title: Multilaboratory validation of a luminex microbead-based suspension array for the identification of the 11 most clinically relevant Shiga toxin-producing Escherichia coli O serogroups.
abstract: Rapid and high-throughput identification and serotyping of Shiga toxin-producing Escherichia coli (STEC) O serogroups is important for detecting, investigating, and controlling STEC infection outbreaks and removing hazardous products from commerce. A Luminex microbead-based suspension array has been developed to identify the 11 most clinically relevant STEC serogroups: O26, O45, O91, O103, O104, O111, O113, O121, O128, O145, and O157. Here we present results of a blinded multilaboratory collaborative study involving 10 participants from nine laboratories using 55 unknown strains. From the total 495 analyses, two false-positive and three false-negative results were obtained, indicating the assay to be a rapid, high-throughput, and robust method for identifying clinically relevant STEC serogroups.
authors: U.S. Food and Drug Administration, San Francisco District, Alameda, California 94502, USA. andrew.lin@fda.hhs.gov
authors: Andrew
authors: A
authors: Lin
authors: Julie A
authors: JA
authors: Kase
authors: Michelle M
authors: MM
authors: Moore
authors: Insook
authors: I
authors: Son
authors: Nelly
authors: N
authors: Tran
authors: Laurie M
authors: LM
authors: Clotilde
authors: Karen
authors: K
authors: Jarvis
authors: Kelly
authors: K
authors: Jones
authors: Kuppuswamy
authors: K
authors: Kasturi
authors: Khamphet
authors: K
authors: Nabe
authors: Melissa
authors: M
authors: Nucci
authors: Gail S
authors: GS
authors: Wagley
authors: Fei
authors: F
authors: Wang
authors: Beilei
authors: B
authors: Ge
authors: Thomas S
authors: TS
authors: Hammack
mesh_terms: D015169:Colony Count, Microbial / Q000592:standards*; D005506:Food Contamination / Q000032:analysis*; D005516:Food Microbiology; D006801:Humans; D007753:Laboratories / Q000592:standards*; D008863:Microspheres; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012703:Serotyping / Q000379:methods / Q000592:standards; D054323:Shiga-Toxigenic Escherichia coli / Q000145:classification / Q000302:isolation & purification*