Siemens Healthcare Diagnostics Inc.
BN ProSpec System Update Instruction Manual - Version 1.1.3
Instruction Manual
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BN ProSpec® System
Instruction Manual – Instructions for Use –
Please exchange the following sections of your Instruction Manual: – Title page – Chapter 15.8 (pages 15-55 to 15-66)
Manual Version: 1.1.3 Date of Issue: October 2003 We reserve the right to make changes in the course of technical development without previous notice.
Copyright © 2003, Dade Behring Marburg GmbH. All rights reserved. P.O. Box 1149 D-35001 Marburg Neither this manual nor any parts of it may be duplicated or transmitted in any way without the written approval of Dade Behring Marburg GmbH.
Manual, Order No.: 1 000 574.1003
BN ProSpec® System
Instruction Manual – Instructions for Use –
Manual Version: 1.1.3 Date of Issue: October 2003 We reserve the right to make changes in the course of technical development without previous notice.
Copyright © 2003, Dade Behring Marburg GmbH. All rights reserved. P.O. Box 1149 D-35001 Marburg Neither this manual nor any parts of it may be duplicated or transmitted in any way without the written approval of Dade Behring Marburg GmbH.
Manual, Order No.: 1 000 574.1003
Updating Version
Trademarks
Date
Changes
Manual
Software
1.0
1.0
05/00
Launch version
1.0
1.0
08/00
Launch version (incl. US)
1.0
1.0.2
09/00
Update
1.1
1.1
04/01
Update
1.1
1.1
08/01
Update US
1.1.1
1.1
04/02
Update
1.1.2
1.1
09/03
Update version IvDD
1.1.3
1.1.2
10/03
Update
BN ProSpec is a registered trademark of Dade Behring Marburg GmbH in the USA, Germany and other countries. The BN ProSpec® System in the following will be called BN ProSpec®. Dimension is a registered trademark of Dade Behring Inc. MS-DOS and Windows are registered trademarks of Microsoft Corporation.
Software Copyrights
Software of the Dade Behring Marburg GmbH is the copyright property of Dade Behring Marburg GmbH. All rights to this software are retained by Dade Behring Marburg GmbH. You are entitled to use this software as well as the documentation relating to it on one single, non-transferable workstation.
Disclaimer
Dade Behring has validated the provided instructions, reagents, instrument, software and customizable features for this system to optimize product performance and meet product specifications. User defined modifications are not supported by Dade Behring as they may affect performance of the system and test results. It is the responsibility of the user to validate any modifications made to these instructions, instruments, reagents or software provided by Dade Behring.
Dade Behring Marburg GmbH P.O. Box 1149 D-35001 Marburg Germany
15 Appendix
15.8 Assay Protocols A table of assay data is given on the following pages. Please see the package inserts of the reagents for features.
15
BN ProSpec® System – Instruction Manual – Version 1.1.3
15
55
15 Appendix
15
15
56
BN ProSpec® System – Instruction Manual – Version 1.1.3
BN ProSpec® System – Instruction Manual – Version 1.1.3
IgG2
IgG3
IgG3n
IgG4
IgG4n
IgA
IgAs
IgM
IgMs
C3
C4
TRF
ALB
AAT
a2M
HPT
AAG
PRE
sTfR
52
64
78
65
79
2
22
3
23
4
5
6
7
8
9
10
11
12
13
15
15
CER
HPX
IgG1
51
14
IgG
7)
7)
7)
Abbreviation
1
Dade Behring Assay No.
Serum Plasma 8)
Serum
IgG Subclass 4
IgA
Serum
Serum
Serum
Serum
Serum
Serum
Serum
Serum 0.14 - 4.4 Plasma 11)
Serum
Serum
Transferrin
Albumin
α1-Antitrypsin
α2-Macroglobulin
Haptoglobin
α1-Acid Glycoprotein
Prealbumin
soluble Transferrin Receptor
Hemopexin
Ceruloplasmin
0.07 - 2.2
0.2 - 6.4
0.02 - 0.6
0.19 - 6.0
0.26 - 8.3
0.2 - 6.4
0.16 - 5.2
6.9 - 110
0.35 - 5.6
0.06 - 1.9
Serum
C4
0.12 - 4.1
0.05 - 1.6
0.2 - 6.4
0.06 - 2.0
0.25 - 8.0
Serum
Serum
Serum
0.03 - 0.8
0.09 - 2.8
0.02 - 0.55
0.05 - 1.6
0.14 - 4.4
0.02 - 0.6
0.05 - 1.5
0.07 - 2.1
0.05 - 1.6
0.04 - 1.3
0.35 - 5.5
0.09 - 1.4
0.02 - 0.48
0.03 - 1.0
0.05 - 1.6
0.2 - 6.4
0.06 - 2.0
0.25 - 8.0
0.02 - 0.65
0.033 - 2.1 0.0017-0.11
0.1 - 3.1
0.35 - 11
C3c
IgM
IgM
9)
Serum
IgG Subclass 4
Serum
Serum Plasma 8)
IgG Subclass 3
9)
0.052 - 3.3 0.0026-0.17
Serum
IgG Subclass 3
IgA
0.08 - 2.6
Serum
0.04 - 1.4
IgG Subclass 2
0.85 - 27
Serum
0.07 - 2.3
IgG Subclass 1
1.4 - 46
Initial Minimum Measuring Measuring 1) Range Range 1)
Serum
Sample Type
IgG
Protein
0.2 - 0.6
0.5 - 1.15
0.76 - 1.76
0.2 - 0.4
0.5 - 1.2
0.3 - 2
1.3 - 3
0.9 - 2
35 - 52
2 - 3.6
0.1 - 0.4
0.9 - 1.8
0.4 - 2.3
0.7 - 4
0.03 - 2.0
0.08 - 1.4
0.11 - 0.85
0.2 - 1.1
1.5 - 6.4
4.9 - 11.4
7 - 16
12)
g/L
10)
6 weeks 6 weeks 6 weeks 6 weeks 6 weeks 6 weeks
5 2 5 2 5 2 5 2 5 2 5 2 5 2 5 2 5 2 2
N Antiserum to Human C4 N Antiserum to Human Transferrin N Antiserum to Human Albumin N Antiserum to Human α1-Antitrypsin N Antiserum to Human α2-Macroglobulin N Antiserum to Human Haptoglobin N Antiserum to Human α1-acid Glycoprotein N Antiserum to Human Prealbumin
g/L
g/L
7)
6 weeks 6 weeks
5 2
N Antiserum to Human C3c
N Antiserum to Human IgM
N Antiserum to Human IgM
N Antiserum to Human Ceruloplasmin
N Antiserum to Human Hemopexin
2
2
2
6 weeks 6 weeks
5 2
N Antiserum to Human IgA
4 weeks
6 weeks
4 weeks
2 weeks
6 weeks 6 weeks
6 weeks 4 weeks
6 weeks 6 weeks
6 weeks 6 weeks
6 weeks 4 weeks
6 weeks 6 weeks
6 weeks 6 weeks
N Antiserum to Human IgA
5 2
5 days
4 weeks
2 weeks
2 weeks
4 weeks
1.5
2.0
1.5
1.5
2 weeks
4 weeks 2 weeks
5 2 1.5
On-board Reagent Stability 3)
Vol. (mL)
2.0
N Latex IgG4
N AS to IgG4
N Latex IgG3
N AS to IgG3
N AS to IgG2
N AS to IgG1
N Antiserum to Human IgG
Reagent
mg/L N sTfR Reagent
g/L
g/L
g/L
g/L
g/L
g/L
g/L
g/L
g/L
g/L
5)
5)
g/L
g/L
5)
5)
g/L
6)
g/L
g/L
5)
5)
g/L
5)
g/L
g/L
5)
6)
g/L
Unit
5)
Reference Range 2)
N/T Protein Controls SL/L, M, H
N/T Protein Controls SL/L, M, H
N/T Protein Controls SL/L, M, H
N/T Protein Controls SL/L, M, H
N/T Protein Controls SL/L, M, H
N/T Protein Controls SL/L, M, H
N/T Protein Controls SL/L, M, H
N/T Protein Controls SL/L, M, H
N/T Protein Controls SL/L, M, H
N/T Protein Controls SL/L, M, H
N/T Protein Controls SL/L, M, H
N/T Protein Controls SL/L, M, H
N/T Protein Controls SL/L, M, H
N/T Protein Controls SL/L, M, H
N/T Protein Controls SL/L, M, H
N/T Protein Controls SL/L, M, H
N/T Protein Controls SL/L, M, H
N/T Protein Controls SL/L, M, H
N/T Protein Controls SL/L, M, H
N/T Protein Controls SL/L, M, H
N/T Protein Controls SL/L, M, H
N/T Protein Controls SL/L, M, H
N/T Protein Controls SL/L, M, H
Recommended Control(s)
7 days
7 days
7 days
7 days
7 days
7 days
7 days
7 days
7 days
7 days
7 days
7 days
7 days
7 days
7 days
7 days
7 days
7 days
7 days
7 days
7 days
7 days
7 days
On-board Stability of the Control(s) 3)
15 Appendix
57
15
15
58
IgG
IgG1
IgG2
IgG3
IgG3n
IgG4
IgG4n
IgA
IgAs
IgM
IgMs
C3
C4
TRF
ALB
AAT
a2M
HPT
AAG
PRE
sTfR
HPX
CER
1
51
52
64
78
65
79
2
22
3
23
4
5
6
7
8
9
10
11
12
13
14
15
7)
9)
9)
7)
7)
Abbreviation
Standard
N Protein Standard SL
N Protein Standard SL
N Protein Standard SL
N Protein Standard SL
N Protein Standard SL
N Protein Standard SL
N Protein Standard SL
N Protein Standard SL
N Protein Standard SL
N Protein Standard SL
N Protein Standard SL
N Protein Standard SL
N Protein Standard SL
N Protein Standard SL
N Protein Standard SL
N Protein Standard SL
N Protein Standard SL
N Protein Standard SL
N Protein Standard SL
N Protein Standard SL
N Protein Standard SL
N Protein Standard SL
N Protein Standard SL
15
Dade Behring Assay No.
6
6
6
6
6
6
6
6
5
5
6
6
6
6
6
6
7
6
7
6
6
6
6
No. of Standard Dilutions
2.5 - 80
2.5 - 80
5 - 160
2.5 - 80
2.5 - 80
2.5 - 80
5 - 160
5 - 160
160 - 2560
10 - 160
2.5 - 80
5 - 160
2.5 - 80
2.5 - 80
5 - 160
5 - 160
320 - 20480
5 - 160
320 - 20480
2.5 - 80
5 - 160
20 - 640
80 - 2560
Standard Dilutions 1: 4)
20
20
20
5
20
20
20
20
400
20
20
20
5
20
5
20
2000
20
2000
20
20
100
400
Initial Sample Dil. 1: 4)
5
5
20
5
5
5
5
5
20
5
5
5
5
20
5
20
100
5
100
5
5
5
20
100
20
70
50
15
10
20
20
15
10
100
20
50
5 + 45
20
20
5 + 50
25
5 + 35
25
25
25
100
Minimum Sample Sample Volume Dil. (µL) 1: 4)
40
40
60
40
30
40
40
40
30
40
40
40
40
40
40
40
50
40
55
40
40
40
40
Reagent Volume (µL)
0
0
30
30
0
0
0
0
0
0
0
0
30
0
30
0
25
10
25
0
10
0
0
100
60
80
30 N Diluent
40 N Diluent 13)
80
60
125
80
80
80
130
80
60
80
50
100
50
100
125
80
80
80
100
80
100
80
80
55 + 30
80
6)
6)
6)
80
75 N Diluent
55 + 10 N Diluent 80
70
70
6)
6)
70 N Diluent
55 + 15 N Diluent
6)
70 70
70
70
60
70
6)
70
100
6
6
6
6
6
6
6
6
6
6
6
6
6
2+4
6
6
2+6
12
2+6
6
12
6
6
Suppl. Reagent Buffer for Buffer for Reaction Volume Sample Reagent Time (µL) (µL) (µL) (min)
Fixed Time
Fixed Time
VLinIntegral
Fixed Time
Fixed Time
Fixed Time
Fixed Time
Fixed Time
Fixed Time
Fixed Time
Fixed Time
Fixed Time
Fixed Time
Fixed Time with Pre-reaction
Fixed Time
Fixed Time
Fixed Time with Pre-reaction
Fixed Time
Fixed Time with Pre-reaction
Fixed Time
Fixed Time
Fixed Time
Fixed Time
Evaluation Method
15 Appendix
BN ProSpec® System – Instruction Manual – Version 1.1.3
BN ProSpec® System – Instruction Manual – Version 1.1.3
lam
TPS
A-I
ApoB
A-II
ApoE
Lpa
FRT
18
19
30
31
45
46
39
50
RF
kap
17
54
RbP
22 - 350
Serum
Serum
Serum
Serum
Serum
Serum Plasma 11)
Serum Plasma 11)
Serum
Total Protein
Apolipoprotein A-I
Apolipoprotein B
Apolipoprotein A-II
Apolipoprotein E
Lipoprotein(a)
Ferritin
RF
7)
7)
10 - 600
2.5 - 160
10 - 640
10 - 600
0.03 - 0.4
0.01 - 0.19
0.01 - 0.19
0.25 - 4.0
0.05 - 1.5
5.5 - 88
0.04 - 1.3
0.07 - 2.3
0.1 - 1.6
0.01 - 0.19
0.05 - 0.76
0.25 - 4.0
0.19 - 6.0
0.16 - 5.0
Ig/L-chain, type lambda Serum
7)
0.28 - 9.1
0.01 - 0.2
Initial Minimum Measuring Measuring Range 1) Range 1)
Ig/L-chain, type kappa Serum
Sample Type
0.01 - 0.2
Protein
Retinol binding Protein Serum
Abbreviation
16
Dade Behring Assay No.
17)
17)
16)
17)
17)
16)
g/L
5)14)
15
< 15
2
N Antiserum to Human Ig/L-chain, λ type
7)
N Antiserum to Human Apolipoprotein E
N Latex Ferritin Reagent
N Latex Lp(a) Reagent
7)
N Antiserum to Human Apolipoprotein A-II
N Antiserum to Human Apolipoprotein B
4 weeks
8 days 8 days
4 2
4 weeks
6 weeks
6 weeks
6 weeks 6 weeks
6 weeks 6 weeks
4 weeks
4 weeks
6 weeks
On-board Reagent Stability 3)
3
2
2
2
5 2
5 2
2
N Antiserum to Human Ig/L-chain, κ type
N Antiserum to Human Apolipoprotein A-I
2
Vol. (mL)
N Antiserum to Human RbP
Reagent
IU/mL N RF Reagent
12)16) µg/L 10 - 250 Men: 20 - 290 Women: premenopausal: 4.5 - 170 postmenopausal: 24 - 260
g/L
g/L
g/L
g/L
g/L
g/L
g/L
g/L
Unit
5)14)
16) < 0.3 Caucasian: Men: < 0.02 - 0.74 Women: < 0.02 - 0.72 African-American: Men: 0.04 - 1.14 Women: 0.02 - 1.08 Hispanic-American: Men: 0.02 - 0.53 Women: 0.02 - 0.46
0.023 - 0.063
0.26 - 0.51
0.55 - 1.35 Men: 0.55 - 1.40 Women: 0.55 - 1.25
1.15 - 2.1 Men: 1.10 - 2.05 Women: 1.25 - 2.15
66 - 83
0.9 - 2.1
1.7 - 3.7
0.03 - 0.06
Reference Range 2)
N/T Rheumatology Controls SL/1, SL/2
N/T Protein Controls SL/L, M, H
N Lp(a) Control SY
Apolipoprotein Control Serum CHD
Apolipoprotein Control Serum CHD
Apolipoprotein Control Serum CHD
Apolipoprotein Control Serum CHD
N/T Protein Controls SL/L, M, H
N/T Protein Controls SL/L, M, H
N/T Protein Controls SL/L, M, H
N/T Protein Controls SL/L, M, H
Recommended Control(s)
7 days
7 days
7 days
7 days
7 days
7 days
7 days
7 days
7 days
7 days
7 days
On-board Stability of the Control(s) 3)
15 Appendix
59
15
15
60
A-I
ApoB
A-II
ApoE
Lpa
30
31
45
46
39
RF
TPS
19
54
lam
18
FRT
kap
17
50
RbP
16
N Apolipoprotein Standard Serum
7)
N Rheumatology Standard SL
N Protein Standard SL
N Lp(a) Standard SY
N Apolipoprotein Standard Serum
N Apolipoprotein Standard Serum
N Apolipoprotein Standard Serum
N Protein Standard SL
N Protein Standard SL
N Protein Standard SL
N Protein Standard SL
Standard
7)
7)
Abbreviation
15
Dade Behring Assay No.
7
7
5
5
5
5
6
5
6
6
5
No. of Standard Dilutions
5 - 320
10 - 640
40 - 640
1 - 20
10 - 160
5 - 80
5 - 160
80 - 1280
5 - 160
5 - 160
1 - 20
Standard Dilutions 1: 4)
20
20
400
5
20
20
20
400
20
20
5
Initial Sample Dil. 1: 4)
20
5
100
5
5
20
5
100
5
5
5
20
120
30
25
40
30
10
100
10
10
50
Minimum Sample Sample Volume Dil. (µL) 1: 4)
50
40
50
30
40
40
40
30 15) TCA 20%
40
30
40
Reagent Volume (µL)
40
25
0
10
10
10
10
0
0
0
10
18)
18)
18)
40 N Diluent
40 N Diluent
80 N Diluent
60 N Diluent
80
80
70
80
70 N Diluent
80
80
60
85 N Diluent
60 N Diluent
80
80
80
6)
18)
80
100 N Diluent
80
80
100
6)
6)
6
6
6
6
6
6
6
6
6
6
6
Suppl. Reagent Buffer for Buffer for Reaction Volume Sample Reagent Time (µL) (µL) (µL) (min)
Fixed Time
VLinIntegral
Fixed Time
Fixed Time
Fixed Time
Fixed Time
Fixed Time
Endpoint
Fixed Time
Fixed Time
Fixed Time
Evaluation Method
15 Appendix
BN ProSpec® System – Instruction Manual – Version 1.1.3
ASL
CRP2
CRPj
CRP1
IgE1
IgE2
ADNs
b2M
MYO
CysC
SAA
bTP
C1I
FIB
AT3
PLS
FNC
a2MU
IgGU
kapU
42
56
71
57
74
58
59
60
66
72
BN ProSpec® System – Instruction Manual – Version 1.1.3
32
70
40
41
43
44
20
21
24
0.05 - 1.6 0.8 - 50
18 - 1150 2.3 - 290 75 - 3000 0.7 - 23 25 - 400
Serum Plasma 8)
Serum Plasma 8)
Serum
Serum Plasma 8)
Serum Plasma 8)
Serum 0.23 - 8.0 Plasma 11)
Serum Plasma 11)
IgE
IgE sensitive
ADNase B
β2-Microglobulin
Myoglobin
Cystatin C
SAA
β-Trace Protein
7)
7)
0.03 - 0.54 0.01 - 0.2 0.02 - 0.65
Plasma 23) 0.03 - 0.54
Plasma 23) 0.01 - 0.2
Plasma 23) 0.08 - 2.6
3.6 - 58 7.1 - 450
Urine
Urine
Antithrombin III
Plasminogen
Fibronectin
α2-Macroglobulin
IgG
Ig/L-chain, type kappa Urine
7)
7)
7)
7)
15 7.1 - 450
3.6 - 58
2.7 - 85
0.15 - 2.4
Plasma 23) 0.59 - 9.4
Fibrinogen
2.7 - 85
0.03 - 0.4
Serum 0.03 - 0.4 Plasma 22)
0.003 - 0.16
0.18 - 5.8
75 - 3000
2.3 - 290
4.5 - 290
0.16 - 10
0.13 - 8.0
C1-Inhibitor
0.25 - 16
3 - 200
6.3 - 100
3.1 - 200
Serum Plasma 8)
CRP1
7)
2.5 - 160
Serum Plasma 8)
CRP Japan
19)
0.16 - 10
0.16 - 10
Serum Plasma 8)
CRP sensitive
13 - 400
Initial Minimum Measuring Measuring Range 1) Range 1) 50 - 1600
Sample Type
Serum
Protein
ASL
Abbreviation
55
Dade Behring Assay No.
20)
5)
5)
16)
< 7.1
< 9.6
< 9.4
0.25 - 0.4
0.06 - 0.25
0.19 - 0.31
1.8 - 3.5
Reagent
N Myoglobin Reagent
N Latex β2-Microglobulin Reagent
25)
mg/L
N Antiserum to Human Ig/L-chain, κ type
mg/L N Antiserum to Human IgG
2
4 weeks
4 weeks 2 weeks
6 weeks
6 weeks
5 2
2
N Antiserum to Human Fibronectin
24)
2
N Antiserum to Human Plasminogen
6 weeks
6 weeks 6 weeks
2
N Antiserum to Human Antithrombin III
4 weeks
4 weeks
4 weeks
4 weeks
4 weeks
1 week
6 weeks
4 weeks
6 weeks
6 weeks
6 weeks 6 weeks
6 weeks 6 weeks
6 weeks 6 weeks
4 weeks 4 weeks
On-board Reagent Stability 3)
5 2
2
N Antiserum to Human Fibrinogen
2
2
2
7)
7)21)
7)
2
2
3
2
3
3
5 2
5 2
5 2
3 2
Vol. (mL)
N Antiserum to Human C1 Inhibitor
24)
g/L
g/L
g/L
g/L
g/L
mg/L N βTP Reagent
mg/L N Latex SAA
mg/L N Cystatin C Reagent
µg/L
mg/L
U/mL N ADNase B Reagent
IU/mL N Latex IgE mono Reagent
IU/mL N Latex IgE mono Reagent
mg/L N High Sensitivity CRP
mg/L N High Sensitivity CRP
mg/L N High Sensitivity CRP
IU/mL N ASL Reagent
Unit
N Antiserum to Human mg/L α2-Macroglobulin
22)
22)
22)
22)
Serum: 0.21 - 0.39 16) Citrated plasma: 0.18 - 0.32
< 6.8
0.53 - 0.95
< 70
0.7 - 1.8
< 200
< 100
<3
<3
<3
< 200 Caucasian: < 370 Japanese: < 240
Reference Range 2)
N/T Protein Control LC
N/T Protein Control LC
N/T Protein Control LC
N/T Protein Control PY
N/T Protein Control PY
N/T Protein Control PY
N/T Protein Control PY
N/T Protein Control PY
N/T Protein Control LC
N SAA Control SY (human)
N Cystatin C Control
N Myoglobin Control (human)
7)
7 days
7 days
7 days
7 days
7 days
7 days
7 days
7 days
7 days
7 days
7 days
7 days
7 days
7 days
N ADNase B Control Serum (human) N/T Protein Controls SL/M, H
7 days
7 days
7 days
7 days
6 days
7 days
On-board Stability of the Control(s) 3)
N/T Protein Controls SL/L, M
N/T Protein Controls SL/L, M, H
N/T Rheumatology Controls SL/1, SL/2
N/T Rheumatology Controls SL/1, SL/2
Apolipoprotein Control Serum CHD
N/T Rheumatology Controls SL/1, SL/2
Recommended Control(s)
15 Appendix
15
61
15
ASL
CRP2
CRPj
CRP1
IgE1
IgE2
ADNs
b2M
MYO
CysC
SAA
bTP
C1I
FIB
AT3
PLS
FNC
a2MU
IgGU
kapU
55
42
56
71
57
74
62
58
59
60
66
72
32
70
40
41
43
44
20
21
24
19)
N Protein Standard UY
7)
N Protein Standard PY
N Protein Standard SL
N Protein Standard SL
N Protein Standard SL
7)
7)
7)
7)
N Protein Standard PY
N Protein Standard PY
N Protein Standard PY
N Protein Standard PY
N SAA Standard SY (human)
N Protein Standard UY
N Myoglobin Standard (human)
N Protein Standard SL
7)
N ADNase B Standard Serum (human)
N Protein Standard SL
N Protein Standard SL
N Rheumatology Standard SL
N CRP Standard (human)
N Rheumatology Standard SL
N Rheumatology Standard SL
Standard
7)
7)
19)
Abbreviation
15
Dade Behring Assay No.
7
5
6
6
5
5
5
5
7
7
6
5
6
6
8
7
7
7
7
6
No. of Standard Dilutions
5 - 320
160 - 2560
20 - 640
2.5 - 80
2.5 - 40
2.5 - 40
5 - 80
2.5 - 40
10 - 640
20 - 1280
20 - 640
40 - 640
20 - 640
1 - 40
10 - 1280
10 - 640
40 - 2560
40 - 2560
40 - 2560
40 - 1280
Standard Dilutions 1: 4)
1
1
1
20
5
5
20
5
100
400
100
20
400
5
5
20
400
400
20
400
Initial Sample Dil. 1: 4)
1
1
1
5
5
5
5
5
1
100
20
5
100
5
5
5
20
20
20
100
10
100
100
100
100
100
20
100
35
40
30
80
50
20
80
80
40
60
40
70
Minimum Sample Sample Volume Dil. (µL) 1: 4)
40
40
40
40
40
40
40
40
50
50
40
75
70
50
60
60
40
40
40
40
Reagent Volume (µL)
0
0
0
0
30
30
30
30
15
30
10
20
15
70
20
20
5
5
5
50
60 N Diluent 40 N Diluent 40 N Diluent 50 N Diluent 70 N Diluent 75 20 + 80 N Diluent 60 N Diluent 70 N Diluent
70 N Diluent 30 N Diluent 30 N Diluent 50 N Diluent 55 N Diluent 75 60 N Diluent 60 N Diluent 80 N Diluent 100
80 100 100
6)
13)
13)
18)
13)
18)
18)
18) 6)
6)
6)
6)
80
100
100
100
60 N Diluent
50 N Diluent
6)
80
60
60
60
60
60
80
60
60 N Diluent
70 N Diluent
6)
18)
50
40
18)
6
6
12
6
6
6
6
6
12
6
6
12
6
12
6
6
6
6
6
6
Suppl. Reagent Buffer for Buffer for Reaction Volume Sample Reagent Time (µL) (µL) (µL) (min)
Fixed Time
Fixed Time
Fixed Time
Fixed Time
Fixed Time
Fixed Time
Fixed Time
Fixed Time
Fixed Time
VLinIntegral
Fixed Time
Fixed Time
VLinIntegral
Fixed Time
VLinIntegral
VLinIntegral
VLinIntegral
Fixed Time
VLinIntegral
Fixed Time
Evaluation Method
15 Appendix
BN ProSpec® System – Instruction Manual – Version 1.1.3
lamU
TRFU
ALBU
TPU
a1MU
b2MU
IgGC
IgAC
IgMC
ALBC
a2MC
TPC
26
27
28
29
73
61
62
63
67
BN ProSpec® System – Instruction Manual – Version 1.1.3
68
69
Urine
Urine
CSF
CSF
α1-Microglobulin
β2-Microglobulin
IgG
CSF
CSF
α2-Macroglobulin
Total Protein
7)
7)
Serum
CSF
CSF
IgM
Serum
1.25 - 41.5
Urine
Total Protein
IgA
3.6 - 115
Urine
Albumin
0.25 - 8.3
3.6 - 115
0.2 - 5.8
5.6 - 180
110 - 3500
2.2 - 68
2.2 - 35
110 - 3500
5.0 - 160
86 - 2750
270 - 8600
0.13 - 4.2
110 - 3500
5.0 - 160
17 - 550
54 - 1700
0.13 - 4.2
500 - 16600 100 - 3300
0.2 - 5.8
5.6 - 180
110 - 3500
11 - 340
2.2 - 35
Urine
Transferrin
3.9 - 250
Initial Minimum Measuring Measuring Range 1) Range 1) 3.9 - 250
Sample Type
Ig/L-chain, type lambda Urine
Protein
Albumin
7)
7)
Abbreviation
25
Dade Behring Assay No.
180 - 430
<5
< 350
< 1.3
<5
< 34
< 0.2
< 12
< 100
< 30
< 2.2
< 3.9
24)
25)
Reference Range 2)
mg/L
mg/L
mg/L
5 2 5 2
N Antiserum to Human α2-Macroglobulin
2
N Antiserum to Human Albumin
mg/L N IgM Reagent
mg/L N IgA Reagent
6 weeks 6 weeks
6 weeks 4 weeks
2 weeks
2 weeks
4 weeks 2 weeks
5 2
2
6 weeks
3
6 weeks
6 weeks 4 weeks
N Latex β2-Microglobulin Reagent
5 2
N Antiserum to Human Albumin
6 weeks 6 weeks
2
5 2
N Antiserum to Human Transferrin
4 weeks
On-board Reagent Stability 3)
N Antiserum to Human α1-Microglobulin
2
Vol. (mL)
N Antiserum to Human Ig/L-chain, λ type
Reagent
mg/L N Antiserum to Human IgG
mg/L
mg/L
mg/L
mg/L
mg/L
mg/L
Unit
N/T Protein Control LC
N/T Protein Control LC
N/T Protein Control LC
N/T Protein Control LC, N IgM Control (human)
N/T Protein Control LC, N IgA Control (human)
N/T Protein Control LC
N/T Protein Controls SL/L, M
N/T Protein Control LC
N/T Protein Control LC
N/T Protein Control LC
N/T Protein Control LC
N/T Protein Control LC
Recommended Control(s)
7 days
7 days
7 days
7 days 7 days
7 days 7 days
7 days
7 days
7 days
7 days
7 days
7 days
7 days
On-board Stability of the Control(s) 3)
15 Appendix
15
15
63
15
64
ALBU
TPU
a1MU
b2MU
IgGC
IgAC
IgMC
ALBC
a2MC
27
28
29
73
61
62
63
67
68
TPC
TRFU
26
69
lamU
25
7)
7)
7)
7)
Abbreviation
Standard
N Protein Standard SL
N Protein Standard SL
N Protein Standard SL
N IgM Standard (human)
N IgA Standard (human)
N Protein Standard SL
N Protein Standard SL
N Protein Standard UY
N Protein Standard SL
N Protein Standard SL
N Protein Standard SL
N Protein Standard SL
15
Dade Behring Assay No.
6
6
6
6
6
6
6
6
6
6
5
7
No. of Standard Dilutions
20 - 640
10 - 320
80 - 2560
10 - 320
10 - 320
80 - 2560
20 - 640
2.5 - 80
20 - 640
640-20480
80 - 1280
5 - 320
Standard Dilutions 1: 4)
1
1
5
2000
1
2000
26)
1
1
1
400
1
400
1
5 26)
1
26)
26)
100
1
1
1
1
1
20
100
15
20
20
100
2 + 50
20
20
5 + 95
100
4 + 16
Minimum Sample Sample Volume Dil. (µL) 1: 4)
1
100
1
1
5
1
1
Initial Sample Dil. 1: 4)
30 15) TCA 20%
40
30
50
50
40
70
40
30 15) TCA 20%
40
40
40
Reagent Volume (µL)
0
0
0
10
10
0
15
10
0
0
0
0
18)
18)
90 N Diluent
100
100
60 N Diluent
60 N Diluent
80 N Diluent
60
130
60 N Diluent
60 N Diluent
60
70 N Diluent
55 N Diluent
13)
100
70
90
80 N Diluent
100
60
100
18)
90 N Diluent
55 + 30
100
55 + 30
6
6
6
6
6
6
3+6
6
6
2+4
6
1+6
Suppl. Reagent Buffer for Buffer for Reaction Volume Sample Reagent Time (µL) (µL) (µL) (min)
Endpoint
Fixed Time
Fixed Time
Fixed Time
Fixed Time
Fixed Time
VLinIntegral with Pre-reaction
Fixed Time
Endpoint
Fixed Time with Pre-reaction
Fixed Time
Fixed Time with Pre-reaction
Evaluation Method
15 Appendix
BN ProSpec® System – Instruction Manual – Version 1.1.3
15 Appendix
Remarks
1)
The exact measuring range depends on the assigned value of the relevant standard lot. Results which are outside the measuring range can be analyzed using a different sample dilution (integrated in the software).
2)
Literature references are given in the package insert of the relevant reagent.
3)
On-board stability depends on environmental conditions and fill volume. These are typical figures derived from internal studies but no product specifications. It is recommended to monitor reagent stability by running controls according to the instruction for use. For assays employing a supplementary reagent the figures apply for reagent and the respective supplementary reagent.
4)
Automatic dilution with N Diluent.
5)
Pediatric reference ranges for IgG, IgG subclasses, IgA, IgM, IgE and Ig/L-chains in serum are dependent on age and can vary over a wide range.
6)
N Supplementary Reagent/Precipitation, Code No.: OUMU.
7)
Not available in the US.
8)
EDTA plasma and heparinized plasma.
9)
Assay protocols are for low protein concentrations in patient samples which require a lower measuring range. See package insert for description of IgAs/IgMs in the US, or IgA sensitive/IgM sensitive outside the US.
10) A lower reference range applies for fresh samples. 11) Heparinized plasma. 12) Reference range for the sTfR/Ferritin-Index: 0.38 - 1.54. 13) N Supplementary Reagent L, Code No.: OQTD. 14) Adults’ reference range for the Ig/L-chains quotient in serum, κ/λ: 1.35 - 2.65. 15) Commercially available from, for example, VWR International (Merck), order no.: 109415. 16) Reference range specification in the BN ProSpec® Software. 17) Reference range for the Apo B/Apo A-I quotient: 0.35 - 1.0 (men), 0.3 - 0.9 (women). 18) N Supplementary Reagent is included in the kit. 19) Only available in Japan. 20) Research assay, no specification for reference range. 21) For Research Use Only. 22) Citrated plasma. 23) EDTA plasma and citrated plasma. 24) Reference range refers to second morning urine specimens. 25) Reference range for the free Ig/L-chains quotient in urine, κ/λ: 0.75 - 4.0. 26) Serum sample dilution needs to be selected manually.
15
BN ProSpec® System – Instruction Manual – Version 1.1.3
15
65
15 Appendix
15
15
66
BN ProSpec® System – Instruction Manual – Version 1.1.3