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Quality Requirements

Rilibak - German Guidelines for Quality

An unofficial English translation of the RiliBÄK (Richtlinien der Bundesärztekammer). The term ‘RiliBÄK’ is an abbreviation meaning literally the Guidelines ("Rili") of the German Federal Medical Council (BÄK).

 

First posted October 2009. Updated 2014, 2015

[2015 PLEASE NOTE: An official English translation version of the Rili-BAEK is now available.]

These guidelines include specifications for Acceptable % Root Mean Standard Deviation (RMSD) and Acceptable relative deviation for interlaboratory tests.

There are two types of target values listed for the interlaboratory test specifications. RMW means that a Reference Method Value was used to set the guideline. SW means that a target value specific for the test method (more like a peer group median) was used to set the guideline.

For more information on the meaning and use of these recommendations, read the accompanying guest essay by Jim Pierson-Perry and Oswald Sonntag.

 

Analytes in Plasma, Serum, and Whole Blood

# Analyte Acceptable
% RMSD		 Validity range of columns 3 and 5 Acceptable relative deviation
in interlab tests		 Type of target value
in interlab tests
lower limit upper limit units
1 Activated partial thromboplastin time (aPTT) 10.5% 20 120 s 18.0% SW
2 Alanine aminotransferase (ALT) 11.5% 30 300 U/L 21.0% RMW
0.33 5.0 ukat/L
3 Albumin 12.5% 20 70 g/L 20.0% SW
4 Alkaline phoshatase (AP) 11.0% 20 600 U/L 18.0% SW
0.33 10 ukat/L
5 alpha-Fetoprotein(AFP) 17.0% 5 250 kIU/L 24.0% SW
6 Aspartate aminotransferase (AST) 11.5% 20 400 U/L 21.0% RMW
0.33 6.67 ukat/L
7 Bilirubin (total) 13.0% >2 30 mg/dL 22.0% SW
>34 513 umol/L
22.0% 0.1 ≤ 2 mg/dL
1.7 ≤ 34 umol/L
8 Ca 15-3 16.0% 10 250 U/ml 24.0% SW
9 Calcium (total) 6.0% 1 6 mmol/L 10.0% RMW
10 Calcium (ionized) 7.5% >1 2.5 mmol/L 15.0% SW
14.5% 0.2 ≤ 1 mmol/L 18.0%
11 Carbamazepin 12.0% 2 20 mg/L 20.0% SW
12 Carcinoembryonic antigen (CEA) 14.0% 1 200 ug/L 24.0% SW
13 Chloride 4.5% 70 150 mmol/L 8.0% RMW
14 Cholesterin (total) 7.0% 50 350 mg/dL 13.0% RMW
1.3 9.1 mmol/L
15 Cortisol 16.0% >60 500 ug/L 30.0% RMW
>166 1380 nmol/L
18.5% 20 ≤60 ug/L
55 ≤ 166 nmol/L
16 Creatine kinase (CK) 11.0% 50 1000 U/L 20.0% RMW
0.83 16.7 ukat/L
17 C-reactive protein (CRP) 13.5% 1 120 mg/L 20.0% RMW
18 Digitoxin 15.5% 5 80 ug/L 30.0% RMW
19 Digoxin 14.0% >1 5 ug/L 30.0% RMW
17.5% 0.5 ≤ 1 ug/L
20 Erythrocytes 4.0% 1.5 7 1012/L 8.0% RMW
21 Estradiol, 17-beta 22.0% 10 500 ng/L 35.0% RMW
37 1835 pmol/L
22 Ethanol (clin. toxicological) 9.0% >0.06 5 g/L 12.0% SW
15.0% 0.2 ≤ 0.6 g/L 21.0%
23 Ferritin 13.5% 10 600 ug/L 25.0% SW
24 FSH 14.0% 4 70 U/L 21.0% SW
25 Gamma-Glutamyl-Transferase (y-GT) 11.5% 20 300 U/L 21.0% RMW
0.33 5 ukat/L
26 Glucose 11.0% 40 400 mg/dL 15.0% RMW
2.2 22 mmol/L
27 Hematocrit 5.0% 10 60 % 9.0% TV
0.1 0.6 L/L
28 Hemoglobin 4.0% 2 20 g/dL 6.0% RMW
1.2 12.4 mmol/L
29 Hemoglobin A1c (HbA1c)
Hemoglobin beta chain (Blood)-N-(1-deoxyfructos-1-yl)
haemoglobin beta chain		 10.0% 30 140 mmol/molHb 18.0% RMV
30 Uric acid 7.0% 2 13 mg/dL 13.0% RMW
119 773 umol/L
31 Urea 10.5% 15 200 mg/dL 20.0% RMV
2.5 33 mmol/L
32 Human chorionic gonadotropin (hCG) 14.0% >100 1500 IU/L 30.0% TV
17.0% 2 ≤ 100 g/L
33 Immunoglobulin A 12.0% 0.5 6 g/L 20.0% SW
34 Immunoglobulin G 10.0% 4 30 g/L 18.0% SW
35 Immunoglobulin M 13.0% 0.4 5 g/L 26.0% SW
36 Potassium 4.5% 2 8 mmol/L 8.0% RMW
37 Creatinine 11.5% 0.5 10 mg/dL 20.0% RMW
44 884 umol/L
38 Lactate 11.0% 9 90 mg/dL 18.0% SW
1 10 mmol/L
39 Lactate dehydrogenase (LDH) 9.0% 100 700 U/L 18.0% RMW
1.67 11.7 ukat/L
40 Leukocytes 6.5% 2 30 109/L 18.0% RMV
41 Lithium 6.0% 0.3 3.5 mmol/L 12.0% RMW
42 Magnesium 7.5% 0.3 3.5 mmol/L 15.0% RMW
43 Sodium 3.0% 110 180 mmol/L 5.0% RMW
44 pCO2 7.5% ≤35   mmHg 12.0% SW
6.5% >35
45 pH 0.4% 6.75 7.80   0.80% RMW
46 Pheonbarbital 10% 8 80 mg/L 20.0% SW
47 Phenytoin 11.0% 3 35 mg/L 20.0% SW
48 Phosphate (anorganic) 9.0% 1 10 mg/dL 16.0% RMW
0.3 3.2 mmol/L
49 pO2 5.5% >125 350 mmHg 12.0% SW
7.0% >80 ≤ 125 mmHg 18.0%
11.0% 40 ≤ 80 mmHg 18.0%
50 Progesterone 17.0% >5.0 35 ug/L 35.0% RMW
> 16 111 nmol/L
22.0% 0.2 ≤ 5.0 ug/L
0.6 ≤ 16 nmol/L
51 Prostate-specific antigen (PSA) 15.5% 0.2 50 ug/L 25.0% SW
52 Protein (Total) 6.0% 35 110 g/L 10.0% RMW
53 Testosterone 20.5% 0.2 20 ug/L 35.0% RMW
0.7 69 nmol/L
54 Theophylline 13.0% 3 40 mg/L 24.0% RMW
55 Thromboplastin time 11.5% 10 120 % 23.0% SW
56 Thrombocytes 7.5% >300 700 109/L 13.0% SW
8.5% >150 ≤ 300 109/L 15.0%
13.5% 40 ≤ 150 109/L 18.0%
57 Thyrotropic hormone (TSH) 13.5% 0.1 40 mU/L 24.0% SW
58 Thyroxine, total 12.5% 0.5 22 ug/L 24.0% RMW
6.4 283 nmol/L
59 Thyroxine, free (FT4) 13.0% >20 85 ng/L 20.0% SW
>26 109 pmol/L
60 Transferrin 8.0% 0.5 6 g/L 12.0% SW
61 Triglycerides 9.0% 60 400 mg/dL 16.0% RMW
0.68 4.6 mmol/L
62 Triiodine thyronine, total (T3) 15.0% >1.2 10 ug/L 24.0% SW
>1.8 15 nmol/L
16.0% 0.2 ≤ 1.2 ug/L
0.3 ≤ 1.8 nmol/L
63 Triidione thyronine, free (T3) 13.0% 1 25 ng/L 20.0% SW
1.5 39 pmol/L
64 Troponin I 20.0% 0.1 35 ug/L 33.0% SW
65 Troponin T 16.0% >1 8 ug/L 33.0% SW
21.0% 0.08 ≤ 1 ug/L
66 Valproic acid 11.5% 20 150 mg/L 20.0% SW
67 Vancomycin 12.0% 4 100 mg/L 18.0% SW

 

Table B 1 b: Analytes in urine

# Analyte Acceptable
% RMSD		 Validity range of columns 3 and 5 Acceptable relative deviation
in interlaboratory tests		 type of target value
in interlaboratory tests
lower limit upper limit units
1 Albumin 15.0% 1 500 mg/L 26.0% SW
2 Calcium 8.5% 0.5 6 mmol/L 17.0% SW
3 Glucose 11.0% 100 4000 mg/L 22.0% RMW
0.6 22 mmol/L
4 Uric acid 13.5% 5 300 mg/L 23.0% RMW
30 1784 umol/L
5 Urea 13.5% 0.1 20 g/L 21.0% RMW
1.7 333 mmol/L
6 Potassium 8.5% 2 140 mmol/L 15.0% RMW
7 Creatinin 12.0% 0.01 3 g/L 21.0% RMW
0.1 27 mmol/L
8 Sodium 6.5% 50 200 mmol/L 12.0% RMW
9 Phosphate (anorganic) 11.5% 30 900 mg/L 20.0% SW
1 29 mmol/L
10 Protein (total) 11.5% 5 10000 mg/L 24.0% SW

 

 

Table B 1 c: Analytes in cerebrospinal fluid

# Analyte Acceptable
% RMSD		 Validity range of columns 3 and 5 Acceptable relative deviation
in interlaboratory tests		 Type of target value
in interlaboratory tests
lower limit upper limit units
1 Albumin 13.5% 20 1000 mg/L 23.0% SW
2 Glucose 9.5% 20 300 mg/dL 18.0% RMW
1.1 17 mmol/L
3 Immunoglobulin A 15.5% 2 40 mg/L 27.0% SW
4 Immunoglobulin G 12.0% 15 500 mg/L 20.0% SW
5 Immunoglobulin M 15.5% 1 30 mg/L 33.0% SW
6 Lactate 11.5% 10 99 mg/dL 20.0% SW
1.1 11 mmol/L
7 Protein (total) 13.5% 10 2000 mg/L 23.0% SW