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Procedures for Detection and Quantitation

Focus Questions for
Detection/Quantitation Committee

Method Developers Requirements

What does a method developer have to do to determine/demonstrate the applicability of a new method or technology (e.g., matrices the method is applicable to, sensitivity in different media; bias, precision, selectivity as a function of concentration).

Regulatory Agency Needs

What procedures are appropriate for a regulatory agency to use when determining the general usuability of a method or measurement technology (i.e., what regulatory limits could be set and there would be general acceptance that they are generally achievable). This includes determining:

what is the lowest level that one can be confident that, if present, the analyte will be detected (freedom from false negatives);
what is the lowest level that one can be confident that the analyte can be measured with a specified level of quality;
what is the lowest concentration that if the analyte is reported to be present one can be confident that the analyte is actually there (freedom from false positives).

Requirements on Laboratory

What would a laboratory have to do to demonstrate that their measurement system is achieving the sensitivity required by the particular application (e.g., permit or regulatory requirement)

Enforcement Community Needs

What procedures need to be required of the monitoring community so as to enable enforcement officials to determine if an analytical system achieved the level of sensitivity that was required. (Converse of the laboratory question)

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