Verification Process of American CLSI M52-Commercial Microbial Identification System and Antimicrobial Susceptibility Testing System / 现代检验医学杂志

Before performing patient testing with commercial microbial test systems,each laboratory must verify that it can obtain performance specifications comparable to those of the manufacturer.This includes trueness,precision (reproducibility),and reportable range of test results,and verifying that the manufacturer's reference ranges are appropriate for the laboratory's patient population.American Clinical and Laboratory Standards Institute has set up a committeeto develop a verification process and a quality assurance program for commercial microbial identification system and antimicrobial susceptibility testing system,in order to provide recommendations for US Food and Drug Administration (FDA).This guidance is applicable to instrument systems widely used in clinical laboratories and can also be used for manual testing of microbiological identification and antimicrobial susceptibility testing.The aim of this article is to provide advice for the microbial identification system and antimicrobial susceptibility testing system verification process,based on principles of microbiological identification and antimicrobial susceptibility and CLSI M52 guideline.

Comparison of Two Kinds of Automated Microbial Identification System Used in the Identification of Brucella / 现代检验医学杂志

Objective To compare Vitek2 Compact and Walkaway 40 in the identification of Brucella.Methods Used Vitek2 Compact and Walkaway 40 automated microbial identification system to identify clinical isolates and compared with the de-tection of 16S rRNA gene sequences analysis.Results The clinical isolates was identified as Bergeyella zoohelcum or Moraxella by Walkaway 40 and as Brucella melitensis by Vitek2 Compact.16S RNA sequence analysis of the isolate,the se-quence was identical to the sequences of 16S rRNA of Brucella,which excluded the possibility of B.zoohelam and Moraxel-la .Determined that the isolate was B.melitensis.Conclusion Vitek 2 Compact can accurately identified Brucella.Use molec-ular methods to corroborate when the isolates was identified as Brucella by Vitek 2 Compact,this method can greatly im-prove the detection rate of brucellosis and reduce the possibility of misdiagnosis.Walkaway 40 cannot accurately identified Brucella,Misidentification of Brucella can result in wrong treatment of the patient and let the staff in the risk of laboratory-acquired infection.Recommend laboratory should be cautious reporting in the identified B.zoohelam or Moraxella by Walk-away 40 and use Vitek2 Compact or molecular methods for review.