| Study characteristics |
| Patient sampling |
In 2011, all patients with HSCT at the Fundeni Clinical Institute, Bucharest, were screened with serum GM ELISAs while hospitalised. Patients were retrospectively evaluated from 1 January to 31 December 2011 |
| Patient characteristics and setting |
A total of 148 adult and 14 paediatric patients had at least 2 GM ELISA tested while undergoing HSCT in 2011. These patients ranged in age from 1 to 68.1 years (mean 32.4 years). 96 of the recipients were male (59.9%). With 1 exception, all the tested patients received peripheral haematopoietic stem cells |
| Index tests |
A commercially available sandwich ELISA (Platelia Aspergillus, Bio‐Rad, France) was used. The optical density (OD) of the test
specimen is divided by the mean OD of the cut‐off control, and results with an index value of 0.5 or higher are considered positive. A positive GM test result was defined as 2 consecutive tests with an optical density index of ≥ 0.5 or a single test with an optical density index of ≥ 0.8 (this is different from other studies ‐> impact on applicability?) |
| Target condition and reference standard(s) |
The probability of having an invasive fungal infection at any time after HSCT was determined by EORTC/MSG criteria. Reference to Ascioglu 2002. Not clear if the EIA results were included |
| Flow and timing |
The date of the first positive GM test result was considered the date of diagnosis of IA, in high‐risk patients with radiological signs of IA |
| Comparative |
|
| No patients per category |
102 of the 162 patients had no clinical, radiographic or microbiological criteria for IA. 1 had proven IA by biopsy; 6 patients had a probable diagnosis of IA and 53 had a possible diagnosis of IA |
| Notes |
No conflicts of interest reported |
| 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? |
Unclear |
|
|
| |
|
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 |
Unclear |
| 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? |
Yes |
|
|
| Did all patients receive the same reference standard? |
Yes |
|
|
| Were all patients included in the analysis? |
Unclear |
|
|
| |
|
Low |
|
