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

Cohen 1998.

Study characteristics
Patient sampling Cross‐sectional study
 Prospective design
 Sample: unclear
 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 (within 7 days before inclusion)
Clinical selection of patients: implicit criteria (see below)
Presenting signs and symptoms: acute pharyngitis or tonsillitis with dysphagia or fever
Age range for inclusion: 4 to 15 years
Patient characteristics and setting Sample size: 563
 Age (distribution): not reported
GAS prevalence according to culture (with 95% confidence interval): 21.5% (95% CI not reported)
 Country of study: France
 Sex (% of girls): not reported
 Clinical severity assessment: none
 Clinical setting: office‐based
 Multi‐centre study
Index tests Throat swab: 2 different (first one for the RADT, second one only if RADT+)
Commercial name of the RADT: TestPack Plus Strep A (Abbott)
 Type of RADT: EIA
Target condition and reference standard(s) Throat culture medium: inhibitory
 Atmosphere of incubation: anaerobic
 Duration of incubation: 48 hours
 GAS confirmation: latex test
 Number of plates inoculated: 1
 Assessment of GAS antibody response: no
 Relevant details: ‐
Flow and timing No follow‐up
Comparative  
Type of study Journal article (in French)
Notes The study was supported by ASTRA laboratories
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 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 Low
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? No    
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    
    High Low
DOMAIN 4: Flow and Timing
Was the delay between the performance of the RADT and throat culture plating less than 48 hours? Yes    
Did all patients receive a throat culture? No    
Did patients receive the same throat culture method? Yes    
Were undetermined/uninterpretable results reported? Yes    
Were withdrawals from the study explained? Yes    
    High