Needham 1998.

Study characteristics
Patient sampling	Cross‐sectional study Prospective design Sample: consecutive Direct comparison of different RADTs: no Direct comparison of several throat culture techniques: yes (standard versus enriched) Person performing the throat sample: physician Exclusion if recent antibiotics use before inclusion: no Clinical selection of patients: unclear Presenting signs and symptoms: unclear Age range for inclusion: not reported
Patient characteristics and setting	Sample size: 276 Age (distribution): mean = 6.4 years GAS prevalence according to culture (with 95% confidence interval): 31.2% (95% CI not reported) Country of study: USA Sex (% of girls): not reported Clinical severity assessment: none Clinical setting: office‐based Single‐centre study (regarding paediatric participants)
Index tests	Throat swab: 1 single swab (used for culture and then for the RADT) Commercial name of the RADT: Strep A OIA (Biostar) Type of RADT: OIA
Target condition and reference standard(s)	Throat culture medium: standard and enrichment Atmosphere of incubation: aerobic Duration of incubation: 48 hours GAS confirmation: latex test Number of plates inoculated: 1 Assessment of GAS antibody response: no Relevant details: swabs were inoculated on a standard blood agar plate and the pledget from the transport tube was used for culture following incubation in a Todd‐Hewitt enrichment broth. Enriched culture did not identify additional positive specimens as compared to standard culture. The results of the 2 culture techniques were considered equivalent.
Flow and timing	No follow‐up
Comparative
Type of study	Journal article
Notes	The study was funded in part 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)?	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?	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?	Yes
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?	No
		Low