Steatohepatitis tests
| Investigation panel name | Commercial? | Formula and variables | AUROC | Sensitivity (Se) and specificity (Sp) | Comments | Primary ref |
|---|---|---|---|---|---|---|
| HAIR | No | Count of number of features present:
| 0.90 | Threshold ≥2 parameters: Se 0.80, Sp 0.89 | 10 87 | |
| Palekar score | No | Count of number of features present:
| 0.763 | Threshold ≥3 parameters: Se 0.74, Sp 0.66 (PPV 66%, NPV 81%) | 88 | |
| PIIINP | No | Terminal peptide of procollagen III | 0.83 | Threshold >6 ng/mL: Se 0.66, Sp 0.80, PPV 0.94, NPV 0.32 | Discriminating histological diagnosis of ‘non-NASH’ vs NASH | 89 |
| Shimada Index | No | Serum adiponectin, HOMA-IR, serum type IV collagen 7S levels | 0.765 | Serum adiponectin: Se 0.68, Sp 0.79 HOMA-IR: Se 0.51, Sp 0.95 Type IV collagen 7S: Se 0.41, Sp 0.95 Combining 3 markers: Se 0.94, Sp 0.74 | 90 | |
| NASH test | Yes | A patented algorithm including: A2M, ApoA1, haptoglobin, total bilirubin, GGT, ALT, AST, cholesterol, triglycerides, age, gender and BMI | 0.79 | Se 0.33, Sp 0.94 (PPV 66%, NPV 81%) | Validated in other European cohorts91 | 92 |
| Gholam's model | No | −2.627×ln (AST)+2.13 if T2DM | 0.90 | Threshold >6.6: Se 0.83, Sp 0.82 | 93 | |
| NASH diagnostics | Yes | A patented algorithm including: cleaved (M30) and total (M65) CK-18, adiponectin and resistin | 0.85 | Threshold >0.432: Se 0.95, Sp 0.70 | Performed less well in larger follow-up study (AUROC 0.70)94 | 95 |
| NASH diagnostic panel | Yes | A patented algorithm including: T2DM, gender, BMI, triglycerides, cleaved (M30) CK-18 and M65 | 0.81 | Thresholds <0.221 and >0.6183: Se 0.91, Sp 0.92 (PPV 83%, NPV 86%) | 96 | |
| CK-18 | No | Marker of cell necrosis and apoptotic cell death | 0.83 | Cleaved CK-18, threshold >279 U/L: Se 0.71, Sp 0.85 | M30, M65 and M65ED increased in stepwise fashion through non-NASH, NAFLD and NASH (p<0.001). AUROC >0.80 for disease progression.97 | 98 |
| Apoptosis panel | CK-18, soluble Fas and Fas ligand Model combining plasma CK-18 (cleaved and intact), serum adiponectin and serum resistin | 0.93 0.908 | Threshold −0.5509: Se 0.88, Sp 0.89 (PPV 86%, NPV 91%) Se 0.95, Sp 0.70 | 99 95 | ||
| Nice model | No | X=−5.654+(3.780×10–2 * ALT)+(2.215×10–3 ×CK-18)+(1.825 × (metabolic syndrome: yes=1, no=0)) logarithmic transformation=1/(1+Exp(−X)) | 0.83–0.88 | Threshold 0.14: Se 0.84, Sp 0.86 (PPV 44%, NPV 98%) | 100 |
A2M, α2-macroglobulin; ALT, alanine aminotransferase; ApoA1, apolipoprotein A-I; AST, aspartate aminotransferase; AUROC, area under the receiver operating characteristic curve; BMI, body mass index; CK-18, cytokeratin-18; GGT, gamma-glutamyltransferase; HAIR, hypertension, ALT and insulin resistance; NAFLD, non-alcoholic fatty liver disease; NASH, non-alcoholic steatohepatitis; NPV, negative predictive value; PIIINP, procollagen III; PPV, positive predictive value; T2DM, type 2 diabetes mellitus.