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

Nihtinen 2010.

Study characteristics
Patient sampling "All adult allo‐SCT recipients transplanted between January 2001 and December 2002 in Helsinki University Central Hospital were eligible for this study"
Exclusion of patients receiving reduced‐intensity conditioning that does not lead to severe neutropenia
Single group; prospective study; patients consecutively enrolled
Patient characteristics and setting 138 patients were transplanted; 102 patients were left for the final analysis
 Mean age 44 years
 Finland
"All adult allo‐SCT recipients transplanted [...] were eligible for this study"
Representative spectrum? Yes: single group of allo‐SCT recipients; prospective study; patients consecutively enrolled
Index tests Analyses were performed using the GM ELISA test (Platelia Aspergillus, Bio‐Rad, Hercules, CA, USA) according to the manufacturer's instructions. An optical density index of 0.5 was used as the criterion for test positivity
Target condition and reference standard(s) The revised EORTC/MSG criteria were used to define the cases
GM ELISA results were excluded from the criteria for IA
 Acceptable reference standard? Yes
Flow and timing 36 patients were excluded because of reduced‐intensity conditioning or patient refusal; at 1 year after transplantation, 75 patients (73.5%) were alive
Partial verification avoided? Yes: all patients were classified according to the reference criteria
 Withdrawals explained? No: some patients refused, but no reason is given as to why
 Uninterpretable results reported? No: there must have been indeterminate results; but they were not explained
Comparative  
No patients per category Unclear reporting: 1 proven?; 1 probable?; 0 possible?; 100 no IA
Notes Sponsoring precluded? M Richardson is the founder and a shareholder of MoBiAir Diagnostics Ltd. but this seems to have nothing to do with Platelia; so there was no sponsoring by Platelia
Methodological quality
Item Authors' judgement Risk of bias Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled? Yes    
Was a case‐control design avoided? Yes    
Did the study avoid inappropriate exclusions? Yes    
    Low 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    
    Low Low
DOMAIN 4: Flow and Timing
Was there an appropriate interval between index test and reference standard? Yes    
Did all patients receive the same reference standard? Yes    
Were all patients included in the analysis? Yes    
    Low