| Study characteristics |
| Patient sampling |
Febrile, neutropenic paediatric cancer patients were prospectively sampled between April 2003 and April 2004. Patients were included if they had antibiotic‐resistant fever. Patients were given full diagnostic work‐ups for any signs of IFD |
| Patient characteristics and setting |
Sample size: 91 patients
Males/females: 37:25
Mean age: 8 (range 2 to 18)
Presentation: "at risk" for IA including febrile neutropenic cancer patients and fever not responding to antibiotics
Setting: National Cancer Institute, Cairo University |
| Index tests |
Serum samples (unknown volume) were treated with Lyticase, then extracted using QIAamp DNA Mini Kit (Qiagen), PCR amplified 420 bp products from 18S gene (universal fungal assay). Single round conventional PCR with 30 cycles. Products detected on agarose gel |
| Target condition and reference standard(s) |
Target condition was IFD; CT scan, blood culture and Aspergillus antigen detection were used to aid in defining cases of IFD according to the EORTC/MSG (2002) criteria |
| Flow and timing |
91 patients tested, unknown sample numbers during 1 year period. All patients were included in 2 × 2 analysis to calculate sensitivity, etc. |
| Comparative |
|
| Notes |
Pan‐fungal conventional PCR used with low cycles, lack of specific IA information may be a problem for inclusion |
| 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? |
Yes |
|
|
| 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? |
Yes |
|
|
| |
|
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? |
Unclear |
|
|
| Were all patients included in the analysis? |
Yes |
|
|
| |
|
Unclear |
|
