Gieseker 2002b.
Study characteristics | |||
Patient sampling | See Gieseker 2002a | ||
Patient characteristics and setting | See Gieseker 2002a | ||
Index tests | Throat swab: 2 different swabs Commercial name of the RADTs: OSOM Ultra Strep A (Genzyme) Type of RADTs: EIA |
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Target condition and reference standard(s) | See Gieseker 2002a | ||
Flow and timing | No follow‐up | ||
Comparative | |||
Type of study | Journal article | ||
Notes | Supported by a grant from one of the manufacturers of the RADTs under evaluation (Genzyme) | ||
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? | No | ||
Were patients seen in an ambulatory care setting? | Yes | ||
High | 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? | 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? | No | ||
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 |