Domain	Patient selection	Index test	Reference standard	Flow and timing
Description	Describe methods of patient selection Describe included participants (prior testing, presentation, intended use of index test and setting)	Describe the index test and how it was conducted and interpreted	Describe the reference standard and how it was conducted and interpreted	Describe any participants who did not receive the index test(s) and/or reference standard or who were excluded from the 2 × 2 table (refer to flow diagram) Describe the time interval and any interventions between index test(s) and reference standard
Signalling questions (yes, no, unclear)	Was a consecutive or random sample of participants enrolled? Was a case‐control design avoided? Did the study avoid inappropriate exclusions?	Were the index test results interpreted without knowledge of results of the reference standard? If a threshold was used, was it prespecified?	Is the reference standard likely to correctly classify the target condition? Were the reference standard results interpreted without knowledge of results of the index test?	Did all participants receive a reference standard? Did all participants receive the same reference standard? Were all participants included in the analysis?
Risk of bias (high, low, unclear)	Could the selection of participants have introduced bias?	Could the conduct or interpretation of the index test have introduced bias?	Could the reference standard, its conduct or its interpretation have introduced bias?	Could the participant flow have introduced bias?
Concerns regarding applicability (high, low, unclear)	Are there concerns that included participants do not match the review question?	Are there concerns that the index test, its conduct or its interpretation differs from the review question?	Are there concerns that the target condition as defined by the reference standard does not match the review question?