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Method Validation of a Qualitative Test

Evaluation of a qualitative method usually involves comparison between a new method and an established method to determine if the same results are obtained using both methods. The problem with comparison between qualitative methods is that it may be difficult to determine which result is correct and which is not correct. Any discordant samples should be repeated by both methods for confirmation. A fourfold table can be constructed to compare the two methods. The table, as shown on the right, contains two variables (the new method and the established method), each with two levels of variables (positive and negative). The calculation shown below the table can be used to evaluate the correlation. Acceptable correlation is often considered to be > .95, or 95%. In the example that is shown below the calculation formula, the measurement of agreement appears to be satisfactory. The two discrepant results in the example may be attributed to chance variation between methods. The two discrepant results could also be explained, for example, by a difference in test sensitivity. Reviewing the manufacturers' package inserts may reveal differences between test sensitivity and specificity. For a qualitative procedure, sensitivity is not the detection limit, as it is with quantitative tests. Rather, it is the point at which a test is considered positive (the cutoff). The specificity of the test is the ability of the method to accurately report a negative value when the test is indeed negative (below the cutoff).

Method Validation of a Qualitative Test


Evaluation using previously tested proficiency testing samples with known results for the method being tested may also provide method validation data. In this case, it is important to ensure that the samples were properly stored and are at room temperature when testing commences. It may also be possible to evaluate the new method against clinical symptoms and/or supplementary tests. If a patient is diagnosed with the disease or condition in question based on clinical symptoms and/or other types of tests, and the result of the qualitative test that is being validated is positive, this information can be documented as part of the method validation data. For example, a rapid strep A method is being validated and a patient test result is positive using the rapid method. A strep culture is set up simultaneously and the result of the culture is positive for betahemolytic Group A Streptococcus. Therefore, the rapid qualitative method is accurate in this case. This information should be included in the method validation documentation.