Trabaud 2020 [A].

Study characteristics
Patient Sampling	Purpose: Diagnosis of current acute and convalescent‐phase infection Design: Single‐group study to estimate sensitivity [1] COVID patients (N = 68, 82 samples) [1a] infected hospitalised patients (N = 40) [1b] infected non‐hospitalised healthcare workers (N = 28) Recruitment: Recruited infected hospitalised patients and non‐hospitalised infected healthcare workers Prospective or retrospective: Retrospective Sample size: 82 (82) samples from 68 (68) patients of which 66 (66) samples were eligible for our review Further detail: Inclusion: hospitalised patients or non‐hospitalised healthcare workers with RT‐PCR confirmed COVID positive
Patient characteristics and setting	Setting: Inpatients and outpatients Location: Hopital de la Croix‐Rousse, Hospices Civils de Lyon, Lyon Country: France Dates: Not stated Symptoms and severity: 40 hospitalised with 25 in intensive care units 28 non‐hospitalised. All symptomatic (symptoms not stated) Demographics: [1] Age range 7‐81 years (median = 51) [1a] Age range 7‐81 years (median = 64), 11/40 female (27.5%) [1b] Age range 25‐59 years (median = 36), 22/28 female (78.6%) Exposure history: [1a] Not stated [1b] Healthcare workers (HCW) (including physicians, nurses, and lab staff)
Index tests	Test name: [A] Diasorin Liaison [B] bioMeriuex Vidas [C] Siemens Atellica [D] Wantai [E] Abbott Architect [F] Roche Elecsys [G] BioRad Platelia [H] Epitope Diagnostics EDI Manufacturer: [A] Diasorin S.p.A. [B] bioMerieux diagnostics [C] Siemens Healthcare GmbH [D] Beijing Wantai Biological Pharmacy [E] Abbott Diagnostics [F] Roche Diagnostics [G] Bio‐Rad Laboratories, Inc. [H] Epitope Diagnostics Inc. Antibody: [A] IgG [B] IgG [C] Total antibody [D] Total antibody [E] IgG [F] Total antibody [G] Total antibody [H] IgG Antigen target: [A] S1 and S2 [B] S1 and peptide [C] RBD [D] RBD [E] N‐protein [F] N‐protein [G] N‐protein [H] N‐protein Evaluation setting: Laboratory Test method: [A] indirect CLIA [B] Enzyme Linked Fluorescent Assay (ELFA) [C] CLIA [D] ELISA [E] CMIA [F] ECLIA [G] ELISA [H] ELISA Timing of samples: Range 4 to 52 days post‐symptom onset: <= 15 days pso (n = 16) 16‐20 days pso (n = 21) > 20 days pso (n = 45) Samples used: All serum/plasma Test operator: Technicians from the laboratory Definition of test positivity: [A] AU/mL; 12, > 12‐ < 15 borderline [B] ratio; 1 [C] ratio; 1 [D] ratio; > 1.1; >= 0.9‐ <= 1.1 borderline [E] ratio; 1.4 [F] ratio; 1 [G] ratio; 1; >= 0.8‐ < 1 borderline [H] >= 1.1x (NC + 0.18); ≥ 0.9x (NC + 0.18) < 1.1x (NC + 0.18) borderline Blinding reported: not stated (but only COVID cases included in study) Threshold predefined: yes
Target condition and reference standard(s)	Reference standard: RT‐PCR, threshold not stated Samples used: Not stated Timing of reference standard: Not stated Blinded to index test: Yes, prior Incorporated index test: No
Flow and timing	Time interval between index and reference tests: Not stated All patients received same reference standard: Yes Missing data: Yes as 16 samples 4‐15 days pso excluded from review as interval too wide Uninterpretable results: Not stated Indeterminate results: Not stated Unit of analysis: 82 samples from 68 patients
Comparative
Notes	Funding: This work did not receive any specific grant from funding agencies, in the public, commercial or not‐for‐profit sectors. The assay kits were provided by the manufacturers. Publication status: Published paper Source: Journal of Clinical Virology Author COI: Authors declared no conflicts of interest.
Methodological quality
Item	Authors' judgement	Risk of bias	Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled?	Unclear
Was a case‐control design avoided?	No
Did the study avoid inappropriate exclusions?	Unclear
Did the study avoid inappropriate inclusions?	Unclear
Could the selection of patients have introduced bias?		High risk
Are there concerns that the included patients and setting do not match the review question?			High
DOMAIN 2: Index Test (All tests)
DOMAIN 2: Index Test (Antibody tests)
Were the index test results interpreted without knowledge of the results of the reference standard?	No
If a threshold was used, was it pre‐specified?	Yes
Could the conduct or interpretation of the index test have introduced bias?		High risk
Are there concerns that the index test, its conduct, or interpretation differ from the review question?			Unclear
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition?	Yes
Were the reference standard results interpreted without knowledge of the results of the index tests?	Yes
The reference standard does not incorporate the index test	Yes
Could the reference standard, its conduct, or its interpretation have introduced bias?		Low risk
Are there concerns that the target condition as defined by the reference standard does not match the question?			High
DOMAIN 4: Flow and Timing
Was there an appropriate interval between index test and reference standard?	Unclear
Did all patients receive the same reference standard?	Yes
Were all patients included in the analysis?	Yes
Did all participants receive a reference standard?	No
Were results presented per patient?	No
Could the patient flow have introduced bias?		High risk