Wright 2007a.
Study characteristics | |||
Patient sampling | Cross‐sectional study
Prospective design
Sample: unclear
Direct comparison of different RADTs: yes (2 EIAs)
Direct comparison of several throat culture techniques: no
Person performing the throat sample: other ("medical technician") Exclusion if recent antibiotics use before inclusion: no Clinical selection of patients: explicit criteria but not a score (see below) Presenting signs and symptoms: "Criteria for throat swab included sore throat, erythematous tonsils or pharynx, cervical lymphadenopathy, and exudates" Age range for inclusion: 0 to 18 years |
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Patient characteristics and setting | Sample size: 338
Age (distribution): not reported GAS prevalence according to culture (with 95% confidence interval): 26.0% (95% CI not reported) Country of study: USA Sex (% of girls): not reported Clinical severity assessment: none Clinical setting: military air force base Single‐centre study |
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Index tests | Throat swab: 1 double swab (each swab used for antigen detection and culture) Commercial name of the RADT: OSOM Ultra Strep A Type of RADT: EIA |
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Target condition and reference standard(s) | Throat culture medium: standard Atmosphere of incubation: aerobic Duration of incubation: 48 hours GAS confirmation: not reported Number of plates inoculated: not reported Assessment of GAS antibody response: no Relevant details: unclear if the reference standard was a single‐plate culture or a composite of both plates. | ||
Flow and timing | No follow‐up | ||
Comparative | |||
Type of study | Journal article | ||
Notes | — | ||
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? | Unclear | ||
Were patients seen in an ambulatory care setting? | No | ||
Unclear | 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 | ||
Low | Unclear | ||
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? | No | ||
High | High | ||
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 |