Tuaillon 2020 [A].

Study characteristics
Patient Sampling	Purpose: Diagnosis of acute and convalescent‐phase infection Design: Two‐group study to estimate sensitivity and specificity, including: [1] Hospitalised patients with PCR‐proven or suspected COVID‐19 Infection (PCR‐negative were excluded), n = 38 samples [2] Pre‐pandemic controls (samples collected in 2017‐2018 from patients care in the Department of Infectious Diseases), n = 20 Recruitment: Consecutive cases Prospective or retrospective: Prospective Sample size: 58 (38) Further detail: Inclusion criteria: Patients care at the Montpellier University Hospital suspected of a COVID‐19 infection
Patient characteristics and setting	Setting: Inpatient Location: University Hospital, Montpellier Country: France Dates: From 18 March 2020 (ongoing) Symptoms and severity: Severe cases 26/38 (68%); 4/9 day 1 to 6; 9/14 day 7 to 14; 13/15 day >= 15 Demographics: Age reported subgroup (mean, SD): Day 1 to 6 72 y (55‐90y); Day 7 to 14 65 y (39‐86y); Day >= 15 66 y (51‐83y). Sex: 22/38 cases were male (58%). Exposure history: Not stated Non‐Covid group 1: Control Source: 2017‐2018 (pre‐pandemic) Characteristics: Age (mean, SD): 41 (17‐72); sex: 10/20 (50%) Non‐Covid group 2: NA
Index tests	Test name: [A] Zhuhai Livzon Pharmaceutical Group ‐ 2019‐nCoV IgM/IgG [B] UNscience Biotechnology ‐ COVID‐19 IgG/IgM [C] Chongqing iSIA BIO‐Technology ‐ 2019‐nCoV IgM/IgG kit [D] Guangdong Hecin Biotech ‐ 2019‐nCoV IgM kit [E] AccuBiotech ‐ Accu‐Tell COVID‐19 IgG/IgM [F] Acro Biotech ‐ 2019‐nCoV IgM/IgG [G] EUROIMMUN ‐ anti‐SARS‐COV‐2 IgA [H] EUROIMMUN ‐ anti‐SARS‐COV‐2 IgG [I] EUROIMMUN ‐ anti‐SARS‐COV‐2 IgA or IgG [J] ID.Vet ‐ ID Screen SARS‐CoV‐2‐N IgG Indirect ELISA Manufacturer: [A] Zhuhai Livzon Pharmaceutical Group [B] UNscience Biotechnology [C] Chongqing iSIA BIO‐Technology [D] Guangdong Hecin Biotech [E] AccuBiotech [F] Acro Biotech [G] EUROIMMUN [H] EUROIMMUN [I] EUROIMMUN [J] ID.Vet Antibody: [A] [B] [C] IgG and IgM, [C] IgM, [D] [E] [F] IgG and IgM,[G] IgA, [H] IgG, [I] IgA and IgG, [J] IgG Antigen target: [A] [B] [C] [D] [E] [F] unclear, [G] [H] [I] S1,[J] N Evaluation setting: [A] to [F] POC tests [G] to [J] Laboratory Test method: [A] CGIA, [B] CGIA, [C] LFA, [D] CGIA, [E] CGIA, [F] LFA, [G] ELISA, [H] ELISA, [I] ELISA, [J] ELISA Timing of samples: [1] 1‐6 days (n = 9), 7‐14 days (n = 14), ≥ 15 days (n = 15) from the onset of symptoms Samples used: Plasma (as per Material and Methods, 1st paragraph) Test operator: Not stated Definition of test positivity: [A] to [F] any band, even weakly visible: positive [G] ≥ 1.1 positive [H] cut‐off value for a positive ≥ 70% Blinding reported: Not stated Threshold predefined: Yes, as per manufacturer’s instructions
Target condition and reference standard(s)	Reference standard: RT‐PCR; no details Samples used: Not stated Timing of reference standard: Not stated Blinded to index test: Not stated Incorporated index test: No Definition of non‐COVID cases: Pre‐pandemic Samples used: Not stated Timing of reference standard: Pre‐pandemic controls (2017‐2018) Blinded to index test: Not applicable (NA) Incorporated index test: NA
Flow and timing	Time interval between index and reference tests: Not stated All patients received same reference standard: No Missing data: PCR‐negatives excluded Uninterpretable results: None reported Indeterminate results: EUROIMMUN borderline results considered negative Unit of analysis: samples
Comparative
Notes	Funding: This work was supported by Grants from Montpellier University Hospital and Montpellier University (MUSE). Publication status: pre‐print Source: medRxiv Author COI: The authors have declared no competing interest.
Methodological quality
Item	Authors' judgement	Risk of bias	Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled?	Yes
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?	Unclear
If a threshold was used, was it pre‐specified?	Yes
Could the conduct or interpretation of the index test have introduced bias?		Unclear risk
Are there concerns that the index test, its conduct, or interpretation differ from the review question?			Low concern
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?	Unclear
The reference standard does not incorporate the index test	Yes
Could the reference standard, its conduct, or its interpretation have introduced bias?		Unclear 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?	No
Were all patients included in the analysis?	Yes
Did all participants receive a reference standard?	No
Were results presented per patient?	Yes
Could the patient flow have introduced bias?		High risk