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Study flow diagram.
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Figure 1

Study flow diagram.

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Deeks' funnel plot for publication bias.
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Figure 2

Deeks' funnel plot for publication bias.

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Risk of bias and applicability concerns graph: review authors' judgments about each domain presented as percentages across included studies.
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Figure 3

Risk of bias and applicability concerns graph: review authors' judgments about each domain presented as percentages across included studies.

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Risk of bias and applicability concerns summary: review authors' judgments about each domain for each included study.
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Figure 4

Risk of bias and applicability concerns summary: review authors' judgments about each domain for each included study.

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Forest plot of 1 All molecular tests. CI: confidence interval; FN: false negative; FP: false positive; TN: true negative; TP: true positive.
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Figure 5

Forest plot of 1 All molecular tests. CI: confidence interval; FN: false negative; FP: false positive; TN: true negative; TP: true positive.

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Summary receiver operating characteristic plot of all molecular tests.
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Figure 6

Summary receiver operating characteristic plot of all molecular tests.

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Summary receiver operating characteristic plot by type of molecular test. PCR: polymerase chain reaction.
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Figure 7

Summary receiver operating characteristic plot by type of molecular test. PCR: polymerase chain reaction.

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Summary receiver operating characteristic plot subgrouped by sepsis onset.
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Figure 8

Summary receiver operating characteristic plot subgrouped by sepsis onset.

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Summary receiver operating characteristic plot subgrouped by gestational age.
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Figure 9

Summary receiver operating characteristic plot subgrouped by gestational age.

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Forest plot of all molecular tests sorted in order of prevalence. CI: confidence interval; FN: false negative; FP: false positive; TN: true negative; TP: true positive.
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Figure 10

Forest plot of all molecular tests sorted in order of prevalence. CI: confidence interval; FN: false negative; FP: false positive; TN: true negative; TP: true positive.

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Summary receiver operating characteristic plot of all molecular tests where the size of the study symbol is directly proportional to the prevalence of sepsis in the study.
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Figure 11

Summary receiver operating characteristic plot of all molecular tests where the size of the study symbol is directly proportional to the prevalence of sepsis in the study.

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Summary receiver operating characteristic plot of studies that performed molecular tests on blood samples only.
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Figure 12

Summary receiver operating characteristic plot of studies that performed molecular tests on blood samples only.

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Summary receiver operating characteristic plot of molecular tests with good methodologic quality.
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Figure 13

Summary receiver operating characteristic plot of molecular tests with good methodologic quality.

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All molecular tests.
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Test 1

All molecular tests.

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Molecular tests: blood samples only.
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Test 2

Molecular tests: blood samples only.

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Molecular tests with good methodologic quality.
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Test 3

Molecular tests with good methodologic quality.

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Summary of findings Summary of findings table

Groups

Number of studies

Sensitivity

(95% CI)

Specificity

(95% CI)

Quality of evidence using GRADE

All studies

‐

35

0.90 (0.82 to 0.95)

0.93 (0.89 to 0.96)

Moderate quality evidence*

Type of test

Broad‐range PCR

9

0.97 (0.86 to 1.00)

0.93 (0.77 to 0.98)

Moderate quality evidence*

Real‐time PCR

9

0.86 (0.59 to 0.96)

0.94 (0.90 to 0.97)

Moderate quality evidence*

Post‐PCR processing

5

0.97 (0.40 to 1.00)

0.96 (0.93 to 0.98)

Low quality evidence**

Multiplex PCR

6

0.76 (0.60 to 0.88)

0.81 (0.70 to 0.89)

Low quality evidence**

Staphylococcal PCR*

2

‐

‐

Low quality evidence**

Fungal PCR*

4

‐

‐

Low quality evidence**

Type of sepsis

EOS*

2

‐

‐

Low quality evidence**

LOS

10

0.79 (0.69 to 0.86)

0.94 (0.85 to 0.98)

Low quality evidence**

Mixed EOS and LOS

23

0.94 (0.84 to 0.98)

0.92 (0.87 to 0.95)

Moderate quality evidence*

Gestational age

Preterm

5

0.89 (0.75 to 0.96)

0.87 (0.71 to 0.94)

Low quality evidence**

Mixed term and preterm

30

0.90 (0.80 to 0.96)

0.94 (0.90 to 0.96)

Moderate quality evidence*

Prevalence

< 15%

20

0.94 (0.80 to 0.99)

0.95 (0.92 to 0.97)

Moderate quality evidence*

15% to 30%

8

0.85 (0.67 to 0.94)

0.88 (0.79 to 0.94)

Low quality evidence**

>30%

7

0.87 (0.75 to 0.93)

0.93 (0.64 to 0.99)

Low quality evidence**

Specimen

Blood only

32

0.92 (0.84 to 0.96)

0.93 (0.89 to 0.95)

Low quality evidence**

Blood and CSF*

3

‐

‐

Moderate quality evidence*

Quality

Good methodologic studies only

22

0.90 (0.78 to 0.96)

0.93 (0.88 to 0.96)

Moderate quality evidence*

CI: confidence interval; CSF: cerebrospinal fluid; EOS: early‐onset sepsis; LOS: late‐onset sepsis; PCR: polymerase chain reaction.

Summary estimates of sensitivity and specificity were derived from meta‐analyses using the bivariate random‐effects model using statistical software STATA. Summary estimates for the subgroups are presented, where number of studies ≥ 4. *Summary estimates of sensitivity and specificity could not be calculated using STATA if number of studies ≤ 4.

GRADE rating of evidence: reasons for downgrading quality of evidence (Gopalakrishna 2014)

* Evidence downgraded one level for inconsistency of evidence.

** Evidence downgraded two levels for inconsistency and imprecision.
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Summary of findings Summary of findings table
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Table Tests. Data tables by test

Test

No. of studies

No. of participants

1 All molecular tests Show forest plot

35

7339

2 Molecular tests: blood samples only Show forest plot

32

6999

3 Molecular tests with good methodologic quality Show forest plot

22

4150
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Table Tests. Data tables by test
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