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. 2016 Jul 4;2016(7):CD010502. doi: 10.1002/14651858.CD010502.pub2

Mezghani Maleej 2010.

Study characteristics
Patient sampling Cross‐sectional study
 Prospective design
 Sample: consecutive
 Direct comparison of different RADTs: no
 Direct comparison of several throat culture techniques: no
 Person performing the throat sample: physician
Exclusion if recent antibiotics use before inclusion: yes
Clinical selection of patients: implicit criteria (see below)
Presenting signs and symptoms: acute pharyngitis, excluding those with signs suggesting viral aetiology
Age range for inclusion: 2 to 10 years
Patient characteristics and setting Sample size: 504 (445 participants in the contingency table)
 Age (distribution): mean = 5.7 years (range 2 years and 2 months to 10 years)
GAS prevalence according to culture (with 95% confidence interval): 32.9% (95% CI not reported)
 Country of study: Tunisia
 Sex (% of girls): 46%
 Clinical severity assessment: McIsaac score
 Clinical setting: walk‐in clinic
 Single‐centre study
Index tests Throat swab: 2 different swabs
Commercial name of the RADT: OSOM Strep A
 Type of RADT: EIA
Target condition and reference standard(s) Throat culture medium: standard and inhibitory (2 plates)
 Atmosphere of incubation: aerobic with CO2 enrichment
 Duration of incubation: 48 hours
 GAS confirmation: latex test
 Number of plates inoculated: 2
 Assessment of GAS antibody response: no
 Relevant details: ‐
Flow and timing No follow‐up
Comparative  
Type of study Journal article (in French)
Notes We thank Prof. A Hammami for providing data from the contingency table (not extractable in the original publication)
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 it a cross‐sectional study or a RCT? Yes    
Were selection criteria clearly described (at least presenting signs and symptoms and age limits for inclusion)? Yes    
Was clinical selection of patients avoided? No    
Were patients seen in an ambulatory care setting? Yes    
    High High
DOMAIN 2: Index Test All tests
Were the RADT results interpreted with blinding of the results of culture? Yes    
Was the type of the RADT mentioned (EIA or OIA)? Yes    
Were RADTs conducted during consultation time? Yes    
    Low Low
DOMAIN 3: Reference Standard
Were culture results interpreted with blinding of the results of the RADT? Unclear    
Is the throat culture method likely to correctly identify GAS (laboratory culture on a blood agar plate during 48 hr)? Yes    
Were the culture medium, atmosphere, duration of incubation and GAS‐confirmation technique described? Yes    
    Unclear Low
DOMAIN 4: Flow and Timing
Was the delay between the performance of the RADT and throat culture plating less than 48 hours? Unclear    
Did all patients receive a throat culture? Yes    
Did patients receive the same throat culture method? Yes    
Were undetermined/uninterpretable results reported? Yes    
Were withdrawals from the study explained? Yes    
    Low