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 |
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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 |
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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 |
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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 |
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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 |
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Comparative | |||
Notes | Funding: Not stated, public funding Publication status: Published Source: Report accessed via SFM Microbiologie website Author COI: None |
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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 |