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

Toepfner 2013.

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: unclear
Exclusion if recent antibiotics use before inclusion: no
Clinical selection of patients: none
Presenting signs and symptoms: tonsillopharyngitis
Age range for inclusion: not reported
Patient characteristics and setting Sample size: 517 (324 in 2009 and 193 in 2010)
 Age (distribution): not reported
GAS prevalence according to culture (with 95% confidence interval): 17.6% (95% CI not reported)
 Country of study: Germany
 Sex (% of girls): not reported
 Clinical severity assessment: none
 Clinical setting: unclear
 Single‐ or multi‐centre study: unclear
Index tests Throat swab: 1 single swab (used for culture and then for the RADT)
Commercial name of the RADT: QuickVue In‐Line Strep A
 Type of RADT: EIA
Target condition and reference standard(s) Throat culture medium: standard
 Atmosphere of incubation: not reported
 Duration of incubation: not reported
 GAS confirmation: not reported
 Number of plates inoculated: not reported
 Assessment of GAS antibody response: no
 Relevant details: ‐
Flow and timing No follow‐up
Comparative  
Type of study Journal article
Notes In this study, the accuracy of the rapid test was compared between physicians and laboratory technicians. Our review focused on the accuracy of RADT with laboratory culture as the reference standard, therefore we extracted data only for laboratory technicians. The study also comprised 2 phases: before (2009) and after (2010) training of physicians by laboratory technicians. We extracted data only for laboratory technicians, therefore we pooled the data from 2009 and 2010.
We thank Dr. M Hufnagel for confirming that numbers in the published contingency table are from paediatric patients.
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? Unclear    
Were patients seen in an ambulatory care setting? Yes    
    High 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? Unclear    
    Low 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)? Unclear    
Were the culture medium, atmosphere, duration of incubation and GAS‐confirmation technique described? No    
    Unclear Unclear
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