Table 2. Assay performance characteristics.
Alere Triage [10] | PathFast cTnI [11] | Singulex Erenna [12] | |
---|---|---|---|
LOD | N/A (Limit of blank, 10 pg/mL) | 8 pg/mL | 0.1 pg/mL |
LOQ | 20 pg/mL | 19 pg/mL | 0.4 pg/mL |
Reportable range | 10-10,000 pg/mL | 19-50,000 pg/mL | 0.4-600 pg/mL |
99th percentile | 20 pg/mL | 29 pg/mL | 10.2 pg/mL |
CV | 16.7% at 60 pg/mL and 11.0% at 5,000 pg/mL | 6.1% at 29 pg/mL and 3.9% at 251 pg/mL | low-end CV% range of 2-8%, and low-end CV% average 5% |
CV at 99th percentile | <20% | 5% | 9% |
Abbreviations: TnI, troponin; N/A, not available; LOD, level of detection; LOQ, level of quantitation.