Quality Requirements
Belgium EQA performance specifications
Another country heard from? The Belgian Institut Scientifique de Sante Publique has a set of EQA performance specifications. How are they similar and different from the goals we're used to seeing?
Belgium EQA performance specifications
The chemistry report of the WIV-ISP in Belgium provides an interesting set of analytical performance specifications, many of which are differen than those we see in other EQA and regulatory resources. NOTE: Updated now for 2016.
| Analyte |
Goal Type | EQA Performance Specification | CLIA | Ricos Desirable |
| Albumin | State of the art | 10.7 | 10 | 4.07 |
| Alanine aminotransferase (ALT) | State of the art | 13.3 | 20 | 27.48 |
| Aspartate aminotransferase (AST) | Biologic variability | 11.3 | 20 | 16.69 |
| Bilirubin (directl) | State of the art | 24.1 | 44.5 | |
| Bilirubin (total) | State of the art | 12.0 | ± 0.4 mg/dL or ± 20% (greater) | 26.9 |
| Calcium | State of the art | 5.0 | ± 1.0 mg/dL | 2.55 |
| Chloride | State of the art | 5.1 | 5 | 1.5 |
| Cholesterol | Biological variability | 6.5 | 10 | 9.01 |
| HDL-cholesterol | State of the art | 15.3 | 30 | 11.63 |
| Creatinine | State of the art | 10.9 | ± 0.3 mg/dL or ± 15% (greater) | 8.87 |
| Glucose | State of the art | 6.3 | ± 6 mg/dL or ± 10% (greater) | 6.96 |
| γ-Glutamyl transferase (GGT) | State of the art | 14.2 | 22.11 | |
| Immunogobulin A (IgA) | State of the art | 10.6 | ± 3 SD | 13.5 |
| Immunogloblin G (IgG) | State of the art | 9.3 | 25 | 8.0 |
| Immunogloblin M (IgM) | State of the art | 12.2 | ± 3 SD | 16.8 |
| Iron | State of the art | 8.3 | 20 | 30.7 |
| Lactate dehydrogenase (LDH) | State of the art | 10.7 | 20 | 11.4 |
| Lipase | Satete of the art | 14.3 | 37.88 | |
| Magnesium | State of the art | 8.9 | 25 | 4.8 |
| Phosphate | Biological variability | 7.4 | 10.11 | |
| Potassium | Biological variability | 4.8 | ± 0.5 mmol/L | 5.61 |
| Sodium | State of the art | 3.4 | ± 4 mmol/L | 0.73 |
| Total Protein | State of the art | 6.8 | 10 | 3.63 |
| Triglycerides | State of the art | 20.0 | 25 | 25.99 |
| Urate | State of the art | 8.0 | 17 | 11.97 |
| Urea | Biological variability | 9.0 | ± 2 mg/dL or ± 9% (greater) | 15.55 |
One of the things to notice is that the CLIA goals, when they are available, although they are often criticized as being too old or too wide, are quite similar to the Belgium EQA goals, while the differences between the EQA goals and the desirable TEa specifications are frequently quite significant.
Also, very interesting to note that most of the analytes have goals specified through state of the art methods. This probably reflects the fact that instrument performance, as it currently stands, is nowhere near the goals recommended for analytical performance from biological variation. We're still at least a generation away from achieving the Ricos goals for most analytes. And if the Ricos goals are changed, it is most likely that these goals will get smaller, and we'll have to rely on state of the art goals for even more analytes.