Table 1.
Analytical performance of the 6-plex immunoassay.
| Mean (pg/mL) | Intra-assay Precision (%CV) | Inter-assay Precision (%CV) | Intra-assay Precision (%CV) | Inter-assay Precision (%CV) | LOB (pg/mL) | LLOQ (pg/mL) | ULOQ (pg/mL) | 6-plex vs Monoplex, Pearson R/p value | 6-plex vs ELISA, Pearson R/p value | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| QC1 | QC2 | QC1 | QC2 | QC1 | QC2 | Pooled Normal Serum | Pooled Normal Se rum | ||||||
| OPN | 13448.3 | 1228.3 | 2.1 | 5.1 | 3.7 | 4.2 | 12.9 | 13.7 | 19.9 | 157.3 | 37174.3 | 0.9987/0.0013 | 0.8945/0.0066 |
| MIA | 481.7 | 48.3 | 8.6 | 10.0 | 4.4 | 8.4 | 10.2 | 13.7 | 0.1 | 6.7 | 1550.0 | 0.9888/0.0112 | ND* |
| CEACAM-1 | 6141.7 | 658.3 | 9.3 | 6.6 | 8.6 | 16.3 | 16.5 | 19.3 | 19.8 | 96.0 | 20042.7 | 0.9715/0.0285 | ND |
| MIC-1 | 963.3 | 93.3 | 8.1 | 10.3 | 21.5 | 18.8 | 14.1 | 17.4 | 0.1 | 12.0 | 2383.7 | 0.9996/0.0004 | ND |
| SPON1 | 4746.7 | 473.3 | 4.3 | 2.7 | 5.0 | 6.8 | 14.8 | 16.8 | 12.5 | 60.3 | 15124.7 | 0.9675/0.0325 | ND |
| HSP27 | 933.3 | 88.3 | 15.4 | 12.6 | 14.5 | 13.2 | 19.6 | 29.3 | 0.5 | 12.0 | 3078.0 | 0.9997/0.0003 | 0.9254/<0.00001 |
NOTE: QC1, high control. QC2, low control. LOB, limit of blank. LLOQ, lower limit of quantitation. ULOQ, upper limit of quantification.
The correlation of 6-plex vs monoplex was examed on 4 doses of individual recombinant proteins. The correlation of 6-plex vs the
commercial ELISA kit was examed on 7 (OPN) or 13 (HSP27) patient sera.
*
, ND, not determined.