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

Kurtz 2000.

Study characteristics
Patient sampling Cross‐sectional study
 Prospective design
 Sample: unclear
 Direct comparison of different RADTs: no (but comparison of single‐swab versus double‐swab antigen extraction)
 Direct comparison of several throat culture techniques: yes (standard blood agar versus selective medium)
 Person performing the throat sample: not reported
Exclusion if recent antibiotics use before inclusion: yes (previous 7 days)
Clinical selection of patients: explicit criteria but not a score (see below)
Presenting signs and symptoms: children with clinical signs of S. pyogenes pharyngitis ("fever, sore throat, and/or cervical adenitis and the absence of cough, rhinorrhea, lower respiratory infection, and otitis media")
Age range for inclusion: 4 to 15 years
Patient characteristics and setting Sample size: 256
 Age (distribution): not reported
GAS prevalence according to culture (with 95% confidence interval): 30.9% (95% CI not reported)
 Country of study: USA
 Sex (% of girls): not reported
 Clinical severity assessment: none
 Clinical setting: office‐based
 Single‐centre study
Index tests Throat swab: 2 different swabs (each used first for culture and then for performing the RADT; we randomly chose to extract data for swab B)
Commercial name of the RADT: Test Pack Plus (Abbott)
 Type of RADT: EIA
Target condition and reference standard(s) Throat culture medium: standard and inhibitory (composite 2‐plate reference standard)
 Atmosphere of incubation: aerobic
 Duration of incubation: 48 hours
 GAS confirmation: bacitracin disk and latex test
 Number of plates inoculated: 2
 Assessment of GAS antibody response: no
 Relevant details: 2 swabs were taken (A and B). Each swab was first inoculated onto a culture plate (standard or selective) and then used for performing the RADT. Culture positivity was defined as growth from either of the 2 plates. For the results of the RADT, we only extracted data for 1 swab, which was randomly chosen to be swab B.
Flow and timing No follow‐up
Comparative  
Type of study Journal article
Notes 2 swabs were taken (A and B). Each swab was inoculated onto a culture plate (standard or selective) and then used for antigen detection. Culture positivity was defined as growth from either of the 2 plates. For the results of the RADT, we only extracted data for 1 swab, which was randomly chosen to be swab B. Funded in part by Abbott (manufacturer of the RADT).
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)? Yes    
Was clinical selection of patients avoided? No    
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? 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? Unclear    
Did all patients receive a throat culture? Yes    
Did patients receive the same throat culture method? Yes    
Were undetermined/uninterpretable results reported? Yes    
Were withdrawals from the study explained? Yes    
    Low