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When Diagnostic Accuracy Gold Standard procedure is not available...

IVDR – when Diagnostic Accuracy Gold Standard procedure is not available

Diagnostic tests are very common and used by health professionals for detecting the disease condition in human beings. Generally, most of the tests are giving accurate results in comparison with a gold standard method or a well-established standard procedure.

However, certain situations, the gold standard or a well-established standard procedure may not exist for the diagnosis of a particular disease. In such situations, an imperfect reference standard will be used and hence the above mentioned diagnostic accuracy estimates cannot be computed since the subjects’ disease condition is unknown.

The objective of this white paper is to review the statistical methods for the estimation of diagnostic accuracy when gold standard procedure is not available.

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