Delliere 2020 [A].

Study characteristics
Patient Sampling	Purpose: To evaluate the COVID‐19 IgG/IgM Rapid Test Cassette (Orient Gene Biotech, Zhejiang, China) and compare it to simultaneous CMIA IgG testing by the Abbott SARS‐CoV‐2 IgG (ASIA) on Architect Abbott Instrument i2000SR 2‐group study to estimate sensitivity and specificity for diagnosis of active disease Design: Two‐group study: [1] COVID‐19‐positive patients (n = 102, 106 samples) [2] Pre‐pandemic patients (n = 42; 14 occupational health patients with no known disease; 28 hospitalised patients with previous pulmonary infection, rhinovirus, metapneumovirus, influenza A, syncytial respiratory virus, recent malaria,antibodies against cytomegalovirus or Epstein‐Barr, HIV, hepatitis B, toxoplasmosis, rheumatic fever) Recruitment: Unclear Prospective or retrospective: [1] Unclear; [2] retrospective Sample size: 142 (102) patients with 146 (106) samples Further detail: Not stated
Patient characteristics and setting	Setting: Not stated 35/102 hospitalised in a medical unit 28/102 hospitalised in ICU The remaining 39/102 possibly not inpatients (2 asymptomatic and 37 mild symptoms) Location: Hôpital Saint‐Louis, Département des Agents Infectieux, 1 avenue Claude Vellefaux, 75010 Paris, France Country: France Dates: Not stated Symptoms and severity: asymptomatic (n = 2), mild (n = 37), severe symptoms requiring hospitalisation in medical unit (n = 35), critical symptoms requiring hospitalisation in intensive care unit (n = 28) Demographics: Mean age of the patient population was 52 (± 16) years; male = 59/102 (57.8%) Exposure history: Not stated Non‐Covid group 1: Pre‐pandemic controls Source: Not stated Characteristics: No known disease 14/42 Hospitalised patients 28/42: (previous pulmonary infection with endemic coronavirus 16/28; rhinovirus 1/28;metapneumovirus 1/28; influenza A 1/28; syncytial respiratory virus 1/28; recent infection with malaria 3/28; IgM antibodies (Ab) against cytomegalovirus 2/28; IgM Ab against Epstein‐Barr virus 2/28; IgG against HIV 1/28; hepatitis B virus 1/28; toxoplasmosis 1/28; high levels of rheumatic factor 2/28)
Index tests	Test name: [A] Orient Gene COVID‐19 IgG/IgM Rapid Test Cassette [B] Abbott SARS‐CoV‐2 IgG Manufacturer: [A] Orient Gene Biotech, Zhejiang, China [B] Abbott, Illinois, USA Antibody: [A] IgG, IgM [B] IgG Antigen target: [A] and [B] Not stated Evaluation setting: [A] POC, but performed on residual samples in laboratory [B] Performed in lab (on Architect Abbott Instrument i2000SR) Test method: [A] lateral flow assay (LFA) [B] CMIA Timing of samples: [A] and [B] ≥ 4 days (4‐40, median = 18) since onset of symptoms or positive PCR for asymptomatic patients Samples used: [A] and [B] Serum (stored at –20°C upon use) Test operator: [A] All Orient Gene test results were performed and read after 10 min by two clinical microbiologists unblinded regarding the sample group. Indeterminate readings were to be read by a third microbiologist. [B] Tests processed by microbiologists on Architect Abbott Instrument i2000SR Definition of test positivity: [A] The result is read at 10 minutes. The cassette displays a blue control band that turns red when the test has been performed correctly. IgG and IgM are represented by two separated bands and are read visually. All Orient Gene test results were performed and read after 10 min by two clinical microbiologists unblinded regarding the sample group. Indeterminate readings were to be read by a third microbiologist. [B] manufacturer’s recommended cut‐off of 1.4 Blinding reported: [A] microbiologists unblinded regarding the sample group [B] Unclear Threshold predefined: [A] yes, visual [B] yes, manufacturer’s recommended cut‐off of 1.4
Target condition and reference standard(s)	Reference standard: SARS‐COV‐2 RT‐PCR (Cobas® SARS‐CoV‐2 Test, Roche, Meylan, France) Samples used: Not stated Timing of reference standard: Not stated Blinded to index test: Yes, prior to index test Incorporated index test: No Definition of non‐COVID cases: None ‐ pre‐pandemic Samples used: pre‐pandemic Timing of reference standard: pre‐pandemic Blinded to index test: pre‐pandemic Incorporated index test: pre‐pandemic
Flow and timing	Time interval between index and reference tests: Not stated All patients received same reference standard: No. Cases had RT‐PCR, controls untested pre‐pandemic Missing data: Not stated Uninterpretable results: Not stated Indeterminate results: Not stated Unit of analysis: COVID‐19 cases = 106 samples from 102 patients (4 patients with 2 consecutive sera)
Comparative
Notes	Funding: Not stated Publication status: Accepted manuscript posted online 9 June 2020; now published Source: Journal of Clinical Microbiology Author COI: The authors declared no conflict 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?	No
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?	No
Were all patients included in the analysis?	Yes
Did all participants receive a reference standard?	Unclear
Were results presented per patient?	No
Could the patient flow have introduced bias?		High risk