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

Rogo 2010b.

Study characteristics
Patient sampling See Rogo 2010a
Patient characteristics and setting See Rogo 2010a
Index tests Throat swab: 3 different swabs (each swab used for culture and then for the RADT)
Commercial name of the RADT: OSOM Strep A (Genzyme)
 Type of RADT: EIA
Target condition and reference standard(s) See Rogo 2010a
Flow and timing No follow‐up
Comparative  
Type of study Journal article
Notes The study was funded by the manufacturer of one of the 3 RADTs under evaluation (Acceava)
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? Yes    
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? 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? 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