Accuracy is one of the last performance parameters to be defined for the assay. By this time, the values for positive and negative results have been defined and the assay has been shown to be specific and reproducible for detecting the ana-lyte(s) for which it was developed. It is now time to take the assay out for a test run.

Accuracy refers to the ability of the test to produce a correct result compared with an external standard. External standards can be previously tested patient samples from interlaboratory exchanges or proficiency surveys. The standards can also be target nucleic acids or viruses spiked into the appropriate specimen matrix. Table 3 lists commercial sources for standards that might be used for accuracy studies.

To verify the accuracy of an assay, a panel of specimens is organized and assayed in a blind manner. For qualitative assays, a panel of known positive and negative samples from each specimen type should be assayed. If possible, positive specimens with low, moderate, and high amounts of the analyte should be included in the panel. For quantitative tests, a panel of samples of known analyte quantity (including samples with no analyte) should be used to verify accuracy. The analyte quantity in the specimens to be tested should span the linear range of the assay. For analytical tests, a panel of samples with known alleles, mutations, or genotypes should be used to verify their respective analytical tests.

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