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ANALIS

CEofix™ CDT kit for Beckman Coulter P/ACE™ MDQ - GB: Instructions for use

QUOTATION
INFORMATION
QUOTATION
INFORMATION
DESCRIPTION DOWNLOADS
DESCRIPTION

Revision 03

1.

Date

2.

Intended use

3.

Principle of the test

4.

Content

5.

Configuration of instrument

6.

Other material needed

7.

Training

8.

Reagent preparation and storage

9.

Type of specimen

10.

Instrument preparation

11.

Sample preparation

12.

Operations

13.

Calibration

14.

Analysis of results

15.

Calculation

16.

Imprecision

17.

Reference range

18.

Interference

19.

Quality Control

20.

References

100 tests per kit

1. Date: 1-Dec-03-Revision: 03

2. Intended use:

The kit is intended for the determination of human Tf (transferrin isoforms) and quantitative determination of CDT (carbohydrate deficient transferrin) in human serum.


3. Principle of the test:

The Tf are separated inside a capillary under the influence of an electrical field. Differences in charge to mass ratio give different migration times.

A UV detector is used and detects the Tf at 200nm.

The kit consists of buffers and method. The buffers use the patented dynamic double coating technique.

CDT is defined as the percent of 0-sialo Tf plus 2-sialo Tf in relation to the sum of all Tf isoforms.

4. Content:

Rinse:1x 30mL aqua bidistallata (PN 10-004743)

Conditioner:1x 40mL NaOH 0.2 M (PN 10-004741)

Initiator:1x 6 mL TRIS/phosphate buffer pH 2.0 (PN 10-004764)

Buffer:1 x 18 mL Tris borate buffer pH 8.5 (PN 10-004762)

Fe solution:1 x 15 mL(PN 10-004765)

5. Configuration of instrument:


-BeckmanCoulter P/ACE MDQ

-UV detector and sample cooling

-P/ACE 32 Karat software version 5.0

(use configuration without CAESAR integration)

6. Other material needed:

- Vials 2 mL (PN 144980)

- caps (PN 144648)

- microtiterplate

- Blank Cartridge assembly 100 x 800 µm (PN 144738)

- Pipettes

- Capillary 50µM ID x 40 cm to the detector (EuroPN: 844111044 or PN 10-004748)


7. Training:

The operator should be familiar with instrument (P/ACE MDQ) operation and maintenance.

8. Reagent preparation and storage:


Reagents are ready to use. Store kit and buffers, in closed container, between 8°C and 30°C until expiration date.

Between operation buffer vials should be capped to avoid evaporation.

If the kit arrived damaged a replacement of the kit should be requested.

The kit contains no hazardous components.

9. Type of specimen:

Biological fluids should be collected in the manner normally used for any clinical laboratory test.

Freshly drawn serum is the preferred specimen.

10. Instrument preparation:

Load the instrument as follow

figure 1

Instrument programming

figure 2

figure 3

figure 4

Or download program: CDT_meth_96well_plate.met

Burn the capillary ends to eliminate the polyimide coating on 2mm.

11. Sample preparation:

Sample: 150 µL Fe solution + 50 µL serum in microtiterplate and mix.

figure 5

12. Operations:

Every day operation:

- clean instrument and interface manifold

- put new rinse, conditioner, initiator buffer vials- put new waste vial - put clean and dry caps on buffer vials

- run  cond.met when system was down for several days (see method).

- prepare samples

- place sample in instrument

- run  CDT_meth_96well_plate.met method

End of day:

- remove samples

- cap buffer vials

Placing new capillary

-When the capillary is broken or when the capillary is not operating properly replace the capillary: according the instrument manual.

-run"cond.met for conditioning

13. Calibration:

No calibration is required for the kit.

Instrument should be maintained and calibrated according to Beckman Coulter specifications.

14. Analysis of results:

Click to see examples

15. Calculation:

% CDT = sum of % 0-Sialo Tf plus % of 2-Sialo Tf.

% X-Sialo Tf = corrected area of X-Sialo Tf in relation to the sum of all Tf isoforms.

(X= 0, 2, 3, 4, 5 or 6).

16. Imprecision:

Imprecision:

Sample

Control

Low

High

Low

High

Asialo

Disialo

Asialo

Disialo

Asialo

Disialo

Asialo

Disialo

Mean

_

0.89

0.68

3.20

_

0.94

0.75

3.59

SD

_

0.06

0.12

0.12

_

0.06

0.07

0.13

CV

_

7.2

18.7

3.9

_

6.6

9.0

3.6

NCCLS EP5-A (N=80) Lanz C., Thormann W. University of Bern Switzerland on P/ACE MDQ

17. Reference range:

Each laboratory should establish its own reference range to conform to patient population.

figure 6

18. Interference:

-Heterozygote Tf variants, such as BC Tf and DC Tf are easily detected by observing two peaks of about 40% corrected area percent.

- Some monoclonal or biclonal gammapathie can interact in the Tf region.

19. Quality Control:

Pooled control or commercially available control should be included in each run.

20. References:

1. Legros F. et al. Carbohydrate-deficient Transferrin Isoforms Measured by Capi

REVISION 02

1.

Date

2.

Intended use

3.

Principle of the test

4.

Content

5.

Configuration of instrument

6.

Other material needed

7.

Training

8.

Reagent preparation and storage

9.

Type of specimen

10.

Instrument preparation

11.

Sample preparation

12.

Operations

13.

Calibration

14.

Analysis of results

15.

Calculation

16.

Imprecision

17.

Reference range

18.

Interference

19.

Quality Control

20.

References

100 tests per kit

1. Date: 1-Dec-03-Revision: 02

2. Intended use:

The kit is intended for the determination of human Tf (transferrin isoforms) and quantitative determination of CDT (carbohydrate deficient transferrin) in human serum.


3. Principle of the test:

The Tf are separated inside a capillary under the influence of an electrical field. Differences in charge to mass ratio give different migration times.

A UV detector is used and detects the Tf at 200nm.

The kit consists of buffers and method. The buffers use the patented dynamic double coating technique.

CDT is defined as the percent of 0-sialo Tf plus 2-sialo Tf in relation to the sum of all Tf isoforms.

4. Content:

Rinse:1x 30mL aqua bidistallata (PN 10-004743)

Conditioner:1x 40mL NaOH 0.2 M (PN 10-004741)

Initiator:1x 6 mL TRIS/phosphate buffer pH 2.0 (PN 10-004764)

Buffer:1 x 18 mL Tris borate buffer pH 8.5 (PN 10-004762)

Fe solution:1 x 15 mL(PN 10-004765)

5. Configuration of instrument:


-BeckmanCoulter P/ACE MDQ

-UV detector and sample cooling

-P/ACE 32 Karat software version 5.0

(use configuration without CAESAR integration)

6. Other material needed:

- Vials 2 mL (PN 144980)

- caps (PN 144648)

- microtiterplate

- Blank Cartridge assembly 100 x 800 µm (PN 144738)

- Pipettes

- Capillary 50µM ID x 40 cm to the detector (EuroPN: 844111044 or PN 10-004748)


7. Training:

The operator should be familiar with instrument (P/ACE MDQ) operation and maintenance.

8. Reagent preparation and storage:


Reagents are ready to use. Store kit and buffers, in closed container, between 8°C and 30°C until expiration date.

Between operation buffer vials should be capped to avoid evaporation.

If the kit arrived damaged a replacement of the kit should be requested.

The kit contains no hazardous components.

9. Type of specimen:

Biological fluids should be collected in the manner normally used for any clinical laboratory test.

Freshly drawn serum is the preferred specimen.

10. Instrument preparation:

Load the instrument as follow

figure 1

Instrument programming

figure 2

figure 7

figure 4

Or download program: CDT_meth_96well_plate.met

Burn the capillary ends to eliminate the polyimide coating on 2mm.

11. Sample preparation:

Sample: 150 µL Fe solution + 50 µL serum in microtiterplate and mix.

figure 5

12. Operations:

Every day operation:

- clean instrument and interface manifold

- put new rinse, conditioner, initiator buffer vials- put new waste vial - put clean and dry caps on buffer vials

- run  cond.met when system was down for several days (see method).

- prepare samples

- place sample in instrument

- run  CDT_meth_96well_plate.met method

End of day:

- remove samples

- cap buffer vials

Placing new capillary

-When the capillary is broken or when the capillary is not operating properly replace the capillary: according the instrument manual.

-run"cond.met for conditioning

13. Calibration:

No calibration is required for the kit.

Instrument should be maintained and calibrated according to Beckman Coulter specifications.

14. Analysis of results:

Click to see examples

15. Calculation:

% CDT = sum of % 0-Sialo Tf plus % of 2-Sialo Tf.

% X-Sialo Tf = corrected area of X-Sialo Tf in relation to the sum of all Tf isoforms.

(X= 0, 2, 3, 4, 5 or 6).

16. Imprecision:

figure 8

Tree samples were run in duplicate, twice a day over 3 days in a sequence.
Total imprecision (N=12) was showing a CV of 3.03 % for a sample with low 2-sialo Tf (0.81%) to 1.24 % for a sample with a high value (3.14 % 2-sialo Tf).
(Table:1)

17. Reference range:

Each laboratory should establish its own reference range to conform to patient population.

figure 9

18. Interference:

-Heterozygote Tf variants, such as BC Tf and DC Tf are easily detected by observing two peaks of about 40% corrected area percent.

- Some monoclonal or biclonal gammapathie can interact in the Tf region.

19. Quality Control:

Pooled control or commercially available control should be included in each run.

20. References:

1. Legros F. et al. Carbohydrate-deficient Transferrin Isoforms Measured by Capillary Zone Elelectrophoresis for Detection of Alcohol Abuse. Clin Chem 2002;48: 2177-2186.

2. Lanz C. et al. Evaluation and optimization of capillary zone electrophoresis with different dynamic capillary coatings for the determination of carbohydrate-deficient transferrin in human serum. J Chromatogr A 2002; 979: 43-57.

3. Legros F. et al. Use of Capillary Zone Electrophoresis for Differentiating Excessive from Moderate Alcohol Consumption. Clin Chem 2003;49:440-449.

4. Lanz C, et al. Capillary zone electrophoresis with a dynamic double coating for analysis of carbohydrate-deficient transferrin in human serum. Precision performance and pattern recognition. J Chromatog A 2003;1013:131-474 .

5. Ramdani B. et al. Analyte Comigrating with Trisialotransferrin during Capillary Zone Electrophoresis of Sera from Patients with Cancer. Clin Chem 2003;49:1854-1864.

6. Carchon H. et al. Diagnosis of Congenital Disorders of Glycosylation by Capillary Zone Electrophoresis of Serum Transferrin. Clin Chem 2004;50:101-111.

7. Lanz C. et al. Capillary zone electrophoresis with a dynamic double coating for analysis of carbohydrate-deficient transferrin in human serum: Impact of resolution between disialo- and trisialotransferrin on reference limites. Electrophoresis 2003;24: 4272-4281.

8. Martello S. et al. Determination of carbohydrate deficient transferrin (CDT) with capillary electrophoresis: an inter laboratory comparison. Forensic Sci Int 2004; 141:153-157.

9. Lanz C. et al. Improved capillary electrophoresis method for the determination of carbohydrate-deficient transferrin in patient sera. Electrophoresis 2004; 25: 2309-2318.

10. Loiseaux M.-N. et al. La transferrine hyposialylée et le %CDT Mesure par électrophorèse capillaire avec le coffret CEofix CDT (ANALIS) chez des sujets consommateurs modérés. Immuno-analyse de Biologie spécialisée 2004 19 : 148-156.

11. Wielder et al. Comparison of HPLC and Capillary Electrophoresis for Confirmatory Testing of the Alcohol Misuse Marker Carbohydrate-Deficient Transferrin. Clin Chem 2005; 51: 1528-1530.

12. Bortolotti et al. Analysis of Carbohydrate-Deficient Transferrin: Comparative Evaluation of Turbidimetric Immunoassay, Capillary Electrophoresis and HPLC. Clin Chem 2005; 51: 2368-2371.

13. Appenzeller et al. Altered Distribution of Transferrin Isoforms According to Serum Storage Conditions. Clin. Chem. 2005; 51: 2159-2161.

14. Appenzeller et al. Drugs and chronic alcohol abuse in drivers. Forensic Sci Int 2005; 155: 83-90.

15. Schwan et al. Performance of Asialotransferrin in Detecting Alcohol Abuse. Alcohol Clin Exp Res 2005; 29: 81-83

16. Piagnerelli et al. Rapid alterations in Transferrin Sialylation during Sepsis. Shock, 2005; 24: 48-52.

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