| Study characteristics |
| Patient Sampling |
Serum samples from 80 patients with hepatitis B virus (HBV) infection and HCC (HCC group), 80 patients with HBV‐related liver cirrhosis (LC group), 80 patients with chronic hepatitis B virus infection (HBV group) or 80 healthy controls (HC group).
Age range: 32‐76. Males 88% |
| Patient characteristics and setting |
|
| Index tests |
AFP was detected using electrochemiluminescence immunoassay (Elecsys and cobas e analyzers, Roche Diagnostics Mannheim, Germany)
No predefinition of a cut‐off value. |
| Target condition and reference standard(s) |
The diagnosis of primary HCC was based on guidelines of the American Association for the Study of Liver Diseases [22]. All patients were diagnosed either by histopathological results after surgical resection or by imaging findings (ultrasound, computed tomography or magnetic resonance) combined with AFP serum levels. Controls: no definition |
| Flow and timing |
No information on interval between index test and reference standard |
| Comparative |
|
| Notes |
Conflicts of interest relevant to this article were not reported. |
| 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? |
Yes |
|
|
| 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) |
| Were the index test results interpreted without knowledge of the results of the reference standard? |
|
|
|
| If a threshold was used, was it pre‐specified? |
|
|
|
| Could the conduct or interpretation of the index test have introduced bias? |
|
|
|
| Are there concerns that the index test, its conduct, or interpretation differ from the review question? |
|
|
|
| DOMAIN 2: Index Test (US) |
| Were the index test results interpreted without knowledge of the results of the reference standard? |
|
|
|
| If a threshold was used, was it pre‐specified? |
|
|
|
| Could the conduct or interpretation of the index test have introduced bias? |
|
|
|
| Are there concerns that the index test, its conduct, or interpretation differ from the review question? |
|
|
|
| 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? |
No |
|
|
| 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 |
|
