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

Marr 2004.

Study characteristics
Patient sampling Patients were enrolled prospectively; blood samples were analysed after storage
Patient characteristics and setting 67 participants
 Age ranged from 5 to 66 years
 No information about gender
 USA
Children and adults undergoing bone marrow transplantation. Monitoring clinical course, no further information provided.
Representative spectrum? Unclear: children and adults undergoing bone marrow transplantation; although it seems not to be a case‐control design, this can not completely be ruled out
Index tests Platelia. Blood samples were obtained weekly. Samples were frozen and relabeled randomly; samples were analysed blinded to both the source of the samples and clinical data. Samples that had an ODI above 0.5 were tested again to verify positive result. At least 1 sample had to be obtained within 1 week before or after diagnosis
Target condition and reference standard(s) Invasive aspergillosis, as defined by EORTC criteria (Ascioglu 2002)
Incorporation avoided? Yes: ELISA was explicitly excluded from EORTC criteria
 Acceptable reference standard? Yes: EORTC criteria (Ascioglu 2002)
Flow and timing Time interval not reported
Partial verification avoided? Unclear: all cases were classified according to the reference criteria. What they did to find controls is not entirely clear
 Withdrawals explained? Yes
 Uninterpretable results reported? Not reported
Comparative  
No patients per category 13 proven, 11 probable, 8 possible, 35 no IA
Notes Sponsoring precluded? No: financed by National Institute of Health and Bio‐Rad Labs. 3 authors have also worked as consultants for Bio‐Rad Labs
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? Yes    
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? Yes    
    Low 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? Yes    
    Low