Quality Requirements
Optimal Biological Variation database specifications
How good can you get? The Biologic Variation database, compiled by the Spanish CC society and Dr. Carmen Ricos, not only includes desriable specifications for imprecision, bias and total error, but also optimal specifications. For labs in search of "stretch" goals, here's the place to start. Updated for 2014.
[Please note: in October 2018, the EFLM and SEQC requested that Westgard.com no longer display this data.]
Optimal 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 2014: see what was updated here.
IMPORTANT UPDATE: "[T]he BV data on your website is provided by the Analytical Quality Commission of the SEQC....
"The Analytical Quality Commission and ourselves have discussed this and agree that the EFLM database probably will provide estimates of Total allowable error. Furthermore, once the EFLM database is available, the BV database provided by the SEQC should be removed from both your website and the SEQC website. We would therefore not agree to new data being added to the 2014 BV database update. The aim is for the EFLM website to be available within 4-6 months and we will contact you once it has been published. Thank you for your understanding.
Kind regards,
Aasne Krine Aarsand, Sverre Sandberg, Pilar Fernandez Calle, Carmen Perich & Carmen Ricos
On behalf of the Working Group on Biological Variation, EFLM and the Analytical Quality Commission, SEQC, April 26, 2018"
See The References
See The original Guest Essay
Note on abbreviations:
CVI = 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 | Optimal Specification | ||||
| CVI | CVG | CV(%) | Bias (%) | TEa | ||
| S- | α-Amylase | 8.7 | 28.3 | 2.2 | 3.7 | 7.3 |
| U- | α-Amylase | 94.0 | 46.0 | 23.5 | 13.1 | 51.9 |
| U- | α-Amylase pancreatic | 69.5 | 105.0 | 17.4 | 15.7 | 44.4 |
| S- | α1-Acid Glycoprotein | 11.3 | 24.9 | 2.8 | 3.4 | 8.1 |
| S- | α-Fetoprotein | 12.2 | 45.6 | 3.1 | 5.9 | 10.9 |
| S- | Alanine aminotransferase (ALT) | 19.4 | 41.6 | 4.9 | 5.7 | 13.7 |
| S- | Aspartate aminotransferase(AST) | 12.3 | 23.1 | 3.1 | 3.3 | 8.3 |
| U- | Albumin | 35.0 | 35.0 | 9.9 | 7.0 | 23.3 |
| U- | Aldosterone | 32.6 | 39.0 | 8.2 | 6.4 | 19.8 |
| S- | Bilirubin | 21.8 | 28.4 | 5.5 | 4.5 | 13.5 |
| S- | Bilirubin, conjugated | 36.8 | 43.2 | 9.2 | 7.1 | 22.3 |
| S- | C4 Complement | 8.9 | 33.4 | 2.2 | 4.3 | 8.0 |
| S- | CA 125 Antigen | 24.7 | 54.6 | 6.2 | 7.5 | 17.7 |
| S- | CA 15.3 Antigen | 6.1 | 62.9 | 1.5 | 7.9 | 10.4 |
| S- | CA 19.9 Antigen | 15.95 | 130.5 | 4.0 | 16.4 | 23.0 |
| U- | Calcium, output | 26.2 | 27.0 | 6.6 | 4.7 | 15.5 |
| S- | Carcinoembryonic Antigen (CEA) | 12.7 | 55.6 | 3.2 | 7.1 | 12.4 |
| S- | Cholesterol | 5.95 | 15.3 | 1.5 | 2.1 | 4.5 |
| S- | Cortisol | 15.2 | 38.1 | 3.8 | 5.1 | 11.4 |
| S- | C peptide | 16.6 | 23.2 | 4.2 | 3.6 | 10.4 |
| S- | C reactive protein | 42.2 | 76.3 | 10.6 | 10.9 | 28.3 |
| S- | Creatine kinase | 22.8 | 40.0 | 5.7 | 5.8 | 15.2 |
| S- | Creatinine kinase MB, % | 6.9 | 42.8 | 1.7 | 5.4 | 8.3 |
| S- | Creatinine kinase MB, mass | 18.4 | 56.6 | 4.6 | 7.4 | 15.0 |
| S- | Creatinine | 11.0 | 23.0 | 2.8 | 3.2 | 7.7 |
| S- | Cyfra 21.1 Antigen | 22.2 | 31.1 | 5.6 | 4.8 | 13.9 |
| S- | Estradiol | 22.5 | 24.4 | 5.6 | 4.1 | 13.4 |
| S- | Ferritin | 14.2 | 15.0 | 3.6 | 2.6 | 8.4 |
| S- | Folate | 24.0 | 73.0 | 6.0 | 9.6 | 19.5 |
| S- | Follicle Stimulating Hormone (FSH) | 11.0 | 47.2 | 2.8 | 6.1 | 10.6 |
| S- | γ-Glutamyltransferase | 13.4 | 42.15 | 3.4 | 5.5 | 11.1 |
| S- | Haptoglobin | 20.4 | 36.4 | 5.1 | 5.2 | 13.6 |
| S- | Immunoglobulin A | 5.4 | 35.9 | 1.4 | 4.5 | 6.8 |
| S- | Immunoglobulin M | 5.9 | 47.3 | 1.5 | 6.0 | 8.4 |
| S- | Iron | 26.5 | 23.2 | 6.6 | 4.4 | 15.3 |
| B- | Lactate | 27.2 | 16.7 | 6.8 | 4.0 | 15.2 |
| S- | Lactate dehydrogenase | 8.6 | 14.7 | 2.2 | 2.1 | 5.7 |
| S- | Luteinizing Hormone (LH) | 23.0 | 27.4 | 5.8 | 4.5 | 14.0 |
| S- | Myoglobulin | 17.6 | 46.3 | 4.4 | 6.2 | 13.5 |
| U- | Osmalality | 28.3 | 57.9 | 7.1 | 8.1 | 19.7 |
| B- | pH | 3.5 | 2.0 | 0.9 | 0.5 | 1.9 |
| S- | Parathyroid hormone (PTH) | 25.9 | 23.8 | 6.5 | 4.4 | 15.1 |
| S- | Phosphate | 8.15 | 10.8 | 2.0 | 1.7 | 5.1 |
| U- | Phosphate, output | 18.0 | 22.6 | 4.5 | 3.6 | 11.0 |
| U- | Potassium, output | 24.4 | 22.2 | 6.1 | 4.1 | 14.2 |
| S- | Prolactin | 23.0 | 34.95 | 5.8 | 5.2 | 14.7 |
| S- | Prostatic specific antigen (PSA) | 18.1 | 72.4 | 4.5 | 9.3 | 16.8 |
| U- | Protein, output | 35.5 | 23.7 | 8.9 | 5.3 | 20.0 |
| U- | Sodium, output | 28.7 | 16.7 | 7.2 | 4.2 | 16.0 |
| S- | Triglyceride | 19.9 | 32.7 | 5.0 | 4.8 | 13.0 |
| S- | Thyroid Stimulating Hormone (TSH) | 19.3 | 24.6 | 4.8 | 3.9 | 11.9 |
| S- | Thyroglobulin | 14.0 | 39.0 | 3.5 | 5.2 | 11.0 |
| S- | Urate | 8.6 | 17.5 | 2.2 | 2.4 | 6.0 |
| U- | Urate | 16.8 | 14.4 | 4.2 | 2.8 | 9.7 |
| S- | Urea | 12.1 | 18.7 | 3.0 | 2.8 | 7.8 |
| U- | Urea | 17.4 | 25.4 | 4.4 | 3.8 | 11.0 |