Donatelli 1992a.

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: laboratory personnel (data from nurses not extracted) Exclusion if recent antibiotics use before inclusion: no Clinical selection of patients: none Presenting signs and symptoms: patients presenting with and symptoms of acute pharyngitis Age range for inclusion: not reported (performed in a children's hospital)
Patient characteristics and setting	Sample size: 180 Age (distribution): not reported GAS prevalence according to culture (with 95% confidence interval): 22.8% (95% CI not reported) Country of study: USA Sex (% of girls): not reported Clinical severity assessment: none Clinical setting: mixed (general paediatric clinic and emergency department) Single‐centre study
Index tests	Throat swab: 2 different swabs Commercial name of the RADT: Directgen 1‐2‐3 Type of RADT: EIA (liposome assay)
Target condition and reference standard(s)	Throat culture medium: standard Atmosphere of incubation: anaerobic Duration of incubation: 48 hours GAS confirmation: other (PYR test during first third of the study, then latex test) 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 compared results obtained by nurses and by laboratory technologists; we extracted data only for laboratory technologists. This study was funded in part by Health and Welfare Canada
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?	Yes
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?	Unclear
		Unclear	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)?	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?	No
Were withdrawals from the study explained?	Yes
		Low