Specifications
| Incubation Time | 1 Hour |
| Sample Volume | 12.5 µl |
| Accuracy (Recovery Range) | 80-120% |
Precision
Intra-Assay %CV
Inter-Assay %CV |
≤10%
≤15% |
| Cross-reactivity | Negligible |
Representative assay working ranges, assay sensitivity, and precision. The LLOQ, ULOQ, LOD, and inter-assay precision %CV are the mean data determined from three independent multiplex assays in a serum-based matrix. LLOQ and ULOQ are defined as the boundary standard curve points for which the performance specifications were met for 10% intra-assay CV, 15% inter-assay CV, and recovery range of 80–120%. Data were generated using the magnetic workflow with the Bio-Plex Pro II wash station.
| |
| Targets | LLOQ | ULOQ | LOD | Intra-assay %CV | Inter-assay %CV |
| |
| Adiponectin* | 38.0 | | 62,043 | | 8.4 | | 4 | 3 |
| |
| 8-Plex Assays | | | | | | |
| Ghrelin | 3.1 | | 7,296 | | 0.8 | | 5 | 4 |
| GIP | 13.4 | | 14,999 | | 2.3 | | 4 | 10 |
| GLP-1 | 3.4 | | 1,969 | | 0.8 | | 6 | 11 |
| Glucagon | 24.0 | | 3,067 | | 7.0 | | 6 | 6 |
| Insulin | 93.4 | | 47,815 | | 22.0 | | 6 | 4 |
| Leptin | 17.1 | | 69,900 | | 6.2 | | 4 | 3 |
| PAI-1 | 0.7 | | 2,922 | | 0.5 | | 5 | 2 |
| Resistin | 125.9 | | 257,870 | | 32.0 | | 4 | 4 |
| |
*Due to the different dilution scheme, adiponectin was assayed as a single assay.
Assay Performance Definitions
Assay working range — the range of concentrations within which the assay is precise and accurate. Boundaries of the assay working range are the lower limit of quantitation (LLOQ) and the upper limit of quantitation (ULOQ). Precision is expressed as the coefficient of variation (%CV) at concentrations within the assay working range. Accuracy is expressed as a ratio of the observed concentration vs. the expected concentration of a known amount of spiked analyte within the assay working range.
Precision — the coefficient of variation (%CV) at concentrations within the assay working range
Accuracy — ratio of the observed concentration versus the expected concentration of a known amount of spiked analyte within the assay working range
Sensitivity (Limit of Detection, LOD) — the concentration of analyte for which the fluorescence intensity signal is 2-fold of the standard deviation above the background signal.
