| Study characteristics |
| Patient Sampling |
60 Egyptian patients with HCV‐related liver cirrhosis (LC) were selected from those admitted to the Internal Medicine and Tropical Medicine Departments in Tanta University Hospital; among them, 30 patients with HCC and 30 patients without HCC.
Age range not reported. Males 70% |
| Patient characteristics and setting |
|
| Index tests |
The second part of the blood sample was drawn into ethylenediaminetetraacetic acid (EDTA) tubes and plasma was obtained by centrifuging the blood sample for 15 minutes at room temperature at 1000 g within 30 minutes after collection, aliquoted, and stored at 80° C until measurements of osteopontin (OPN) and AFP levels. Plasma AFP levels were measured using a commercially available enzyme immunometric assay kit (CanAg AFP EIA kit, Fujirebio Diagnostics AB, Majnabbeterminalen,Goteborg, Sweden), according to the manufacturer’s instructions. |
| Target condition and reference standard(s) |
The diagnosis of HCC was based on typical imaging studies and/or histopathology according to American Association for the Study of Liver Diseases (AASLD) practice guidelines. The diagnosis of Liver Cirrhosis was established on the basis of clinical, laboratory, imaging (ultrasonography and computed tomography), and histological examinations. |
| 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? |
No |
|
|
| Was a case‐control design avoided? |
Unclear |
|
|
| 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? |
Yes |
|
|
| Were all patients included in the analysis? |
Yes |
|
|
| Could the patient flow have introduced bias? |
|
Unclear risk |
|
