Table 1 Criteria for evaluating multiplex assays

1.

Analytical performance parameters (for example, precision, analytical sensitivity, and linearity) of assays should be available for each analyte.

2.

The clinical performance (clinical sensitivity and specificity) of each analyte within the multiplex should be comparable to that of assays for individual analytes.

3.

The time required to produce all results of multiplex assay should be less than the sum of time required to produce results of individual assays.

4.

The combination of multiplex assays should be appropriate for answering clinical questions; that is, the combinations of analytes measured within multiplex assay should make clinical sense.