Regueras De Lorenzo 2012.
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: physicians Exclusion if recent antibiotics use before inclusion: yes (within a week before enrollment) Clinical selection of patients: none Presenting signs and symptoms: acute tonsillitis and/or pharyngitis Age range for inclusion: 2 to 14 years |
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Patient characteristics and setting | Sample size: 192
Age (distribution): mean (SD) = 7.2 (2.8) years GAS prevalence according to culture (with 95% confidence interval): 38.5% (95% CI not reported) Country of study: Spain Sex (% of girls): 48.4% Clinical severity assessment: Centor score Clinical setting: office‐based Multi‐centre study |
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Index tests | Throat swab: 2 different swabs (1 for culture, 1 for performing the RADT) Commercial name of the RADT: TestPack Plus (Inverness) Type of RAD: EIA |
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Target condition and reference standard(s) | Throat culture medium: inhibitory Atmosphere of incubation: aerobic with CO2 enrichment Duration of incubation: 48 hours GAS confirmation: 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 (in Spanish) | ||
Notes | Supported by a public research grant (Institute of Health Carlos III) and EU funding (FEDER) | ||
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? | Yes | ||
Was the type of the RADT mentioned (EIA or OIA)? | Yes | ||
Were RADTs conducted during consultation time? | Yes | ||
Low | Low | ||
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? | No | ||
Low |