Drulak 1988.

Study characteristics
Patient sampling	Cross‐sectional study Prospective design Sample: unclear Direct comparison of different RADTs: no Direct comparison of several throat culture techniques: no Person performing the throat sample: other ("staff") Exclusion if recent antibiotics use before inclusion: no Clinical selection of patients: none Presenting signs and symptoms: pharyngitis Age range for inclusion: < 18 years
Patient characteristics and setting	Sample size: 280 Age (distribution): not reported GAS prevalence according to culture (with 95% confidence interval): 20.4% (95% CI not reported) Country of study: Canada Sex (% of girls): not reported Clinical severity assessment: none Clinical setting: outpatient clinic ("outpatient department of a large paediatric institution") Single‐centre study
Index tests	Throat swab: 1 double swab (1 swab for the RADT, 1 swab for culture) Commercial name of the RADT: Visuwell Strep A (ADI) Type of RADT: EIA
Target condition and reference standard(s)	Throat culture medium: standard Atmosphere of incubation: anaerobic during 24 hours then aerobic with CO2 enrichment during 24 hours Duration of incubation: 48 hours GAS confirmation: other (capillary tube precipitation) 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	The study had 2 parts: 1 with adults and children (n = 585), the second with children only (n = 280). The data used for this systematic review were restricted to the second part because paediatric data were not extractable from the first part of the study Study conducted by the manufacturer of the RADT under investigation (Visuwell, ADI)
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?	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?	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?	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