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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.

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.