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

Schwartz 1997a.

Study characteristics
Patient sampling Cross‐sectional study
 Prospective design
 Sample: unclear
 Direct comparison of different RADTs: yes (2 different EIAs)
 Direct comparison of several throat culture techniques: no
 Person performing the throat sample: not reported
Exclusion if recent antibiotics use before inclusion: no
Clinical selection of patients: not reported
Presenting signs and symptoms: unclear
Age range for inclusion: unclear
Patient characteristics and setting Sample size: 258
 Age (distribution): not reported
GAS prevalence according to culture (with 95% confidence interval): 40.0% (95% CI not reported)
 Country of study: USA
 Sex (% of girls): not reported
 Clinical severity assessment: none
 Clinical setting: office‐based (paediatric clinic)
 Single‐centre study
Index tests Throat swab: not reported
Commercial name of the RADT: OSOM Strep A (Wyntek)
 Type of RADT: EIA
Target condition and reference standard(s) Throat culture medium: standard
 Atmosphere of incubation: aerobic
 Duration of incubation: 24 hours
 GAS confirmation: not reported
 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
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)? No    
Was clinical selection of patients avoided? Unclear    
Were patients seen in an ambulatory care setting? Yes    
    High Unclear
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)? No    
Were the culture medium, atmosphere, duration of incubation and GAS‐confirmation technique described? Yes    
    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