Single Laboratory Verification of New Microbiological Methods
Oral Presentation
Prepared by C. Fricker
Analytical Services Inc, 130 Allen Brook Lane, Williston, Vermont, 05495, United States
Contact Information: [email protected]; 802-878-5138
ABSTRACT
Adoption of a new microbiological method into a laboratory requires that the capability of the laboratory and its personnel in performing the method has been demonstrated. Many approaches have been described for this purpose but none has been universally accepted. The International Standards Organisation (ISO) has been working to develop procedures for initial demonstration of performance characteristics of methods and more recently on procedures for single laboratory verification. The parameters that are required for verification include sensitivity, specificity, false positive rate, false negative rate, efficiency, repeatability, uncertainty of counting and robustness.
This presentation will describe some of the steps required to generate these data and will also discuss some of the issues associated with presenting these data to regulatory or accreditation bodies. In particular, issues relating to “false negative rates” will be discussed and an argument put forward that suggests that some of our current thinking about the False Negative Rate is incorrect!
Oral Presentation
Prepared by C. Fricker
Analytical Services Inc, 130 Allen Brook Lane, Williston, Vermont, 05495, United States
Contact Information: [email protected]; 802-878-5138
ABSTRACT
Adoption of a new microbiological method into a laboratory requires that the capability of the laboratory and its personnel in performing the method has been demonstrated. Many approaches have been described for this purpose but none has been universally accepted. The International Standards Organisation (ISO) has been working to develop procedures for initial demonstration of performance characteristics of methods and more recently on procedures for single laboratory verification. The parameters that are required for verification include sensitivity, specificity, false positive rate, false negative rate, efficiency, repeatability, uncertainty of counting and robustness.
This presentation will describe some of the steps required to generate these data and will also discuss some of the issues associated with presenting these data to regulatory or accreditation bodies. In particular, issues relating to “false negative rates” will be discussed and an argument put forward that suggests that some of our current thinking about the False Negative Rate is incorrect!
