CP CS 2016 Booklet ccb9dd43 385b 32b3 88f3 553d7044acbd
RCPA Quality Assurance Programs Pty Limited ABN 32 003 520 072
2016
CSF 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
CSF PROGRAM 1. INTRODUCTION This booklet is designed to assist you with classifying the method you use to analyse samples in the CSF 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 - Analytical Principle Category 2 - Measurement System Category 3 - Reagent Source Category 4 - 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. Beckman Array 09F Beckman Immage 09U 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 (001-200) 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 glucose method is hexokinase on an Hitachi Modular with reagents from Roche Diagnostics and you use an analyser specific calibrator supplied by the manufacturer of your analyser, the classification is: CATEGORY ANALYTE
GLUCOSE
1
2
3
4
A
21L
021
A
N.B. If any of your classifications are "@ OTHER" then please provide additional information. 2. CHANGING METHOD CLASSIFICATION To change a method classification use the Changing Method Classification sheets 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 clasification 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
ANALYTE
Page
TOTAL PROTEIN
1
GLUCOSE
2
LACTATE
3
ALBUMIN
4
IgG
5
XANTHOCHROMIA SCREEN
(Bilirubin & Haemoglobin Net Absorbance)
6
XANTHOCHROMIA SCREEN
(Bilirubin Concentration)
7
OLIGOCLONAL BANDING
(CSF & Serum)
8
CSF/MB/Index
CSF PROGRAM 2016 NOTIFICATION OF CHANGING METHOD CLASSIFICATION CHANGE EFFECTIVE FROM CYCLE
ANALYTE
N.B.
SAMPLE DELETE METHOD ()
CATEGORY 1
2
3
4
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
PROTEIN (TOTAL) ANALYTICAL PRINCIPLE A Benzethonium Chloride B Biuret
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 Any other calibrator not supplied by the manufacturer of your analyser.
C Coomassie Blue E Pyrogallol red-molybdate G Copper-azo dye
@ OTHER
@ OTHER
Category 1
@ OTHER
Category 2
@ OTHER
Category 3
Category 4
1
GLUCOSE ANALYTICAL PRINCIPLE A Hexokinase B Glucose oxidase
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.
C Glucose oxidase – oxygen electrode
@ OTHER
A Analyser Specific Calibrator supplied by manufacturer of your analyser. B Any other calibrator not supplied by the manufacturer of your analyser.
@ OTHER
Category 1
CALIBRATOR
@ OTHER
Category 2
@ OTHER
Category 3
Category 4
2
LACTATE ANALYTICAL PRINCIPLE A Enzymatic B
Enzyme Electrode Sensor
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 Any other calibrator not supplied by the manufacturer of your analyser.
@ OTHER
@ OTHER
Category 1
@ OTHER
Category 2
@ OTHER
Category 3
Category 4
3
ALBUMIN ANALYTICAL PRINCIPLE A Bromcresol Green B Immunonephelometric
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.
C Immunoturbidimetric
@ OTHER
Category 1
A Analyser Specific Calibrator supplied by manufacturer of your analyser. B Any other calibrator not supplied by the manufacturer of your analyser.
E Bromocresol Purple
@ OTHER
CALIBRATOR
@ OTHER
Category 2
@ OTHER
Category 3
Category 4
4
IMMUNOGLOBULIN G ANALYTICAL PRINCIPLE B Immunoturbidimetric C Immunonephelometric
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 Any other calibrator not supplied by the manufacturer of your analyser.
@ OTHER
@ OTHER
Category 1
@ OTHER
Category 2
@ OTHER
Category 3
Category 4
5
XANTHOCHROMIA SCREEN (Bilirubin & Haemoglobin Net Absorbance) ANALYTICAL PRINCIPLE
MEASUREMENT SYSTEM
A Visual Inspection
No Code Visual
B Spectrophotometry
59A Spectrophotometer Instrument
REAGENT SOURCE Not applicable.
CALIBRATOR Not applicable.
C Chemical Analysis
@
OTHER
Category 1
@
OTHER
Category 2
Category 3
Category 4
6
XANTHOCHROMIA SCREEN (Bilirubin Concentration) ANALYTICAL PRINCIPLE CHEMICAL REACTION Accelerator:
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
Any other calibrator not supplied by the manufacturer of your analyser.
M
Factor based on molar extinction coefficient.
A Caffeine Benzoate C Chemical Oxidation (vandate) G Surfactant H Diazonium Salt J Dichloroaniline
B Spectrophotometry
@ OTHER
@ OTHER
Category 1
@ OTHER
Category 2
@ OTHER
Category 3
Category 4
7
OLIGOCLONAL BANDS (CSF & Serum) SEPARATION PRINCIPLE
SEPARATION SYSTEM MANUFACTURER Select from Measurement System Master List at front of booklet or
A EPG B EPG with concentration
VISUALISATION PRINCIPLE
IDENTIFICATION PRINCIPLE
Select from the codes below.
A Total protein staining
295 Acid Violet
B Immunoelectrophoresis
291 Amido Black
C Immunofixation
290 Coomassie Blue G250
D Immunoblotting
09 Beckman Coulter C IEF 40 Bio-Rad D IEF with concentration 44 Helena 297 Coomassie Blue R250
E Capillary electrophoresis 62 Pharmacia
293 HRP Labelled Antisera 76 Sebia 345 ALP Labelled Antisera 00A No instrument – Manual Method
289 Paragon Blue 294 Protein Dye and Labelled Antisera 292 Protein Stain and Silver Enhancement
@ OTHER
@ OTHER
Category 1
@ OTHER
Category 2
@ OTHER
Category 3
Category 4
8
9
2016
CSF 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
CSF PROGRAM 1. INTRODUCTION This booklet is designed to assist you with classifying the method you use to analyse samples in the CSF 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 - Analytical Principle Category 2 - Measurement System Category 3 - Reagent Source Category 4 - 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. Beckman Array 09F Beckman Immage 09U 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 (001-200) 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 glucose method is hexokinase on an Hitachi Modular with reagents from Roche Diagnostics and you use an analyser specific calibrator supplied by the manufacturer of your analyser, the classification is: CATEGORY ANALYTE
GLUCOSE
1
2
3
4
A
21L
021
A
N.B. If any of your classifications are "@ OTHER" then please provide additional information. 2. CHANGING METHOD CLASSIFICATION To change a method classification use the Changing Method Classification sheets 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 clasification 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
ANALYTE
Page
TOTAL PROTEIN
1
GLUCOSE
2
LACTATE
3
ALBUMIN
4
IgG
5
XANTHOCHROMIA SCREEN
(Bilirubin & Haemoglobin Net Absorbance)
6
XANTHOCHROMIA SCREEN
(Bilirubin Concentration)
7
OLIGOCLONAL BANDING
(CSF & Serum)
8
CSF/MB/Index
CSF PROGRAM 2016 NOTIFICATION OF CHANGING METHOD CLASSIFICATION CHANGE EFFECTIVE FROM CYCLE
ANALYTE
N.B.
SAMPLE DELETE METHOD ()
CATEGORY 1
2
3
4
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
PROTEIN (TOTAL) ANALYTICAL PRINCIPLE A Benzethonium Chloride B Biuret
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 Any other calibrator not supplied by the manufacturer of your analyser.
C Coomassie Blue E Pyrogallol red-molybdate G Copper-azo dye
@ OTHER
@ OTHER
Category 1
@ OTHER
Category 2
@ OTHER
Category 3
Category 4
1
GLUCOSE ANALYTICAL PRINCIPLE A Hexokinase B Glucose oxidase
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.
C Glucose oxidase – oxygen electrode
@ OTHER
A Analyser Specific Calibrator supplied by manufacturer of your analyser. B Any other calibrator not supplied by the manufacturer of your analyser.
@ OTHER
Category 1
CALIBRATOR
@ OTHER
Category 2
@ OTHER
Category 3
Category 4
2
LACTATE ANALYTICAL PRINCIPLE A Enzymatic B
Enzyme Electrode Sensor
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 Any other calibrator not supplied by the manufacturer of your analyser.
@ OTHER
@ OTHER
Category 1
@ OTHER
Category 2
@ OTHER
Category 3
Category 4
3
ALBUMIN ANALYTICAL PRINCIPLE A Bromcresol Green B Immunonephelometric
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.
C Immunoturbidimetric
@ OTHER
Category 1
A Analyser Specific Calibrator supplied by manufacturer of your analyser. B Any other calibrator not supplied by the manufacturer of your analyser.
E Bromocresol Purple
@ OTHER
CALIBRATOR
@ OTHER
Category 2
@ OTHER
Category 3
Category 4
4
IMMUNOGLOBULIN G ANALYTICAL PRINCIPLE B Immunoturbidimetric C Immunonephelometric
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 Any other calibrator not supplied by the manufacturer of your analyser.
@ OTHER
@ OTHER
Category 1
@ OTHER
Category 2
@ OTHER
Category 3
Category 4
5
XANTHOCHROMIA SCREEN (Bilirubin & Haemoglobin Net Absorbance) ANALYTICAL PRINCIPLE
MEASUREMENT SYSTEM
A Visual Inspection
No Code Visual
B Spectrophotometry
59A Spectrophotometer Instrument
REAGENT SOURCE Not applicable.
CALIBRATOR Not applicable.
C Chemical Analysis
@
OTHER
Category 1
@
OTHER
Category 2
Category 3
Category 4
6
XANTHOCHROMIA SCREEN (Bilirubin Concentration) ANALYTICAL PRINCIPLE CHEMICAL REACTION Accelerator:
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
Any other calibrator not supplied by the manufacturer of your analyser.
M
Factor based on molar extinction coefficient.
A Caffeine Benzoate C Chemical Oxidation (vandate) G Surfactant H Diazonium Salt J Dichloroaniline
B Spectrophotometry
@ OTHER
@ OTHER
Category 1
@ OTHER
Category 2
@ OTHER
Category 3
Category 4
7
OLIGOCLONAL BANDS (CSF & Serum) SEPARATION PRINCIPLE
SEPARATION SYSTEM MANUFACTURER Select from Measurement System Master List at front of booklet or
A EPG B EPG with concentration
VISUALISATION PRINCIPLE
IDENTIFICATION PRINCIPLE
Select from the codes below.
A Total protein staining
295 Acid Violet
B Immunoelectrophoresis
291 Amido Black
C Immunofixation
290 Coomassie Blue G250
D Immunoblotting
09 Beckman Coulter C IEF 40 Bio-Rad D IEF with concentration 44 Helena 297 Coomassie Blue R250
E Capillary electrophoresis 62 Pharmacia
293 HRP Labelled Antisera 76 Sebia 345 ALP Labelled Antisera 00A No instrument – Manual Method
289 Paragon Blue 294 Protein Dye and Labelled Antisera 292 Protein Stain and Silver Enhancement
@ OTHER
@ OTHER
Category 1
@ OTHER
Category 2
@ OTHER
Category 3
Category 4
8
9
