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. 2015 Dec 30;2015(12):CD007394. doi: 10.1002/14651858.CD007394.pub2

Pinel 2003.

Study characteristics
Patient sampling Prospective; series of patients with same risk profile
Not reported whether selection was done consecutively, but no reason to assume it was not
Patient characteristics and setting 3327 serum samples from 807 participants
 No information about age
 62% of the cases were male
 France
Patients from haematological and intensive care units that were at risk for invasive fungal infections
 Inpatients, monitoring clinical course
Representative spectrum? Yes: patients from haematological and intensive care units that were at risk of invasive fungal infections
Index tests Platelia. 2 consecutive positive patient samples were necessary to suspect IA. In analyses also looked at single sample results. Cut‐offs analysed: > 1.0 ODI subsequently; 0.5, 1.0, 1.5 as single sample
Target condition and reference standard(s) Invasive aspergillosis, as defined by EORTC criteria (Ascioglu 2002)
Incorporation avoided? The authors did not explicitly report the exclusion of the ELISA results from the EORTC criteria, so blinding also unclear
 Acceptable reference standard? Yes: EORTC criteria (Ascioglu 2002)
Flow and timing Time interval was not reported.
Partial verification avoided? Yes: all patients were classified according to reference criteria
 Withdrawals explained? No
 Uninterpretable results reported? No
Comparative  
No patients per category 3 proven, 31 probable, 22 possible, 751 no IA
Notes Also clinical and radiological signs reported
Nothing reported about financial support
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 a case‐control design avoided? Yes    
Did the study avoid inappropriate exclusions? Unclear    
    Unclear Low
DOMAIN 2: Index Test All tests
Were the index test results interpreted without knowledge of the results of the reference standard? Unclear    
If a threshold was used, was it pre‐specified? Yes    
    Low Low
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition? Yes    
Were the reference standard results interpreted without knowledge of the results of the index tests? Unclear    
    Unclear Low
DOMAIN 4: Flow and Timing
Was there an appropriate interval between index test and reference standard? Unclear    
Did all patients receive the same reference standard? Yes    
Were all patients included in the analysis? Unclear    
    Unclear