Roe 1995a.
Study characteristics | |||
Patient sampling | Cross‐sectional study
Prospective design
Sample: unclear
Direct comparison of different RADTs: yes
Direct comparison of several throat culture techniques: yes (1 plate versus 2 plates versus enrichment broth)
Person performing the throat sample: other ("clinical personnel") Exclusion if recent antibiotics use before inclusion: no Clinical selection of patients: none Presenting signs and symptoms: symptomatic pharyngitis Age range for inclusion: not reported ("children") |
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Patient characteristics and setting | Sample size: 500
Age (distribution): not reported GAS prevalence according to culture (with 95% confidence interval): 30.2% (95% CI not reported) Country of study: USA Sex (% of girls): not reported Clinical severity assessment: none Clinical setting: mixed (children's hospital clinic and emergency department) Single‐centre study |
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Index tests | Throat swab: 2 different swabs (each swab used for culture and then for the RADT) Commercial name of the RADT: Strep A OIA (Biostar) Type of RADT: OIA |
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Target condition and reference standard(s) | Throat culture medium: inhibitory and enrichment Atmosphere of incubation: aerobic Duration of incubation: 48 hours GAS confirmation: latex test Number of plates inoculated: 2 or 3 Assessment of GAS antibody response: no Relevant details: 2 swabs were taken for each patient. Each swab was used for culture on a selective medium and then for antigen detection by one or the other RADTs. If both selective plates were negative for GAS, the pledgets were incubated in a Todd‐Hewitt enrichment broth with subsequent culture. The reference standard was the isolation of GAS by any one (or more than one) of the plates. | ||
Flow and timing | No follow‐up | ||
Comparative | |||
Type of study | Journal article | ||
Notes | A co‐author was affiliated with the manufacturer of one of the RADTs under evaluation (Abbott) | ||
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 | 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? | Yes | ||
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? | Yes | ||
Did all patients receive a throat culture? | Yes | ||
Did patients receive the same throat culture method? | No | ||
Were undetermined/uninterpretable results reported? | No | ||
Were withdrawals from the study explained? | Yes | ||
Low |