Quality Requirements
European Biologic Goals
In the early 1990s, a group of European scientists fromed to recommend the best targets for imprecision, inaccuracy, and total error (calculated from biologic variation). This became called the "European Biologic Goals and Calculated Biologic Allowable Total Errors." While later eclipsed by the work of Dr. Carmen Ricos et al (the biodatabase desirable specifications), these quality requirements remain an important resource.
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]
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) |
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) |