| Study characteristics |
| Patient sampling |
Neonates were enrolled if they met inclusion criteria during the study period. |
| Patient characteristics and setting |
Neonates with suspected sepsis during the period of December 2004 to June 2005. Participant demographics not available. |
| Index tests |
Real‐time PCR using universal primers. |
| Target condition and reference standard(s) |
Neonatal sepsis and blood culture. |
| Flow and timing |
Blood samples for PCR and culture were drawn concurrently. |
| Comparative |
|
| Notes |
Recalculated sensitivity, specificity, PPV, and NPV as samples positive for PCR were also positive for human DNA and not bacterial DNA. Participant demographics not available. |
| 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? |
Unclear |
|
|
| |
|
Unclear |
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 |
|
