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

Maltezou 2008.

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: unclear
Exclusion if recent antibiotics use before inclusion: yes (within the previous week)
Clinical selection of patients: clinical score (Centor)
Presenting signs and symptoms: clinical evidence of pharyngitis including one of the 4 Centor criteria (fever, tonsillar exudate, tender enlarged anterior cervical lymph nodes and absence of cough)
Age range for inclusion: 2 to 14 years
Patient characteristics and setting Sample size: 432
 Age (distribution): mean = 6.8 years (calculated from data in table 1)
GAS prevalence according to culture (with 95% confidence interval): 27.3% (95% CI not reported)
 Country of study: Greece
 Sex (% of girls): 53.9%
 Clinical severity assessment: Centor score
 Clinical setting: mixed (office‐based and hospital outpatient clinic)
 Multi‐centre study
Index tests Throat swab: 2 different swabs (1 swab for culture, 1 swab for performing the RADT)
Commercial name of the RADT: Link 2 Strep A Rapid Test (Becton Dickinson)
 Type of RADT: EIA
Target condition and reference standard(s) Throat culture medium: standard
 Atmosphere of incubation: not reported
 Duration of incubation: 48 hours
 GAS confirmation: bacitracin disk and latex test
 Number of plates inoculated: not reported
 Assessment of GAS antibody response: no
 Relevant details: ‐
Flow and timing No follow‐up
Comparative  
Type of study Journal article
Notes Funded by the Hellenic Center for Disease Control and Prevention
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    
    Unclear 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? No    
    High High
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