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. 2022 Nov 17;2022(11):CD013652. doi: 10.1002/14651858.CD013652.pub2

Brochot 2020 [A].

Study characteristics
Patient Sampling Purpose: Diagnosis of acute and convalescent‐phase COVID‐19 infection
Design: Multi‐group study estimating sensitivity and specificity including:
[1] patients hospitalised for COVID‐19 (n = 20);
[2] non‐hospitalised patients but PCR confirmed with SARS‐CoV‐2 (n = 58);
[3] patients participating in screening campaigns, also described as outpatients with no history of SARS‐CoV‐2 infection (n = 62);
[4] and samples from patients with a history of other seasonal coronavirus infections (n = 28).
Study focused mainly on agreement between evaluated assays; data could be extracted for samples with PCR+ result (from group [1] and group [2]) at two time points and for non‐COVID‐19 cases (group [3])
Recruitment: Unclear
Prospective or retrospective: Retrospective
Sample size: 168 (78)
Further detail: Not further described
Patient characteristics and setting Setting: Hospital in patients, outpatients and community screening
Location: Amiens University medical Center, Amiens
Country: France
Dates: Not stated
Symptoms and severity: Not stated
Demographics: Available in the supplement. Could not open the file***
Exposure history: Not stated
Non‐Covid group 1: Outpatients with no history of SARS‐CoV‐2
***Review authors think that some of these have had Covid but have not had it PCR‐confirmed ‐ if you look at Fig 2, quite a number of samples have positive serology results, too many to all be false positives. What we did in this case, was to report the group in item A2 (as publication authors have done) but then we did not use the data because there was apparently no reference standard for them.
Source: During pandemic
Characteristics:
Non‐Covid group 2: Other human coronavirus infections
Source: Not clearly described; may be pre‐pandemic
Characteristics: Not stated
Index tests Test name: Assays identified only by manufacturer:
[A] Abbott; [B] Biorad; [C] Euroimmun; [D] Liaison; [E] Wantai
Manufacturer:
[A] Abbott; [B] Biorad; [C] Euroimmun; [D] Liaison; [E] Wantai
Antibody: [A] IgG; [B] total antibodies; [C] IgG; [D] IgG; [E] total antibodies
Antigen target: [A] nucleocapsid; [B] nucleocapsid; [C] spike 1; [D] spike1/2; [E] receptor binding domain
Evaluation setting: Laboratory
Test method: [A] CLIA; [B] ELISA; [C] ELISA; [D] CLIA; [E] ELISA
Timing of samples: Time pso not given; number of samples by time post‐PCR+ given only for day 31‐50 (n = 21) and > 50 days (n = 14)
Samples used: Serum
Test operator: Not stated
Definition of test positivity: Positivity thresholds were as follows: [A] Abbott >= 1.4; [B] Biorad >= 1; [C] Euroimmun >= 1.1; [D] Liaison >= 15; [E] Wantai >= 1
Samples with a 'doubtful' signal were tested a second time; if the same result was obtained, result was considered negative
Blinding reported: Not stated
Threshold predefined: Yes, manufacturer defined thresholds used
Target condition and reference standard(s) Reference standard: PCR; no further details
Samples used: Nasopharyngeal swab
Timing of reference standard: Not stated
Blinded to index test: Not stated
Incorporated index test: Not stated
Definition of non‐COVID cases: PCR for group 3. Pre‐pandemic for group 4
Samples used: Nasopharyngeal swab
Timing of reference standard: Not stated
Blinded to index test: Not stated 
Yes; conducted first (and was basis for selection of samples for testing)
Incorporated index test: No
Flow and timing Time interval between index and reference tests: Not stated
All patients received same reference standard: No
Missing data: None reported
Uninterpretable results: None reported
Indeterminate results: None reported
Unit of analysis: Not stated; referred to selection of 'samples' but also stated that longitudinal data not available (Discussion)
Comparative  
Notes Funding: This work was supported by a grant from the Amiens University Medical Center
Publication status: Published paper
Source: Journal of Clinical Virology
Author COI: Authors declared no COI present
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? 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? Unclear    
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?   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? Unclear    
Did all participants receive a reference standard? Yes    
Were results presented per patient? Unclear    
Could the patient flow have introduced bias?   High risk