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

Donatelli 1992b.

Study characteristics
Patient sampling Cross‐sectional study
 Prospective design
 Sample: unclear
 Direct comparison of different RADTs: yes
 Direct comparison of several throat culture techniques: no
 Person performing the throat sample: laboratory personnel (data from nurses not extracted)
Exclusion if recent antibiotics use before inclusion: no
Clinical selection of patients: none
Presenting signs and symptoms: patients presenting with and symptoms of acute pharyngitis
Age range for inclusion: not reported
Patient characteristics and setting Sample size: 203
 Age (distribution): not reported
GAS prevalence according to culture (with 95% confidence interval): 21.7% (95% CI not reported)
 Country of study: USA
 Sex (% of girls): not reported
 Clinical severity assessment: none
 Clinical setting: mixed (general paediatric clinic and emergency department)
 Single‐centre study
Index tests Throat swab: 2 different swabs
Commercial name of the RADT: ICON Strep A
 Type of RADT: EIA
Target condition and reference standard(s) Throat culture medium: standard
 Atmosphere of incubation: anaerobic
 Duration of incubation: 48 hours
 GAS confirmation: other (PYR test during first third of the study, then 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
Notes The study compared results obtained by nurses and by laboratory technologists; we extracted data only for laboratory technologists. This study was funded in part by Health and Welfare Canada
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? Unclear    
    Unclear Unclear
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    
    Low 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? Yes    
    Low