Omran 2016.

Study characteristics
Patient Sampling	A total of 88 consecutive Egyptian individuals attending the Tropical Medicine Department, Mansoura University hospitals, Mansoura, Egypt during the period from May 2012 to April 2013 were enrolled in this study. They were classified into 3 groups. The first group included 53 patients with hepatocellular carcinoma (HCC), the second group included 20 patients with liver cirrhosis, and the third group of 15 apparently healthy participants serving as control group were included. Patients with heart failure, kidney failure, rheumatoid arthritis, autoimmune liver diseases, hepatitis B virus, metabolic disorders, or other malignancies were excluded. Age range: 42‐70. Males 71%
Patient characteristics and setting
Index tests	AFP: the level of serum alpha fetoprotein was estimated by chemiluminescence, with IMMULITE (1000) AFP kit (Diagnostic Products Corporation; Los Angeles, CA, USA). AFP cut‐off value 400 ng/mL
Target condition and reference standard(s)	HCC: the diagnosis of HCC was done according to American Association for the Study of Liver Diseases (AASLD) practice guidelines.
Flow and timing	No information on interval between index test and reference standard
Comparative
Notes	No information on 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?	Yes
Was a case‐control design avoided?	No
Did the study avoid inappropriate exclusions?	No
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