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

Küçük 2014.

Study characteristics
Patient sampling Cross‐sectional study
 Retrospective design
 Sample: consecutive
 Direct comparison of different RADTs: no
 Direct comparison of several throat culture techniques: no
 Person performing the throat sample: not reported
Exclusion if recent antibiotics use before inclusion: yes (without precision)
Clinical selection of patients: explicit criteria but not a score
Presenting signs and symptoms: acute sore throat, fever and acutely inflamed throat/tonsils with or without exudates
Age range for inclusion: 0 to 17 years
Patient characteristics and setting Sample size: 892
 Age (distribution): mean = 5.3 years
GAS prevalence according to culture (with 95% confidence interval): 24.1% (95% CI not reported)
 Country of study: Turkey
 Sex (% of girls): 42%
 Clinical severity assessment: none
 Clinical setting: mixed (paediatric emergency department and outpatient clinics)
 Multi‐centre study
Index tests Throat swab: 2 different swabs
Commercial name of the RADT: QuickVue In‐Line Strep A (Quidel)
 Type of RADT: EIA
Target condition and reference standard(s) Throat culture medium: standard
 Atmosphere of incubation: not reported
 Duration of incubation: not reported
 GAS confirmation: bacitracin disk
 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
Notes The authors reported using the "QuickVue Strep A (Quidel) cassette". Quidel manufactures several RADTs that use a cassette; we assumed the study evaluated the most simple one, QuickVue In‐Line Strep A kit.
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? No    
    High High
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)? Unclear    
Were the culture medium, atmosphere, duration of incubation and GAS‐confirmation technique described? No    
    Unclear Unclear
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? Yes    
Did patients receive the same throat culture method? Yes    
Were undetermined/uninterpretable results reported? No    
Were withdrawals from the study explained? Yes    
    Low