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Last updated (December 2012)


Data Submission Requirements
&
Definitions


Method manufacturers seeking Performance Tested Methodssm status are required to submit data for the following parameters when applicable to the specific method format.

Calibration Curves - In the case of quantitative methods, a sufficient number of standard solutions are needed to define the response in relation to concentration. The number of standard solutions is a function of the range of concentration. In most cases, a minimum of 5 concentrations of standard solutions (not zero) is required to prepare a calibration curve. Calibration curves are not required to be linear; the curve should be statistically tested and expressed. Response at various concentrations in pure or defined solvent, and response at various concentrations in matrix(es) should be presented. For qualitative methods , the entire response range may be examined by testing a series of test samples and standards consisting of negative test samples, test samples at the specification level (as stated in the kit insert), test samples bracketing the specification level, and strong positive test samples. There should be between 5 and 10 replicate test samples at each concentration. A response curve of % positive (or negative) v.s. concentration should be constructed.

Matrix - The commodity or material to which the kit is applicable must be clearly stated.

Accuracy - Accuracy is considered the closeness of the determined value to the true value. For quantitative methods, recovery of added analyte over an appropriate range of concentrations (mean range variability) is taken as an indication of accuracy. Recovery should be determined using at least 6 test samples each at 3 concentrations for each matrix covering the range of concern including one concentration near the specification level, one at mid-range, and one at the high end. For qualitative methods, recovery should be estimated by comparison of results with an existing method.

Precision - Precision is the degree of agreement of measurements under specific conditions. For quantitative methods, the relative standard deviation of individual results should be determined from different days, different analysts, different calibration curves, different batches of reagents, and for different matrixes. For qualitative methods, the precision cannot be expressed as a standard deviation or coefficient of variation, but may be expressed as true and false/positive (or negative) rates. These rates should be determined at several concentrations including the specification level.

Comparison to Existing Methods - Comparison to an existing method when applicable is strongly recommended (preferably a validated or collaboratively studied method).

Cross Reactivity - Cross reactivity is the study of the test kit response to analogues, metabolites, or other non-target components that may be present in the matrix(es).

Stability - Stability studies of the test kit components could be generated as part of ruggedness testing and might include factors such as time, temperature, and freeze/thaw cycles.

Detection Limit - For quantitative methods, the detection limit is defined as the mean value of the matrix blank readings plus 3 standard deviations, expressed in analyte concentration.

Limit of Quantitation - The limit of quantitation is equal to or greater than the lowest concentration point on the calibration curve. For quantitative methods, the limit is determined by actual analysis of at least 6 fortified test samples per matrix. It is not determined by extrapolation.

False Positive / False Negative Rates - The false positive/false negative rates may be determined for qualitative methods . Data from a confirmatory method comparison should be provided if such a method(s) is applicable to the same matrix(es) and concentration range(s).

Ruggedness Test - Ruggedness test is an intra-laboratory study to examine the behavior of an analytical process when small changes in the environmental and/or operating conditions are made, akin to those likely to arise in different test environments

 
 
 
 
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