Na 2013.

Study characteristics
Patient Sampling	A total of 260 individuals visiting the Yonsei University Health System from July 2008 to December 2009 were enrolled. All participants were classified in the following groups: patients with HCC (HBV‐positive, 57), liver cirrhosis (LC; HBVpositive, 27), chronic hepatitis (CH; HBV‐positive, 37), cholangiocarcinoma (CC; 22), gastric cancer (GC; 31), and pancreatic cancer (PC; 34), along with 52 HDs having no liver‐related diseases when examined at the Severance Hospital of Yonsei University. Age range: 33‐65. Males 67%
Patient characteristics and setting
Index tests	Both hCE1 and AFP proteins in plasma samples were quantified by ELISA. A commercially available AFP ELISA kit was purchased from Panomics (Fremont, CA), and protocols recommended by the manufacturer were used. Clinically recommended AFP cut‐off values 20 ng/mL and 100 ng/mL
Target condition and reference standard(s)	The diagnosis of HCC was made by the pathologists at the Severance Hospital of Yonsei University.
Flow and timing	No information on interval between index test and reference standard
Comparative
Notes	"The authors declare there are no conflicts of interest."
Methodological quality
Item	Authors' judgement	Risk of bias	Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled?	No
Was a case‐control design avoided?	No
Did the study avoid inappropriate exclusions?	Unclear
Could the selection of patients have introduced bias?		High risk
Are there concerns that the included patients and setting do not match the review question?			High
DOMAIN 2: Index Test (AFP)
Were the index test results interpreted without knowledge of the results of the reference standard?	No
If a threshold was used, was it pre‐specified?	Yes
Could the conduct or interpretation of the index test have introduced bias?		High risk
Are there concerns that the index test, its conduct, or interpretation differ from the review question?			Low concern
DOMAIN 2: Index Test (US+AFP)
DOMAIN 2: Index Test (US)
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition?	No
Were the reference standard results interpreted without knowledge of the results of the index tests?	Yes
Could the reference standard, its conduct, or its interpretation have introduced bias?		High 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?	Unclear
Did all patients receive the same reference standard?	No
Were all patients included in the analysis?	Yes
Could the patient flow have introduced bias?		High risk