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APTEC DIAGNOSTICS 23.07.2014 APPLICATION TO BE VALIDATED BY THE USER
APPLICATION NOTE ADVIA 2400
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 15 Digits 1
R1 diluent vol 0 M-wave.L. 340
R2 diluent vol 0 S-wave.L.
Serum reac.s.vol 4 Analy.Mthd EPA
Serum dil.method STD Calc.Mthd MSTD
Serum dil.s.vol 30 Qualit.judge Not do
Serum dil.volume 120 Calculation method setting
Serum dil.posit 0 M-DET.P.l 0
Reaction time 10 min. M-DET.P.m 40
Reagent 1 stir Weak M-DET.P.n 41
Reagent 2 stir Weak S-DET.P.p 20
Reanalysis conditions S-DET.P.r. 21
Serum reac.smp.vol (u) 10 Check D.P.I. 0
Serum dilut.method (u) STD Limit value 0.003
Serum dil.smp.vol (u) 30 Variance 10.0
Serum diluent vol (u) 120 * Prozone
Serum diluent posi (u) 0 Prozone form NONE
Serum reac.smp.vol (d) 2 Prozone limit 9.999
Serum dilut.method (d) STD Prozone judge Upper limit
Serum dil.smp.vol (d) 30 M-DET.P.m 0
Serum diluent vol (d) 120 M-DET.P.n 0
Serum diluent posi (d) 0 S-DET.P.p 0
S-DET.P.p 0
Reaction rate method
Cycle 2 * Endpoint
Factor 2 Re.absorb (u) 9.999
E2 corre Not do Re.absorb (d) -9.999
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 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 2400
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 15 Digits *
R1 diluent vol 0 M-wave.L. 340
R2 diluent vol 0 S-wave.L.
Serum reac.s.vol 5 Analy.Mthd EPA
Serum dil.method SPECIAL Calc.Mthd MSTD
Serum dil.s.vol 10 Qualit.judge Not do
Serum dil.volume 90 Calculation method setting
Serum dil.posit 0 M-DET.P.l 0
Reaction time 10 min. M-DET.P.m 40
Reagent 1 stir Weak M-DET.P.n 41
Reagent 2 stir Weak S-DET.P.p 20
Reanalysis conditions S-DET.P.r. 21
Serum reac.smp.vol (u) 10 Check D.P.I. 0
Serum dilut.method (u) SPECIAL Limit value 0.003
Serum dil.smp.vol (u) 10 Variance 10.0
Serum diluent vol (u) 90 * Prozone
Serum diluent posi (u) 0 Prozone form NONE
Serum reac.smp.vol (d) 2 Prozone limit 9.999
Serum dilut.method (d) SPECIAL Prozone judge Upper limit
Serum dil.smp.vol (d) 10 M-DET.P.m 0
Serum diluent vol (d) 90 M-DET.P.n 0
Serum diluent posi (d) 0 S-DET.P.p 0
S-DET.P.p 0
Reaction rate method
Cycle 2 * Endpoint
Factor 2 Re.absorb (u) 9.999
E2 corre Not do Re.absorb (d) -9.999
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 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 2400
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 18 Digits *
R1 diluent vol 0 M-wave.L. 340
R2 diluent vol 0 S-wave.L.
Serum reac.s.vol 3 Analy.Mthd EPA
Serum dil.method STD Calc.Mthd MSTD
Serum dil.s.vol 30 Qualit.judge Not do
Serum dil.volume 120 Calculation method setting
Serum dil.posit 0 M-DET.P.l 0
Reaction time 10 min. M-DET.P.m 40
Reagent 1 stir Weak M-DET.P.n 41
Reagent 2 stir Weak S-DET.P.p 20
Reanalysis conditions S-DET.P.r. 21
Serum reac.smp.vol (u) 2 Check D.P.I. 0
Serum dilut.method (u) SPECIAL Limit value 0.003
Serum dil.smp.vol (u) 0 Variance 10.0
Serum diluent vol (u) 0 * Prozone
Serum diluent posi (u) 0 Prozone form NONE
Serum reac.smp.vol (d) 3 Prozone limit 9.999
Serum dilut.method (d) SPECIAL Prozone judge Upper limit
Serum dil.smp.vol (d) 10 M-DET.P.m 0
Serum diluent vol (d) 90 M-DET.P.n 0
Serum diluent posi (d) 0 S-DET.P.p 0
S-DET.P.p 0
Reaction rate method
Cycle 2 * Endpoint
Factor 2 Re.absorb (u) 9.999
E2 corre Not do Re.absorb (d) -9.999
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 2400
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 20 Digits 1
R1 diluent vol 0 M-wave.L. 694
R2 diluent vol 0 S-wave.L. NO
Serum reac.s.vol 7 Analy.Mthd EPA
Serum dil.method STD Calc.Mthd MSTD
Serum dil.s.vol 30 Qualit.judge Not do
Serum dil.volume 120 Calculation method setting
Serum dil.posit 0 M-DET.P.l 0
Reaction time 10 min. M-DET.P.m 40
Reagent 1 stir Weak M-DET.P.n 41
Reagent 2 stir Weak S-DET.P.p 20
Reanalysis conditions S-DET.P.r. 21
Serum reac.smp.vol (u) 14 Check D.P.I. 0
Serum dilut.method (u) STD Limit value 0.003
Serum dil.smp.vol (u) 30 Variance 10.0
Serum diluent vol (u) 120 * Prozone
Serum diluent posi (u) 0 Prozone form NONE
Serum reac.smp.vol (d) 3 Prozone limit 9.999
Serum dilut.method (d) STD Prozone judge Upper limit
Serum dil.smp.vol (d) 30 M-DET.P.m 0
Serum diluent vol (d) 120 M-DET.P.n 0
Serum diluent posi (d) 0 S-DET.P.p 0
S-DET.P.p 0
Reaction rate method
Cycle 2 * Endpoint
Factor 2 Re.absorb (u) 9.999
E2 corre Not do Re.absorb (d) -9.999
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
* 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 2400
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 16 Digits 1
R1 diluent vol 0 M-wave.L. 340
R2 diluent vol 0 S-wave.L.
Serum reac.s.vol 6 Analy.Mthd EPA
Serum dil.method STD Calc.Mthd MSTD
Serum dil.s.vol 30 Qualit.judge Not do
Serum dil.volume 120 Calculation method setting
Serum dil.posit 0 M-DET.P.l 0
Reaction time 10 min. M-DET.P.m 40
Reagent 1 stir Weak M-DET.P.n 41
Reagent 2 stir Weak S-DET.P.p 20
Reanalysis conditions S-DET.P.r. 21
Serum reac.smp.vol (u) 12 Check D.P.I. 0
Serum dilut.method (u) STD Limit value 0.003
Serum dil.smp.vol (u) 30 Variance 10.0
Serum diluent vol (u) 120 * Prozone
Serum diluent posi (u) 0 Prozone form NONE
Serum reac.smp.vol (d) 3 Prozone limit 9.999
Serum dilut.method (d) STD Prozone judge Upper limit
Serum dil.smp.vol (d) 30 M-DET.P.m 0
Serum diluent vol (d) 120 M-DET.P.n 0
Serum diluent posi (d) 0 S-DET.P.p 0
S-DET.P.p 0
Reaction rate method
Cycle 2 * Endpoint
Factor 2 Re.absorb (u) 9.999
E2 corre Not do Re.absorb (d) -9.999
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 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 2400
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 16 Digits 1
R1 diluent vol 0 M-wave.L. 340
R2 diluent vol 0 S-wave.L.
Serum reac.s.vol 8 Analy.Mthd EPA
Serum dil.method STD Calc.Mthd MSTD
Serum dil.s.vol 30 Qualit.judge Not do
Serum dil.volume 120 Calculation method setting
Serum dil.posit 0 M-DET.P.l 0
Reaction time 10 min. M-DET.P.m 40
Reagent 1 stir Weak M-DET.P.n 41
Reagent 2 stir Weak S-DET.P.p 20
Reanalysis conditions S-DET.P.r. 21
Serum reac.smp.vol (u) 16 Check D.P.I. 0
Serum dilut.method (u) STD Limit value 0.003
Serum dil.smp.vol (u) 30 Variance 10.0
Serum diluent vol (u) 120 * Prozone
Serum diluent posi (u) 0 Prozone form NONE
Serum reac.smp.vol (d) 4 Prozone limit 9.999
Serum dilut.method (d) STD Prozone judge Upper limit
Serum dil.smp.vol (d) 30 M-DET.P.m 0
Serum diluent vol (d) 120 M-DET.P.n 0
Serum diluent posi (d) 0 S-DET.P.p 0
S-DET.P.p 0
Reaction rate method
Cycle 2 * Endpoint
Factor 2 Re.absorb (u) 9.999
E2 corre Not do Re.absorb (d) -9.999
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 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 2400
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 15 Digits 1
R1 diluent vol 0 M-wave.L. 340
R2 diluent vol 0 S-wave.L.
Serum reac.s.vol 5 Analy.Mthd EPA
Serum dil.method STD Calc.Mthd MSTD
Serum dil.s.vol 30 Qualit.judge Not do
Serum dil.volume 120 Calculation method setting
Serum dil.posit 0 M-DET.P.l 0
Reaction time 10 min. M-DET.P.m 40
Reagent 1 stir Weak M-DET.P.n 41
Reagent 2 stir Weak S-DET.P.p 20
Reanalysis conditions S-DET.P.r. 21
Serum reac.smp.vol (u) 2 Check D.P.I. 0
Serum dilut.method (u) NONE Limit value 0.003
Serum dil.smp.vol (u) 0 Variance 10.0
Serum diluent vol (u) 0 * Prozone
Serum diluent posi (u) 0 Prozone form NONE
Serum reac.smp.vol (d) 2 Prozone limit 9.999
Serum dilut.method (d) STD Prozone judge Upper limit
Serum dil.smp.vol (d) 30 M-DET.P.m 0
Serum diluent vol (d) 120 M-DET.P.n 0
Serum diluent posi (d) 0 S-DET.P.p 0
S-DET.P.p 0
Reaction rate method
Cycle 2 * Endpoint
Factor 2 Re.absorb (u) 9.999
E2 corre Not do Re.absorb (d) -9.999
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 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
APPLICATION NOTE ADVIA 2400
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 15 Digits 1
R1 diluent vol 0 M-wave.L. 340
R2 diluent vol 0 S-wave.L.
Serum reac.s.vol 10 Analy.Mthd EPA
Serum dil.method NONE Calc.Mthd MSTD
Serum dil.s.vol 0 Qualit.judge Not do
Serum dil.volume 0 Calculation method setting
Serum dil.posit 0 M-DET.P.l 0
Reaction time 10 min. M-DET.P.m 40
Reagent 1 stir Weak M-DET.P.n 41
Reagent 2 stir Weak S-DET.P.p 20
Reanalysis conditions S-DET.P.r. 21
Serum reac.smp.vol (u) 20 Check D.P.I. 0
Serum dilut.method (u) NONE Limit value 0.003
Serum dil.smp.vol (u) 0 Variance 10.0
Serum diluent vol (u) 0 * Prozone
Serum diluent posi (u) 0 Prozone form NONE
Serum reac.smp.vol (d) 5 Prozone limit 9.999
Serum dilut.method (d) NONE Prozone judge Upper limit
Serum dil.smp.vol (d) 0 M-DET.P.m 0
Serum diluent vol (d) 0 M-DET.P.n 0
Serum diluent posi (d) 0 S-DET.P.p 0
S-DET.P.p 0
Reaction rate method
Cycle 2 * Endpoint
Factor 2 Re.absorb (u) 9.999
E2 corre Not do Re.absorb (d) -9.999
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 24.07.2014 APPLICATION TO BE VALDATED BY THE USER
APPLICATION NOTE ADVIA 2400
IgA KIT 2nd Generation
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 150 Name IGA
R2 volume 15 Digits 1
R1 diluent vol 0 M-wave.L. 340
R2 diluent vol 0 S-wave.L.
Serum reac.s.vol 3 Analy.Mthd EPA
Serum dil.method STD Calc.Mthd MSTD
Serum dil.s.vol 30 Qualit.judge Not do
Serum dil.volume 120 Calculation method setting
Serum dil.posit 0 M-DET.P.l 0
Reaction time 10 min. M-DET.P.m 40
Reagent 1 stir Weak M-DET.P.n 41
Reagent 2 stir Weak S-DET.P.p 20
Reanalysis conditions S-DET.P.r. 21
Serum reac.smp.vol (u) 6 Check D.P.I. 0
Serum dilut.method (u) STD Limit value 0.003
Serum dil.smp.vol (u) 30 Variance 10.0
Serum diluent vol (u) 120 * Prozone
Serum diluent posi (u) 0 Prozone form NONE
Serum reac.smp.vol (d) 3 Prozone limit 9.999
Serum dilut.method (d) SPECIAL Prozone judge Upper limit
Serum dil.smp.vol (d) 10 M-DET.P.m 0
Serum diluent vol (d) 90 M-DET.P.n 0
Serum diluent posi (d) 0 S-DET.P.p 0
S-DET.P.p 0
Reaction rate method
Cycle 2 * Endpoint
Factor 2 Re.absorb (u) 9.999
E2 corre Not do Re.absorb (d) -9.999
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 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 2400
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 15 Digits 1
R1 diluent vol 0 M-wave.L. 340
R2 diluent vol 0 S-wave.L.
Serum reac.s.vol 3 Analy.Mthd EPA
Serum dil.method SPECIAL Calc.Mthd MSTD
Serum dil.s.vol 5 Qualit.judge Not do
Serum dil.volume 120 Calculation method setting
Serum dil.posit 0 M-DET.P.l 0
Reaction time 10 min. M-DET.P.m 40
Reagent 1 stir Weak M-DET.P.n 41
Reagent 2 stir Weak S-DET.P.p 20
Reanalysis conditions S-DET.P.r. 21
Serum reac.smp.vol (u) 6 Check D.P.I. 0
Serum dilut.method (u) SPECIAL Limit value 0.003
Serum dil.smp.vol (u) 5 Variance 10.0
Serum diluent vol (u) 120 * Prozone
Serum diluent posi (u) 0 Prozone form NONE
Serum reac.smp.vol (d) 3 Prozone limit 9.999
Serum dilut.method (d) Special Prozone judge Upper limit
Serum dil.smp.vol (d) 5 M-DET.P.m 0
Serum diluent vol (d) 245 M-DET.P.n 0
Serum diluent posi (d) 0 S-DET.P.p 0
S-DET.P.p 0
Reaction rate method
Cycle 2 * Endpoint
Factor 2 Re.absorb (u) 9.999
E2 corre Not do Re.absorb (d) -9.999
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 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 2400
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 15 Digits 1
R1 diluent vol 0 M-wave.L. 340
R2 diluent vol 0 S-wave.L.
Serum reac.s.vol 9 Analy.Mthd EPA
Serum dil.method SPECIAL Calc.Mthd MSTD
Serum dil.s.vol 10 Qualit.judge Not do
Serum dil.volume 90 Calculation method setting
Serum dil.posit 0 M-DET.P.l 0
Reaction time 10 min. M-DET.P.m 40
Reagent 1 stir Weak M-DET.P.n 41
Reagent 2 stir Weak S-DET.P.p 20
Reanalysis conditions S-DET.P.r. 21
Serum reac.smp.vol (u) 2 Check D.P.I. 0
Serum dilut.method (u) NONE Limit value 0.003
Serum dil.smp.vol (u) 0 Variance 10.0
Serum diluent vol (u) 0 * Prozone
Serum diluent posi (u) 0 Prozone form NONE
Serum reac.smp.vol (d) 4 Prozone limit 9.999
Serum dilut.method (d) SPECIAL Prozone judge Upper limit
Serum dil.smp.vol (d) 10 M-DET.P.m 0
Serum diluent vol (d) 90 M-DET.P.n 0
Serum diluent posi (d) 0 S-DET.P.p 0
S-DET.P.p 0
Reaction rate method
Cycle 2 * Endpoint
Factor 2 Re.absorb (u) 9.999
E2 corre Not do Re.absorb (d) -9.999
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 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 2400
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 15 Digits 1
R1 diluent vol 0 M-wave.L. 340
R2 diluent vol 0 S-wave.L.
Serum reac.s.vol 6 Analy.Mthd EPA
Serum dil.method NONE Calc.Mthd MSTD
Serum dil.s.vol 0 Qualit.judge Not do
Serum dil.volume 0 Calculation method setting
Serum dil.posit 0 M-DET.P.l 0
Reaction time 10 min. M-DET.P.m 40
Reagent 1 stir Weak M-DET.P.n 41
Reagent 2 stir Weak S-DET.P.p 20
Reanalysis conditions S-DET.P.r. 21
Serum reac.smp.vol (u) 12 Check D.P.I. 0
Serum dilut.method (u) NONE Limit value 0.003
Serum dil.smp.vol (u) 0 Variance 10.0
Serum diluent vol (u) 0 * Prozone
Serum diluent posi (u) 0 Prozone form NONE
Serum reac.smp.vol (d) 3 Prozone limit 9.999
Serum dilut.method (d) NONE Prozone judge Upper limit
Serum dil.smp.vol (d) 0 M-DET.P.m 0
Serum diluent vol (d) 0 M-DET.P.n 0
Serum diluent posi (d) 0 S-DET.P.p 0
S-DET.P.p 0
Reaction rate method
Cycle 2 * Endpoint
Factor 2 Re.absorb (u) 9.999
E2 corre Not do Re.absorb (d) -9.999
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 28.07.2014 APPLICATIONS TO BE VALIDATED BY THE USER
APPLICATION NOTE ADVIA 2400
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 15 Digits 1
R1 diluent vol 0 M-wave.L. 340
R2 diluent vol 0 S-wave.L.
Serum reac.s.vol 6 Analy.Mthd EPA
Serum dil.method STD Calc.Mthd MSTD
Serum dil.s.vol 30 Qualit.judge Not do
Serum dil.volume 120 Calculation method setting
Serum dil.posit 0 M-DET.P.l 0
Reaction time 10 min. M-DET.P.m 40
Reagent 1 stir Weak M-DET.P.n 41
Reagent 2 stir Weak S-DET.P.p 20
Reanalysis conditions S-DET.P.r. 21
Serum reac.smp.vol (u) 12 Check D.P.I. 0
Serum dilut.method (u) STD Limit value 0.003
Serum dil.smp.vol (u) 30 Variance 10.0
Serum diluent vol (u) 120 * Prozone
Serum diluent posi (u) 0 Prozone form NONE
Serum reac.smp.vol (d) 3 Prozone limit 9.999
Serum dilut.method (d) STD Prozone judge Upper limit
Serum dil.smp.vol (d) 30 M-DET.P.m 0
Serum diluent vol (d) 120 M-DET.P.n 0
Serum diluent posi (d) 0 S-DET.P.p 0
S-DET.P.p 0
Reaction rate method
Cycle 2 * Endpoint
Factor 2 Re.absorb (u) 9.999
E2 corre Not do Re.absorb (d) -9.999
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 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 2400
Rheumatoid Factor KIT 3rd Generation
1. Reagent preparation Sample: Ready for use Reagent: Buffer, ready for use Start: Reagent, 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 17 Digits 1
R1 diluent vol 0 M-wave.L. 340
R2 diluent vol 0 S-wave.L.
Serum reac.s.vol 25 Analy.Mthd EPA
Serum dil.method STD Calc.Mthd MSTD
Serum dil.s.vol 30 Qualit.judge Not do
Serum dil.volume 120 Calculation method setting
Serum dil.posit 0 M-DET.P.l 0
Reaction time 10 min. M-DET.P.m 40
Reagent 1 stir Weak M-DET.P.n 41
Reagent 2 stir Weak S-DET.P.p 20
Reanalysis conditions S-DET.P.r. 21
Serum reac.smp.vol (u) 10 Check D.P.I. 0
Serum dilut.method (u) NONE Limit value 0.003
Serum dil.smp.vol (u) 0 Variance 10.0
Serum diluent vol (u) 0 * Prozone
Serum diluent posi (u) 0 Prozone form NONE
Serum reac.smp.vol (d) 12 Prozone limit 9.999
Serum dilut.method (d) STD Prozone judge Upper limit
Serum dil.smp.vol (d) 30 M-DET.P.m 0
Serum diluent vol (d) 120 M-DET.P.n 0
Serum diluent posi (d) 0 S-DET.P.p 0
S-DET.P.p 0
Reaction rate method
Cycle 2 * Endpoint
Factor 2 Re.absorb (u) 9.999
E2 corre Not do Re.absorb (d) -9.999
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
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
