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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). Updated in 2024.

 Rili-BAEK German Guidelines for Quality

First posted October 2009. Updated in 2014, 2015, 2024.

 

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

The Rili-BAEK were updated on May 30th, 2023. These are the data tables from the authorized English translation released in late 2024.

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. RMV means that a Reference Method Value was used to set the guideline. NV means that a nominal value specific to the measurement method 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.

The main change in the 2024 update is the naming convention of the source of target values. But the specifications for glucose in particular were dramatically reduced. All 2024 changes are highlight in bold.

Analytes in Plasma, Serum, and Whole Blood

# Analyte Acceptable
% RMSD		 Validity range
 Acceptable relative deviation
in interlab tests		 Type of target value
in interlab tests
lower limit upper limit units
1 1,25-OHs-vitamin D 25.0% 10 160 ng/L -- --
2 25-OH-vitamin D 25.0% 5 120 ug/L -- --
3 ACE 23.0% 10 200 U/L -- --
4 Activated partial thromboplastin time (aPTT) 10.5% 20 120 s 18.0% NV
5 Alanine aminotransferase (ALT) 11.5% 30 300 U/L 21.0% RMV
0.5 5.0 ukat/L
6 Albumin 12.5% 20 70 g/L 21.0% NV
7 Aldosterone (only in plasma) 25.0% 5 1,000 pg/mL -- --
8 Alkaline phoshatase (AP) 11.0% 20 600 U/L 18.0% NV
0.33 10 ukat/L
9 alpha-Amylase 7.0% 20 1,000 U/L -- --
0.33 16.7 ukat/L
10 alpha-Fetoprotein(AFP) 17.0% 5 250 kIU/L 24.0% NV
11 ApoA1 10.0% 50 250 mg/dL 15.0% NV
12 ApoB 10.0% 40 200 mg/dL 15.0% NV
13 Aspartate aminotransferase (AST) 11.5% 20 400 U/L 21.0% RMV
0.33 6.67 ukat/L
14 Bilirubin (total) 13.0% >2 30 mg/dL 22.0% NV
>34 513 umol/L
22.0% 0.1 ≤ 2 mg/dL
1.7 ≤ 34 umol/L
15 BNP 15.0% 20 5,000 U/ml 24.0% SW
16 Ca 15-3  16.0%  10 250 U/mL  24.0% NV
17 Ca 19-9 20.0% 5 500 U/mL -- --
18 Ca 125 16.0% 10 1,000 U/mL -- --
19 Calcium (total) 6.0% 1 6 mmol/L 10.0% RMV
20 Calcium (ionized) 7.5% >1 2.5 mmol/L 15.0% NV
14.5% 0.2 ≤ 1 mmol/L 18.0%
21 Carbamazepine 12.0% 2 20 mg/L 20.0% NV
22 Carcinoembryonic antigen (CEA) 14.0% 1 200 ug/L 24.0% NV
23 CDT 25.0% 0.5 10 % -- --
24 Chloride 4.5% 70 150 mmol/L 8.0% RMV
25 Cholesterol, total 7.0% 50 350 mg/dL 13.0% RMV
1.3 9.1 mmol/L
26 Cortisol 16.0% >60 500 ug/L 30.0% RMV
>166 1380 nmol/L
18.5% 20 ≤60 ug/L
55 ≤ 166 nmol/L
27 Creatine kinase (CK) 11.0% 50 1,000 U/L 20.0% RMV
0.83 16.7 ukat/L
28 C-reactive protein (CRP) 13.5% 1 120 mg/L 20.0% NV
29 Cyclosporine A 25.0% 20 1,500 ng/mL -- --
30 Cystatin C 13.0% 0.3 6 mg/L -- --
31 D-Dimer 20.0% 0.1 5 mg/L -- --
32 Digitoxin 15.5% 5 80 ug/L 30.0% RMV
33 Erythrocytes 4.0% 1.5 7 1012/L 8.0% RMV
34 Estradiol, 17-beta 22.0% 10 500 ng/L 35.0% RMV
37 1835 pmol/L
35 Ethanol (clin. toxicological) 9.0% >0.06 5 g/L 12.0% NV
15.0% 0.2 ≤ 0.6 g/L 21.0%
36 Ferritin 13.5% 10 600 ug/L 25.0% NV
37 Fibrinogen 20.0% 0.5 10 g/L -- --
38 Folic acid 25.0% 1 40 ng/mL -- --
39 Free PSA 20.0% <30   ng/mL -- --
40 FSH 14.0% 4 70 U/L 21.0% NV
41 Gamma-Glutamyl-Transferase (y-GT) 11.5% 20 300 U/L 21.0% RMV
0.33 5 ukat/L
42 Gentamicin 25.0% 0.5 15 ug/mL --
43 Glucose 5.0% 40 400 mg/dL 8.0% RMV
2.2 22 mmol/L
44 Hematocrit 5.0% 10 60 % 9.0% NV
0.1 0.6 L/L
45 Hemoglobin 4.0% 2 20 g/dL 6.0% RMV
1.2 12.4 mmol/L
46 Hemoglobin A1c (HbA1c) 5.0%
3.0%		 30 140 mmol/molHb 8.0% RMV
47 Haptoglobin larger 1 g/L 10.0% >1 6 g/L -- --
Haptoglobin smaller 1 g/L 20.0% 0.05 1.0 g/L -- --
48 Uric acid 7.0% 2 13 mg/dL 13.0% RMV
119 773 umol/L
49 Urea 10.5% 15 200 mg/dL 20.0% RMV
2.5 33 mmol/L
50 HDL-C 13.0% 10 120 mg/dL -- --
0.26 3.1 mmol/L
51 Human chorionic gonadotropin (hCG) 14.0% >100 1,500 IU/L 30.0% NV
17.0% 2 ≤ 100 IU/L
52 Immunoglobulin A (IgA) 12.0% 0.5 6 g/L 20.0% NV
53 Immunoglobulin E (IgE, total) 20.0% 0.1 1,000 U/mL -- --
54 Immunoglobulin G (IgG) 10.0% 4 30 g/L 18.0% NV
55 Immunoglobulin M (IgM) 13.0% 0.4 5 g/L 26.0% NV
56 Interluekin 6 (IL-6) 18.0% 3 2,000 pg.mL -- --
57 Potassium 4.5% 2 8 mmol/L 8.0% RMV
58 Creatinine 11.5% 0.5 10 mg/dL 20.0% RMV
44 884 umol/L
59 Lactate 11.0% 9 90 mg/dL 18.0% NV
1 10 mmol/L
60 Lactate dehydrogenase (LDH) 9.0% 100 700 U/L 18.0% RMV
1.67 11.7 ukat/L
61 LDL-C 9.0% 30 300 mg/dL -- --
0.78 7.8 mmol/L
62 Leukocytes 6.5% 2 30 109/L 18.0% RMV
63 LH 15.0% 0.2 150 U/L -- --
64 Lipase 11.0% 20 1,000 U/L -- --
0.33 16.7 ukat/L
65 Lithium 6.0% 0.3 3.5 mmol/L 12.0% RMV
66 Magnesium 7.5% 0.3 3.5 mmol/L 15.0% RMV
67 Methotrexate 25.0% 0.05 10 umol/L -- --
68 Sodium 3.0% 110 180 mmol/L 5.0% RMV
69 NT-proBNP 15.0% 30 10,000 pg/mL -- --
70 pCO2 7.5% ≤35   mmHg 12.0% NV
6.5% >35
71 pH 0.4% 6.75 7.80   0.80% NV
72 Pheonbarbital 10% 8 80 mg/L 20.0% NV
73 Phenytoin 11.0% 3 35 mg/L 20.0% NV
74 Phosphate (anorganic) 9.0% 1 10 mg/dL 16.0% NV
0.3 3.2 mmol/L
75 pO2 5.5% >125 350 mmHg 12.0% NV
7.0% >80 ≤ 125 mmHg 18.0%  
11.0% 40 ≤ 80 mmHg 18.0%  
76 Procalcitonin 18.0% 0.1 60 ng/mL --  
77 Progesterone 17.0% >5.0 35 ug/L 35.0% RMV
> 16 111 nmol/L
22.0% 0.2 ≤ 5.0 ug/L
0.6 ≤ 16 nmol/L
78 Prostate-specific antigen (PSA) 15.5% 0.2 50 ug/L 25.0% NV
79 Protein (Total) 6.0% 35 110 g/L 10.0% RMV
80 Prothrombin time 11.5% 10 120 % 23.0% NV
81 Renin 25.0% 1 300 ng/L -- --
82 Reticulocytes automated measurement 25.0% 20 400 Cells/nL -- --
83 Tacrolimus 25.0% 1 50 ng/mL -- --
84 Testosterone 20.5% 0.2 20 ug/L 35.0% RMV
0.7 69 nmol/L
85 Theophylline 13.0% 3 40 mg/L 24.0% RMV
86 Thrombocytes 7.5% >300 700 109/L 13.0% NV
8.5% >150 <300 109/L 15.0%
13.5% 40 <150 109/L 18.0%
87 Thyreotropic hormone (TSH) 13.5% 0.1 40 mU/L 24.0% NV
88 Thyroxine, free (FT4) 13.0% >20 85 ng/L 20.0% NV
>26 109 pmol/L
89 Transferrin 8.0% 0.5 6 g/L 12.0% NV
90 Triglycerides 9.0% 60 400 mg/dL 16.0% RMV
0.68 4.6 mmol/L
91 Triidione thyronine, free (T3) 13.0% 1 25 ng/L 20.0% NV
1.5 39 pmol/L
92 Troponin cardiac 20.0% 10 3,000 ng/L 33.0% NV
93 Valproic acid 11.5% 20 150 mg/L 20.0% NV
94 Vancomycin 12.0% 4 100 mg/L 18.0% NV
95 Vitamin B12 25.0% 50 1,500 pg/mL -- --

 

Table B 1 b: Analytes in urine

# Analyte Acceptable
% RMSD		 Validity range
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% NV
2 Calcium 8.5% 0.5 6 mmol/L 17.0% NV
3 Glucose 5.0% 100 4000 mg/L 8.0% RMV
0.6 22 mmol/L
4 Uric acid 13.5% 5 300 mg/L 23.0% RMV
30 1784 umol/L
5 Urea 13.5% 0.1 20 g/L 21.0% RMV
1.7 333 mmol/L
6 Potassium 8.5% 2 140 mmol/L 15.0% RMV
7 Creatinine 12.0% 0.01 3 g/L 21.0% RMV
0.1 27 mmol/L
8 Sodium 6.5% 50 200 mmol/L 12.0% RMV
9 Phosphate (anorganic) 11.5% 30 900 mg/L 20.0% NV
1 29 mmol/L
10 Protein (total) 11.5% 5 10,000 mg/L 24.0% NV

 

 

Table B 1 c: Analytes in cerebrospinal fluid

# Analyte Acceptable
% RMSD		 Validity range
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% NV
2 Glucose 5.0% 20 300 mg/dL 8.0% RMV
1.1 17 mmol/L
3 Immunoglobulin A 15.5% 2 40 mg/L 27.0% NV
4 Immunoglobulin G 12.0% 15 500 mg/L 20.0% NV
5 Immunoglobulin M 15.5% 1 30 mg/L 33.0% NV
6 Lactate 11.5% 10 99 mg/dL 20.0% NV
1.1 11 mmol/L
7 Protein (total) 13.5% 10 2000 mg/L 23.0% NV

 

Table B 1-2 d: Measurands in dried blood

# Analyte Acceptable
% RMSD		 Validity range
Acceptable relative deviation
in interlaboratory tests		 Type of target value
in interlaboratory tests
lower limit upper limit units
1 17-OH-progesterone 20% 15 120 nmol/L 30% NV
2 IRT 20% 30 180 ug/L 30% NV
3 PAP 20% 1 6.3 ug/L 30% NV
4 TSH 20% 8 60 mU/L 30% NV