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

Mlejnek 2014.

Study characteristics
Patient sampling Cross‐sectional study
 Retrospective design
 Sample: consecutive
 Direct comparison of different RADTs: no
 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: unclear
Presenting signs and symptoms: not reported ("all patients who had rapid strep screens")
Age range for inclusion: < 21 years
Patient characteristics and setting Sample size: 3423
 Age (distribution): not reported
GAS prevalence according to culture (with 95% confidence interval): 16.8% (95% CI not reported)
 Country of study: USA
 Sex (% of girls): not reported
 Clinical severity assessment: none
 Clinical setting: emergency department
 Single‐centre study
Index tests Throat swab (1 single, 1 double, 2 different): not reported
Commercial name of the RADT: OSOM Strep A
 Type of RADT: EIA
Target condition and reference standard(s) Throat culture medium: standard
 Atmosphere of incubation: aerobic with CO2 enrichment
 Duration of incubation: 48 hours
 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 Conference abstract (Annual Meeting of the Society for Academic Emergency Medicine, Dallas, Texas, USA, May 2014)
Notes We thank Dr. JR Mlejnek for sharing additional information that was not part of the original conference abstract
Methodological quality
Item Authors' judgement Risk of bias Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled? Yes    
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    
    Unclear 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? No    
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    
    High 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? No    
Did patients receive the same throat culture method? Yes    
Were undetermined/uninterpretable results reported? No    
Were withdrawals from the study explained? Yes    
    High