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

Roe 1995a.

Study characteristics
Patient sampling Cross‐sectional study
 Prospective design
 Sample: unclear
 Direct comparison of different RADTs: yes
 Direct comparison of several throat culture techniques: yes (1 plate versus 2 plates versus enrichment broth)
 Person performing the throat sample: other ("clinical personnel")
Exclusion if recent antibiotics use before inclusion: no
Clinical selection of patients: none
Presenting signs and symptoms: symptomatic pharyngitis
Age range for inclusion: not reported ("children")
Patient characteristics and setting Sample size: 500
 Age (distribution): not reported
GAS prevalence according to culture (with 95% confidence interval): 30.2% (95% CI not reported)
 Country of study: USA
 Sex (% of girls): not reported
 Clinical severity assessment: none
 Clinical setting: mixed (children's hospital clinic and emergency department)
 Single‐centre study
Index tests Throat swab: 2 different swabs (each swab used for culture and then for the RADT)
Commercial name of the RADT: Strep A OIA (Biostar)
 Type of RADT: OIA
Target condition and reference standard(s) Throat culture medium: inhibitory and enrichment
 Atmosphere of incubation: aerobic
 Duration of incubation: 48 hours
 GAS confirmation: latex test
 Number of plates inoculated: 2 or 3
 Assessment of GAS antibody response: no
 Relevant details: 2 swabs were taken for each patient. Each swab was used for culture on a selective medium and then for antigen detection by one or the other RADTs. If both selective plates were negative for GAS, the pledgets were incubated in a Todd‐Hewitt enrichment broth with subsequent culture. The reference standard was the isolation of GAS by any one (or more than one) of the plates.
Flow and timing No follow‐up
Comparative  
Type of study Journal article
Notes A co‐author was affiliated with the manufacturer of one of the RADTs under evaluation (Abbott)
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 Low
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? Yes    
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? Yes    
Did all patients receive a throat culture? Yes    
Did patients receive the same throat culture method? No    
Were undetermined/uninterpretable results reported? No    
Were withdrawals from the study explained? Yes    
    Low