| Study characteristics |
| Patient sampling |
Prospective collection of samples from patients undergoing chemotherapy or HSCT who had developed febrile neutropenia between August 2002 and July 2003. Blood samples collected from consecutive patients twice weekly; only patients from whom 3 samples were obtained per febrile episode were analysed |
| Patient characteristics and setting |
Sample size: 65 patients
Males/females: 23:6
Mean age: 37 (range 16 to 62)
Presentation: episodes of febrile neutropenia in patients undergoing chemotherapy or HSCT
Setting: Westmead Hospital, NSW, Australia |
| Index tests |
Blood collected twice weekly; DNA extracted from 500 µl EDTA blood using the GenElute Mammalian Genomic DNA Kit (Sigma‐Aldrich) with modified protocol that included RCLB, followed by lyticase treatment; no bead beating. Conventional nested PCR no qPCR assay modified from (Skladny 1999). Aspergillus specific targeting 18S. Sensitivity of 10 CFU/ml |
| Target condition and reference standard(s) |
Target condition was IA, classified according to the EORTC/MSG criteria (2002). IA defined at the end of "at risk" episodes |
| Flow and timing |
998 blood samples from 65 patients (29 adults and 36 children) were collected between August 2002 and July 2003. Separate 2 × 2 analyses were carried out to calculate sensitivity, etc, with possible cases excluded, or with possible cases included as true negatives or true positives. |
| Comparative |
|
| Notes |
|
| 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 |
|
|
| |
|
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? |
No |
|
|
| |
|
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 |
|
