Knupfer 2001.

Study characteristics
Patient Sampling	Cross‐sectional study, consecutive sampling
Patient characteristics and setting	Sample size: 135 Gestational age: preterm (23–36 weeks) Race/ethnicity: "Caucasians" (presumed white) and Asians Prior phototherapy: in some infants Setting: obstetrics department and NICU at the University of Leipzig, Leipzig, Germany
Index tests	TcB Device: BiliChek Site of TcB measurement: forehead
Target condition and reference standard(s)	Target condition: neonatal hyperbilirubinaemia TSB measurement method: diazo method (unclear if reference standard interpreted without knowledge of results of index test)
Flow and timing	Time interval between tests: not reported Number of paired results: 400
Comparative
Notes	.
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
Could the selection of patients have introduced bias?		Low risk
Are there concerns that the included patients and setting do not match the review question?			Low concern
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
Could the reference standard, its conduct, or its interpretation have introduced bias?		Low risk
Are there concerns that the target condition as defined by the reference standard does not match the question?			Low concern
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
Could the patient flow have introduced bias?		Low risk