Toepfner 2013.
Study characteristics | |||
Patient sampling | Cross‐sectional study
Prospective design
Sample: unclear
Direct comparison of different RADTs: yes
Direct comparison of several throat culture techniques: no
Person performing the throat sample: unclear Exclusion if recent antibiotics use before inclusion: no Clinical selection of patients: none Presenting signs and symptoms: tonsillopharyngitis Age range for inclusion: not reported |
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Patient characteristics and setting | Sample size: 517 (324 in 2009 and 193 in 2010)
Age (distribution): not reported GAS prevalence according to culture (with 95% confidence interval): 17.6% (95% CI not reported) Country of study: Germany Sex (% of girls): not reported Clinical severity assessment: none Clinical setting: unclear Single‐ or multi‐centre study: unclear |
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Index tests | Throat swab: 1 single swab (used for culture and then for the RADT) Commercial name of the RADT: QuickVue In‐Line Strep A Type of RADT: EIA |
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Target condition and reference standard(s) | Throat culture medium: standard Atmosphere of incubation: not reported Duration of incubation: not reported GAS confirmation: not reported Number of plates inoculated: not reported Assessment of GAS antibody response: no Relevant details: ‐ | ||
Flow and timing | No follow‐up | ||
Comparative | |||
Type of study | Journal article | ||
Notes | In this study, the accuracy of the rapid test was compared between physicians and laboratory technicians. Our review focused on the accuracy of RADT with laboratory culture as the reference standard, therefore we extracted data only for laboratory technicians. The study also comprised 2 phases: before (2009) and after (2010) training of physicians by laboratory technicians. We extracted data only for laboratory technicians, therefore we pooled the data from 2009 and 2010. We thank Dr. M Hufnagel for confirming that numbers in the published contingency table are from paediatric patients. |
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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? | Unclear | ||
Were patients seen in an ambulatory care setting? | Yes | ||
High | Unclear | ||
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? | Unclear | ||
Is the throat culture method likely to correctly identify GAS (laboratory culture on a blood agar plate during 48 hr)? | Unclear | ||
Were the culture medium, atmosphere, duration of incubation and GAS‐confirmation technique described? | No | ||
Unclear | Unclear | ||
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 |