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. 2021 Apr 15;2021(4):CD013346. doi: 10.1002/14651858.CD013346.pub2

Ahmed Mohamed 2016.

Study characteristics
Patient Sampling Serum samples were obtained from sixty patients with chronic liver disease, divided into two groups: Group (I) included 40 patients with HCC. Patients with cancers other than HCC or metastatic liver cancer were excluded. Group (II) included 20 patients with liver cirrhosis and without any evidence of HCC, and Group (III) included 20 healthy adults recruited as controls.
Age range: 48‐89. Males 77.5%
Patient characteristics and setting  
Index tests Serum AFP and osteopontin levels were determined using an enzyme‐linked binding protein assay kit. AFP was assayed by an enzyme immunoassay (EIA) Kit (Roche Mannheim, Germany).
Target condition and reference standard(s) HCC was diagnosed by abdominal US and confirmed by triphasic CT scan. AFP was assayed by an enzyme immunoassay (EIA) Kit (Roche Mannheim, Germany).
Flow and timing No information on interval between index test and reference standard
Comparative  
Notes Authors declared 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? Unclear    
If a threshold was used, was it pre‐specified? No    
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? Yes    
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?   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? 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