CP SD 2016 Booklet 4c9d22c9 6175 8ebb 282e 11dd5eddc5be
RCPA Quality Assurance Programs Pty Limited ABN 32 003 520 072
2016
SPECIAL DRUGS PROGRAM METHOD CLASSIFICATION BOOKLET
RCPAQAP CHEMICAL PATHOLOGY 257 Gilbert Street, Adelaide SA 5000 Tel: +61 8 7324 8300 Fax: +61 8 8410 5935 Email: [email protected] Web: www.rcpaqap.com.au/chempath
SPECIAL DRUGS PROGRAM 1. INTRODUCTION This booklet is designed to assist you with classifying the method you use to analyse samples in the Special Therapeutic Drugs Program. The information provided will allow you to compare your results with those from participants using your method and will also allow organisers to compare the performance of the various methods and instrumentation used. The 4 basic categories used are: Category 1 Category 2 Category 3 Category 4
-
Analytical Principle Measurement System Reagent Source Calibrator or Additional Information
Categories 1 and 4 use one alphabetical letter A - Z. Category 2 - Measurement System Select from the Measurement System Master List which can be found in the Documents tab in the myQAP Portal. Two digits followed by an alphabetical letter are used. The two digits (01-99) refer to a particular manufacturer or instrument type and the letter specifies the actual instrument. e.g. Abbott ARCHITECT(i1000SR, i2000SR, i4000SR) - 01P Abbott ARCHITECT(c4000, c8000, c16000) - 01S Category 3 - Reagent Source Select from the Reagent Source Master List which can be found in the Documents tab in the myQAP Portal.. Three digits (001-999) are used to specify individual reagent suppliers. Please complete the METHOD CLASSIFICATION SHEET and return it as soon as possible. Only indicate one choice in each subsection of the method classification. For example, if your Gentamicin method is Luminescent Immunoassay on ARCHITECT (i1000SR, i2000SR, i4000SR) using Abbott reagents, the classification is:
ANALYTE Gentamicin
CATEGORY 1
2
3
4
J
01P
001
A
N.B. If any of your classifications are "@ OTHER" then please provide additional information on the reverse side of the Method Classification Sheet. 2. CHANGING METHOD CLASSIFICATION To change a method classification use the Method Classification sheet in this book or download a copy from the Forms tab in the myQAP Portal. Check that your lab number, sample numbers and program name are entered. Method classifications may be changed during the cycle, except for the last two samples. Any method changes received by the RCPAQAP Office for the last two samples will be held and entered in the next cycle. 3. REPORTING AND DELETING ANALYTES Analytes will be reported if results are entered or a method classification has been provided. If you wish to delete an analyte you may delete the method code on the Method Classification Sheet found in this booklet.
METHOD CLASSIFICATION BOOKLET INDEX
METHOD CLASSIFICATION SHEETS
SPECIAL THERAPEUTIC DRUGS
ANTIBIOTICS
ANALYTE
ANALYTE
Page
Page
AMIODARONE
1
AMIKACIN
8
CLOZAPINE
2
GENTAMICIN
9
METHOTREXATE
3
TOBRAMICIN
10
MYCOPHENOLATE
4
VANCOMYCIN
11
TRICYCLIC ANTIDEPRESSANT SCREEN
5
IMMUNOSUPPRESSANTS
AMITRIPTYLINE
6
ANALYTE
NORTRIPTYLINE
7
SD/MB/Index
Page
CYCLOSPORIN
12
SIROLIMUS
13
TACROLIMUS
14
SPECIAL DRUGS PROGRAM 2016 NOTIFICATION OF CHANGING METHOD CLASSIFICATION CHANGE EFFECTIVE FROM CYCLE
ANALYTE
SAMPLE DELETE METHOD ()
CATEGORY 1
2
3
4
N.B. If you indicate that you wish to delete a method code, you will no longer receive a report for this analyte. IF ANY OF THE CLASSIFICATIONS ABOVE ARE “@ OTHER” PLEASE COMPLETE THE SECTION BELOW.
ANALYTE
CATEGORY NUMBER
Additional Information e.g. reference, manufacturer, instrument
AMIODARONE ANALYTICAL PRINCIPLE H HPLC (other than MS/MS) L LCMSMS
MEASUREMENT SYSTEM CHROMATOGRAPHY SAMPLE PREPARATION 22A 22B 22C 22D 22E 22F 22G 22H 22I 22J 22K 22L 22M 22N
Ion Exchange Alumina Ion Exchange + Alumina Liquid/Liquid Extraction (LLE) Ion Exchange + Solvent Extraction Direct Injection Protein Precipitation (no extraction) Solid Phase Extraction (off line) Reverse Phase Normal Phase Acid Extraction Protein Precipitation + Solvent Extraction Solid Phase Extraction (on line) Dilution (for AA and ICPMS-dilution not extraction) 22O AQC Derivatization 22@ Other sample preparation method
@ OTHER
Category 1
@ OTHER
REAGENT SOURCE Select from Reagent Source Master List which can be found in the myQAP ‘Documents’ tab.
@ OTHER
Category 2
Category 3
CALIBRATOR A
In House
B
Chromsystems
C
Recipe
D
Other Commercial
@ OTHER
Category 4
1
CLOZAPINE ANALYTICAL PRINCIPLE H HPLC (other than MS/MS)
MEASUREMENT SYSTEM
CHROMATOGRAPHY SAMPLE PREPARATION
L LCMSMS
REAGENT SOURCE
Select from Reagent Source Master List which can be found in the myQAP ‘Documents’ tab.
22A 22B 22C 22D 22E 22F 22G 22H 22I 22J 22K 22L 22M 22N
Ion Exchange Alumina Ion Exchange + Alumina Liquid/Liquid Extraction (LLE) Ion Exchange + Solvent Extraction Direct Injection Protein Precipitation (no extraction) Solid Phase Extraction (off line) Reverse Phase Normal Phase Acid Extraction Protein Precipitation + Solvent Extraction Solid Phase Extraction (on line) Dilution (for AA and ICPMS-dilution not extraction) 22O AQC Derivatization 22@ Other sample preparation method
@ OTHER
Category 1
@ OTHER
@ OTHER
Category 2
Category 3
CALIBRATOR
A
In House
B
Chromsystems
C
Recipe
D
Other Commercial
@ OTHER
Category 4
2
METHOTREXATE ANALYTICAL PRINCIPLE P Fluorescence Polarisation Immunoassay (FPIA)
MEASUREMENT SYSTEM Select from Measurement System Master List which can be found in the myQAP ‘Documents’ tab.
REAGENT SOURCE Select from Reagent Source Master List which can be found in the myQAP ‘Documents’ tab.
CALIBRATOR A Analyser Specific Calibrator Supplied by manufacturer of your analyser.
Q EMIT B
@ OTHER
@ OTHER
Category 1
@ OTHER
Category 2
Any other calibrator not supplied by the manufacturer of your analyser.
@ OTHER
Category 3
Category 4
3
MYCOPHENOLATE ANALYTICAL PRINCIPLE C CEDIA H HPLC L LCMSMS Q EMIT T Enzymatic
MEASUREMENT SYSTEM CHROMATOGRAPHY SAMPLE PREPARATION 22A 22B 22C 22D 22E 22F 22G 22H 22I 22J 22K 22L 22M 22N
Ion Exchange Alumina Ion Exchange + Alumina Liquid/Liquid Extraction (LLE) Ion Exchange + Solvent Extraction Direct Injection Protein Precipitation (no extraction) Solid Phase Extraction (off line) Reverse Phase Normal Phase Acid Extraction Protein Precipitation + Solvent Extraction Solid Phase Extraction (on line) Dilution (for AA and ICPMS-dilution not extraction) 22O AQC Derivatization 22@ Other sample preparation method
REAGENT SOURCE Select from Reagent Source Master List which can be found in the myQAP ‘Documents’ tab.
CALIBRATOR Chromatography A
In House
B
Chromsystems
C
Recipe
D
Other Commercial
Immunoassay M Analyser Specific Calibrator Supplied by manufacturer of your analyser. N
Any other calibrator not supplied by the manufacturer of your analyser.
IMMUNOASSAY Select from Measurement System Master List which can be found in the myQAP ‘Documents’ tab. @ OTHER
Category 1
@ OTHER
@ OTHER
Category 2
Category 3
@ OTHER
Category 4
4
TRICYCLIC ANTIDEPRESSANT SCREEN ANALYTICAL PRINCIPLE E EIA P Fluorescence Polarisation Immunoassay (FPIA)
MEASUREMENT SYSTEM Select from Measurement System Master List which can be found in the myQAP ‘Documents’ tab.
REAGENT SOURCE Select from Reagent Source Master List which can be found in the myQAP ‘Documents’ tab.
CALIBRATOR A Analyser Specific Calibrator Supplied by manufacturer of your analyser. B
Q EMIT
Any other calibrator not supplied by the manufacturer of your analyser.
T LC TOF MS
@ OTHER
@ OTHER
Category 1
@ OTHER
Category 2
@ OTHER
Category 3
Category 4
5
AMITRIPTYLINE ANALYTICAL PRINCIPLE G GLC
MEASUREMENT SYSTEM
CHROMATOGRAPHY SAMPLE PREPARATION
H HPLC 22A 22B 22C 22D 22E 22F 22G 22H 22I 22J 22K 22L 22M 22N
Ion Exchange Alumina Ion Exchange + Alumina Liquid/Liquid Extraction (LLE) Ion Exchange + Solvent Extraction Direct Injection Protein Precipitation (no extraction) Solid Phase Extraction (off line) Reverse Phase Normal Phase Acid Extraction Protein Precipitation + Solvent Extraction Solid Phase Extraction (on line) Dilution (for AA and ICPMS-dilution not extraction) 22O AQC Derivatization 22@ Other sample preparation method
@ OTHER
Category 1
@ OTHER
REAGENT SOURCE
Select from Reagent Source Master List which can be found in the myQAP ‘Documents’ tab.
@ OTHER
Category 2
Category 3
CALIBRATOR
A
In House
B
Chromsystems
C
Recipe
D
Other Commercial
@ OTHER
Category 4
6
NORTRIPTYLINE ANALYTICAL PRINCIPLE G GLC
MEASUREMENT SYSTEM
CHROMATOGRAPHY SAMPLE PREPARATION
H HPLC 22A 22B 22C 22D 22E 22F 22G 22H 22I 22J 22K 22L 22M 22N
Ion Exchange Alumina Ion Exchange + Alumina Liquid/Liquid Extraction (LLE) Ion Exchange + Solvent Extraction Direct Injection Protein Precipitation (no extraction) Solid Phase Extraction (off line) Reverse Phase Normal Phase Acid Extraction Protein Precipitation + Solvent Extraction Solid Phase Extraction (on line) Dilution (for AA and ICPMS-dilution not extraction) 22O AQC Derivatization 22@ Other sample preparation method
@ OTHER
Category 1
@ OTHER
REAGENT SOURCE
Select from Reagent Source Master List which can be found in the myQAP ‘Documents’ tab.
@ OTHER
Category 2
Category 3
CALIBRATOR
A
In House
B
Chromsystems
C
Recipe
D
Other Commercial
@ OTHER
Category 4
7
AMIKACIN ANALYTICAL PRINCIPLE K Kinetic Interaction of Microparticles in Solution (KIMS)
MEASUREMENT SYSTEM Select from Measurement System Master List which can be found in the myQAP ‘Documents’ tab.
REAGENT SOURCE Select from Reagent Source Master List which can be found in the myQAP ‘Documents’ tab.
L Latex Inhibition
CALIBRATOR A Analyser Specific Calibrator Supplied by manufacturer of your analyser. B
N Particle-enhanced Turbidimetric Inhibition Immunoassay (PETINIA)
Any other calibrator not supplied by the manufacturer of your analyser.
P Fluorescence Polarisation Immunoassay (FPIA) Q EMIT K Kinetic Interaction of Microparticles in Solution (KIMS)
@ OTHER
@ OTHER
Category 1
@ OTHER
Category 2
@ OTHER
Category 3
Category 4
8
GENTAMICIN ANALYTICAL PRINCIPLE C CEDIA J Luminescent Immunoassay (LIA –Competitive Assay)
MEASUREMENT SYSTEM Select from Measurement System Master List which can be found in the myQAP ‘Documents’ tab.
REAGENT SOURCE Select from Reagent Source Master List which can be found in the myQAP ‘Documents’ tab.
CALIBRATOR A Analyser Specific Calibrator Supplied by manufacturer of your analyser. B
K Kinetic Interaction of Microparticles in Solution (KIMS)
Any other calibrator not supplied by the manufacturer of your analyser.
N Particle-enhanced Turbidimetric Inhibition Immunoassay (PETINIA) P Fluorescence Polarisation Immunoassay (FPIA) Q EMIT
@ OTHER
@ OTHER
Category 1
@ OTHER
Category 2
@ OTHER
Category 3
Category 4
9
TOBRAMYCIN ANALYTICAL PRINCIPLE C CEDIA J Luminescent Immunoassay (LIA–Competitive Assay)
MEASUREMENT SYSTEM Select from Measurement System Master List which can be found in the myQAP ‘Documents’ tab.
REAGENT SOURCE Select from Reagent Source Master List which can be found in the myQAP ‘Documents’ tab.
CALIBRATOR A Analyser Specific Calibrator Supplied by manufacturer of your analyser. B
K Kinetic Interaction of Microparticles in Solution (KIMS)
Any other calibrator not supplied by the manufacturer of your analyser.
N Particle-enhanced Turbidimetric Inhibition Immunoassay (PETINIA) P Fluorescence Polarisation Immunoassay (FPIA) Q EMIT
@ OTHER
@ OTHER
Category 1
@ OTHER
Category 2
@ OTHER
Category 3
Category 4
10
VANCOMYCIN ANALYTICAL PRINCIPLE C CEDIA J Luminescent Immunoassay (LIA–Competitive Assay)
MEASUREMENT SYSTEM Select from Measurement System Master List which can be found in the myQAP ‘Documents’ tab.
REAGENT SOURCE Select from Reagent Source Master List which can be found in the myQAP ‘Documents’ tab.
CALIBRATOR A Analyser Specific Calibrator Supplied by manufacturer of your analyser. B
K Kinetic Interaction of Microparticles in Solution (KIMS)
Any other calibrator not supplied by the manufacturer of your analyser.
N Particle-enhanced Turbidimetric Inhibition Immunoassay (PETINIA) P Fluorescence Polarisation Immunoassay (FPIA) Q EMIT S Enzyme Immunoassay (EIA)
@ OTHER
@ OTHER
Category 1
@ OTHER
Category 2
@ OTHER
Category 3
Category 4
11
CYCLOSPORIN ANALYTICAL PRINCIPLE A ACMIA B RIA C CEDIA D Immunochemiluminometric Assay (ICMA) H HPLC (other than MS/MS) I
Electrochemiluminescence (ECLIA)
J Luminescent Immunoassay (LIA–Competitive Assay) L LCMSMS P Fluorescence Polarisation Immunoassay (FPIA) Q EMIT S Enzyme Immunoassay (EIA)
@ OTHER
Category 1
MEASUREMENT SYSTEM CHROMATOGRAPHY SAMPLE PREPARATION 22A 22B 22C 22D 22E 22F 22G 22H 22I 22J 22K 22L 22M 22N
Ion Exchange Alumina Ion Exchange + Alumina Liquid/Liquid Extraction (LLE) Ion Exchange + Solvent Extraction Direct Injection Protein Precipitation (no extraction) Solid Phase Extraction (off line) Reverse Phase Normal Phase Acid Extraction Protein Precipitation + Solvent Extraction Solid Phase Extraction (on line) Dilution (for AA and ICPMS-dilution not extraction) 22O AQC Derivatization 22@ Other sample preparation method
REAGENT SOURCE Select from Reagent Source Master List which can be found in the myQAP ‘Documents’ tab.
A
In House
B
Chromsystems
C
Recipe
D
Other Commercial
M Analyser Specific Calibrator Supplied by manufacturer of your analyser. N
Any other calibrator not supplied by the manufacture of your analyser.
@ OTHER
Category 2
Chromatography
Immunoassay
IMMUNOASSAY Select from Measurement System Master List which can be found in the myQAP ‘Documents’ tab. @ OTHER
CALIBRATOR
Category 3
@ OTHER
Category 4
12
SIROLIMUS ANALYTICAL PRINCIPLE H HPLC (other than MS/MS) I Electrochemiluminescence (ECLIA) J Luminescent Immunoassay (LIA– Competitive Assay) L LCMSMS M Microparticle Enzyme Immunoassay (MEIA) P Fluorescence Polarisation Immunoassay (FPIA)
MEASUREMENT SYSTEM
CHROMATOGRAPHY SAMPLE PREPARATION 22A 22B 22C 22D 22E 22F 22G 22H 22I 22J 22K 22L 22M 22N
Ion Exchange Alumina Ion Exchange + Alumina Liquid/Liquid Extraction (LLE) Ion Exchange + Solvent Extraction Direct Injection Protein Precipitation (no extraction) Solid Phase Extraction (off line) Reverse Phase Normal Phase Acid Extraction Protein Precipitation + Solvent Extraction Solid Phase Extraction (on line) Dilution (for AA and ICPMS-dilution not extraction) 22O AQC Derivatization 22@ Other sample preparation method
REAGENT SOURCE
CALIBRATOR
Select from Reagent Source Chromatography Master List which can be found A In House in the myQAP ‘Documents’ tab. B Chromsystems C
Recipe
D
Other Commercial
Immunoassay M Analyser Specific Calibrator Supplied by manufacturer of your analyser. N
Any other calibrator not supplied by the manufacturer of your analyser.
IMMUNOASSAY Select from Measurement System Master List which can be found in the myQAP ‘Documents’ tab. @ OTHER
Category 1
@ OTHER
@ OTHER
Category 2
Category 3
@ OTHER
Category 4 13
TACROLIMUS ANALYTICAL PRINCIPLE A ACMIA
MEASUREMENT SYSTEM CHROMATOGRAPHY SAMPLE PREPERATION
H HPLC (other than MS/MS) J Luminescent Immunoassay (LIA–Competitive Assay) L LCMSMS M Microparticle Enzyme Immunoassay (MEIA) Q EMIT
REAGENT SOURCE Select from Reagent Source Master List which can be found in the myQAP ‘Documents’ tab.
22A 22B 22C 22D 22E 22F 22G 22H 22I 22J 22K 22L 22M 22N
Ion Exchange Alumina Ion Exchange + Alumina Liquid/Liquid Extraction (LLE) Ion Exchange + Solvent Extraction Direct Injection Protein Precipitation (no extraction) Solid Phase Extraction (off line) Reverse Phase Normal Phase Acid Extraction Protein Precipitation + Solvent Extraction Solid Phase Extraction (on line) Dilution (for AA and ICPMS-dilution not extraction) 22O AQC Derivatization 22@ Other sample preparation method
Category 1
@ OTHER
@ OTHER
Category 2
Chromatography A
In House
B
Chromsystems
C
Recipe
D
Other Commercial
Immunoassay
IMMUNOASSAY Select from Measurement System Master List which can be found in the myQAP ‘Documents’ tab. @ OTHER
CALIBRATOR
Category 3
M
Analyser Specific Calibrator Supplied by manufacturer of your analyser.
N
Any other calibrator not supplied by the manufacturer of your analyser.
@ OTHER
Category 4
14
15
2016
SPECIAL DRUGS PROGRAM METHOD CLASSIFICATION BOOKLET
RCPAQAP CHEMICAL PATHOLOGY 257 Gilbert Street, Adelaide SA 5000 Tel: +61 8 7324 8300 Fax: +61 8 8410 5935 Email: [email protected] Web: www.rcpaqap.com.au/chempath
SPECIAL DRUGS PROGRAM 1. INTRODUCTION This booklet is designed to assist you with classifying the method you use to analyse samples in the Special Therapeutic Drugs Program. The information provided will allow you to compare your results with those from participants using your method and will also allow organisers to compare the performance of the various methods and instrumentation used. The 4 basic categories used are: Category 1 Category 2 Category 3 Category 4
-
Analytical Principle Measurement System Reagent Source Calibrator or Additional Information
Categories 1 and 4 use one alphabetical letter A - Z. Category 2 - Measurement System Select from the Measurement System Master List which can be found in the Documents tab in the myQAP Portal. Two digits followed by an alphabetical letter are used. The two digits (01-99) refer to a particular manufacturer or instrument type and the letter specifies the actual instrument. e.g. Abbott ARCHITECT(i1000SR, i2000SR, i4000SR) - 01P Abbott ARCHITECT(c4000, c8000, c16000) - 01S Category 3 - Reagent Source Select from the Reagent Source Master List which can be found in the Documents tab in the myQAP Portal.. Three digits (001-999) are used to specify individual reagent suppliers. Please complete the METHOD CLASSIFICATION SHEET and return it as soon as possible. Only indicate one choice in each subsection of the method classification. For example, if your Gentamicin method is Luminescent Immunoassay on ARCHITECT (i1000SR, i2000SR, i4000SR) using Abbott reagents, the classification is:
ANALYTE Gentamicin
CATEGORY 1
2
3
4
J
01P
001
A
N.B. If any of your classifications are "@ OTHER" then please provide additional information on the reverse side of the Method Classification Sheet. 2. CHANGING METHOD CLASSIFICATION To change a method classification use the Method Classification sheet in this book or download a copy from the Forms tab in the myQAP Portal. Check that your lab number, sample numbers and program name are entered. Method classifications may be changed during the cycle, except for the last two samples. Any method changes received by the RCPAQAP Office for the last two samples will be held and entered in the next cycle. 3. REPORTING AND DELETING ANALYTES Analytes will be reported if results are entered or a method classification has been provided. If you wish to delete an analyte you may delete the method code on the Method Classification Sheet found in this booklet.
METHOD CLASSIFICATION BOOKLET INDEX
METHOD CLASSIFICATION SHEETS
SPECIAL THERAPEUTIC DRUGS
ANTIBIOTICS
ANALYTE
ANALYTE
Page
Page
AMIODARONE
1
AMIKACIN
8
CLOZAPINE
2
GENTAMICIN
9
METHOTREXATE
3
TOBRAMICIN
10
MYCOPHENOLATE
4
VANCOMYCIN
11
TRICYCLIC ANTIDEPRESSANT SCREEN
5
IMMUNOSUPPRESSANTS
AMITRIPTYLINE
6
ANALYTE
NORTRIPTYLINE
7
SD/MB/Index
Page
CYCLOSPORIN
12
SIROLIMUS
13
TACROLIMUS
14
SPECIAL DRUGS PROGRAM 2016 NOTIFICATION OF CHANGING METHOD CLASSIFICATION CHANGE EFFECTIVE FROM CYCLE
ANALYTE
SAMPLE DELETE METHOD ()
CATEGORY 1
2
3
4
N.B. If you indicate that you wish to delete a method code, you will no longer receive a report for this analyte. IF ANY OF THE CLASSIFICATIONS ABOVE ARE “@ OTHER” PLEASE COMPLETE THE SECTION BELOW.
ANALYTE
CATEGORY NUMBER
Additional Information e.g. reference, manufacturer, instrument
AMIODARONE ANALYTICAL PRINCIPLE H HPLC (other than MS/MS) L LCMSMS
MEASUREMENT SYSTEM CHROMATOGRAPHY SAMPLE PREPARATION 22A 22B 22C 22D 22E 22F 22G 22H 22I 22J 22K 22L 22M 22N
Ion Exchange Alumina Ion Exchange + Alumina Liquid/Liquid Extraction (LLE) Ion Exchange + Solvent Extraction Direct Injection Protein Precipitation (no extraction) Solid Phase Extraction (off line) Reverse Phase Normal Phase Acid Extraction Protein Precipitation + Solvent Extraction Solid Phase Extraction (on line) Dilution (for AA and ICPMS-dilution not extraction) 22O AQC Derivatization 22@ Other sample preparation method
@ OTHER
Category 1
@ OTHER
REAGENT SOURCE Select from Reagent Source Master List which can be found in the myQAP ‘Documents’ tab.
@ OTHER
Category 2
Category 3
CALIBRATOR A
In House
B
Chromsystems
C
Recipe
D
Other Commercial
@ OTHER
Category 4
1
CLOZAPINE ANALYTICAL PRINCIPLE H HPLC (other than MS/MS)
MEASUREMENT SYSTEM
CHROMATOGRAPHY SAMPLE PREPARATION
L LCMSMS
REAGENT SOURCE
Select from Reagent Source Master List which can be found in the myQAP ‘Documents’ tab.
22A 22B 22C 22D 22E 22F 22G 22H 22I 22J 22K 22L 22M 22N
Ion Exchange Alumina Ion Exchange + Alumina Liquid/Liquid Extraction (LLE) Ion Exchange + Solvent Extraction Direct Injection Protein Precipitation (no extraction) Solid Phase Extraction (off line) Reverse Phase Normal Phase Acid Extraction Protein Precipitation + Solvent Extraction Solid Phase Extraction (on line) Dilution (for AA and ICPMS-dilution not extraction) 22O AQC Derivatization 22@ Other sample preparation method
@ OTHER
Category 1
@ OTHER
@ OTHER
Category 2
Category 3
CALIBRATOR
A
In House
B
Chromsystems
C
Recipe
D
Other Commercial
@ OTHER
Category 4
2
METHOTREXATE ANALYTICAL PRINCIPLE P Fluorescence Polarisation Immunoassay (FPIA)
MEASUREMENT SYSTEM Select from Measurement System Master List which can be found in the myQAP ‘Documents’ tab.
REAGENT SOURCE Select from Reagent Source Master List which can be found in the myQAP ‘Documents’ tab.
CALIBRATOR A Analyser Specific Calibrator Supplied by manufacturer of your analyser.
Q EMIT B
@ OTHER
@ OTHER
Category 1
@ OTHER
Category 2
Any other calibrator not supplied by the manufacturer of your analyser.
@ OTHER
Category 3
Category 4
3
MYCOPHENOLATE ANALYTICAL PRINCIPLE C CEDIA H HPLC L LCMSMS Q EMIT T Enzymatic
MEASUREMENT SYSTEM CHROMATOGRAPHY SAMPLE PREPARATION 22A 22B 22C 22D 22E 22F 22G 22H 22I 22J 22K 22L 22M 22N
Ion Exchange Alumina Ion Exchange + Alumina Liquid/Liquid Extraction (LLE) Ion Exchange + Solvent Extraction Direct Injection Protein Precipitation (no extraction) Solid Phase Extraction (off line) Reverse Phase Normal Phase Acid Extraction Protein Precipitation + Solvent Extraction Solid Phase Extraction (on line) Dilution (for AA and ICPMS-dilution not extraction) 22O AQC Derivatization 22@ Other sample preparation method
REAGENT SOURCE Select from Reagent Source Master List which can be found in the myQAP ‘Documents’ tab.
CALIBRATOR Chromatography A
In House
B
Chromsystems
C
Recipe
D
Other Commercial
Immunoassay M Analyser Specific Calibrator Supplied by manufacturer of your analyser. N
Any other calibrator not supplied by the manufacturer of your analyser.
IMMUNOASSAY Select from Measurement System Master List which can be found in the myQAP ‘Documents’ tab. @ OTHER
Category 1
@ OTHER
@ OTHER
Category 2
Category 3
@ OTHER
Category 4
4
TRICYCLIC ANTIDEPRESSANT SCREEN ANALYTICAL PRINCIPLE E EIA P Fluorescence Polarisation Immunoassay (FPIA)
MEASUREMENT SYSTEM Select from Measurement System Master List which can be found in the myQAP ‘Documents’ tab.
REAGENT SOURCE Select from Reagent Source Master List which can be found in the myQAP ‘Documents’ tab.
CALIBRATOR A Analyser Specific Calibrator Supplied by manufacturer of your analyser. B
Q EMIT
Any other calibrator not supplied by the manufacturer of your analyser.
T LC TOF MS
@ OTHER
@ OTHER
Category 1
@ OTHER
Category 2
@ OTHER
Category 3
Category 4
5
AMITRIPTYLINE ANALYTICAL PRINCIPLE G GLC
MEASUREMENT SYSTEM
CHROMATOGRAPHY SAMPLE PREPARATION
H HPLC 22A 22B 22C 22D 22E 22F 22G 22H 22I 22J 22K 22L 22M 22N
Ion Exchange Alumina Ion Exchange + Alumina Liquid/Liquid Extraction (LLE) Ion Exchange + Solvent Extraction Direct Injection Protein Precipitation (no extraction) Solid Phase Extraction (off line) Reverse Phase Normal Phase Acid Extraction Protein Precipitation + Solvent Extraction Solid Phase Extraction (on line) Dilution (for AA and ICPMS-dilution not extraction) 22O AQC Derivatization 22@ Other sample preparation method
@ OTHER
Category 1
@ OTHER
REAGENT SOURCE
Select from Reagent Source Master List which can be found in the myQAP ‘Documents’ tab.
@ OTHER
Category 2
Category 3
CALIBRATOR
A
In House
B
Chromsystems
C
Recipe
D
Other Commercial
@ OTHER
Category 4
6
NORTRIPTYLINE ANALYTICAL PRINCIPLE G GLC
MEASUREMENT SYSTEM
CHROMATOGRAPHY SAMPLE PREPARATION
H HPLC 22A 22B 22C 22D 22E 22F 22G 22H 22I 22J 22K 22L 22M 22N
Ion Exchange Alumina Ion Exchange + Alumina Liquid/Liquid Extraction (LLE) Ion Exchange + Solvent Extraction Direct Injection Protein Precipitation (no extraction) Solid Phase Extraction (off line) Reverse Phase Normal Phase Acid Extraction Protein Precipitation + Solvent Extraction Solid Phase Extraction (on line) Dilution (for AA and ICPMS-dilution not extraction) 22O AQC Derivatization 22@ Other sample preparation method
@ OTHER
Category 1
@ OTHER
REAGENT SOURCE
Select from Reagent Source Master List which can be found in the myQAP ‘Documents’ tab.
@ OTHER
Category 2
Category 3
CALIBRATOR
A
In House
B
Chromsystems
C
Recipe
D
Other Commercial
@ OTHER
Category 4
7
AMIKACIN ANALYTICAL PRINCIPLE K Kinetic Interaction of Microparticles in Solution (KIMS)
MEASUREMENT SYSTEM Select from Measurement System Master List which can be found in the myQAP ‘Documents’ tab.
REAGENT SOURCE Select from Reagent Source Master List which can be found in the myQAP ‘Documents’ tab.
L Latex Inhibition
CALIBRATOR A Analyser Specific Calibrator Supplied by manufacturer of your analyser. B
N Particle-enhanced Turbidimetric Inhibition Immunoassay (PETINIA)
Any other calibrator not supplied by the manufacturer of your analyser.
P Fluorescence Polarisation Immunoassay (FPIA) Q EMIT K Kinetic Interaction of Microparticles in Solution (KIMS)
@ OTHER
@ OTHER
Category 1
@ OTHER
Category 2
@ OTHER
Category 3
Category 4
8
GENTAMICIN ANALYTICAL PRINCIPLE C CEDIA J Luminescent Immunoassay (LIA –Competitive Assay)
MEASUREMENT SYSTEM Select from Measurement System Master List which can be found in the myQAP ‘Documents’ tab.
REAGENT SOURCE Select from Reagent Source Master List which can be found in the myQAP ‘Documents’ tab.
CALIBRATOR A Analyser Specific Calibrator Supplied by manufacturer of your analyser. B
K Kinetic Interaction of Microparticles in Solution (KIMS)
Any other calibrator not supplied by the manufacturer of your analyser.
N Particle-enhanced Turbidimetric Inhibition Immunoassay (PETINIA) P Fluorescence Polarisation Immunoassay (FPIA) Q EMIT
@ OTHER
@ OTHER
Category 1
@ OTHER
Category 2
@ OTHER
Category 3
Category 4
9
TOBRAMYCIN ANALYTICAL PRINCIPLE C CEDIA J Luminescent Immunoassay (LIA–Competitive Assay)
MEASUREMENT SYSTEM Select from Measurement System Master List which can be found in the myQAP ‘Documents’ tab.
REAGENT SOURCE Select from Reagent Source Master List which can be found in the myQAP ‘Documents’ tab.
CALIBRATOR A Analyser Specific Calibrator Supplied by manufacturer of your analyser. B
K Kinetic Interaction of Microparticles in Solution (KIMS)
Any other calibrator not supplied by the manufacturer of your analyser.
N Particle-enhanced Turbidimetric Inhibition Immunoassay (PETINIA) P Fluorescence Polarisation Immunoassay (FPIA) Q EMIT
@ OTHER
@ OTHER
Category 1
@ OTHER
Category 2
@ OTHER
Category 3
Category 4
10
VANCOMYCIN ANALYTICAL PRINCIPLE C CEDIA J Luminescent Immunoassay (LIA–Competitive Assay)
MEASUREMENT SYSTEM Select from Measurement System Master List which can be found in the myQAP ‘Documents’ tab.
REAGENT SOURCE Select from Reagent Source Master List which can be found in the myQAP ‘Documents’ tab.
CALIBRATOR A Analyser Specific Calibrator Supplied by manufacturer of your analyser. B
K Kinetic Interaction of Microparticles in Solution (KIMS)
Any other calibrator not supplied by the manufacturer of your analyser.
N Particle-enhanced Turbidimetric Inhibition Immunoassay (PETINIA) P Fluorescence Polarisation Immunoassay (FPIA) Q EMIT S Enzyme Immunoassay (EIA)
@ OTHER
@ OTHER
Category 1
@ OTHER
Category 2
@ OTHER
Category 3
Category 4
11
CYCLOSPORIN ANALYTICAL PRINCIPLE A ACMIA B RIA C CEDIA D Immunochemiluminometric Assay (ICMA) H HPLC (other than MS/MS) I
Electrochemiluminescence (ECLIA)
J Luminescent Immunoassay (LIA–Competitive Assay) L LCMSMS P Fluorescence Polarisation Immunoassay (FPIA) Q EMIT S Enzyme Immunoassay (EIA)
@ OTHER
Category 1
MEASUREMENT SYSTEM CHROMATOGRAPHY SAMPLE PREPARATION 22A 22B 22C 22D 22E 22F 22G 22H 22I 22J 22K 22L 22M 22N
Ion Exchange Alumina Ion Exchange + Alumina Liquid/Liquid Extraction (LLE) Ion Exchange + Solvent Extraction Direct Injection Protein Precipitation (no extraction) Solid Phase Extraction (off line) Reverse Phase Normal Phase Acid Extraction Protein Precipitation + Solvent Extraction Solid Phase Extraction (on line) Dilution (for AA and ICPMS-dilution not extraction) 22O AQC Derivatization 22@ Other sample preparation method
REAGENT SOURCE Select from Reagent Source Master List which can be found in the myQAP ‘Documents’ tab.
A
In House
B
Chromsystems
C
Recipe
D
Other Commercial
M Analyser Specific Calibrator Supplied by manufacturer of your analyser. N
Any other calibrator not supplied by the manufacture of your analyser.
@ OTHER
Category 2
Chromatography
Immunoassay
IMMUNOASSAY Select from Measurement System Master List which can be found in the myQAP ‘Documents’ tab. @ OTHER
CALIBRATOR
Category 3
@ OTHER
Category 4
12
SIROLIMUS ANALYTICAL PRINCIPLE H HPLC (other than MS/MS) I Electrochemiluminescence (ECLIA) J Luminescent Immunoassay (LIA– Competitive Assay) L LCMSMS M Microparticle Enzyme Immunoassay (MEIA) P Fluorescence Polarisation Immunoassay (FPIA)
MEASUREMENT SYSTEM
CHROMATOGRAPHY SAMPLE PREPARATION 22A 22B 22C 22D 22E 22F 22G 22H 22I 22J 22K 22L 22M 22N
Ion Exchange Alumina Ion Exchange + Alumina Liquid/Liquid Extraction (LLE) Ion Exchange + Solvent Extraction Direct Injection Protein Precipitation (no extraction) Solid Phase Extraction (off line) Reverse Phase Normal Phase Acid Extraction Protein Precipitation + Solvent Extraction Solid Phase Extraction (on line) Dilution (for AA and ICPMS-dilution not extraction) 22O AQC Derivatization 22@ Other sample preparation method
REAGENT SOURCE
CALIBRATOR
Select from Reagent Source Chromatography Master List which can be found A In House in the myQAP ‘Documents’ tab. B Chromsystems C
Recipe
D
Other Commercial
Immunoassay M Analyser Specific Calibrator Supplied by manufacturer of your analyser. N
Any other calibrator not supplied by the manufacturer of your analyser.
IMMUNOASSAY Select from Measurement System Master List which can be found in the myQAP ‘Documents’ tab. @ OTHER
Category 1
@ OTHER
@ OTHER
Category 2
Category 3
@ OTHER
Category 4 13
TACROLIMUS ANALYTICAL PRINCIPLE A ACMIA
MEASUREMENT SYSTEM CHROMATOGRAPHY SAMPLE PREPERATION
H HPLC (other than MS/MS) J Luminescent Immunoassay (LIA–Competitive Assay) L LCMSMS M Microparticle Enzyme Immunoassay (MEIA) Q EMIT
REAGENT SOURCE Select from Reagent Source Master List which can be found in the myQAP ‘Documents’ tab.
22A 22B 22C 22D 22E 22F 22G 22H 22I 22J 22K 22L 22M 22N
Ion Exchange Alumina Ion Exchange + Alumina Liquid/Liquid Extraction (LLE) Ion Exchange + Solvent Extraction Direct Injection Protein Precipitation (no extraction) Solid Phase Extraction (off line) Reverse Phase Normal Phase Acid Extraction Protein Precipitation + Solvent Extraction Solid Phase Extraction (on line) Dilution (for AA and ICPMS-dilution not extraction) 22O AQC Derivatization 22@ Other sample preparation method
Category 1
@ OTHER
@ OTHER
Category 2
Chromatography A
In House
B
Chromsystems
C
Recipe
D
Other Commercial
Immunoassay
IMMUNOASSAY Select from Measurement System Master List which can be found in the myQAP ‘Documents’ tab. @ OTHER
CALIBRATOR
Category 3
M
Analyser Specific Calibrator Supplied by manufacturer of your analyser.
N
Any other calibrator not supplied by the manufacturer of your analyser.
@ OTHER
Category 4
14
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