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APTEC DIAGNOSTICS 31.01.01
APPLICATION NOTE ADVIA 1650
1-ANTITRYPSIN BI (AUT-KIT)
1. Reagent preparation Sample: Ready for use Reagent: Buffer, ready for use Start: Antiserum, ready for use Calibrator: Ready for use. Use saline 9 g/L as zero point.
2. Analytical Parameters (Chemistry) TYPE #
Analytical conditions Sub-analy. conditions
R1 volume 100 Name AAT
R2 volume 0 Digits *
R3 volume 15 M-wave.L. 340
R4 volume 0 S-wave.L.
R1 diluent vol 0 Analy.Mthd EPA
R2 diluent vol 0 Calc.Mthd MSTD
R3 diluent vol 0 Qualit.judge Not do
R4 diluent vol 0 Calculation method setting
Serum reac.s.vol 2 M-DET.P.l 0
Serum dil.method SPECIAL M-DET.P.m 94
Serum dil.s.vol 10 M-DET.P.n 98
Serum dil.volume 90 S-DET.P.p 42
Serum dil.posit 0 S-DET.P.r. 46
Reaction time 10 min. Check D.P.I. 0
Reagent 1 stir Weak Limit value 0.003
Reagent 2 stir Weak Variance 10.0
Reagent 3 stir Weak * Prozone
Reagent 4 stir Weak Prozone form NONE
Prozone limit
Reanalysis conditions Prozone judge
Serum reac.smp.vol (u) 4 M-DET.P.m
Serum dilut.method (u) STD M-DET.P.n
Serum dil.smp.vol (u) 30 S-DET.P.p
Serum diluent vol (u) 120 S-DET.P.p
Serum diluent posi (u) 0 S-DET.r
Serum reac.smp.vol (d) 2 * Endpoint
Serum dilut.method (d) SPECIAL Re.absorb (u) 1.700
Serum dil.smp.vol (d) 5 Re.absorb (d) -1.450
Serum diluent vol (d) 95
Serum diluent posi (d) 0
Standard settings Multi-STD
Formula LOGIT– LOG3 Axis conv. NO CONVERT Points 5
POS Coeff (FV) Dil.method Dil.smp.vol Diluent vol. Diluent pos. STD-H STD-L
BLK *
1 * ** SPECIAL 10 90 0 9.999 -9.999
2 * ** SPECIAL 10 90 0 9.999 -9.999
3 * ** SPECIAL 10 90 0 9.999 -9.999
4 * ** SPECIAL 10 90 0 9.999 -9.999
5 * ** SPECIAL 10 90 0 9.999 -9.999
* Data entered by operator ** Concentration of standard
3. Order information AAT/AUT-000 1 x 10 mL Antiserum 5 x 25 mL Buffer MPS/STS-5X1 Protein Standard Set, 5 x 1 mL
139F003 Immunology Control Low, 1mL 139F002 Immunology Control High, 1 mL
APTEC DIAGNOSTICS 23.07.2014 APPLICATION TO BE VALIDATED BY THE USER
APPLICATION NOTE ADVIA 1650
1 – Acid Glycoprotein AUT KIT
1. Reagent preparation Sample: Ready for use. Reagent: Buffer, ready for use. Start: Antiserum, ready for use. Calibrator: Ready for use. Use saline 9 g/L as zero point.
2. Analytical Parameters (Chemistry) TYPE #
Analytical conditions Sub-analy. conditions
R1 volume 110 Name AGP
R2 volume 0 Digits *
R3 volume 15 M-wave.L. 340
R4 volume 0 S-wave.L.
R1 diluent vol 0 Analy.Mthd EPA
R2 diluent vol 0 Calc.Mthd MSTD
R3 diluent vol 0 Qualit.judge Not do
R4 diluent vol 0 Calculation method setting
Serum reac.s.vol 4 M-DET.P.l 0
Serum dil.method STD M-DET.P.m 94
Serum dil.s.vol 30 M-DET.P.n 98
Serum dil.volume 120 S-DET.P.p 42
Serum dil.posit 0 S-DET.P.r. 46
Reaction time 10 min. Check D.P.I. 0
Reagent 1 stir Weak Limit value 0.003
Reagent 2 stir Weak Variance 10.0
Reagent 3 stir Weak * Prozone
Reagent 4 stir Weak Prozone form NONE
Prozone limit
Reanalysis conditions Prozone judge
Serum reac.smp.vol (u) 10 M-DET.P.m
Serum dilut.method (u) STD M-DET.P.n
Serum dil.smp.vol (u) 30 S-DET.P.p
Serum diluent vol (u) 120 S-DET.P.p
Serum diluent posi (u) 0 S-DET.r
Serum reac.smp.vol (d) 2 * Endpoint
Serum dilut.method (d) STD Re.absorb (u) 1.700
Serum dil.smp.vol (d) 30 Re.absorb (d) -1.450
Serum diluent vol (d) 120
Serum diluent posi (d) 0
Standard settings Multi-STD
Formula LOGIT– LOG3 Axis conv. NO CONVERT Points 5
POS Coeff (FV) Dil.method Dil.smp.vol Diluent vol. Diluent pos. STD-H STD-L
BLK *
1 * ** STD 30 120 0 9.999 -9.999
2 * ** STD 30 120 0 9.999 -9.999
3 * ** STD 30 120 0 9.999 -9.999
4 * ** STD 30 120 0 9.999 -9.999
5 * ** STD 30 120 0 9.999 -9.999
* Data entered by operator ** Concentration of standard
3. Order information AGP/AUT-000 1 x 10 mL Antiserum 5 x 25 mL Buffer MPS/STS-5X1 Protein Standard Set, 5 x 1 mL MPS/STH-001 Protein Standard High, 1 mL 139F003 Immunology Control Low, 1mL 139F002 Immunology Control High, 1 mL
APTEC DIAGNOSTICS 24.07.2014 APPLICATION TO BE VALIDATED BY THE USER
APPLICATION NOTE ADVIA 1650
APO B AUT KIT
1. Reagent preparation Sample: Ready for use. Reagent: Buffer, ready for use. Start: Antiserum, ready for use. Calibrator: Solve APO A1/B Standard High, ready for use. Use saline 9 g/L as zero point.
2. Analytical Parameters (Chemistry) TYPE #
Analytical conditions Sub-analy. conditions
R1 volume 125 Name APB
R2 volume 0 Digits *
R3 volume 15 M-wave.L. 340
R4 volume 0 S-wave.L.
R1 diluent vol 0 Analy.Mthd EPA
R2 diluent vol 0 Calc.Mthd MSTD
R3 diluent vol 0 Qualit.judge Not do
R4 diluent vol 0 Calculation method setting
Serum reac.s.vol 5 M-DET.P.l 0
Serum dil.method SPECIAL M-DET.P.m 94
Serum dil.s.vol 10 M-DET.P.n 98
Serum dil.volume 90 S-DET.P.p 42
Serum dil.posit 0 S-DET.P.r. 46
Reaction time 10 min. Check D.P.I. 0
Reagent 1 stir Weak Limit value 0.003
Reagent 2 stir Weak Variance 10.0
Reagent 3 stir Weak * Prozone
Reagent 4 stir Weak Prozone form NONE
Prozone limit
Reanalysis conditions Prozone judge
Serum reac.smp.vol (u) 10 M-DET.P.m
Serum dilut.method (u) SPECIAL M-DET.P.n
Serum dil.smp.vol (u) 10 S-DET.P.p
Serum diluent vol (u) 90 S-DET.P.p
Serum diluent posi (u) 0 S-DET.r
Serum reac.smp.vol (d) 4 * Endpoint
Serum dilut.method (d) SPECIAL Re.absorb (u) 1.700
Serum dil.smp.vol (d) 10 Re.absorb (d) -1.450
Serum diluent vol (d) 90
Serum diluent posi (d) 0
Standard settings Multi-STD
Formula LOGIT– LOG3 Axis conv. NO CONVERT Points 5
POS Coeff (FV) Dil.method Dil.smp.vol Diluent vol. Diluent pos. STD-H STD-L
BLK *
1 * ** SPECIAL 1 159 0 9.999 -9.999
2 * ** SPECIAL 2 318 0 9.999 -9.999
3 * ** SPECIAL 2 158 0 9.999 -9.999
4 * ** SPECIAL 5 195 0 9.999 -9.999
5 * ** SPECIAL 10 190 0 9.999 -9.999
* Data entered by operator ** Concentration of standard
3. Order information APB/AUT-000 1 x 10 mL Antiserum 5 x 25 mL Buffer 147E002 APO A1/B Standard High, 1 mL 147F001 APO A1/B Control, 1 mL
APTEC DIAGNOSTICS 24.07.2014 APPLICATION TO BE VALIDATED BY THE USER
APPLICATION NOTE ADVIA 1650
APO A1 AUT KIT
1. Reagent preparation Sample: Ready for use. Reagent: Buffer, ready for use. Start: Antiserum, ready for use. Calibrator: Solve APO A1/B Standard High, ready for use. Use saline 9 g/L as zero point.
2. Analytical Parameters (Chemistry) TYPE #
Analytical conditions Sub-analy. conditions
R1 volume 100 Name APA
R2 volume 0 Digits *
R3 volume 18 M-wave.L. 340
R4 volume 0 S-wave.L.
R1 diluent vol 0 Analy.Mthd EPA
R2 diluent vol 0 Calc.Mthd MSTD
R3 diluent vol 0 Qualit.judge Not do
R4 diluent vol 0 Calculation method setting
Serum reac.s.vol 3 M-DET.P.l 0
Serum dil.method STD M-DET.P.m 94
Serum dil.s.vol 30 M-DET.P.n 98
Serum dil.volume 120 S-DET.P.p 42
Serum dil.posit 0 S-DET.P.r. 46
Reaction time 10 min. Check D.P.I. 0
Reagent 1 stir Weak Limit value 0.003
Reagent 2 stir Weak Variance 10.0
Reagent 3 stir Weak * Prozone
Reagent 4 stir Weak Prozone form NONE
Prozone limit
Reanalysis conditions Prozone judge
Serum reac.smp.vol (u) 2 M-DET.P.m
Serum dilut.method (u) NONE M-DET.P.n
Serum dil.smp.vol (u) 0 S-DET.P.p
Serum diluent vol (u) 0 S-DET.P.p
Serum diluent posi (u) 0 S-DET.r
Serum reac.smp.vol (d) 3 * Endpoint
Serum dilut.method (d) SPECIAL Re.absorb (u) 1.700
Serum dil.smp.vol (d) 10 Re.absorb (d) -1.450
Serum diluent vol (d) 90
Serum diluent posi (d) 0
Standard settings Multi-STD
Formula LOGIT– LOG3 Axis conv. NO CONVERT Points 6
POS Coeff (FV) Dil.method Dil.smp.vol Diluent vol. Diluent pos. STD-H STD-L
BLK *
1 * ** SPECIAL 2 158 0 9.999 -9.999
2 * ** SPECIAL 5 195 0 9.999 -9.999
3 * ** SPECIAL 10 190 0 9.999 -9.999
4 * ** SPECIAL 20 180 0 9.999 -9.999
5 * ** STD 30 120 0 9.999 -9.999
* Data entered by operator ** Concentration of standard
3. Order information APA/AUT-000 1 x 10 mL Antiserum 5 x 25 mL Buffer 147E002 APO A1/B Standard High, 1 mL 147F001 APO A1/B Control, 1 mL
APTEC DIAGNOSTICS 24.07.2014 APPLICATION TO BE VALIDATED BY THE USER
APPLICATION NOTE ADVIA 1650
Anti-streptolysin (O) AUT KIT
1. Reagent preparation Sample: Ready for use. Reagent: Buffer, ready for use. Start: Latex, ready for use. Calibrator: ASL Standard Set, ready for use. Use saline 9 g/L as zero point.
2. Analytical Parameters (Chemistry) TYPE #
Analytical conditions Sub-analy. conditions
R1 volume 125 Name ASL
R2 volume 0 Digits 0
R3 volume 20 M-wave.L. 596
R4 volume 0 S-wave.L.
R1 diluent vol 0 Analy.Mthd EPA
R2 diluent vol 0 Calc.Mthd MSTD
R3 diluent vol 0 Qualit.judge Not do
R4 diluent vol 0 Calculation method setting
Serum reac.s.vol 7 M-DET.P.l 0
Serum dil.method STD M-DET.P.m 94
Serum dil.s.vol 30 M-DET.P.n 98
Serum dil.volume 120 S-DET.P.p 42
Serum dil.posit 0 S-DET.P.r. 46
Reaction time 10 min. Check D.P.I. 0
Reagent 1 stir Weak Limit value 0.003
Reagent 2 stir Weak Variance 10.0
Reagent 3 stir Weak * Prozone
Reagent 4 stir Weak Prozone form NONE
Prozone limit
Reanalysis conditions Prozone judge
Serum reac.smp.vol (u) 14 M-DET.P.m
Serum dilut.method (u) STD M-DET.P.n
Serum dil.smp.vol (u) 30 S-DET.P.p
Serum diluent vol (u) 120 S-DET.P.p
Serum diluent posi (u) 0 S-DET.r
Serum reac.smp.vol (d) 3 * Endpoint
Serum dilut.method (d) STD Re.absorb (u) 1.700
Serum dil.smp.vol (d) 30 Re.absorb (d) -1.450
Serum diluent vol (d) 120
Serum diluent posi (d) 0
Standard settings Multi-STD
Formula LOGIT– LOG3 Axis conv. NO CONVERT Points 4
POS Coeff (FV) Dil.method Dil.smp.vol Diluent vol. Diluent pos. STD-H STD-L
BLK *
1 * ** STD 30 120 0 9.999 -9.999
2 * ** STD 30 120 0 9.999 -9.999
3 * ** STD 30 120 0 9.999 -9.999
4 * ** STD 30 120 0 9.999 -9.999
* Data entered by operator ** Concentration of standard
3. Order information ASL/AUT-000 1 x 10 mL Latex 5 x 25 mL Buffer ASL/STS-4X1 ASL Standard Set, 4 x 1 mL ASL/STH-001 ASL Standard High, 1 mL ASL/SST-001 ASL Standard Super High, 1 mL ASL/CON-001 ASL Control, 1 mL 139F003 Immunology Control Low, 1mL 139F002 Immunology Control High, 1 mL
APTEC DIAGNOSTICS 24.07.2014 APPLICATION TO BE VALIDATED BY THE USER
APPLICATION NOTE ADVIA 1650
Complement C3 AUT KIT
1. Reagent preparation Sample: Ready for use. Reagent: Buffer, ready for use. Start: Antiserum, ready for use. Calibrator: Protein Standard Set, ready for use. Use saline 9 g/L as zero point.
2. Analytical Parameters (Chemistry) TYPE #
Analytical conditions Sub-analy. conditions
R1 volume 100 Name C3C
R2 volume 0 Digits *
R3 volume 16 M-wave.L. 340
R4 volume 0 S-wave.L.
R1 diluent vol 0 Analy.Mthd EPA
R2 diluent vol 0 Calc.Mthd MSTD
R3 diluent vol 0 Qualit.judge Not do
R4 diluent vol 0 Calculation method setting
Serum reac.s.vol 6 M-DET.P.l 0
Serum dil.method STD M-DET.P.m 94
Serum dil.s.vol 30 M-DET.P.n 98
Serum dil.volume 120 S-DET.P.p 42
Serum dil.posit 0 S-DET.P.r. 46
Reaction time 10 min. Check D.P.I. 0
Reagent 1 stir Weak Limit value 0.003
Reagent 2 stir Weak Variance 10.0
Reagent 3 stir Weak * Prozone
Reagent 4 stir Weak Prozone form NONE
Prozone limit
Reanalysis conditions Prozone judge
Serum reac.smp.vol (u) 12 M-DET.P.m
Serum dilut.method (u) STD M-DET.P.n
Serum dil.smp.vol (u) 30 S-DET.P.p
Serum diluent vol (u) 120 S-DET.P.p
Serum diluent posi (u) 0 S-DET.r
Serum reac.smp.vol (d) 3 * Endpoint
Serum dilut.method (d) STD Re.absorb (u) 1.700
Serum dil.smp.vol (d) 30 Re.absorb (d) -1.450
Serum diluent vol (d) 120
Serum diluent posi (d) 0
Standard settings Multi-STD
Formula LOGIT– LOG3 Axis conv. NO CONVERT Points 5
POS Coeff (FV) Dil.method Dil.smp.vol Diluent vol. Diluent pos. STD-H STD-L
BLK *
1 * ** STD 30 120 0 9.999 -9.999
2 * ** STD 30 120 0 9.999 -9.999
3 * ** STD 30 120 0 9.999 -9.999
4 * ** STD 30 120 0 9.999 -9.999
5 * ** STD 30 120 0 9.999 -9.999
* Data entered by operator ** Concentration of standard
3. Order information C3C/AUT-000 1 x 10 mL Antiserum 5 x 25 mL Buffer MPS/STS-5X1 Protein Standard Set, 5 x 1 mL MPS/STH-001 Protein Standard High, 1 mL 139F003 Immunology Control Low, 1mL 139F002 Immunology Control High, 1 mL
APTEC DIAGNOSTICS 25.07.2014 APPLICATION TO BE VALIDATED BY THE USER
APPLICATION NOTE ADVIA 1650
Complement C4 AUT KIT
1. Reagent preparation Sample: Ready for use. Reagent: Buffer, ready for use. Start: Antiserum, ready for use. Calibrator: Proetin Standard Set, ready for use. Use saline 9 g/L as zero point.
2. Analytical Parameters (Chemistry) TYPE #
Analytical conditions Sub-analy. conditions
R1 volume 100 Name C4C
R2 volume 0 Digits *
R3 volume 16 M-wave.L. 340
R4 volume 0 S-wave.L.
R1 diluent vol 0 Analy.Mthd EPA
R2 diluent vol 0 Calc.Mthd MSTD
R3 diluent vol 0 Qualit.judge Not do
R4 diluent vol 0 Calculation method setting
Serum reac.s.vol 8 M-DET.P.l 0
Serum dil.method STD M-DET.P.m 94
Serum dil.s.vol 30 M-DET.P.n 98
Serum dil.volume 120 S-DET.P.p 42
Serum dil.posit 0 S-DET.P.r. 46
Reaction time 10 min. Check D.P.I. 0
Reagent 1 stir Weak Limit value 0.003
Reagent 2 stir Weak Variance 10.0
Reagent 3 stir Weak * Prozone
Reagent 4 stir Weak Prozone form NONE
Prozone limit
Reanalysis conditions Prozone judge
Serum reac.smp.vol (u) 16 M-DET.P.m
Serum dilut.method (u) STD M-DET.P.n
Serum dil.smp.vol (u) 30 S-DET.P.p
Serum diluent vol (u) 120 S-DET.P.p
Serum diluent posi (u) 0 S-DET.r
Serum reac.smp.vol (d) 4 * Endpoint
Serum dilut.method (d) STD Re.absorb (u) 1.700
Serum dil.smp.vol (d) 30 Re.absorb (d) -1.450
Serum diluent vol (d) 120
Serum diluent posi (d) 0
Standard settings Multi-STD
Formula LOGIT– LOG3 Axis conv. NO CONVERT Points 5
POS Coeff (FV) Dil.method Dil.smp.vol Diluent vol. Diluent pos. STD-H STD-L
BLK *
1 * ** STD 30 120 0 9.999 -9.999
2 * ** STD 30 120 0 9.999 -9.999
3 * ** STD 30 120 0 9.999 -9.999
4 * ** STD 30 120 0 9.999 -9.999
5 * ** STD 30 120 0 9.999 -9.999
* Data entered by operator ** Concentration of standard
3. Order information C4C/AUT-000 1 x 10 mL Antiserum 5 x 25 mL Buffer MPS/STS-5X1 Protein Standard Set, 5 x 1 mL MPS/STH-001 Protein Standard High, 1 mL 139F003 Immunology Control Low, 1mL 139F002 Immunology Control High, 1 mL
APTEC DIAGNOSTICS 25.07.2014 APPLICATION TO BE VALIDATED BY THE USER
APPLICATION NOTE ADVIA 1650
Ceruloplasmin AUT KIT
1. Reagent preparation Sample: Ready for use. Reagent: Buffer, ready for use. Start: Antiserum, ready for use. Calibrator: Protein Standard Set, ready for use. Use saline 9 g/L as zero point.
2. Analytical Parameters (Chemistry) TYPE #
Analytical conditions Sub-analy. conditions
R1 volume 100 Name CER
R2 volume 0 Digits *
R3 volume 15 M-wave.L. 340
R4 volume 0 S-wave.L.
R1 diluent vol 0 Analy.Mthd EPA
R2 diluent vol 0 Calc.Mthd MSTD
R3 diluent vol 0 Qualit.judge Not do
R4 diluent vol 0 Calculation method setting
Serum reac.s.vol 5 M-DET.P.l 0
Serum dil.method STD M-DET.P.m 94
Serum dil.s.vol 30 M-DET.P.n 98
Serum dil.volume 120 S-DET.P.p 42
Serum dil.posit 0 S-DET.P.r. 46
Reaction time 10 min. Check D.P.I. 0
Reagent 1 stir Weak Limit value 0.003
Reagent 2 stir Weak Variance 10.0
Reagent 3 stir Weak * Prozone
Reagent 4 stir Weak Prozone form NONE
Prozone limit
Reanalysis conditions Prozone judge
Serum reac.smp.vol (u) 2 M-DET.P.m
Serum dilut.method (u) NONE M-DET.P.n
Serum dil.smp.vol (u) 0 S-DET.P.p
Serum diluent vol (u) 0 S-DET.P.p
Serum diluent posi (u) 0 S-DET.r
Serum reac.smp.vol (d) 2 * Endpoint
Serum dilut.method (d) STD Re.absorb (u) 1.700
Serum dil.smp.vol (d) 30 Re.absorb (d) -1.450
Serum diluent vol (d) 120
Serum diluent posi (d) 0
Standard settings Multi-STD
Formula LOGIT– LOG3 Axis conv. NO CONVERT Points 5
POS Coeff (FV) Dil.method Dil.smp.vol Diluent vol. Diluent pos. STD-H STD-L
BLK *
1 * ** STD 30 120 0 9.999 -9.999
2 * ** STD 30 120 0 9.999 -9.999
3 * ** STD 30 120 0 9.999 -9.999
4 * ** STD 30 120 0 9.999 -9.999
5 * ** STD 30 120 0 9.999 -9.999
* Data entered by operator ** Concentration of standard
3. Order information CER/AUT-000 1 x 10 mL Antiserum
5 x 25 mL Buffer MPS/STS-5X1 Protein Standard Set, 5 x 1 mL MPS/STH-001 Protein Standard High, 1 mL 139F003 Immunology Control Low, 1mL 139F002 Immunology Control High, 1 mL
APTEC DIAGNOSTICS 25.07.2014 APPLICATION TO BE VALIDATED BY THE USER
APTEC DIAGNOSTICS 25.07.2014 APPLICATION TO BE VALIDATED BY THE USER
APPLICATION NOTE ADVIA 1650
CRP AUT KIT
1. Reagent preparation Sample: Ready for use. Reagent: Buffer, ready for use. Start: Antiserum, ready for use. Calibrator: CRP Standard Set, ready for use. Use Saline 9 g/L as zero point.
2. Analytical Parameters (Chemistry) TYPE #
Analytical conditions Sub-analy. conditions
R1 volume 150 Name CRP
R2 volume 0 Digits *
R3 volume 15 M-wave.L. 340
R4 volume 0 S-wave.L.
R1 diluent vol 0 Analy.Mthd EPA
R2 diluent vol 0 Calc.Mthd MSTD
R3 diluent vol 0 Qualit.judge Not do
R4 diluent vol 0 Calculation method setting
Serum reac.s.vol 10 M-DET.P.l 0
Serum dil.method NONE M-DET.P.m 94
Serum dil.s.vol 0 M-DET.P.n 98
Serum dil.volume 0 S-DET.P.p 42
Serum dil.posit 0 S-DET.P.r. 46
Reaction time 10 min. Check D.P.I. 0
Reagent 1 stir Weak Limit value 0.003
Reagent 2 stir Weak Variance 10.0
Reagent 3 stir Weak * Prozone
Reagent 4 stir Weak Prozone form NONE
Prozone limit
Reanalysis conditions Prozone judge
Serum reac.smp.vol (u) 20 M-DET.P.m
Serum dilut.method (u) NONE M-DET.P.n
Serum dil.smp.vol (u) 0 S-DET.P.p
Serum diluent vol (u) 0 S-DET.P.p
Serum diluent posi (u) 0 S-DET.r
Serum reac.smp.vol (d) 5 * Endpoint
Serum dilut.method (d) NONE Re.absorb (u) 1.700
Serum dil.smp.vol (d) 0 Re.absorb (d) -1.450
Serum diluent vol (d) 0
Serum diluent posi (d) 0
Standard settings Multi-STD
Formula LOGIT– LOG3 Axis conv. NO CONVERT Points 6
POS Coeff (FV) Dil.method Dil.smp.vol Diluent vol. Diluent pos. STD-H STD-L
BLK *
1 * ** NONE 0 0 0 9.999 -9.999
2 * ** NONE 0 0 0 9.999 -9.999
3 * ** NONE 0 0 0 9.999 -9.999
4 * ** NONE 0 0 0 9.999 -9.999
5 * ** NONE 0 0 0 9.999 -9.999
* Data entered by operator ** Concentration of standard
3. Order information CRP/AUT-000 1 x 10 mL Antiserum
5 x 25 mL Buffer CRP/STS-5X1 CRP Standard Set, 5 x 1 mL CRP/STH-001 CRP Standard High, 1 mL CRP/SST-001 CRP Standard Super High, 1 mL CRP/COL-001 CRP Control Low, 1 mL CRP/COH-001 CRP Control High, 1 mL 139F003 Immunology Control Low, 1mL 139F002 Immunology Control High, 1 mL
APTEC DIAGNOSTICS 31. 01.01
APPLICATION NOTE ADVIA 1650
HAPTOGLOBIN BI (AUT-KIT) 1. Reagent preparation Sample: Ready for use Reagent: Buffer, ready for use Start: Antiserum, ready for use Calibrator: Ready for use. Use saline 9 g/L as zero point.
2. Analytical Parameters (Chemistry) TYPE #
Analytical conditions Sub-analy. conditions
R1 volume 100 Name HAP
R2 volume 0 Digits *
R3 volume 15 M-wave.L. 340
R4 volume 0 S-wave.L.
R1 diluent vol 0 Analy.Mthd EPA
R2 diluent vol 0 Calc.Mthd MSTD
R3 diluent vol 0 Qualit.judge Not do
R4 diluent vol 0 Calculation method setting
Serum reac.s.vol 4 M-DET.P.l 0
Serum dil.method STD M-DET.P.m 94
Serum dil.s.vol 30 M-DET.P.n 98
Serum dil.volume 120 S-DET.P.p 42
Serum dil.posit 0 S-DET.P.r. 46
Reaction time 10 min. Check D.P.I. 0
Reagent 1 stir Weak Limit value 0.003
Reagent 2 stir Weak Variance 10.0
Reagent 3 stir Weak * Prozone
Reagent 4 stir Weak Prozone form NONE
Prozone limit
Reanalysis conditions Prozone judge
Serum reac.smp.vol (u) 4 M-DET.P.m
Serum dilut.method (u) NONE M-DET.P.n
Serum dil.smp.vol (u) 0 S-DET.P.p
Serum diluent vol (u) 0 S-DET.P.p
Serum diluent posi (u) 0 S-DET.r
Serum reac.smp.vol (d) 2 * Endpoint
Serum dilut.method (d) STD Re.absorb (u) 1.700
Serum dil.smp.vol (d) 30 Re.absorb (d) -1.450
Serum diluent vol (d) 120
Serum diluent posi (d) 0
Standard settings Multi-STD
Formula LOGIT– LOG3 Axis conv. NO CONVERT Points 5
POS Coeff (FV) Dil.method Dil.smp.vol Diluent vol. Diluent pos. STD-H STD-L
BLK *
1 * ** STD 30 120 0 9.999 -9.999
2 * ** STD 30 120 0 9.999 -9.999
3 * ** STD 30 120 0 9.999 -9.999
4 * ** STD 30 120 0 9.999 -9.999
5 * ** STD 30 120 0 9.999 -9.999
* Data entered by operator ** Concentration of standard
3. Order information HAP/AUT-000 1 x 10 mL Antiserum 5 x 25 mL Buffer MPS/STS-5X1 Protein Standard Set, 5 x 1 mL
139F003 Immunology Control Low, 1mL 139F002 Immunology Control High, 1 mL
APTEC DIAGNOSTICS 24.07.2014 APPLICATION TO BE VALIDATED BY THE USER
APPLICATION NOTE ADVIA 1650
IgA KIT 2nd Generation
1. Reagent preparation Sample: Ready for use. Reagent: Buffer, ready for use. Start: Antiserum, ready for use. Calibrator: Protein Standard Set, ready for use. Use saline 9 g/L as zero point.
2. Analytical Parameters (Chemistry) TYPE #
Analytical conditions Sub-analy. conditions
R1 volume 150 Name IgA
R2 volume 0 Digits *
R3 volume 15 M-wave.L. 340
R4 volume 0 S-wave.L.
R1 diluent vol 0 Analy.Mthd EPA
R2 diluent vol 0 Calc.Mthd MSTD
R3 diluent vol 0 Qualit.judge Not do
R4 diluent vol 0 Calculation method setting
Serum reac.s.vol 3 M-DET.P.l 0
Serum dil.method STD M-DET.P.m 94
Serum dil.s.vol 30 M-DET.P.n 98
Serum dil.volume 120 S-DET.P.p 42
Serum dil.posit 0 S-DET.P.r. 46
Reaction time 10 min. Check D.P.I. 0
Reagent 1 stir Weak Limit value 0.003
Reagent 2 stir Weak Variance 10.0
Reagent 3 stir Weak * Prozone
Reagent 4 stir Weak Prozone form NONE
Prozone limit
Reanalysis conditions Prozone judge
Serum reac.smp.vol (u) 6 M-DET.P.m
Serum dilut.method (u) STD M-DET.P.n
Serum dil.smp.vol (u) 30 S-DET.P.p
Serum diluent vol (u) 120 S-DET.P.p
Serum diluent posi (u) 0 S-DET.r
Serum reac.smp.vol (d) 3 * Endpoint
Serum dilut.method (d) SPECIAL Re.absorb (u) 1.700
Serum dil.smp.vol (d) 10 Re.absorb (d) -1.450
Serum diluent vol (d) 90
Serum diluent posi (d) 0
Standard settings Multi-STD
Formula LOGIT– LOG3 Axis conv. NO CONVERT Points 5
POS Coeff (FV) Dil.method Dil.smp.vol Diluent vol. Diluent pos. STD-H STD-L
BLK *
1 * ** STD 30 120 0 9.999 -9.999
2 * ** STD 30 120 0 9.999 -9.999
3 * ** STD 30 120 0 9.999 -9.999
4 * ** STD 30 120 0 9.999 -9.999
5 * ** STD 30 120 0 9.999 -9.999
* Data entered by operator ** Concentration of standard
3. Order information 104C002 1 x 10 mL Antiserum 5 x 25 mL Buffer MPS/STS-5X1 Protein Standard Set, 5 x 1 mL MPS/STH-001 Protein Standard High, 1 mL 139F003 Immunology Control Low, 1mL 139F002 Immunology Control High, 1 mL
APTEC DIAGNOSTICS 25.07.2014 APPLICATION TO BE VALIDATED BY THE USER
APPLICATION NOTE ADVIA 1650
IgG KIT 2nd Generation
1. Reagent preparation Sample: Ready for use. Reagent: Buffer, ready for use. Start: Antiserum, ready for use. Calibrator: Protein Standard Set, ready for use. Use saline 9 g/L as zero point.
2. Analytical Parameters (Chemistry) TYPE #
Analytical conditions Sub-analy. conditions
R1 volume 150 Name IgG2
R2 volume 0 Digits *
R3 volume 15 M-wave.L. 340
R4 volume 0 S-wave.L.
R1 diluent vol 0 Analy.Mthd EPA
R2 diluent vol 0 Calc.Mthd MSTD
R3 diluent vol 0 Qualit.judge Not do
R4 diluent vol 0 Calculation method setting
Serum reac.s.vol 3 M-DET.P.l 0
Serum dil.method SPECIAL M-DET.P.m 94
Serum dil.s.vol 5 M-DET.P.n 98
Serum dil.volume 120 S-DET.P.p 42
Serum dil.posit 0 S-DET.P.r. 46
Reaction time 10 min. Check D.P.I. 0
Reagent 1 stir Weak Limit value 0.003
Reagent 2 stir Weak Variance 10.0
Reagent 3 stir Weak * Prozone
Reagent 4 stir Weak Prozone form NONE
Prozone limit
Reanalysis conditions Prozone judge
Serum reac.smp.vol (u) 6 M-DET.P.m
Serum dilut.method (u) SPECIAL M-DET.P.n
Serum dil.smp.vol (u) 5 S-DET.P.p
Serum diluent vol (u) 120 S-DET.P.p
Serum diluent posi (u) 0 S-DET.r
Serum reac.smp.vol (d) 3 * Endpoint
Serum dilut.method (d) SPECIAL Re.absorb (u) 1.700
Serum dil.smp.vol (d) 5 Re.absorb (d) -1.450
Serum diluent vol (d) 245
Serum diluent posi (d) 0
Standard settings Multi-STD
Formula LOGIT– LOG3 Axis conv. NO CONVERT Points 5
POS Coeff (FV) Dil.method Dil.smp.vol Diluent vol. Diluent pos. STD-H STD-L
BLK *
1 * ** SPECIAL 5 120 0 9.999 -9.999
2 * ** SPECIAL 5 120 0 9.999 -9.999
3 * ** SPECIAL 5 120 0 9.999 -9.999
4 * ** SPECIAL 5 120 0 9.999 -9.999
5 * ** SPECIAL 5 120 0 9.999 -9.999
* Data entered by operator ** Concentration of standard
3. Order information 105C003 1 x 5 mL Antiserum 5 x 25 mL Buffer MPS/STS-5X1 Protein Standard Set, 5 x 1 mL MPS/STH-001 Protein Standard High, 1 mL 139F003 Immunology Control Low, 1mL 139F002 Immunology Control High, 1 mL
APTEC DIAGNOSTICS 24.07.2014 APPLICATION TO BE VALIDATED BY THE USER
APPLICATION NOTE ADVIA 1650
IgM KIT 2nd Generation
1. Reagent preparation Sample: Ready for use. Reagent: Buffer, ready for use. Start: Antiserum, ready for use. Calibrator: Protein Standard Set, ready for use. Use saline 9 g/L as zero point.
2. Analytical Parameters (Chemistry) TYPE #
Analytical conditions Sub-analy. conditions
R1 volume 150 Name IgM
R2 volume 0 Digits *
R3 volume 15 M-wave.L. 340
R4 volume 0 S-wave.L.
R1 diluent vol 0 Analy.Mthd EPA
R2 diluent vol 0 Calc.Mthd MSTD
R3 diluent vol 0 Qualit.judge Not do
R4 diluent vol 0 Calculation method setting
Serum reac.s.vol 9 M-DET.P.l 0
Serum dil.method SPECIAL M-DET.P.m 94
Serum dil.s.vol 10 M-DET.P.n 98
Serum dil.volume 90 S-DET.P.p 42
Serum dil.posit 0 S-DET.P.r. 46
Reaction time 10 min. Check D.P.I. 0
Reagent 1 stir Weak Limit value 0.003
Reagent 2 stir Weak Variance 10.0
Reagent 3 stir Weak * Prozone
Reagent 4 stir Weak Prozone form NONE
Prozone limit
Reanalysis conditions Prozone judge
Serum reac.smp.vol (u) 2 M-DET.P.m
Serum dilut.method (u) NONE M-DET.P.n
Serum dil.smp.vol (u) 0 S-DET.P.p
Serum diluent vol (u) 0 S-DET.P.p
Serum diluent posi (u) 0 S-DET.r
Serum reac.smp.vol (d) 4 * Endpoint
Serum dilut.method (d) SPECIAL Re.absorb (u) 1.700
Serum dil.smp.vol (d) 10 Re.absorb (d) -1.450
Serum diluent vol (d) 90
Serum diluent posi (d) 0
Standard settings Multi-STD
Formula LOGIT– LOG3 Axis conv. NO CONVERT Points 5
POS Coeff (FV) Dil.method Dil.smp.vol Diluent vol. Diluent pos. STD-H STD-L
BLK *
1 * ** SPECIAL 10 90 0 9.999 -9.999
2 * ** SPECIAL 10 90 0 9.999 -9.999
3 * ** SPECIAL 10 90 0 9.999 -9.999
4 * ** SPECIAL 10 90 0 9.999 -9.999
5 * ** SPECIAL 10 90 0 9.999 -9.999
* Data entered by operator ** Concentration of standard
3. Order information 106C002 1 x 10 mL Antiserum 5 x 25 mL Buffer MPS/STS-5X1 Protein Standard Set, 5 x 1 mL MPS/STH-001 Protein Standard High, 1 mL 139F003 Immunology Control Low, 1mL 139F002 Immunology Control High, 1 mL
APTEC DIAGNOSTICS 25.07.2014 APPLICATION TO BE VALIDATED BY THE USER
APPLICATION NOTE ADVIA 1650
Microalbumin KIT 2nd Generation
1. Reagent preparation Sample: Centrifugen urine, ready for use. Reagent: Buffer, ready for use. Start: Antiserum, ready for use. Calibrator: Microalbumin Standard Set, ready for use. Use saline 9 g/L as zero point.
2. Analytical Parameters (Chemistry) TYPE #
Analytical conditions Sub-analy. conditions
R1 volume 95 Name MAL
R2 volume 0 Digits *
R3 volume 15 M-wave.L. 340
R4 volume 0 S-wave.L.
R1 diluent vol 0 Analy.Mthd EPA
R2 diluent vol 0 Calc.Mthd MSTD
R3 diluent vol 0 Qualit.judge Not do
R4 diluent vol 0 Calculation method setting
Serum reac.s.vol 6 M-DET.P.l 0
Serum dil.method NONE M-DET.P.m 94
Serum dil.s.vol 0 M-DET.P.n 98
Serum dil.volume 0 S-DET.P.p 42
Serum dil.posit 0 S-DET.P.r. 46
Reaction time 10 min. Check D.P.I. 0
Reagent 1 stir Weak Limit value 0.003
Reagent 2 stir Weak Variance 10.0
Reagent 3 stir Weak * Prozone
Reagent 4 stir Weak Prozone form NONE
Prozone limit
Reanalysis conditions Prozone judge
Serum reac.smp.vol (u) 12 M-DET.P.m
Serum dilut.method (u) NONE M-DET.P.n
Serum dil.smp.vol (u) 0 S-DET.P.p
Serum diluent vol (u) 0 S-DET.P.p
Serum diluent posi (u) 0 S-DET.r
Serum reac.smp.vol (d) 3 * Endpoint
Serum dilut.method (d) NONE Re.absorb (u) 1.700
Serum dil.smp.vol (d) 0 Re.absorb (d) -1.450
Serum diluent vol (d) 0
Serum diluent posi (d) 0
Standard settings Multi-STD
Formula LOGIT-LOG3 Axis conv. NO CONVERT Points 6
POS Coeff (FV) Dil.method Dil.smp.vol Diluent vol. Diluent pos. STD-H STD-L
BLK *
1 * ** NONE 0 0 0 9.999 -9.999
2 * ** NONE 0 0 0 9.999 -9.999
3 * ** NONE 0 0 0 9.999 -9.999
4 * ** NONE 0 0 0 9.999 -9.999
5 * ** NONE 0 0 0 9.999 -9.999
* Data entered by operator ** Concentration of standard
3. Order information 102C002 1 x 10 mL Antiserum 5 x 25 mL Buffer MAL/STS-5x1 Microalbumin Standard Set, 5 x 1 mL MAL/STD-001 Microalbumin Standard, 1 mL MAL/CON-001 Microalbumin Control, 1 mL 102F003 Microalbumin Control Low, 1 mL
APTEC DIAGNOSTICS 15.03.2004
APPLICATION NOTE ADVIA 1650
PREALBUMIN BI (AUT-KIT)
1. Reagent preparation Sample: Ready for use Reagent: Buffer, ready for use Start: Antiserum, ready for use Calibrator: Protein standard set, ready for use.
2. Analytical Parameters (Chemistry) TYPE #
Analytical conditions Sub-analy. conditions
R1 volume 100 Name PAL
R2 volume 0 Digits *
R3 volume 15 M-wave.L. 340
R4 volume 0 S-wave.L.
R1 diluent vol 0 Analy.Mthd EPA
R2 diluent vol 0 Calc.Mthd MSTD
R3 diluent vol 0 Qualit.judge Not do
R4 diluent vol 0 Calculation method setting
Serum reac.s.vol 6 M-DET.P.l 0
Serum dil.method STD M-DET.P.m 94
Serum dil.s.vol 30 M-DET.P.n 98
Serum dil.volume 120 S-DET.P.p 42
Serum dil.posit 0 S-DET.P.r. 46
Reaction time 10 min. Check D.P.I. 0
Reagent 1 stir Weak Limit value 0.003
Reagent 2 stir Weak Variance 10.0
Reagent 3 stir Weak * Prozone
Reagent 4 stir Weak Prozone form NONE
Prozone limit
Reanalysis conditions Prozone judge
Serum reac.smp.vol (u) 12 M-DET.P.m
Serum dilut.method (u) STD M-DET.P.n
Serum dil.smp.vol (u) 30 S-DET.P.p
Serum diluent vol (u) 120 S-DET.P.p
Serum diluent posi (u) 0 S-DET.r
Serum reac.smp.vol (d) 3 * Endpoint
Serum dilut.method (d) STD Re.absorb (u) 1.700
Serum dil.smp.vol (d) 30 Re.absorb (d) -1.450
Serum diluent vol (d) 120
Serum diluent posi (d) 0
Standard settings Multi-STD
Formula LOGIT– LOG3 Axis conv. NO CONVERT Points 5
POS Coeff (FV) Dil.method Dil.smp.vol Diluent vol. Diluent pos. STD-H STD-L
BLK *
1 * ** STD 30 120 0 9.999 -9.999
2 * ** STD 30 120 0 9.999 -9.999
3 * ** STD 30 120 0 9.999 -9.999
4 * ** STD 30 120 0 9.999 -9.999
5 * ** STD 30 120 0 9.999 -9.999
* Data entered by operator ** Concentration of standard
3. Order information PAL/AUT-000 1 x 10 mL Antiserum 5 x 25 mL Buffer MPS/STS-5X1 Protein Standard Set, 5 x 1 mL
139F003 Immunology Control Low, 1mL 139F002 Immunology Control High, 1 mL
APTEC DIAGNOSTICS 28.07.2014 APPLICATIONS TO BE VALIDATED BY THE USER
APPLICATION NOTE ADVIA 1650
Prealbumin AUT KIT
1. Reagent preparation Sample: Ready for use. Reagent: Buffer, ready for use. Start: Antiserum, ready for use. Calibrator: Protein Standard Set, ready for use. Use saline 9 g/L as zero point.
2. Analytical Parameters (Chemistry) TYPE #
Analytical conditions Sub-analy. conditions
R1 volume 150 Name PAL
R2 volume 0 Digits *
R3 volume 15 M-wave.L. 340
R4 volume 0 S-wave.L.
R1 diluent vol 0 Analy.Mthd EPA
R2 diluent vol 0 Calc.Mthd MSTD
R3 diluent vol 0 Qualit.judge Not do
R4 diluent vol 0 Calculation method setting
Serum reac.s.vol 6 M-DET.P.l 0
Serum dil.method STD M-DET.P.m 94
Serum dil.s.vol 30 M-DET.P.n 98
Serum dil.volume 120 S-DET.P.p 42
Serum dil.posit 0 S-DET.P.r. 46
Reaction time 10 min. Check D.P.I. 0
Reagent 1 stir Weak Limit value 0.003
Reagent 2 stir Weak Variance 10.0
Reagent 3 stir Weak * Prozone
Reagent 4 stir Weak Prozone form NONE
Prozone limit
Reanalysis conditions Prozone judge
Serum reac.smp.vol (u) 12 M-DET.P.m
Serum dilut.method (u) STD M-DET.P.n
Serum dil.smp.vol (u) 30 S-DET.P.p
Serum diluent vol (u) 120 S-DET.P.p
Serum diluent posi (u) 0 S-DET.r
Serum reac.smp.vol (d) 3 * Endpoint
Serum dilut.method (d) STD Re.absorb (u) 1.700
Serum dil.smp.vol (d) 30 Re.absorb (d) -1.450
Serum diluent vol (d) 120
Serum diluent posi (d) 0
Standard settings Multi-STD
Formula LOGIT– LOG3 Axis conv. NO CONVERT Points 5
POS Coeff (FV) Dil.method Dil.smp.vol Diluent vol. Diluent pos. STD-H STD-L
BLK *
1 * ** STD 30 120 0 9.999 -9.999
2 * ** STD 30 120 0 9.999 -9.999
3 * ** STD 30 120 0 9.999 -9.999
4 * ** STD 30 120 0 9.999 -9.999
5 * ** STD 30 120 0 9.999 -9.999
* Data entered by operator ** Concentration of standard
3. Order information PAL/AUT-000 1 x 10 mL Antiserum 5 x 25 mL Buffer MPS/STS-5X1 Protein Standard Set, 5 x 1 mL MPS/STH-001 Protein Standard High, 1 mL 139F003 Immunology Control Low, 1mL 139F002 Immunology Control High, 1 mL
APTEC DIAGNOSTICS 24.07.2014 APPLICATION TO BE VALIDATED BY THE USER
APPLICATION NOTE ADVIA 1650
Rheumatoid Factor KIT 3rd Generation
1. Reagent preparation Sample: Ready for use. Reagent: Ready for use. Buffer: Ready for use. Calibrator: RF Standard Set, ready for use. Use NaCL 9 g/L as zero point.
2. Analytical Parameters (Chemistry) TYPE #
Analytical conditions Sub-analy. conditions
R1 volume 85 Name RF
R2 volume 0 Digits *
R3 volume 17 M-wave.L. 340
R4 volume 0 S-wave.L.
R1 diluent vol 0 Analy.Mthd EPA
R2 diluent vol 0 Calc.Mthd MSTD
R3 diluent vol 0 Qualit.judge Not do
R4 diluent vol 0 Calculation method setting
Serum reac.s.vol 25 M-DET.P.l 0
Serum dil.method STD M-DET.P.m 94
Serum dil.s.vol 30 M-DET.P.n 98
Serum dil.volume 120 S-DET.P.p 42
Serum dil.posit 0 S-DET.P.r. 46
Reaction time 10 min. Check D.P.I. 0
Reagent 1 stir Weak Limit value 0.003
Reagent 2 stir Weak Variance 10.0
Reagent 3 stir Weak * Prozone
Reagent 4 stir Weak Prozone form NONE
Prozone limit
Reanalysis conditions Prozone judge
Serum reac.smp.vol (u) 10 M-DET.P.m
Serum dilut.method (u) NONE M-DET.P.n
Serum dil.smp.vol (u) 0 S-DET.P.p
Serum diluent vol (u) 0 S-DET.P.p
Serum diluent posi (u) 0 S-DET.r
Serum reac.smp.vol (d) 12 * Endpoint
Serum dilut.method (d) STD Re.absorb (u) 1.700
Serum dil.smp.vol (d) 30 Re.absorb (d) -1.450
Serum diluent vol (d) 120
Serum diluent posi (d) 0
Standard settings Multi-STD
Formula LOGIT– LOG3 Axis conv. NO CONVERT Points 6
POS Coeff (FV) Dil.method Dil.smp.vol Diluent vol. Diluent pos. STD-H STD-L
BLK *
1 * ** STD 30 120 0 9.999 -9.999
2 * ** STD 30 120 0 9.999 -9.999
3 * ** STD 30 120 0 9.999 -9.999
4 * ** STD 30 120 0 9.999 -9.999
5 * ** STD 30 120 0 9.999 -9.999
* Data entered by operator ** Concentration of standard
3. Order information 100C011 1 x 25 mL Reagent 5 x 25 mL Buffer RHF/STS-5x1 RF Standard Set, 5 x 1 mL RHF/SST-001 RF Standard Super High, 1 mL RHF/SSH-001 RF Standard High, 1 mL RHF/CON-001 RF Control, 1 mL 139F003 Immunology Control Low, 1mL 139F002 Immunology Control High, 1 mL
