Sensitivity and Specificity of the BAX® for Screening/Listeria monocytogenes Assay: Internal Validation and Independent Laboratory Study

Autor:	W. M. Barbour, Curiale M, A. M. Hochberg, Gangar, Roering A, Peter M. Mrozinski
Rok vydání:	2001
Předmět:	Pharmacology Significant difference food and beverages Biology medicine.disease_cause Analytical Chemistry Listeria species Listeria monocytogenes medicine Environmental Chemistry Food science Internal validation Agronomy and Crop Science Food Science
Zdroj:	Journal of AOAC INTERNATIONAL. 84:1087-1098
ISSN:	1944-7922 1060-3271
DOI:	10.1093/jaoac/84.4.1087
Popis:	In this study to certify the BAX® for Screening/Listeria monocytogenes assay (DuPont Qualicon, Wilmington, DE), an internal evaluation was conducted on 16 food types that were simultaneously analyzed with the BAX system (BAX), and the ISO method for the detection of L. monocytogenes (ISO). No statistically significant difference in performance between the BAX and ISO methods was observed. Inclusivity/exclusivity testing showed that the BAX system was able to detect 97 of 97 (100%) of L. monocytogenes strains tested. None of 56 other Listeria species or non-Listeria tested gave a reproducible positive BAX result. Ruggedness testing demonstrated that performance of the assay was not affected by reasonable variability in the operating parameters. BAX was then submitted for independent laboratory validation. In this phase, BAX was compared with standard culture methods for the detection of L. monocytogenes in chicken (USDA-FSIS), crab meat (BAM), and milk (AOAC). This study validated product claims of sensitivity and specificity >98% in accordance with AOAC Performance Tested MethodSM requirements.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::76d725d99f6f25a19e654a2e86ab6af3 https://doi.org/10.1093/jaoac/84.4.1087 Zobrazit plný text záznamu