Table 3.
Assay Manufacturer Analytical System | ne | Laboratory (%) results within allowable limitsa for Sample A–D | Laboratories achieved satisfactory performanceb (%) | |||
---|---|---|---|---|---|---|
| ||||||
Sample A (15.5 ng/dl) | Sample B (30.0 ng/dl) | Sample C (402 ng/dl) | Sample D (498 ng/dl) | |||
Beckman Coulter | ||||||
Access 2 | 6 | 0 | 83 | 100 | 100 | 83 |
Unicel DxI 600 | 2 | 0 | 50 | 100 | 100 | 50 |
Unicel DxI 800 | 10 | 10 | 90 | 100 | 100 | 90 |
Siemens | ||||||
ADVIA Centaur (XP, XPT) | 36 | 42 | 50 | 89 | 97 | 56 |
ADVIA Centaur CP | 3 | 33 | 66 | 100 | 66 | 33 |
Immulite 1000 | 3d | 66 | 66 | 66 | 0 | 33 |
Immulite 2000 XPi | 19d | 100 | 79 | 58 | 68 | 68 |
Coat-A-Count | 3 | 100 | 100 | 100 | 100 | 100 |
Ortho Clinical Diagnostics | ||||||
VITROS ECiQ | 2 | 50 | 50 | 0 | 100 | 50 |
VITROS 5600 | 1 | 0 | 100 | 100 | 0 | 0 |
Roche Diagnostics | ||||||
Cobas e401,e601,e602 | 5 | 80 | 60 | 100 | 100 | 100 |
MODULAR series | 9 | 78 | 89 | 100 | 100 | 100 |
Elecsys | 7 | 100 | 71 | 100 | 100 | 100 |
LC-MS/MS | 4 | 50 | 100 | 100 | 100 | 100 |
Abbott AxSYM | 3 | 0 | 33 | 100 | 100 | 33 |
Tosoh Bioscience AIA | 1 | 0 | 100 | 100 | 0 | 0 |
MP Biomedicals | 1 | 0 | 100 | 100 | 100 | 100 |
Overall performance | 115 | 55 | 71 | 86 | 89 | 73 |
Results were within the limits of RMP-defined target ±25.1%.
Satisfactory performance of a laboratory is defined as laboratory’s results within the allowable limit for ≥3 of the 4 specimens.
Only the laboratories that submitted results for all 4 samples were evaluated.
Laboratories reported results as <20 and received a pass credit of 100%.
n = number of participating laboratories.