| (1) Was the spectrum of patients representative of the patients who will receive the test in practice? |
| (2) Were selection criteria clearly described? |
| (3) Is the reference standard likely to classify the target condition correctly? |
| (4) Is the time period between reference test and index test short enough to be reasonably sure that the target condition did not change between the two tests? |
| (5) Did the whole sample or a random selection of the sample receive verification using a reference standard of diagnosis? |
| (6) Did patients receive the same reference standard regardless of index test result? |
| (7) Was the reference standard independent of the index test (that is, the index test did not form part of the reference standard)? |
| (8a) Was the execution of the index test described in sufficient detail to permit its replication? |
| (8b) Was the execution of the reference standard described in sufficient detail to permit its replication? |
| (9a) Were the index test results interpreted without knowledge of the results of the reference standard? |
| (10) Were the same clinical data available when test results were interpreted as would be available when the test is used in clinical practice? |
| (11) Were uninterpretable/intermediate test results reported? |
| (12) Were withdrawals from the study explained? |
