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

Mirza 2007b.

Study characteristics
Patient sampling Cross‐sectional study
 Retrospective design
 Sample: unclear
 Direct comparison of different RADTs: no
 Direct comparison of several throat culture techniques: no
 Person performing the throat sample: nurses
Exclusion if recent antibiotics use before inclusion: no
Clinical selection of patients: unclear
Presenting signs and symptoms: unclear
Age range for inclusion: < 18 years
Patient characteristics and setting Sample size: total 6865 (only 5135 included in the meta‐analysis, i.e., those with RADT negative results also cultured)
 Age (distribution): not reported
GAS prevalence according to culture (with 95% confidence interval): 29.3% (95% CI not reported)
 Country of study: USA
 Sex (% of girls): not reported
 Clinical severity assessment: none
 Clinical setting: unclear ("children's hospital")
 Single‐centre study
Index tests Throat swab: 2 different swabs (1 swab for performing the RADT, 1 swab for culture)
Commercial name of the RADT: Signify Strep A (Abbott)
 Type of RADT: EIA
Target condition and reference standard(s) Throat culture medium: inhibitory
 Atmosphere of incubation: not reported
 Duration of incubation: not reported
 GAS confirmation: not reported
 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 See Mirza 2007a
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? Unclear    
    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? No    
    Low High
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)? Unclear    
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? Unclear    
Did all patients receive a throat culture? No    
Did patients receive the same throat culture method? Yes    
Were undetermined/uninterpretable results reported? No    
Were withdrawals from the study explained? Yes    
    High