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. 2022 Jul 22;2022(7):CD013705. doi: 10.1002/14651858.CD013705.pub3
Patient sampling items Patient characteristics and setting items Index test items Reference standard items Flow and timing items Notes items
A1 Purpose B1 Setting D1.1 Test name (please include product code if reported) E1 Reference standard for cases including threshold F1 What was the time interval between index and reference tests? G1 Funding
A2 Design (and description of groups labelled [1] [2] …) B2 Location (include name of institution if available) D1.2 Manufacturer E1.1 PCR genetic targets F2 Did all patients receive the same reference standard? G2 Publication status
A3 Recruitment B3 Country D1.3 Antigen or genetic target E2 Samples used F3 Missing data G3 Source (preprint or journal name)
A4 Were cases recruited prospectively or retrospectively? B4 Dates D1.4 Antibodies used E3 Timing of reference standard F4 Uninterpretable result s G4 Study author CoI (including any manufacturer affiliations)
A5 Sample size (virus/COVID cases) B5 Symptoms and severity D1.5 POC or laboratory E4 Was it blind to index test? F5 Indeterminate results (index) G5 Comment
A6 Inclusion and exclusion criteria B6 Demographics D1.6 Assay format E5 Did it incorporate index test? F5.1 Indeterminate results (reference)  
A7 Comment B7 Exposure history D1.7 When were samples taken? E6 Reference standard for non‐cases F6 Samples or patients  
  B8 Comment D1.8 Samples used (include who collected by) E7 Samples used F7 Comment  
  Non‐COVID patients (if additional groups) D1.8.1 Transport media (volume and manufacturer detail) E8 Timing of reference standard    
  C1.1 Group name D1.8.2 Sample storage and timing of test E9 Was it blind to index test?    
  C1.2 Source and time D1.9 Who applied the test (include reported training/e)? E10 Did it incorporate index test?    
  C1.3 Characteristics D1.10 How was positive defined? E11 Comment    
  C2.1 Group name D1.11 Blinded to reference standard      
  C2.2 Source and time D1.12 Threshold predefined      
  C2.3 Characteristics D1.13 Comment      
CoI: conflict of interest; POC: point of care; PCR: reverse transcription polymerase chain reaction