Quality Requirements
Spanish Minimum Consensus Performance Specifications
What's the absolute minimum for quality? In 2015, four Spanish EQA providers updated their earlier consensus goals to expand a common set of minimum performance specifications for tests.
Consensus Minimum analytical performance specifications of inter-laboratory comparisons: agreement among Spanish EQAP organizers (2015)
Quality analytical specifications obtained by consensus through intercomparison programs AEFA/AEBM, SEQC and SEHH. [Asociación Espanola de Farmacéuticos Analistas (AEFA), Asociación Espanola de Biopatología Médica (AEBM), Espana Sociedad Espanola de Hematología y Hemoterapia (SEHH), Sociedad Espanola de Bioquímica Clínica y Patología Molecular (SEQC)] http://dx.doi.org/10.1016/j.cali.2015.06.006 Revista de Calidad Asistencial, Volume 30, Issue 6, Pages 341-343 R. Blázquez, E. Prada, C. Ricós, G. Gutiérrez-Bassini, J. Morancho, Á. Salas, J.M. Jou, F. Ramón
This recent publication is an expansion of a 2012 report:
Carmen Ricos, Francisco Ramon, Angel Salas, Antonio Buno, Rafael Calafell, Jorge Morancho, Gabriella Gutierrez-Bassini and Josep M Jou, Interdisciplinary Expert Committee for Quality Specifications in the Clinical Laboratory, Clin Chem Lab Med 2012;50(3):485-461. The previous article had been printed with permission of the authors
The table below does not include all the analytes listed in the full article above. This is just an excerpt:
Sample type |
Analyte |
Consensus Minimum Quality Specification |
CLIA | Ricos Desirable |
Serum | Amylase | 35 | 30 | 14.6 |
Urine | Amylase | 35 | 88.82 (pancreatic) | |
Serum | α-fetoprotein (AFP) | 20 | ± 3 SD | 21.9 |
Serum | Alkaline phosphatase (ALP) | 31 | 30 | 12.04 |
Serum | Albumin | 14 | 10 | 4.07 |
Urine | Albumin | 38 | 46.1 | |
Serum | Alanine aminotransferase (ALT) | 23 | 20 | 27.48 |
Serum | Aspartate aminotransferase (AST) | 21 | 20 | 16.69 |
Serum | Bilirubin (total) | 24 | ± 0.4 mg/dL or ± 20% (greater) | 26.94 |
Serum | Calcium | 11 | ± 1.0 mg/dL | 2.55 |
Urine | Calcium | 30 | 34.1 | |
Serum | Carcinoembryonic antigen (CEA) | 16 | 24.7 | |
Serum | Chloride | 9 | 5 | 1.5 |
Urine | Chloride | 12 | ||
Serum | Cholesterol | 11 | 10 | 9.01 |
Serum | HDL-cholesterol | 33 | 30 | 11.63 |
Serum | Cortisol | 28 | 25 | 22.8 |
Serum | Creatinine kinase (CK) | 24 | 30 | 30.3 |
Serum | Creatinine | 20 | ± 0.3 mg/dL or ± 15% (greater) | 8.87 |
Urine | Creatinine | 15 | 28.4 | |
Serum | Digoxin | 20 | ± 20% or ± 0.2 ng/mL (greater) | |
Blood | Erythrocytes | 4 | 6 | 4.4 |
Serum | Estradiol | 26 | 26.86 | |
Serum | Ferritin | 21 | 16.9 | |
Plasma | Fibrinogen | 24 | 20 | 13.6 |
Serum | Follitropin (FSH) | 14 | 21.19 | |
Serum | γ-Glutamyl transferase (GGT) | 22 | 22.11 | |
Serum | Glucose | 11 | ± 6 mg/dL or ± 10% (greater) | 6.96 |
Urine | Glucose | 12 | ||
Blood | Hematocrit | 8 | 6 | 3.97 |
Blood | Hemoglobin | 5 | 7 | 4.19 |
Blood | Hemoglobin A1c | 12 | 3 | |
Serum | Immunogobulin A (IgA) | 21 | ± 3 SD | 13.5 |
Serum | Immunogloblin G (IgG) | 16 | 25 | 8.0 |
Serum | Immunogloblin M (IgM) | 28 | ± 3 SD | 16.8 |
Serum | Iron | 24 | 20 | 30.7 |
Serum | Lactate dehydrogenase (LDH) | 26 | 20 | 11.4 |
Blood | Leukocytes | 9 | 15 | 15.49 |
Serum | Lithium | 18 | ± 0.3 mmol/L or ± 20% (greater) | |
Serum | Lutropin (LH) | 17 | 27.92 | |
Blood | Mean corpuscular hemoglobin (MCH) | 5 | 2.5 | |
Blood | Mean corpuscular volume (MCV) | 7 | 2.42 | |
Plasma | Partial thromboplastin time (PTTA), ratio | 15 | ||
Plasma | Partial thromboplastin time (PTTA), s | 27 | 15 | |
Serum | Phenobarbital | 15 | 20 | |
Serum | Phenytoin | 13 | 25 | |
Serum | Phosphate | 17 | 10.11 | |
Urine | Phosphate | 16 | 22.1 | |
Blood | Platelets | 16 | 25 | 13.4 |
Serum | Potassium | 8 | ± 0.5 mmol/L | 5.61 |
Urine | Potassium | 12 | 28.4 | |
Serum | Progesterone | 26 | ||
Serum | Prolactin | 22 | 29.4 | |
Serum | Protein | 12 | 10 | 3.63 |
Urine | Protein | 34 | 40.0 | |
Plasma | Prothrombin time (PT % ), % | 29 | 5.3 | |
Plasma | Prothrombin time (PTr), ratio | 17 | ||
Blood | Reticulocytes (%) | 35 | ||
Blood | Reticulocytes (x 109/l) | 39 | 16.8 | |
Serum | Sodium | 5 | ± 4 mmol/L | 0.73 |
Urine | Sodium | 10 | 32.0 | |
Serum | Testosterone | 23 | 13.61 | |
serum | Thriiodothyronine (T3) | 24 | ± 3 SD | 12.94 |
Serum | Thyrotropin (TSH) | 15 | ± 3 SD | 23.7 |
Serum | Total prostatic specific antigen (PSA) | 17 | 33.6 | |
Serum | Throxine, Free (FT4) | 16 | ± 3 SD | 8.0 |
Serum | Total thyroxine (TT4) | 24 | ± 3 SD | 7.0 |
Serum | Triglycerides | 18 | 25 | 25.99 |
Serum | Urate | 17 | 17 | 11.97 |
Urine | Urate | 15 | 19.39 | |
Serum | Urea | 19 | ± 2 mg/dL or ± 9% (greater) | 15.55 |
Urine | Urea | 19 | 22.1 |
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 these new consensus goals, while the differences between the consensus goals and the desirable TEa specifications are frequently quite significant.
Further, there are no differences in the analyte specifications in 2012 and the updates to those same analytes in 2015. So there is a consistent performance in the field.