[Study ID]

First author, year of publication

Type of study

Journal article, unpublished data

Participants

Sample size

Country of study

Baseline characteristics (gestational age, postnatal age, race, body weight)

Study design

Retrospective/prospective design

Sample (consecutive, random or unclear)

Study criteria

Inclusion criteria

Exclusion criteria

Reference standard

Name of assay/manufacturer

Name of instrument

Cut‐off values

Time between reference standard performance and TcB measurement

Blinding of operator to TcB result

Index test

Name of device

Cut‐off values

Operator training

site of measurement (forehead, sternum)

Target condition

Universal screening of newborns for hyperbilirubinaemia

Diagnostic determination of hyperbilirubinaemia in visibly jaundiced newborns

Monitoring of bilirubin in newborns on therapy for hyperbilirubinaemia

Data

Number of true positives and false positives

Number of true negatives and false negatives

Number of undetermined/uninterpretable results

Sensitivity and specificity of index test

Number of missing results for index test

Number of missing results for reference standard

Notes

Source of funding (whether any author is affiliated with the manufacturer of the index test; the study was directly funded by the manufacturer; authors reported conflicts of interests related to the manufacturer or other funding sources)