Donnlly i Milk Ngativ Micrococcus lutus GT1943 ATCC 381 Watr Ngativ Rhoococcus qui GT665 ATCC 6939 Hors Ngativ Rhoococcus ascians GT3524 ATCC Ngativ BHI broth, 35 C or 48 h Staphylococcus aurus A179 ATCC Plural lui Ngativ Staphylococcus pirmiis A183 ATCC Human nos Ngativ Staphylococcus saprophyticus A185 ATCC Human urin Ngativ Strptococcus qui GT3596 ATCC Ngativ CBAB/ BHI Broth Strptococcus gallolyticus GT668 ATCC Ngativ Strptococcus mutans GT412 ATCC Human mouth Ngativ BHI Broth or 48 h Strptococcus sanguinis GT411 ATCC Human Ngativ a I othr than TSB, h, 36 C. b Amrican Typ Cultur Collction, Univrsity Blv., Manassas, VA c Nogn Corp., 620 Lshr Plac, Lansing, MI Lan O Laks, 1200 County Roa F Wst, Arn Hills, MN Institut o Hygin an Molcular Microbiology, Univrsity o Würzburg, D8700 Würzburg, Grmany. Halth Canaa, Burau o Microbial Hazars, Ottawa K1A 0L2, Canaa. g Cntrs or Disas Control an Prvntion, 1600 Cliton R., Atlanta, GA h U.S. Foo an Drug Aministration, 6751 Stgr Dr., Cincinnati, OH i Dpartmnt o Nutrition an Foo Scincs, Univrsity o Vrmont, Nutrition an Foo Scincs, 355 MLS Carrigan Wing, Burlington, VT

6 Tabl 3. Probability o tction calculations or ANSR Listria monocytogns prsumptiv an conirm rsults, 16 h tim point Inoc. lvl ANSR prsumptiv rsult ANSR conirm rsult Matrix/sampl siz Inoculum strain (CFU/portion) a N b X c POD CP 95% CI x POD CC 95% CI POD CP 95% CI g Hot ogs, 125 g Mxican-styl chs, 25 g Cantaloup, 25 g L. monocytogns 1/2b 0.69 (0.36, 1.2) , , , > , , , (0.42, 1.4) , , , (2.5, 53) , , , (0.16, 0.49) , , , (2.1, 15) , , , , , , 0.62 Guacamol, 25 g L. monocytogns 1/2c 0.29 (0.10, 0.60) , , , 0.19 Pasturiz liqui gg h, 25 g Sprout irrigation watr, 25 ml Stainlss stl L. monocytogns 1/2a L. monocytogns 1/2b L. monocytogns 1/2a + E. acium 27 (6.5, 117) , , , (1.0, 3.3) , , , (1.2, 3.7) , , , (11, 122) , , , (0.15, 0.72) , , , (2.1, 23) , , , (2.3, 47) , , , /31,00 3,700/312, , , , ,000/3,120, , , , / Stainlss stl i L. monocytogns 1/2a + 430/1, , , , 0.23 E. acalis 820/7, , , , 0.43 a Dtrmin by most probabl numbr analysis xcpt or stainlss stl whr trmination was by titr o inoculum. b N = Numbr o tst portions. c x = Numbr o positiv tst portions. POD CP = Caniat mtho prsumptiv positiv outcoms POD CC = Caniat mtho prsumptiv positiv outcoms conirm positiv. POD CP = Dirnc btwn th caniat mtho prsumptiv an caniat mtho conirm POD valus. g 95% CI = I th coninc intrval o a POD os not contain zro, thn th irnc is statistically signiicant at th 5% lvl. h 24 h or pasturiz liqui gg. i Trial prorm by inpnnt laboratory.

7 Nogn ANSR or Listria monocytogns AOAC Crtiication Numbr Tabl 4. Probability o tction calculations or ANSR Listria monocytogns prsumptiv an conirm rsults, 24 h tim point Foo typ Hot ogs, 125 g Hot ogs, 125 g h Mxican-styl chs, 25 g Inoculum strain L. monocytogns 1/2b Mxican-styl chs, 25 g h L. monocytogns 1/2b Cantaloup, 25 g Guacamol, 25 g L. monocytogns 1/2c Pasturiz liqui gg, 25 i g Sprout irrigation watr, 25 ml Stainlss stl L. monocytogns 1/2a L. monocytogns 1/2b L. monocytogns 1/2a + E. acium Stainlss stl h L. monocytogns 1/2a + E. acalis Inoc. lvl ANSR prsumptiv rsult ANSR conirm rsult (CFU/portion) a N b X c POD CP 95% CI x POD CC 95% CI a Dtrmin by MPN analysis. b N = Numbr o tst portions. c x = Numbr o positiv tst portions. POD CP = Caniat mtho prsumptiv positiv outcoms POD CC = Caniat mtho prsumptiv positiv outcoms conirm positiv. POD CP = Dirnc btwn th caniat mtho prsumptiv an caniat mtho conirm POD valus. g 95% CI = I th coninc intrval o a POD os not contain zro, thn th irnc is statistically signiicant at th 5% lvl. h Trial prorm by inpnnt laboratory. POD CP 95% CI g 0.69 (0.36, 1.2) , , , 0.12 > , , , (0.55, 1.6) , , , (3.2, 17) , , , (0.42, 1.4) , , , (2.5, 53) , , , (0.41, 1.1) , , , (0.89, 4.1) , , , (0.16, 0.49) , , , (2.1, 15) , , , (0.10, 0.60) , , , (6.5, 117) , , , (1.0, 3.3) , , , (1.2, 3.7) , , , (11, 122) , , , (0.15, 0.72) , , , (2.1, 23) , , , (2.3, 47) , , , /31,00 3,700/312, , , , ,000/3,120, , , , / 430/1, , , , /7, , , ,

8 Nogn ANSR or Listria monocytogns AOAC Crtiication Numbr i 30 h or pasturiz liqui gg. Tabl 5. Probability o tction calculations or ANSR Listria monocytogns conirm an rrnc mtho rsults, 16 h tim point Foo typ Inoculum strain Inoc. lvl ANSR conirm rsult Rrnc mtho rsult (CFU/portion) a N b X c POD C 95% CI x POD R 95% CI POD C 95% CI g Hot ogs, 125 g Mxican-styl chs, 25 g L. monocytogns 1/2b Cantaloup, 25 g Guacamol, 25 g L. monocytogns 1/2c Pasturiz liqui gg h, 25 g Sprout irrigation watr, 25 ml Stainlss stl L. monocytogns 1/2a L. monocytogns 1/2b L. monocytogns 1/2a + E. acium Stainlss stl i L. monocytogns 1/2a + E. acalis a Dtrmin by most probabl numbr analysis. b N = Numbr o tst portions. c x = Numbr o positiv tst portions. POD CP = Caniat mtho prsumptiv positiv outcoms conirm positiv. POD CC = Rrnc mtho conirm positiv outcoms. POD CP = Dirnc btwn th caniat mtho an rrnc mtho POD valus. g 95% CI = I th coninc intrval o a POD os not contain zro, thn th irnc is statistically signiicant at th 5% lvl. h 24 h or pasturiz liqui gg (0.36, 1.2) , , , 0.18 > , , , (0.42, 1.4) , , , (2.5, 53) , , , (0.16, 0.49) , , , (2.1, 15) , , , (0.10, 0.60) , , , (6.5, 117) , , , (1.0, 3.3) , , , (1.2, 3.7) , , , (11, 122) , , , (0.15, 0.72) , , , (2.1, 23) , , , (2.3, 47) , , , /31,00 3,700/312, , , , ,000/3,120, , , , / 430/1, , , , /7, , , ,

9 Nogn ANSR or Listria monocytogns AOAC Crtiication Numbr i Trial prorm by inpnnt laboratory. Tabl 6. Probability o tction calculations or ANSR Listria monocytogns conirm an rrnc mtho rsults, 24 h tim point Foo typ Inoculum strain Inoc. lvl ANSR conirm rsult Rrnc mtho rsult (CFU/portion) a N b X c POD C 95% CI x POD R 95% CI POD C 95% CI g Hot ogs, 125 g 0.69 (0.36, 1.2) , , , 0.78 > , , , 0.43 Hot ogs, 125 g h Mxican-styl chs, 25 g L. monocytogns 1/2b 0.92 (0.55, 1.6) , , , (3.2, 17) , , , (0.42, 1.4) , , , (2.5, 53) , , , 0.43 Mxican-styl chs, 25 g h L. monocytogns 1/2b 0.69 (0.41, 1.1) , , , (0.89, 4.1) , , , 0.43 Cantaloup, 25 g Guacamol, 25 g L. monocytogns 1/2c 0.31 (0.16, 0.49) , , , (2.1, 15) , , , (0.10, 0.60) , , , (6.5, 117) , , , 0.43 Pasturiz liqui gg i, 25 g Sprout irrigation watr, 25 ml Stainlss stl L. monocytogns 1/2a L. monocytogns 1/2b L. monocytogns 1/2a + Entrococcus acium 1.7 (1.0, 3.3) , , , (1.2, 3.7) , , , (11, 122) , , , (0.15, 0.72) , , , (2.1, 23) , , , (2.3, 47) , , , /31,00 3,700/312, , , , ,000/3,120, , , , 0.43 Stainlss stl h L. monocytogns 1/2a + Entrococcus acalis a Dtrmin by most probabl numbr analysis. b N = Numbr o tst portions. c x = Numbr o positiv tst portions. POD CP = Caniat mtho prsumptiv positiv outcoms conirm positiv. POD CC = Rrnc mtho conirm positiv outcoms. POD CP = Dirnc btwn th caniat mtho an rrnc mtho POD valus. 0/ 430/1, , , , /7, , , ,

10 Nogn ANSR or Listria monocytogns AOAC Crtiication Numbr g 95% CI = I th coninc intrval o a POD os not contain zro, thn th irnc is statistically signiicant at th 5% lvl. h Trial prorm by inpnnt laboratory. I 30 h or pasturiz liqui gg. ORIGINAL CERTIFICATION DATE Jun 30, 2015 METHOD MODIFICATION RECORD Non Unr this AOAC Prormanc Tst SM Licns Numbr, this mtho is istribut by: CERTIFICATION RENEWAL RECORD Nwly approv SUMMARY OF MODIFICATION Unr this AOAC Prormanc Tst SM Licns Numbr, this mtho is istribut as: 5

CERTIFICATION. Certificate No. The AOAC Research Institute hereby certifies that the performance of the test kit known as:

CERTIFICATION. Certificate No. The AOAC Research Institute hereby certifies that the performance of the test kit known as: Dborah McKnzi CERTIFICATION AOAC Prformanc Tst SM Crtificat No. 050501 Th AOAC Rsarch Institut hrby crtifis that th prformanc of th tst kit known as: BAX Systm PCR Assay for MP PCR Assay for manufactur

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