▸ Was the spectrum of patients representative of patients who will receive the test in practice?

▸ Were selection criteria clearly described?

▸ Is the reference standard likely to correctly classify the target condition?

▸ Is the time period between reference standard and index test short enough to be reasonably sure that the target condition did not change between the two tests?

▸ Did the whole sample or a random selection of sample receive verification using a reference standard diagnosis?

▸ Did patients receive the same reference standard regardless of the index test result?

▸ Was the reference standard independent of the index test (that is, the index test did not form part of the reference standard?)

▸ Was the execution of the index test described in sufficient detail to permit replication of the test?

▸ Was the execution of the reference standard described in sufficient detail to permit its replication?

▸ Were the index test results interpreted without knowledge of the results of the reference standard?

▸ Were the reference standard results interpreted without knowledge of the results of the index test?

▸ Were the same clinical data available when test results were interpreted as would be available when the test is used in practice?

▸ Were interpretable intermediate test results reported?

▸ Were withdrawals from the study explained?