Study characteristics |
Patient sampling |
All infants with suspected sepsis in the NICU and PICU during the study period were considered for inclusion in the study. |
Patient characteristics and setting |
Infants admitted in the NICU (n = 46) and PICU (n = 17) with suspected sepsis during the period from November 1999 to November 2000. PCR and blood culture data separately for neonates not available. |
Index tests |
Fungal conventional PCR targeting 18S rRNA. |
Target condition and reference standard(s) |
Suspected sepsis and blood culture. |
Flow and timing |
Excess blood used for culture was used for PCR. |
Comparative |
|
Notes |
PCR and blood culture data separately for neonates not available. It was unclear how many of the infants admitted in the PICU were neonates hence, not all infants may have met the target condition of neonatal sepsis defined in this study. PCR products were analyzed by 2 independent observers blinded to blood culture results and participant information. |
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 |
High |
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? |
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 |
High |
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 |
|