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