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

Regueras De Lorenzo 2012.

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: physicians
Exclusion if recent antibiotics use before inclusion: yes (within a week before enrollment)
Clinical selection of patients: none
Presenting signs and symptoms: acute tonsillitis and/or pharyngitis
Age range for inclusion: 2 to 14 years
Patient characteristics and setting Sample size: 192
 Age (distribution): mean (SD) = 7.2 (2.8) years
GAS prevalence according to culture (with 95% confidence interval): 38.5% (95% CI not reported)
 Country of study: Spain
 Sex (% of girls): 48.4%
 Clinical severity assessment: Centor score
 Clinical setting: office‐based
 Multi‐centre study
Index tests Throat swab: 2 different swabs (1 for culture, 1 for performing the RADT)
Commercial name of the RADT: TestPack Plus (Inverness)
 Type of RAD: EIA
Target condition and reference standard(s) Throat culture medium: inhibitory
 Atmosphere of incubation: aerobic with CO2 enrichment
 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 Spanish)
Notes Supported by a public research grant (Institute of Health Carlos III) and EU funding (FEDER)
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? Yes    
Were patients seen in an ambulatory care setting? Yes    
    Low 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? 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? No    
Were withdrawals from the study explained? No    
    Low