The influence of uninterpretability on the assessment of diagnostic tests.

A frequent problem faced by physicians utilizing diagnostic tests is the occurrence of uninterpretable test results. Such results, if they occur commonly, can seriously impair the diagnostic performance of the test. Moreover, in assessing the characteristics of the test, i.e. sensitivity, specificity, etc. failure to consider the impact of uninterpretability will artificially inflate the test characteristics. In this paper we explore the implications of this issue. We observe that a relevant factor is the potential repeatability of the test, i.e. whether the cause of uninterpretability is a transient phenomenon or an inherent property of the subject. We distinguish uninterpretable results, in which no result is obtained, from indeterminate results, in which the result is equivocal, or for which predisposing concomitant factors limit the interpretability of the result. Our results demonstrate that the naive approach of ignoring uninterpretable results in test assessments may indeed be unbiased in certain circumstances. However, if the cause of uninterpretability is related to disease status or to the potentially observable test result, then this approach will lead to bias. In either case, the frequency of uninterpretability is an important consideration in the cost-effectiveness of the test.