Background The NEMIS Technologies N-Light(TM) L. monocytogenes assay uses chemiluminescence designed for the qualitative detection of Listeria monocytogenes from environmental surface samples. Objective To validate the NEMIS Technologies N-Light L. monocytogenes assay as part of the AOAC Performance Tested Method(SM) program for the detection of L. monocytogenes on stainless steel, plastic (polystyrene), and ceramic environmental surfaces. Method Using the Vitl Life Science Solutions Lu-mini luminometer, the NEMIS Technologies N-Light L. monocytogenes assay was compared to the ISO 11290-1:2017: Microbiology of the Food Chain-Horizontal method for the detection and enumeration of Listeria monocytogenes and of Listeria spp. - Part 1 using a 1" x 1" stainless steel test area in an unpaired study design. Results The NEMIS Technologies N-Light L. monocytogenes assay using the Vitl Life Science Solutions Lu-mini luminometer demonstrated no statistically significant differences between presumptive and confirmed results or between candidate and reference method results. Data for additional Performance Tested Method(SM) studies met acceptance criteria requirements. Conclusions The NEMIS Technologies N-Light L. monocytogenes assay is an effective method for the qualitative detection of L. monocytogenes from stainless steel, plastic (polystyrene), and ceramic environmental surface samples.
机构:
Winchester Engineering & Analytical Center (WEAC), HFR-NE460, Office of Regulatory Affairs, US Food and Drug AdministrationWinchester Engineering & Analytical Center (WEAC), HFR-NE460, Office of Regulatory Affairs, US Food and Drug Administration
Jin-Qiang Chen
Patrick Regan
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Winchester Engineering & Analytical Center (WEAC), HFR-NE460, Office of Regulatory Affairs, US Food and Drug AdministrationWinchester Engineering & Analytical Center (WEAC), HFR-NE460, Office of Regulatory Affairs, US Food and Drug Administration
Patrick Regan
Pongpan Laksanalamai
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MD DHMH Laboratories Administration, Division of MicrobiologyWinchester Engineering & Analytical Center (WEAC), HFR-NE460, Office of Regulatory Affairs, US Food and Drug Administration
Pongpan Laksanalamai
Stephanie Healey
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Winchester Engineering & Analytical Center (WEAC), HFR-NE460, Office of Regulatory Affairs, US Food and Drug AdministrationWinchester Engineering & Analytical Center (WEAC), HFR-NE460, Office of Regulatory Affairs, US Food and Drug Administration
Stephanie Healey
Zonglin Hu
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Winchester Engineering & Analytical Center (WEAC), HFR-NE460, Office of Regulatory Affairs, US Food and Drug AdministrationWinchester Engineering & Analytical Center (WEAC), HFR-NE460, Office of Regulatory Affairs, US Food and Drug Administration
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Natl Infect Serv, Publ Hlth England Food Water & Environm Microbiol, 61 Colindale Ave, London NW9 5EQ, EnglandNatl Infect Serv, Publ Hlth England Food Water & Environm Microbiol, 61 Colindale Ave, London NW9 5EQ, England
McLauchlin, J.
Aird, H.
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Natl Infect Serv, Publ Hlth England Food Water & Environm Microbiol, York Biotech Campus, York YO41 1LZ, N Yorkshire, EnglandNatl Infect Serv, Publ Hlth England Food Water & Environm Microbiol, 61 Colindale Ave, London NW9 5EQ, England
Aird, H.
Amar, C.
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Natl Infect Serv, Publ Hlth England Gastrointestinal Bacteria Refer, 61 Colindale Ave, London NW9 5EQ, EnglandNatl Infect Serv, Publ Hlth England Food Water & Environm Microbiol, 61 Colindale Ave, London NW9 5EQ, England
Amar, C.
Barker, C.
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Natl Infect Serv, Publ Hlth England Gastrointestinal Bacteria Refer, 61 Colindale Ave, London NW9 5EQ, EnglandNatl Infect Serv, Publ Hlth England Food Water & Environm Microbiol, 61 Colindale Ave, London NW9 5EQ, England
Barker, C.
Dallman, T.
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Natl Infect Serv, Publ Hlth England Gastrointestinal Bacteria Refer, 61 Colindale Ave, London NW9 5EQ, EnglandNatl Infect Serv, Publ Hlth England Food Water & Environm Microbiol, 61 Colindale Ave, London NW9 5EQ, England
Dallman, T.
Elviss, N.
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Natl Infect Serv, Publ Hlth England Food Water & Environm Microbiol, 61 Colindale Ave, London NW9 5EQ, EnglandNatl Infect Serv, Publ Hlth England Food Water & Environm Microbiol, 61 Colindale Ave, London NW9 5EQ, England
Elviss, N.
Jorgensen, F.
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Natl Infect Serv, Publ Hlth England Food Water & Environm Microbiol, Salisbury SP4 0JG, Wilts, EnglandNatl Infect Serv, Publ Hlth England Food Water & Environm Microbiol, 61 Colindale Ave, London NW9 5EQ, England
Jorgensen, F.
Willis, C.
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Natl Infect Serv, Publ Hlth England Food Water & Environm Microbiol, Salisbury SP4 0JG, Wilts, EnglandNatl Infect Serv, Publ Hlth England Food Water & Environm Microbiol, 61 Colindale Ave, London NW9 5EQ, England