Table 1.
Assay characteristics
| HemosIL AcuStar | BioPlex | EliA | QUANTA Lite | |||||
|---|---|---|---|---|---|---|---|---|
| Assay | HemosIL AcuStar Anti‐β2 glycoprotein I IgM, IgG | HemosIL AcuStar Anti‐Cardiolipin IgM, IgG | APLS IgM kit | APLS IgG kit | EliA β2‐Glycoprotein I IgM, IgG | EliA Cardiolipin IgM, IgG | QUANTA Lite β2GPI IgM, IgG | QUANTA Lite ACA IgM, IgG III |
| Technology | Automated 2‐step chemiluminescent immunoassay | Automated 2‐step chemiluminescent immunoassay | Automated multiplex flow immunoassay | Automated multiplex flow immunoassay | Fluorescence enzyme immunoassay | Fluorescence enzyme immunoassay | Enzyme‐linked immunosorbent assay | Enzyme‐linked immunosorbent assay |
| Coating well/particle | Human β2GPI | Bovine cardiolipin with human β2GPI |
1: Human β2GPI 2: Synthetic cardiolipin with human β2GPI |
1: Human β2GPI 2: Synthetic cardiolipin with human β2GPI |
Human β2GPI | Bovine cardiolipin and bovine β2GPI | Purified β2GPI | Purified cardiolipin and bovine β2GPI |
| Conjugate | Isoluminol‐labeled anti‐human IgM/IgG antibody | Isoluminol‐labeled anti‐human IgM/IgG antibody | Phycoerythrin conjugated murine monoclonal anti‐human IgM | Phycoerythrin conjugated anti‐human IgG | β‐galactosidase mouse monoclonal anti‐ IgM, IgG | β‐galactosidase mouse monoclonal anti‐IgG | Peroxidase‐labeled anti‐human IgM, IgG | Peroxidase‐labeled anti‐human IgM, IgG |
| Signal detection | Chemiluminescence | Chemiluminescence | Fluorescence | Fluorescence | Fluorescence | Fluorescence | Chromogenic | Chromogenic |
| Calibration | Internal standard traceable towards Koike's monoclonal antibodies (HCAL for IgG and EY2C9 for IgM) | Internal standard traceable towards Koike's monoclonal antibodies (HCAL for IgG and EY2C9 for IgM) | Internal standard containing human antibodies in serum matrix | Internal standard containing human antibodies in serum matrix | Internal standard containing human IgG or IgM in PBS, traceable to the WHO International Reference Preparation 67/86 | Internal standard containing human IgG or IgM in PBS, traceable to the WHO International Reference Preparation 67/86 | Internal standard containing human serum antibodies to β2GPI referenced to the reference calibrators for IgG/IgM β2GPI available from the Rheumatology Laboratory, Seton Hall University, St. Joseph's Hospital and Medical Center | Internal standard containing human serum antibodies to cardiolipin |
| Manufacturer's cutoff | 20 U/mL | 20 U/mL |
20 MPL‐U/mL (aCL) 20 U/mL (aβ2GPI) |
20 GPL‐U/mL (aCL) 20 U/mL (aβ2GPI) |
10 U/mL | 10 MPL‐U/mL, GPL‐U/mL | 20 SMU, SGU | 20 MPL, GPL |
| Calculation | 250‐262 blood bank donors, 99th percentile | 250‐252 blood bank donors, 99th percentile | 300 blood bank donors, a recommended value | 300 blood bank donors, a recommended value | 400 healthy subjects, a recommended value | 400 healthy subjects, a recommended value | 11‐313 normal donors, a recommended value | 488‐489 normal donors, a recommended value |
aβ2GPI, anti‐β2 glycoprotein I antibodies; aCL, anticardiolipin antibodies; β2GPI, β2 glycoprotein I; GPL, IgG phospholipid units; MPL, IgM phospholipid units; PBS, phosphate‐buffered saline; SGU, standard IgG units; SMU, standard IgM units.