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. 2022 May 20;2022(5):CD013665. doi: 10.1002/14651858.CD013665.pub3

Maechler 2020.

Study characteristics
Patient Sampling Purpose: diagnosis of SARS‐CoV‐2 infection (mild COVID‐19 disease); to describe epidemiological and clinical characteristics; to identify risk factors for SARS‐CoV‐2 infection
Design: cross‐sectional cohort study, prospective data collection
Recruitment: symptomatic patients presenting at the test site. Subgroups not by testing criteria at that time: (1) high‐risk contacts at a nightclub (26/94 positive). (2) Charité employees 125 asymptomatic.
Sample size: n = 4333 (333 cases)
Inclusion criteria: until 24 March 2020: symptomatic patients with high‐risk contacts or return from high‐risk area. From 24 March: also symptomatic people with risk factors and if the test capacity allowed also only symptomatic patients. Plus 2 subgroups of high‐risk patients in a nightclub and Charité employees
Exclusion criteria: none specified
Patient characteristics and setting Facility cases: patients with a positive RT‐PCR for SARS‐CoV‐2 infection
Facility controls: patients with a negative RT‐PCR for SARS‐CoV‐2 infection
Country: Germany
Dates: 03 March 2020‐13 April 2020
Symptoms and severity: mild to relatively more severe. Asymptomatic: 12 cases, 431 controls
Demographics: age: controls median 34.0 years, cases mean 34.0 years
M%/F%: cases 56.8/43.2, controls 48.5/51.5
Exposure history: high‐risk contact: cases 56.8%, controls 36.4%
Index tests
  • Fever

  • Dyspnoea

  • Chest tightness/pain

  • Chills

  • Fatigue

  • Body aches

  • Cough

  • Rhinorrhoea

  • Diarrhoea

  • Sore throat

  • Headache

  • Anosmia

  • Ageusia

Target condition and reference standard(s)
  • TC: SARS‐CoV‐2 infection

  • RS: SARS‐CoV‐2 RT‐PCR test (combined oro‐ and nasopharyngeal swab)

Flow and timing Index tests and reference standard both at presentation
Comparative  
Notes Funding: none declared
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 (All 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? No    
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?     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    
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?     Low concern
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? Yes    
Could the patient flow have introduced bias?   Low risk