| Domain | Patients Selection | Index Test | Reference Standard | Flow and Timing |
| Signaling question (yes, no or unclear) | Was a consecutive or random sample of patients enrolled? | Were the index test results interpreted without knowledge of the results of the reference standard? | Is the reference standard likely to correctly classify the target condition? | Was there an appropriate interval between index tests and reference standard? |
| Did all patients receive a reference standard? | ||||
| Did the study avoid inappropriate exclusions? | Were the reference standard results interpreted without knowledge of the results of the index test? | Did all patients receive the same reference standard? | ||
| Risk of bias (high, low or unclear) | Could the selection of patients have introduced bias? | Could the conduct or interpretation of the index test have introduced bias? | Could the reference standard or its interpretation have introduced bias? | Could the study flow have introduced bias? |
| Concerns about applicability (high, low, or unclear) | Are there concerns that the included patients do not match the review question? | Are there concerns that the index test or its interpretation differ from the review question? | Are there concerns that the target condition as defined by the reference standard does not match the review question? | - |