| Study characteristics |
| Patient Sampling |
We performed a prospective single‐centre study including 164 cases of HCC‐patients and 422 controls seen between 02/2007 and 11/2008.
10 patients had to be excluded due to pregnancy (n = 2), warfarin use (n = 4), or missing data (n = 4).
Age range not reported. Males 56% |
| Patient characteristics and setting |
|
| Index tests |
Serum concentrations of AFP and ® DCP were determined using the Wako LiBASys ® clinical auto‐analyser by a liquid‐phase binding assay [17]. Interassay coefficient of variation for total AFP concentration ranges from 2.6% to 4.6%.
The analytical limit of detection is 0.8 ng/mlL and the assay is linear up to 1,000 ng/mL AFP concentration. |
| Target condition and reference standard(s) |
HCC was verified by histological findings or by two different cross‐sectional scans as defined by the European Association for the Study of the Liver (EASL) guidelines. Controls consisted of patients with viral hepatitis, cirrhosis, other chronic liver diseases such as nonalcoholic steatohepatitis (NASH), autoimmune hepatitis (AIH), and others. Liver diseases were classified according to clinical, serological, and histological criteria. Liver cirrhosis was diagnosed by histology or typical findings such as portal hypertension in known chronic liver diseases. |
| Flow and timing |
|
| 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? |
No |
|
|
| Was a case‐control design avoided? |
No |
|
|
| Did the study avoid inappropriate exclusions? |
Yes |
|
|
| 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? |
Yes |
|
|
| Could the conduct or interpretation of the index test have introduced bias? |
|
Low 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 |
|
