Table 2.
Manufacturer | Analyzers | Core | NS3 | NS4 | NS5 | Assay Format | Solid Phase | Labeled Substance | Sample Vol | Time of Reaction | Gray Zone | Signal-to-Cut-Off Ratio Predictive of a True Positive ≥ 95% Time |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Roche | Elecsys 2010 Cobas e 411 Cobas e 601 Modular analiytics E170 | Present | Present | Present | Absent | CLIA | Magnetic particle | Ruthenium complex | 40 | 18 | 0.9-1.0 | ≥ 3.8 |
Abbott Laboratories | Architect i2000SR system | HCr43 | HCr43 | c100-3 | Absent | CMIA | Paramagnetic particle | Acridinium | 20 | 29 | Not indicated | ≥ 5.0 |
Ortho-Clinical Diagnostics | Vitros EciQ Vitros 3600 system Immunodiagnostic System | c22-3 | c200 | c200 | Present | CLIA | Well | Luminal derivate | 20 | 56 | 0.9-1.0 | ≥ 8.0 |
BioRad | UniCel DxI 800 Access or Access 2 or UniCel (Beckman Coulter) | Present | Present | Present | Absent | CLIA | Paramagnetic particle | Lumi-Phos 530 | 25 | 55 | 0.9-1.0 | ≥ 10.0 |
Abbott Laboratories | AxSYM | HCr43 | C200 | C100-3 | Present | MEIA | Paramagnetic particle | 4- Methylumbelliferyl Phosphate | 33 | 30 | 0.8 - 1.2 | ≥10.0 |
Siemens | Advia centaur | C22-3 | Present | c200 | Present | CLIA | Magnetic particle | Acridinium | 10 | 58 | 0-9-1.0 | ≥ 11.0 |
BioMerieux | Vidas | HCr43 | Present | C100-3 | Absent | ELFA | Well | 4- Methylumbelliferyl Phosphate | 100 | 40 | Not indicated | Not available |
Abbott Laboratories | Prism | HCr43 | HCr43 | c100-3 | Present | CLIA | Well | Acridinium | 50 | 54 | Not indicated | Not available |
DiaSorint | Eti-MAX 3000 | HCr43 | HCr43 | c100-3 | Present | ELISA | Well | 3,3’,5,5’- tetramethylbenzidine | 20 | 90 | Not indicated | Not available |
Ortho-Clinical Diagnostics | Microtite plate | c22-3 | c200 | c200 | Present | ELISA | Well | 3,3’,5,5’- tetramethylbenzidine | 20 | 90 | Not indicated | ≥ 3.8 |
Abbott Laboratories | Semi-automated (IMx) | Present | Present | Present | Present | ELISA | Well | 3,3’,5,5’- tetramethylbenzidine | 20 | 90 | Not indicated | ≥ 3.8 |
ELISA: Enzyme-linked Immunosorbent Assay; CLIA: Chemiluminescence Immunoassay; MEIA: Microparticle capture Enzyme ImmunoAssay Ortho-Clinical Diagnostics, Buckinghamshire, Germany; Roche Diagnostics GmbH, Mannheim Germany; Abbott Laboratories, Wiesbaden, Germany; Siemens Healthcare Diagnostics, Deerfield, IL; BioMerieux Clinical Diagnostics, France; Bio-Rad, Marnes-la-Coquette, France.