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Consolidated Comparison of Immunoassay Performance Specifications

A current comparison of Global Performance Specifications for Immunoassay Assays.

Consolidated Comparison of Immunoassay Performance Specifications

October 6, 2021
Sten Westgard, MS

Extending our consolidation and comparison of performance specifications, started in chemistry, into immunoassays, as well as endocrinology and cancer markers and drugs of abuse. Traditionally, immunoassays have been given fewer goals, and those that are given are generally more permissive. The CLIA targets and other EQA/PT goals are often in sharp contrast to EFLM biological database goals, showing either a gap in the capability of instrumentation, or possibly a lack of will in regulation.

 Routine Immunoassay Performance Specifications (allowable total analytical error, TEa)
Test or Analyte Recommended Choice CLIA CLIA "2019"

 

2014 Desirable
"Ricos goals"

EFLM/
Desirable
EuBIVAS

Rilibak RCPA ALP  

 

2015
"Spanish Min."
Alpha-Fetoprotein (AFP) ± 21.9%    ± 15%   ± 21.9  ± 34.8%   ± 5 kIU/L or 20%      ± 20
 Human Chorionic Gonadotropin (BhCG) ± 18%  or positive/negative    ± 18%  or positive/negative                
 CA 125 ± 35.4%     ± 20%    ± 35.4%  ± 16.1%    ± 6 kU/L or 12%      
 CA 15-3 ± 20.8%         ± 20.8%       ± 6 kU/L or 12%      
 CA 19-9  ± 46.0%          ± 46.0%   ± 37.9%    ± 6 kU/L or 15%      
 Carbamazepine ± 25.0%  ± 25.0%   ± 20.0%         ± 0.5 mg/L or 10%      
 Carcinogenic Embryonic Antigen (CEA) ± 24.7%     ± 15.0%    ± 24.7%  ± 26.9%    ± 0.6 ug/L or 12%      ± 16.0%
 CK-MB ± 25.0%  ± 25.0%   ± 25.0%    ± 16.5%      ± 3.0 U/L or 20%      
 Cortisol ± 22.8%  ± 25.0%   ± 20.0%    ± 22.8%     ± 15 nmol/L or 15%      ± 28.0%
 C-peptide ± 20.8%         ± 20.8%      ± 0.15 nmol/L or 12%      
 Digoxin ± 20%  ± 0.2 ng/mL or 20%   ± 20%          ± 0.2 ug/L or 10%      ± 20%
 Estradiol ± 26.86%    ± 30%     ± 26.86%  ± 17.3%   ± 25 pmol/L or 25%      ± 26%
 Ferritin ± 16.9%     ± 20%    ± 16.9%   ± 13.8%    ± 4.0 ug/L or 15%      ± 21%
 Folate ± 39%     ± 1 ng/mL or 30%    ± 39%      ± 1.5 nmol/L or 25%      
 Follicle Stimulating Hormone (FSH) ± 21.2%     ± 2 IU/L or 18%    ± 21.2%  ± 21.2%     ± 1.0 IU/L or 10%      ± 14%
 Gentamicin ± 25%  ± 25%   ± 25%         ± 0.2 mg/L or 10%      
 Homocysteine ± 15.4%         ± 15.4%     ± 1.5 umol/L or 10%      
 IgE ± 20%    ± 20%                
 Insulin ± 32.9%         ± 32.9%  ± 35.9%    ± 0.6 mU/L or 12%      
 Luteinizing Hormone (LH) ± 27.92%    ± 20%     ± 27.92%  ± 28.4%   ± 1.5 IU/L or 15%      
 Parathyroid Hormone (PTH I-84) ± 30.2%    ± 30%     ± 30.2%  ± 20%   ± 1.0 pmol/L or 12%      
 Phenobarbital ± 20%  ± 20%  ± 15%          ± 0.7 mg/L or 10%       ± 15%
 Phenytoin ± 25% ± 25%  ± 2 mcg/dL or 15%           ± 0.8 mg/L or 10%      ± 13%
 Progesterone ± 25%  ± 25%            ± 2 nmol/L or 15%      ± 26%
 Prolactin ± 20%  ± 20%      ± 29.4%   ± 37.4%   ± 40 mIU/L or 10%       ± 22%
 Prostate Specific Antigen (PSA) ± 33.6%   ± 0.2 ng/dL or 20%     ± 33.6%  ± 16.2%    ± 0.4 ug/L or 8%      ± 17%
 Sex Hormone Binding Globulin (SHBG) ± 20.4%        ± 20.4%  ± 17.2%    ± 6 nmol/L or 12%      
 Testosterone ± 23%   ± 20 ng/dL or 30%     ± 13.6%  ± 16.5%   ± 0.4 nmol/L or 15%      ± 23%
 Theophylline  ± 25% ± 25%   ± 20%         ± 0.5 mg/L or 10%      
Thyroid Stimulating Hormone (TSH) ± 23.7%   ± 2 mIU/L or 20%   ± 23.7% ± 27.7%   ± 0.1 mU/L or 20%     ± 15%
Thyroxine, Free (FT4) ± 8.74%             ± 1.5 pmol/L or 12%      
Thyroxine, Total (TT4) ± 24% ± 1.0 mcg/dL or 20% ± 1.0 mcg/dL or 20%   ± 7% ± 8.7%   ± 12 nmol/L or 10%     ± 24%
Triiodothyronine, Free (FT3) ± 11.3%       ± 11.3% ± 9.3%   ± 12 nmol/L or 10%      
Triiodothyronine, Total (TT3) ± 11.6%       ± 9.22% ± 11.6%   ± 0.7 pmol/L or 20%      
 Troponin I ± 27.9%    ± 0.2 ng/mL or 30%    ± 27.9%      ± 20%      
 Valproic Acid ± 25%  ± 25%  ± 25%          ± 4.0 mg/L or 10%      
 Vancomycin ± 2.0 mcg/dL or 20%     ± 2.0 mcg/dL or 20%          ± 0.2 mg/L or 10%      
 Vitamin B12 ± 30%  ± 30%   ± 25%    ± 30%     ± 18 pmol/L or 15%      
 25-OH Vitamin D ± 20.5%           ± 20.5%    ± 5 ng/mL or 25%      

This is not an exhaustive list of goals. Indeed, RCPA goals and other popular goals are available on other pages on the website here. But this gives an idea of the global range of goals.

Here are the references for the EuBIVAS studies:

a. Biological Variation Estimates Obtained from 91 Healthy Study Participants for 9 Enzymes in Serum, Carobene A, Roraas T, Solvik UO, et al, Clin Chem 63:6. 2018.

b. EuBIVAS: Within- and Between-Subject Biological Variation Data for Electrolytes, Lipids, Urea, Uric Acid, Total Protein, Total Bilirubin, Direct Bilirubin, and Glucose, Aarsand AK, Diaz-Garzon J, Fernandez-CAlle P et al, Clin Chem 64:9 2017

c. The EuBIVAS Project: Within- and Between-Subject Biological Variation Data for Serum Creatinine Using Enzymatic and Alkaline Picrate Methods and Implications for Monitoring, Carobene A, Marino I, Coskun A et al, Clin Chem 63:9. 2017 Estimates from Enzymatic methods used.

d. Biological variation data for lipid cardiovascular risk assessment biomarkers. A systematic review applying the biological variation data critical appraisal checklist (BIVAC), Diaz-Garzon J, Fernandez-CAlle P, Minchinel J et al Clin Chim Acta 495 (August 2019) 467-475.

e. Systematic review of the biological variation data for diabetes related analytes, Gonzalez-Lao E, Corte Z, Simon M et al, Clin Chim Acta 488 (January 2019) 61-67.

f. EFLM database, originally accessed 1/13/2020. most recently updated with SIMED assistance 4/12/21 https://biologicalvariation.eu/meta_calculations

[Thanks to Randox RIQAS for sharing their State of the Art (SOTA) goals from their monthly EQA program]

[Special thanks to Vladimir Procenko, for an informal English translation of the Russia GOST goals, of which Annex A is listed here, which represents the maximum allowable analytical error for a single measurement.]

 

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