| Study characteristics |
| Patient sampling |
Study did not classify whether participants were enrolled randomly or consecutively. Negative controls (n = 30) were not included in the analysis. |
| Patient characteristics and setting |
Infants with suspected sepsis, admitted to the neonatal department and the intensive care unit of the Zhejiang University Children's University in China. It was unclear how many infants were < 28 days old as no participant demographics are available. Study period: September 2007 to June 2008. |
| Index tests |
Broad‐range 16S rRNA‐based real‐time fluorescent PCR. |
| Target condition and reference standard(s) |
Suspected sepsis and the reference standard were cultures of blood and CSF. |
| Flow and timing |
Both index test and reference standard samples were drawn simultaneously. |
| Comparative |
|
| Notes |
No participant demographics available and unclear if some infants were > 28 days of age. |
| 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? |
Yes |
|
|
| |
|
Low |
Unclear |
| 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 |
|
