APPLICATION NOTE MINDRAY BS-120 / BS-200 Acid

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APPLICATION NOTEMINDRAY BS-120 / BS-200α1 – Acid Glycoprotein AUT KITNo Sample Dilution1. Reagent and sample preparationSample:Ready for useBuffer (R1):Ready for useAntiserum (R2): Ready for useCalibration:Dilute the Protein Standard High successively 1:2 in NaCl 9 g/L in order to set up acalibration curve or use the ready for use Protein Standard Set.Use NaCl 9 g/L as zero point.2. Instrument settingNo.UnitSample Vol.Inc. TimeR. Time*mg/dL310-1 / 20R1 BlankL LimitU LimitMix. R Blank00L Limit00U LimitRef. Interval**LowHighAssayPrecisionR1 Vol.AntigenSubstrateAGP24350ParametersTypePrim. Wave.R2 Vol.ResponseL LimitU LimitLinearityL LimitU LimitCal. TypeCalibratorEndpoint340600000ReactionSec. Wave.Lin. LimitS. VolumeRatioAscending02000Full NamePrint No.AGP1CalibrationLogit- Log 5Multical* entered by the user3. Ordering informationAGP/AUT-000 1 x 10 mL Antiserum5 x 25 mL BufferMPS/STH-001 Protein Standard High, 1 mLMPS/STS-5X1 Protein Standard Set, 5 x 1 mL139F003Immunology Control Low, 1mL139F002Immunology Control High, 1 mLAPTEC DIAGNOSTICSAPPLICATION TO BE VALIDATED BY THE USER05.07.2011 – v2

APPLICATION NOTEMINDRAY BS-120 / BS-200α1 – Acid Glycoprotein SD KIT1. Reagent and sample preparationSample:Dilute samples and controls 1/10Buffer (R1):Ready for useAntiserum (R2): Ready for useCalibration:Dilute the Protein Standard High successively 1:10 in NaCl 9 g/L in order to set up acalibration curve.Use NaCl 9 g/L as zero point.2. Instrument settingNo.UnitSample Vol.Inc. TimeR. Time*mg/dL510-1 / 20R1 BlankL LimitU LimitMix. R Blank00L Limit00U LimitRef. Interval**LowHighAssayPrecisionR1 Vol.AntigenSubstrateAGP22500ParametersTypePrim. Wave.R2 Vol.ResponseL LimitU LimitLinearityL LimitU LimitCal. TypeCalibratorEndpoint340500000ReactionSec. Wave.Lin. LimitS. VolumeRatioAscending02000Full NamePrint No.AGP1CalibrationLogit- Log 5Multical* entered by the user3. Ordering information122C0041 x 10 mL Antiserum2 x 25 mL BufferMPS/STH-001 Protein Standard High, 1 mL139F003Immunology Control Low, 1mL139F002Immunology Control High, 1 mLAPTEC DIAGNOSTICSAPPLICATION TO BE VALIDATED BY THE USER30.10.2012

APPLICATION NOTEMINDRAY BS-200α1 – ANTITRYPSIN AUT – KIT1. Reagent preparationSample:Ready for useBuffer R1:Ready for useAntiserum R2: Ready for useCalibrator:Dilute the Protein Standard High successively 1:2 in Saline 9 g/L in order to set up acalibration curve or alternatively use the ready for use Protein Standard Set. UseSaline 9 g/L as zero point.2. Instrument settingNo.UnitSample Vol.Inc. TimeR. Time*mg/dL310-1 / 26R1 Blank0L Limit0U Limit* entered by the userAssayPrecisionR1 Vol.AntigenSubstrateAAT24000Mix. R Blank0L Limit0U LimitParametersTypePrim. Wave.R2 Vol.ResponseL LimitU LimitLinearityL LimitU LimitEndpoint34095000400ReactionSec. Wave.Lin. LimitS. VolumeRatioAscending02000Full NamePrint No.AAT13. Ordering informationAAT/AUT-000 1 x 10 mL Antiserum5 x 25 mL BufferMPS/STH-001 Protein Standard High, 1 mLMPS/STS-5x1 Protein Standard Set, 5 x 1 mL139F003Immunology Control Low, 1mL139F002Immunology Control High, 1mLAPTEC DIAGNOSTICSAPPLICATION TO BE VALIDATED BY THE USER01.10.2010

APPLICATION NOTEMINDRAY BS-120 / BS-200Anti-streptolysin (O) KIT1. Reagent and sample preparationSample:Ready for use.Buffer (R1):Ready for use.Latex (R2):Ready for use.Calibration:Dilute the ASL Standard High successively 1:2 in NaCl 9 g/L in order to set up acalibration curve or use the ready for use ASL Standard Set.Use NaCl 9 g/L as zero point.2. Instrument settingNo.UnitSample Vol.Inc. TimeR. Time*IU/mL310-1 / 20R1 BlankL LimitU LimitMix. R Blank00L Limit00U LimitRef. Interval**LowHighAssayPrecisionR1 Vol.AntigenSubstrateASL03750ParametersTypePrim. Wave.R2 Vol.ResponseL LimitU LimitLinearityL LimitU LimitCal. TypeCalibratorEndpoint630750000ReactionSec. Wave.Lin. LimitS. VolumeRatioAscending02000Full NamePrint No.ASL1CalibrationLogit- Log 5Multical* entered by the user3. Ordering information129C0041 x 10 mL Antiserum2 x 25 mL BufferASL/STH-001 ASL Standard High, 1 mLASL/SST-001 ASL Standard Super High, 1 mLASL/STS-4X1 ASL Standard Set, 4 x 1 mLASL/CON-001 ASL Control, 1 mL139F003Immunology Control Low, 1 mL139F002Immunology Control High, 1 mLAPTEC DIAGNOSTICSAPPLICATION TO BE VALIDATED BY THE USER09.12.2013

APPLICATION NOTEMINDRAY BS-120 / BS-200Complement C3 AUT KITNo Sample Dilution1. Reagent and sample preparationSample:Ready for useBuffer (R1):Ready for useAntiserum (R2): Ready for useCalibration:Dilute the Protein Standard High successively 1:2 in NaCl 9 g/L in order to set up acalibration curve or use the ready for use Protein Standard Set.Use NaCl 9 g/L as zero point.2. Instrument settingNo.UnitSample Vol.Inc. TimeR. Time*mg/dL310-1 / 20R1 BlankL LimitU LimitMix. R Blank00L Limit00U LimitRef. Interval**LowHighAssayPrecisionR1 Vol.AntigenSubstrateC323000ParametersTypePrim. Wave.R2 Vol.ResponseL LimitU LimitLinearityL LimitU LimitCal. TypeCalibratorEndpoint340450000ReactionSec. Wave.Lin. LimitS. VolumeRatioAscending02000Full NamePrint No.C31CalibrationLogit- Log 5Multical* entered by the user3. Ordering informationC3C/AUT-000 1 x 10 mL Antiserum5 x 25 mL BufferMPS/STH-001 Protein Standard High, 1 mLMPS/STS-5X1 Protein Standard Set, 5 x 1 mL139F003Immunology Control Low, 1mL139F002Immunology Control High, 1mLAPTEC DIAGNOSTICSAPPLICATION TO BE VALIDATED BY THE USER07.07.2011 – v2

APPLICATION NOTEMINDRAY BS-120 / BS-200Complement C4 AUT KITNo Sample Dilution1. Reagent and sample preparationSample:Ready for useBuffer (R1):Ready for useAntiserum (R2): Ready for useCalibration:Dilute the Protein Standard High successively 1:2 in NaCl 9 g/L in order to set up acalibration curve or use the ready for use Protein Standard Set.Use NaCl 9 g/L as zero point.2. Instrument settingNo.UnitSample Vol.Inc. TimeR. Time*mg/dL410-1 / 20R1 BlankL LimitU LimitMix. R Blank00L Limit00U LimitRef. Interval**LowHighAssayPrecisionR1 Vol.AntigenSubstrateC422200ParametersTypePrim. Wave.R2 Vol.ResponseL LimitU LimitLinearityL LimitU LimitCal. TypeCalibratorEndpoint340300000ReactionSec. Wave.Lin. LimitS. VolumeRatioAscending02000Full NamePrint No.C41CalibrationLogit- Log 5Multical* entered by the user3. Ordering informationC4C/AUT-000 1 x 10 mL Antiserum5 x 25 mL BufferMPS/STH-001 Protein Standard High, 1 mLMPS/STS-5X1 Protein Standard Set, 5 x 1 mL139F003Immunology Control Low, 1mL139F002Immunology Control High, 1mLAPTEC DIAGNOSTICSAPPLICATION TO BE VALIDATED BY THE USER07.07.2011 – v2

APPLICATION NOTEMINDRAY BS-120 / BS-200CRP AUT KITNo Sample Dilution1. Reagent and sample preparationSample:Ready for use.Buffer (R1):Ready for use.Antiserum (R2): Ready for use.Calibration:Dilute the CRP Standard High successively 1:2 in NaCl 9 g/L in order to set up acalibration curve or use the ready for use CRP Standard Set.Use NaCl 9 g/L as zero point.2. Instrument settingNo.UnitSample Vol.Inc. TimeR. Time*mg/dL1910-1 / 20R1 BlankL LimitU LimitMix. R Blank00L Limit00U LimitRef. Interval**LowHighAssayPrecisionR1 Vol.AntigenSubstrateCRP23000ParametersTypePrim. Wave.R2 Vol.ResponseL LimitU LimitLinearityL LimitU LimitCal. TypeCalibratorEndpoint340300000ReactionSec. Wave.Lin. LimitS. VolumeRatioAscending02000Full NamePrint No.CRP1CalibrationLogit- Log 5Multical* entered by the user3. Ordering informationCRP/AUT-000 1 x 10 mL Antiserum5 x 25 mL BufferCRP/STH-001 CRP Standard High, 1 mLCRP/STS-5X1 CRP Standard Set, 5 x 1 mLCRP/COL-001 CRP Control Low, 1 mLCRP/COH-001 CRP Control High, 1 mL139F003Immunology Control Low, 1mL139F002Immunology Control High, 1mLAPTEC DIAGNOSTICSAPPLICATION TO BE VALIDATED BY THE USER13.11.2014

APPLICATION NOTEMINDRAY BS-120 / BS-200CRP KIT1. Reagent and sample preparationSample:Ready for use.Buffer (R1):Ready for use.Antiserum (R2): Ready for use.Calibration:Dilute the CRP Standard High successively 1:2 in NaCl 9 g/L in order to set up acalibration curve or use the ready for use CRP Standard Set.Use NaCl 9 g/L as zero point.2. Instrument settingNo.UnitSample Vol.Inc. TimeR. Time*Mg/dL1610-1 / 20R1 BlankL LimitU LimitMix. R Blank00L Limit00U LimitRef. Interval**LowHighAssayPrecisionR1 Vol.AntigenSubstrateCRP02500ParametersTypePrim. Wave.R2 Vol.ResponseL LimitU LimitLinearityL LimitU LimitCal. TypeCalibratorEndpoint340500000ReactionSec. Wave.Lin. LimitS. VolumeRatioAscending02000Full NamePrint No.CRP1CalibrationLogit- Log 5Multical* entered by the user3. Ordering 1CRP/COL-001CRP/COH-001139F003139F0021 x 10 mL Antiserum2 x 25 mL BufferCRP Standard High ,1 mLCRP Standard Set, 5 x 1 mLCRP Standard Super High, 1 mLCRP Control Low, 1 mLCRP Control High, 1 mLImmunology Control Low, 1 mLImmunology Control High, 1 mLAPTEC DIAGNOSTICSAPPLICATION TO BE VALIDATED BY THE USER31.07.2013

APPLICATION NOTEMINDRAY BS-120 / BS-200CRP US 2 U2A KITNo Sample Dilution1. Reagent and sample preparationSample:Buffer (R1):Latex (R2):Calibration:Ready for useReady for useReady for useDilute the CRP Standard High US successively 1:2 in NaCl 9 g/L in order to set up acalibration curve.Use NaCl 9 g/L as zero point.2. Instrument im. Wave.250Sample Vol.R1 Vol.R2 Vol.Inc. TimeAntigenResponse0R. TimeSubstrateL LimitU LimitR1 BlankMix. R BlankLinearity00L LimitL LimitL Limit00U LimitU LimitU LimitRef. Interval*LowCal. Type*HighCalibrator* entered by the user*mg/dL210-1 / 20Endpoint630600000ReactionSec. Wave.Lin. LimitS. VolumeRatioAscending0Full NamePrint No.CRP US100CalibrationLogit-Log 5Multical3. Ordering informationCRP/U2A-000 1 x 10 mL Latex2 x 25 mL BufferCRP/SHU-001 CRP Standard High US, 1 mLCRP/CON-001 CRP Control, 1mLCRP/COL-001 CRP Control Low, 1 mLCRP/COH-001 CRP Control High, 1 mL139F003Immunology Control Low, 1mL139F002Immunology Control High, 1mLAPTEC DIAGNOSTICSAPPLICATION TO BE VALIDATED BY THE USER07.07.2011 – v2

APPLICATION NOTEMINDRAY BS-120 / BS-200Ferritin AUT KIT1. Reagent and sample preparationSample:Buffer (R1):Latex (R2):Calibration:Ready for use.Ready for use.Ready for use.Ferritin Standard Set 2nd Generation, ready for use. Use saline 9g/L as zero point.2. Instrument settingNo.UnitSample Vol.Inc. Time*ng/mL2410R. TimeR1 BlankL LimitU Limit-1 / 20AssayPrecisionR1 Vol.AntigenFER0180Substrate0Mix. R BlankL Limit00U Limit00Ref. IntervalLow*High** entered by the userParametersTypePrim. Wave.R2 Vol.ResponseL LimitU LimitLinearityL LimitU LimitCal. TypeCalibratorEndpoint630600000ReactionSec. Wave.Lin. LimitS. VolumeAscending05000RatioFull NamePrint No.0FER1CalibrationLogit-Log 5Multical3. Ordering information132C0111 x 8 mL Latex1 x 24 mL Buffer132E004Ferritin Standard Set 2nd Generation, 5 x 1 mLFER/COL-001 Ferritin Control Low, 1 mLFER/COH-001 Ferritin Control High, 1 mL139F003Immunology Control Low, 1mL139F002Immunology Control High, 1mLAPTEC DIAGNOSTICSAPPLICATION TO BE VALIDATED BY THE USER11.12.2013

APPLICATION NOTEMINDRAY BS-120 / BS-200Haptoglobin AUT KITNo Sample Dilution1. Reagent and sample preparationSample:Ready for useBuffer (R1):Ready for useAntiserum (R2): Ready for useCalibration:Dilute the Protein Standard High successively 1:2 in NaCl 9 g/L in order to set up acalibration curve or use the ready for use Protein Standard Set.Use NaCl 9 g/L as zero point.2. Instrument settingNo.UnitSample Vol.Inc. TimeR. Time*mg/dL310-1 / 20R1 BlankL LimitU LimitMix. R Blank00L Limit00U LimitRef. Interval**LowHighAssayPrecisionR1 Vol.AntigenSubstrateHAP24200ParametersTypePrim. Wave.R2 Vol.ResponseL LimitU LimitLinearityL LimitU LimitCal. TypeCalibratorEndpoint340600000ReactionSec. Wave.Lin. LimitS. VolumeRatioAscending02000Full NamePrint No.HAP1CalibrationLogit-Log 5Multical* entered by the user3. Ordering informationHAP/AUT-000 1 x 10 mL Antiserum5 x 25 mL BufferMPS/STH-001 Protein Standard High, 1 mLMPS/STS-5X1 Protein Standard Set, 5 x 1 mL139F003Immunology Control Low, 1mL139F002Immunology Control High, 1mLAPTEC DIAGNOSTICSAPPLICATION TO BE VALIDATED BY THE USER07.07.2011 – v2

APPLICATION NOTEMINDRAY BS-120 / BS-200IgA KIT 2nd GenerationNo Sample Dilution1. Reagent and sample preparationSample:Ready for useBuffer (R1):Ready for useAntiserum (R2): Ready for useCalibration:Dilute the Protein Standard High successively 1:2 in NaCl 9 g/L in order to set up acalibration curve or use the ready for use Protein Standard Set.Use NaCl 9 g/L as zero point.2. Instrument settingNo.UnitSample Vol.Inc. TimeR. Time*mg/dL310-1 / 20R1 BlankL LimitU LimitMix. R Blank00L Limit00U LimitRef. Interval**LowHighAssayPrecisionR1 Vol.AntigenSubstrateIGA24200ParametersTypePrim. Wave.R2 Vol.ResponseL LimitU LimitLinearityL LimitU LimitCal. TypeCalibratorEndpoint340750000ReactionSec. Wave.Lin. LimitS. VolumeRatioAscending02000Full NamePrint No.IGA1CalibrationLogit-Log 5Multical* entered by the user3. Ordering information104C0021 x 10 mL Antiserum5 x 25 mL BufferMPS/STH-001 Protein Standard High, 1 mLMPS/STS-5X1 Protein Standard Set, 5 x 1 mL139F003Immunology Control Low, 1mL139F002Immunology Control High, 1mLAPTEC DIAGNOSTICSAPPLICATION TO BE VALIDATED BY THE USER07.07.2011 – v2

APPLICATION NOTEMINDRAY BS-120 / BS-200IgG AUT KITNo Sample Dilution1. Reagent and sample preparationSample:Ready for useBuffer (R1):Ready for useAntiserum (R2): Ready for useCalibration:Dilute the Protein Standard High successively 1:2 in NaCl 9 g/L in order to set up acalibration curve or use the ready for use Protein Standard Set.Use NaCl 9 g/L as zero point.2. Instrument settingNo.UnitSample Vol.Inc. TimeR. Time*mg/dL310-1 / 20R1 BlankL LimitU LimitMix. R Blank00L Limit00U LimitRef. Interval**LowHighAssayPrecisionR1 Vol.AntigenSubstrateIGG23800ParametersTypePrim. Wave.R2 Vol.ResponseL LimitU LimitLinearityL LimitU LimitCal. TypeCalibratorEndpoint3401100000ReactionSec. Wave.Lin. LimitS. VolumeRatioAscending02000Full NamePrint No.IGG1CalibrationLogit-Log 5Multical* entered by the user3. Ordering informationIGG/AUT-0001 x 10 mL Antiserum5 x 25 mL BufferMPS/STH-001 Protein Standard High, 1 mLM

MINDRAY BS-120 / BS-200 α1 – Acid Glycoprotein AUT KIT No Sample Dilution 1. Reagent and sample preparation Sample: Ready for use Buffer (R1): Ready for use Antiserum (R2): Ready for use Calibration: Dilute the Protein Standard High successively 1:2 in NaCl 9 g/L in order to set up a calibration curve or use the ready for use Protein Standard Set. Use NaCl 9 g/L as zero point. 2. Instrument .