Clinical Quality RequirementsEUROPEAN BIOLOGIC GOALS AND CALCULATED BIOLOGIC ALLOWABLE TOTAL ERRORS


Proposed and interim (in parenthesis) quality specifications for total analytical imprecision (CV,%) and inaccuracy (as % maximum allowable deviation) for commonly analysed quantities: these should be achieved in at least 95% of experiments performed. [From Frazer CG, Hyltoft Petersen P, Ricos C, Haeckel R. "Proposed quality specifications for imprecision and inaccuracy of analytical systems for clinical chemistry." Eur J Clin Chem Clin Biochem 1992;30:311-317] The total error is calculated from the equation TE = 1.65 (imprecision) + inaccuracy [From Hyltoft Petersen P, Ricos C, Stockl D, Libeer JC, Baadenhuijsen H, Fraser C, Thienpont L. "Proposed guidelines for the internal quality control of analytical results in the medical laboratory." Eur J Clin Chem Clin Biochem 1996;34:983-999]

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European biologic goals and biologic allowable total errors
Quantity Imprecision % Inaccuracy % Total Error %    
Albumin 1.4 (1.8) 1.1 (2.8) 3.4 (5.8)    
Bicarbonate 2.3 (4.9) 1.6 (4.6) 5.4 (12.7)    
Bilirubins 11.3 9.8 28.4    
Calcium 0.9 (1.5) 0.7 (1.8) 2.2 (4.3)    
Chloride 0.7 (1.0) 0.5 (1.4) 1.7 (3.0)    
Cholesterol 2.7 4.1 8.6    
Creatinine 2.2 2.8 (4.4) 6.4 (8.0)    
Glucose 2.2 1.9 (4.4) 5.5 (8.0)    
Iron 15.9 8.9 35.1    
Lithium 3.6 4.2 10.1    
Magnesium 1.1 (2.6) 1.6 (2.2) 3.4 (6.5)    
Phosphate 4.0 3.1 (8.0) 9.7 (14.6)    
Potassium 2.4 1.6 (4.8) 5.6 (8.4)    
Proteins 1.4 1.5 (2.8) 3.8 (5.1)    
Triacylglycols 11.5 15.6 34.6    
Urea 6.3 5.3 15.7    
Urate 4.2 4.0 (8.4) 10.9 (15.3)    

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Quantity Imprecision % Inaccuracy % Total Error %
Acid phosphatase 4.5 2.1 (9.0) 9.5 (16.4)
Alanine aminotransferase 13.6 13.6 36.0
Alkaline phosphatase 3.4 6.4 12.0
Amylase 3.7 6.5 (7.4) 12.6 (13.5)
Aspartate aminotransferase 7.2 6.2 18.0
Creatine kinase 20.7 19.8 54.0
Gamma-Glutamyl transferase 7.4 21.8 34.0
Lactate dehydrogenase 3.9 4.1 (7.8) 10.5 (14.2)

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Quantity Imprecision % Inaccuracy % Total Error %
Thyroxine (total) 3.4 (4.1) 4.1 (6.8) 9.7 (13.6)
Triiodothyronine 4.0 (4.7) 5.5 (8.0) 12.1 (15.8)
Digoxin 3.8 (4.7) 3.9 10.2 (11.7)
Transferrin 2.4 (4.0) 2.3 (4.8) 6.3 (11.4)
IgG 1.9 (3.7) 5.0 8.1 (11.1)
IgA 2.2 (3.8) 12.5 16.1 (18.8)
IgM 2.3 (5.4) 12.7 16.5 (21.6)

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