| 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 | |||||