Table 5.
Main Characteristics of serological assays for hepatitis C virus diagnosis
| Serological assays | Antigen (region of the genome) | Assay/manufacturer | Sensitivity | Specificity | Ref. | |
| EIA | 1st generation EIA | c100-3 (NS3-NS4) | HCV-Ac-EIE Salck | 70%-80% | 50%-70% | [118,119] |
| 2nd generation EIA | c100-3 (NS3-NS4), c33-c (NS3), c22-3 (core) | ORTHO HCV ELISA test system | 92%-95% | [118,119] | ||
| 3rd generation EIA | c100-3 (NS3-NS4), c33-c (NS3), c22-3 (core), NS5 | ORTHO HCV 3.0 ELISA (Ortho)/ETI-AB-HCVK Sorin | 95%-99% | 99% | [57,118] | |
| 4th generation EIA | Monolisa™ HCV AgAb ULTRA (BioRad)/HCV Murex AgAb (Abbott) | 100% | 99.5% | [117,133,144] | ||
| MEIA | HCr43 (Fusion core e NS3), c200 (NS3 - NS4), c100-3 (NS3-NS4), NS5 | AxSYM® HCV 3.0 (Abbott) | 100% | 99.8% | [117,118] | |
| ECLIA | Core, NS3 and NS4 proteins | Elecsys anti-HCV assay (Roche) | 100% | 99.7% | [117,118] | |
| CLIA | [c22-3 (core), c200 (NS3 - NS4) and NS5] | ARCHITECT i4000 anti-HCV assay (Abbott); VITROS Eci anti-HCV assay (Ortho) | 99.5% | 98.2% | [145] | |
| CMIA | HCr43 (core - NS3), c100-3 (NS3-NS4) | ARCHITECT® anti-HCV (Abbott) | 99.1% | 99.6% | [146] | |
| RIBA | RIBA-1 | 5-1-1 (NS4) e c100-3 (NS3-NS4) | NP | NP | [118] | |
| RIBA-2 | 5-1-1 (NS4), c100-3 (NS3-NS4), c33-c (NS3), c22-3 (core) | Chiron RIBA-2.0 RIBA-2 | NP | NP | [148] | |
| RIBA-3 | c100-3 (NS3-NS4), c33-c (NS3), c22-3 (core), NS5 | Chiron RIBA HCV 3.0 SIA | NP | NP | [118] | |
| Biosensor technology | Core protein (p22 fusion protein), NS3, NS4 and NS5 | mBio Diagnostics® company | NP | NP | [57,137] |
NP: Not presented; EIA: Enzyme immunoassay; MEIA: Micro-particle enzyme immunoassay; ECLIA: Electrochemiluminescence immunoassay; CLIA: Chemiluminescence immunoassay; CMIA: Chemiluminescent microparticle immunoassay; RIBA: Recombinant immunoblot assays; HCV: Hepatitis C virus; ELISA: Enzyme-linked immunosorbent assay.