Rimoin 2010a.

Study characteristics
Patient sampling	Cross‐sectional study Prospective design Sample: consecutive Direct comparison of different RADTs: no Direct comparison of several throat culture techniques: no Person performing the throat sample: unclear Exclusion if recent antibiotics use before inclusion: yes (oral use in the 3 days prior to screening or parenteral use in the 28 days before screening) Clinical selection of patients: none Presenting signs and symptoms: sore throat Age range for inclusion: 2 to 12 years
Patient characteristics and setting	Sample size: 184 Age (distribution): mean (SD) = 5.8 (0.21) years GAS prevalence according to culture (with 95% confidence interval): 24.5% (95% CI not reported) Country of study: Brazil Sex (% of girls): 43.3% Clinical severity assessment: Centor score Clinical setting: walk‐in clinic Multi‐centre study (see Rimoin 2010b‐d)
Index tests	Throat swab: 2 different swabs (1 swab for performing the RADT, 1 swab for culture) Commercial name of the RADT: Strep A OIA Max (Biostar) Type of RADT: OIA
Target condition and reference standard(s)	Throat culture medium: standard Atmosphere of incubation: anaerobic Duration of incubation: 48 hours GAS confirmation: bacitracin disk 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	Multi‐centre study conducted in Brazil, Croatia, Egypt and Latvia (see Rimoin 2010b‐d). This study was supported by USAID and WHO. The rapid test kits were provided by Biostar (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?	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)?	Yes
Was clinical selection of patients avoided?	Yes
Were patients seen in an ambulatory care setting?	Yes
		Low	Low
DOMAIN 2: Index Test All tests
Were the RADT results interpreted with blinding of the results of culture?	Unclear
Was the type of the RADT mentioned (EIA or OIA)?	Yes
Were RADTs conducted during consultation time?	No
		Unclear	High
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
		Unclear	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