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Minimum Specifications from Biological Variation database PDF Print

When the best isn't possible, How low can you go? The Biologic Variation database, compiled by the Spanish CC society and Dr. Carmen Ricos, not only includes desirable and optimal specifications for imprecision, bias and total error, but also minimum specifications. For labs unable to achieve the recommended level of quality, here at least is the floor on performance.

Minimum Specifications for Total Error, Imprecision, and Bias, derived from intra- and inter-individual biologic variation

This most recent and extensive listing of biologic goals has been provided by Ricos C, Alvarez V, Cava F, Garcia-Lario JV, Hernandez A, Jimenez CV, Minchinela J, Perich C, Simon M. "Current databases on biologic variation: pros, cons and progress." Scand J Clin Lab Invest 1999;59:491-500. This database was most recently updated in 2012: see what was updated here.

See The Reference List
See The References
See The original Guest Essay

Note on abbreviations:
CVw = within-subject biologic variation
CVg = between-subject biologic variation
I = minimum specification for imprecision
B = minimum specification for inaccuracy
TE = minimum specification for allowable total error

    Analyte   Biologic Variation   Minimum Specification  
CVI CVG CV(%) Bias (%) TEa
 S- α1-Antitrypsin 5.9 16.3 4.4 6.5 13.8
P- α2-Antiplasmin 6.2 --- 4.7 --- ---
S- α2-Macroglobulin 3.4 18.7 2.6 7.1 11.3
S- α-Amylase 8.7 28.3 6.5 11.1 21.9
S- α-Tocopherol 13.8 15.0 10.4 7.6 24.7
S- Acid phosphatase tartrate-resistant 8.0 13.3 6.0 5.8 15.7
P- Activate partial thromboplastin, time (APTT) 2.7 8.6 2.0 3.4 6.7
S- Alanine aminopeptidase 4.1 --- 3.1 --- ---
S- Albumin 3.1 4.2 2.3 2.0 5.8
S- Albumin, glycated 5.2 10.3 3.9 4.3 10.8
S- Alkaline phosphatase, bone isoenzyme 6.2 37.4 4.7 14.2 21.9
S- Amyloid A 25.0 61.0 18.8 24.7 55.7
P- Antithrombin III 5.2 15.3 3.9 6.1 12.5
S- Apolipoprotein B 6.9 22.8 5.2 8.9 17.5
S- Apolipoprotein A1 6.5 13.4 4.9 5.6 13.6
S- β2-Microglobulin 5.9 15.5 4.4 6.2 13.5
P- C Protein 5.8 55.2 4.4 20.8 28.0
S- CA 15.3 Antigen 6.1 62.9 4.6 23.7 31.2
S- Calcium 1.9 2.8 1.4 1.3 3.6
S- Calcium, ionized 1.7 1.9 1.3 1.0 3.1
S- Carbohydrate deficient transferrin 7.1 38.7 5.3 14.8 23.5
(B)Gas Carbon dioxide 4.8 5.3 3.6 2.7 8.6
S- Carnitine, free 7.6 15.2 5.7 6.4 15.8
S- Ceruloplasmin (Ferroxidase) 5.8 11.1 4.4 4.7 11.9
S- Chloride 1.2 1.5 0.9 0.7 2.2
S- Cholinesterase, activity 6.1 18.2 4.6 7.2 14.7
S- Cholinesterase, concentration 7.1 --- 5.3 --- ---
S- Collagen type I C propeptide (PICP) 7.8 26.7 5.9 --- ---
S- Collagen type IIII N propeptide (PIIINP) 13.6 87.2 10.2 33.1 49.9
S- Complement C3 5.2 15.6 3.9 6.2 12.6
S- Creatinine 6.0 14.7 4.5 6.0 13.4
P- Cysteine 5.9 12.3 4.4 5.1 12.4
S- Dehydroepiandrosterone sulfate (DHEA) 5.6 25.9 4.2 9.9

16.9

 

    Analyte   Biologic Variation   Minimum Specification  
CVI CVG CV(%) Bias (%) TEa
B- Erythrocytes, count 3.2 6.1 2.4 2.6 6.5
P- Factor V coagulation 3.6 --- 2.7 --- ---
P- Factor VII coagulation 6.8 19.4 5.1 7.7 16.1
P- Factor VIII coagulation 4.8 19.1 3.6 7.4 13.3
P- Factor X coagulation 5.9 --- 4.4 --- ---
S- Fructosamine 3.4 5.9 2.6 2.6 6.8
S- Globulins, total 5.5 12.9 4.1 5.3 12.1
B- Glutathione Peroxidase 7.2 21.7 5.4 8.6 17.5
S- HDL Cholesterol 7.1 19.7 5.3 7.9 16.6
S- HDL1 Cholesterol 5.5 27.2 4.1 10.4 17.2
S- HDL3 Cholesterol 7.0 14.3 5.3 6.0 14.6
B- Hematocrit 2.8 6.4 2.1 2.6 6.1
B- Hemoglobin 2.8 6.6 2.1 2.7 6.2
B- Hemoglobin A1C 1.9 5.7 1.4 2.3 4.6
P- Homocysteine 9.0 40.3 6.8 15.5 26.6
S- HDL1 Cholesterol 5.5 27.2 4.1 10.4 17.2
S- HDL3 Cholesterol 7.0 14.3 5.3 6.0 14.6
B- Hematocrit 2.8 6.4 2.1 2.6 6.1
B- Hemoglobin 2.8 6.6 2.1 2.7 6.2
B- Hemoglobin A1C 1.9 5.7 1.4 2.3 4.6
P- Homocysteine 9.0 40.3 6.8 15.5 26.6
S- Immunoglobulin A 5.4 35.9 4.1 13.6 20.3
S- Immunoglobulin G 4.5 16.5 3.4 6.4 12.0
S- Immunoglobulin M 5.9 47.3 4.4 17.9 25.2
S- Immunoglobulins, k chain 4.8 15.3 3.6 6.0 12.0
S- Immunoglobulins, l chain 4.8 18.0 3.6 7.0 12.9
S- Lactate dehydrogenase, isoenzyme 1 2.3 8.3 1.7 3.2 6.1
S- Lactate dehydrogenase, isoenzyme 2 3.3 2.4 2.5 1.5 5.6
S- Lactate dehydrogenase, isoenzyme 3 2.8 3.8 2.1 1.8 5.2
S- Lactate dehydrogenase, isoenzyme 4 5.9 5.3 4.4 3.0 10.3
S- Lactate dehydrogenase, isoenzyme 5 8.0 9.6 6.0 4.7 14.6
B- Lymphocytes, CD4 25.0 --- 18.8 --- ---

 

    Analyte   Biologic Variation   Minimum Specification  
CVI CVG CV(%) Bias (%) TEa
(B)Eryth- Magnesium 5.6 11.3 4.2 4.7 11.7
S- Magnesium 3.6 6.4 2.7 2.8 7.2
(B)Eryth- Mean corpuscular hemoglobin 1.6 5.2 1.2 2.0 4.0
(B)Eryth- Mean corpuscular hemoglobin concentration 1.7 2.8 1.3 1.2 3.3
(B)Eryth- Mean corpuscular volume 1.3 4.8 1.0 1.9 3.5
(B)Plat- Mean platelet volume 4.3 8.1 3.2 3.4 8.8
S- Osmolality 1.3 1.2 1.0 0.7 2.3
S- Osteocalcin 6.3 23.1 4.7 9.0 16.8
B- pH 3.5 2.0 2.6 1.5 5.8
P- Plasminogen 7.7 --- 5.8 --- ---
B- Platelet distribution wide 2.8 --- 2.1 --- ---
S- Potassium 4.8 5.6 3.6 2.8 8.7
S- Prolactin 23.0 35.0 17.3 15.7 44.2
S- Protein 2.7 4.0 2.0 1.8 5.2
S- Protein, glycated 0.9 11.6 0.7 4.4 5.5
P- Prothrombin, Time 4.0 6.8 3.0 3.0 7.9
Patient- Reabsorption tubular phosphate 2.7 3.3 2.0 1.6 4.9
B- Red cell distribution wide 3.5 5.7 2.6 2.5 6.8
P- S Protein 5.8 63.4 4.4 23.9 31.1
(B)Eryth- Sodium 1.8 12.4 1.4 4.7 6.9
S- Sodium 0.7 1.0 0.5 0.5 1.3
S- Testosterone 9.3 19.7 7.0 8.2 19.7
S- Thyroxine (T4) 4.9 10.6 3.7 4.4 10.4
S- Thyroxine Binding Globulin (TBG) 0.09 0.06 0.1 0.0 0.2
S- Thyroxine, free (FT4) 5.7 12.1 4.3 5.0 12.1
S- Transferrin 3.0 4.3 2.3 2.0 5.7
S- Triiodothyronine, free (FT3) 7.9 17.6 5.9 7.2 17.0
S- Triiodothyronine, uptake 0.05 --- 0.04 --- ---
S- Vascular cell adhesion molecule-1 (VCAM-1) 5.2 16.0 3.9 6.3 12.7
P- Vascular endotelial growth factor 14.1 18.1 10.6 8.6 26.1
P- Von Willebrand factor 2.5 27.3 1.9 10.3 13.4
S- Water 3.1 0.1 2.3 1.2 5.0

 

 

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