Tools, Technologies and Training for Healthcare Laboratories

Quality Requirements

French EQA performance specifications

One of the leading EQA programs of France is ProBioQual. They have their own set of EQA acceptance limits, which include some copied from the "Ricos goals" but most of them set through analysis of their own participant performance. How do these specifications compare to CLIA and Ricos TEa?

French acceptance criteria for EQA participants (2016)

ProBioQual is one of the major EQA programs in France.

Below is a selection of the acceptance limits for ProBioQual.

Analyte
ProBioQual
Acceptance Limits
CLIA 2014 Ricos Desirable TEa
Amylase 15  30 14.6
Alkaline phosphatase (ALP) 12 30 12.04
Albumin 6 10  4.07
Alanine aminotransferase (ALT) 10 20  27.48
Aspartate aminotransferase (AST) 10  20  16.69
Bilirubin (total) 9 ± 0.4 mg/dL or ± 20% (greater)   26.94
Bilirubin (direct) 25   44.5
Calcium 3.8 ± 1.0 mg/dL  2.55
Chloride 4 5 1.5
Cholesterol 6  10 9.01
Creatinine kinase (CK) 12 30 30.3
Creatinine 10 ± 0.3 mg/dL or ± 15% (greater)  8.87
Ferritin 16.9   16.9
γ-Glutamyl transferase (GGT) 12   22.11
Glucose 5.5 ± 6 mg/dL or ± 10% (greater)   6.96
Immunogloblin G (IgG) 8  25  8.0
Immunogloblin M (IgM) 12  ± 3 SD  16.8
Iron 10 20 30.7
Lactate 15   30.4
Lactate dehydrogenase (LDH) 12 20  11.4
Lipase 15   37.88
Lithium 10 ± 0.3 mmol/L or ± 20% (greater)   
Magnesium 7.2 25 4.8
Phosphate 6    10.11
Potassium 4 ± 0.5 mmol/L   5.61
Prealbumin 14.5   14.5
Protein 5 10.0 3.63
Sodium 2.5 ± 4 mmol/L  0.73
Transferrin 10   3.8
Triglycerides 12 25  25.99
Urate 9 17 11.97
Urea 12 ± 2 mg/dL or ± 9% (greater)  15.55

These goals are unique among our recent survey. They are very difference from CLIA goals, often nearly half as small. Very stringent, sometimes even more stringent than what has been specified as the Ricos desirable total allowable error specification. It's unusual to see that an EQA program is demanding tighter performance than what may be possible due to individual biologic variation. That could be one reason why the Ricos goals are under revision right now; there are analytes where some people believe we need to be even more demanding about analytical performance.