Kurtz 2000.
Study characteristics | |||
Patient sampling | Cross‐sectional study
Prospective design
Sample: unclear
Direct comparison of different RADTs: no (but comparison of single‐swab versus double‐swab antigen extraction)
Direct comparison of several throat culture techniques: yes (standard blood agar versus selective medium)
Person performing the throat sample: not reported Exclusion if recent antibiotics use before inclusion: yes (previous 7 days) Clinical selection of patients: explicit criteria but not a score (see below) Presenting signs and symptoms: children with clinical signs of S. pyogenes pharyngitis ("fever, sore throat, and/or cervical adenitis and the absence of cough, rhinorrhea, lower respiratory infection, and otitis media") Age range for inclusion: 4 to 15 years |
||
Patient characteristics and setting | Sample size: 256
Age (distribution): not reported GAS prevalence according to culture (with 95% confidence interval): 30.9% (95% CI not reported) Country of study: USA Sex (% of girls): not reported Clinical severity assessment: none Clinical setting: office‐based Single‐centre study |
||
Index tests | Throat swab: 2 different swabs (each used first for culture and then for performing the RADT; we randomly chose to extract data for swab B) Commercial name of the RADT: Test Pack Plus (Abbott) Type of RADT: EIA |
||
Target condition and reference standard(s) | Throat culture medium: standard and inhibitory (composite 2‐plate reference standard) Atmosphere of incubation: aerobic Duration of incubation: 48 hours GAS confirmation: bacitracin disk and latex test Number of plates inoculated: 2 Assessment of GAS antibody response: no Relevant details: 2 swabs were taken (A and B). Each swab was first inoculated onto a culture plate (standard or selective) and then used for performing the RADT. Culture positivity was defined as growth from either of the 2 plates. For the results of the RADT, we only extracted data for 1 swab, which was randomly chosen to be swab B. | ||
Flow and timing | No follow‐up | ||
Comparative | |||
Type of study | Journal article | ||
Notes | 2 swabs were taken (A and B). Each swab was inoculated onto a culture plate (standard or selective) and then used for antigen detection. Culture positivity was defined as growth from either of the 2 plates. For the results of the RADT, we only extracted data for 1 swab, which was randomly chosen to be swab B. Funded in part by Abbott (manufacturer of the RADT). | ||
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? | 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? | 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? | Unclear | ||
Did all patients receive a throat culture? | Yes | ||
Did patients receive the same throat culture method? | Yes | ||
Were undetermined/uninterpretable results reported? | Yes | ||
Were withdrawals from the study explained? | Yes | ||
Low |