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. 2021 Mar 24;2021(3):CD013705. doi: 10.1002/14651858.CD013705.pub2

Billaud 2020.

Study characteristics
Patient Sampling Single group study to estimate sensitivity and specificity:
‐ teachers (n=90) and students (n=419) screened for COVID‐19 as part of a cluster investigation (n=509)
Recruitment: Not stated; appears to be open to all
Prospective or retrospective: Prospective
Patient characteristics and setting Setting: Screening
Location: College, Lyon
Country: France
Dates: September 16 and 17
Symptoms and severity: 166/509, 32.6% symptomatic including 152/419 (36%) students
Demographics: Mean, median age
Students 21.6y, 21y (18 to 37y)
Teachers 47.2y, 49y (26 to 64y)
Exposure history: Outbreak investigation
Index tests Test name: Described as "ABBOTT SARS‐COV2 Antigenic Test"; presumed to be Panbio COVID‐19 Ag Test
Manufacturer: Abbott
Antibody: Not stated
Antigen target: Not stated
Test method: Not stated
Samples used: NP; collected by firefighters
Transport media: None used
Sample storage: n/a; tested immediately on site
Test operator: Not stated
Definition of test positivity: Visual line; as per manufacturer
Blinding reported: Yes, performed first
Timing of samples: Not stated but includes people >7 days pso
Target condition and reference standard(s) Reference standard: RT‐PCR; SARS‐COV‐2 (Thermofisher)
Definition of non‐COVID cases: As for cases; single negative
Genetic target(s): Not stated
Samples used: NP (paired)
Timing of reference standard: As for index
Blinded to index test: Not stated
Incorporated index test: No
Flow and timing Time interval between index and reference tests: Simultaneous
All patients received same reference standard: Yes
Missing data: 47 missing, including 11 uninterpretable
Uninterpretable results: 11 uninterpretable on Ag test
Indeterminate results (index test): None reported
Indeterminate results (reference standard): None reported
Unit of analysis: Patients
Comparative  
Notes Funding: Not stated, public funding
Publication status: Published
Source: Report accessed via SFM Microbiologie website
Author COI: None
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? Yes    
Did the study avoid inappropriate exclusions? Yes    
Did the study avoid inappropriate inclusions? Yes    
Could the selection of patients have introduced bias?   Low risk  
Are there concerns that the included patients and setting do not match the review question?     Low concern
DOMAIN 2: Index Test (Antigen tests)
Were the index test results interpreted without knowledge of the results of the reference standard? Yes    
If a threshold was used, was it pre‐specified? Yes    
Could the conduct or interpretation of the index test have introduced bias?   Low risk  
Are there concerns that the index test, its conduct, or interpretation differ from the review question?     Unclear
DOMAIN 2: Index Test (Rapid molecular tests)
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition? No    
Were the reference standard results interpreted without knowledge of the results of the index tests? Unclear    
Reference standard does not incorporate result of index test? Yes    
Could the reference standard, its conduct, or its interpretation have introduced bias?   High 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? Yes    
Did all patients receive the same reference standard? Yes    
Were all patients included in the analysis? No    
Did all participants receive a reference standard? Yes    
Were results presented per patient? Yes    
Could the patient flow have introduced bias?   High risk