Harris 1995.
| 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: physician Exclusion if recent antibiotics use before inclusion: no Clinical selection of patients: none Presenting signs and symptoms: signs of pharyngitis Age range for inclusion: 2 to 18 years |
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| Patient characteristics and setting | Sample size: 519
Age (distribution): not reported GAS prevalence according to culture (with 95% confidence interval): 22.0% (95% CI not reported) Country of study: USA Sex (% of girls): not reported Clinical severity assessment: other (in‐house score) Clinical setting: walk‐in clinic Single‐centre study |
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| 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 |
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| Target condition and reference standard(s) | Throat culture medium: standard 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 | ||
| Notes | RADT kits were provided by the manufacturer (Biostar) | ||
| 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? | 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? | Yes | ||
| Low | |||