Specificity: ability to assess unequivocally the target analyte in the presence of components which might be expected to be present. In other words, the specificity of an assay is the capability of the assay to differentiate similar analytes or other interference from matrix elements which could have a positive or negative effect on the assay value
Accuracy: agreement between the value found and an excepted reference value. The recovery of spiked analyte is within 75125% at all ranges
Precision: variability in the data from replicate determinations of the same homogeneous sample under the normal assay conditions
Detection limit: lowest amount of analyte which can be detected, but not necessarily quantitated, as an exact value
Limits of Quantitation: lowest and highest concentrations of an analyte in a sample that can be quantitatively determined with suitable precision and accuracy
Linearity: ability of the assay to return values that are directly proportional to the concentration of the target pathogen or analyte in the sample
Range: concentrations of analyte or assay values between the low and high limits of quantitation
Ruggedness: reproducibility of the assay under a variety of normal, but variable, test conditions
Robustness: measure of the assay capacity to remain unaffected by small but deliberate changes in test conditions. Robustness measures the effect of deliberate changes (incubation time, temperature, sample preparation, buffer pH) that can be controlled through specifications in the assay protocol.
