cobas h 232 Training Guide

4. Sampling Stability of components

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Test strip handling

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Sample volume

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Sample application

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Measurement Time

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Display of Results

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5. Data Retrieval Stored results

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Printing results (if applicable)

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6. Quality Control Quality control policy

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Instrumental Quality Control

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Liquid Quality Control

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Reconstitution/storage of quality control materials

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External quality assurance

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7. Maintenance & Troubleshooting Paper change (if applicable)

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Error codes

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Cleaning & decontamination

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Point of contact

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Signed:

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For a full protocol refer to the operators manual for your cobas h 232

Do not force the code chip into the meter or you will break it!

3. Slide the new code chip into the slot on the top of the meter as shown until you feel it click into place. Ensure the code chip number and monitor screen are facing you when inserting. The code chip does not insert flush with the black back panel; you can still place your finger behind to remove.

2. Always make sure that the number on the code chip matches the number on the label of the test strip package.

1. Remove the old code chip if one is inserted in the meter. Dispose of code chip with general waste.

cobas h 232 Test Strip Calibration

cobas h 232 Specimen Collection/Preparation Blood Collection Tubes: Use heparinised venous whole blood only. Do not use other anticoagulants, capillary blood, serum or plasma, blood collection tubes containing EDTA, citrate, sodium fluoride or other additives. The following heparin blood collection tubes have been tested: o o o o o

Sarstedt Monovette* Becton Dickinson Vacutainer Becton Dickinson Vacutainer PST II Greiner Vacuette Terumo Venosafe

*In the case of Sarstedt Monovettes, only tubes without separating gel are suitable. No data is available for blood collection tubes supplied by other manufacturers. An influence on the test result in individual cases cannot be ruled out. Sample stability: o o o o o

TroponinT: D-dimer: NT-proBNP: Myoglobin: CK-MB:

8 hours at room temperature. Do not refrigerate or freeze sample 8 hours at room temperature. Do not refrigerate or freeze sample 8 hours at room temperature. Do not refrigerate or freeze sample 6 hours at room temperature. Do not refrigerate or freeze sample 4 hours at room temperature, 8 hours at +2°C to +8°C. Do not freeze.

Sample volume: o o

Fill the collection tube according to manufacturers’ instructions. Apply 150μl to test strip.

Do not touch application area with needle

For a full protocol refer to the operators manual for your cobas h 232

Draw up exactly 150μl blood

cobas h 232 Quick guide to patient testing (part 1)

Do not apply blood with force or at an angle

Steadily apply blood, holding pipette vertically

cobas h 232 Quality Control Testing The cobas h 232 POC system employs several methods to check that the meter and test strips are working properly and that the operator is performing the test correctly. The meter has a number of built-in quality control functions: o A self-check of the electronic components and functions every time the meter is powered on. o A check of test temperature when warming up and during the test o A check of the expiration date and lot information on the test strip using the information from the code chip. In addition, the cobas h 232 POC system provides: o Configurable, prescribed quality control tests using Roche CARDIAC IQC test strips for internal functionality tests. o Definable, prescribed control tests using Roche CARDIAC Control materials for the available test parameters. Instrument Quality Control (IQC) Intended Use: The Roche CARDIAC IQC test serves as a performance check for the optical system of the cobas h 232 instrument. Summary: The Roche Cardiac IQC test consists of two reusable control strips to ensure correct functioning of the instrument. The Roche CARDIAC IQC low test serves to ensure correct functioning of the instrument. The Roche CARDIAC IQC high test serves to check the higher measurement range. Liquid Quality Control Intended Use: The Roche CARDIAC liquid quality control is used for quality control of the Roche CARDIAC specific assay using the cobas h 232 instrument. Summary: The Roche CARDIAC liquid quality control is used for accuracy and precision control.

5) Test strip warms up

1) Touch ‘Patient Test’

7) Countdown to result

3) Insert Test Strip

For a full protocol refer to the operators manual for your cobas h 232

6) Apply 150μl blood then touch

2) If prompted, Input Patient ID

cobas h 232 Quick guide to patient testing (part 2)

8) Result appears

4) If prompted, Insert Code Chip

1) Touch ‘Control Test’

5) Result displayed

3) If prompted, Insert IQC Code Chip

For a full protocol refer to the operators manual for your cobas h 232

4) Test commences

2) Insert IQC Strip

cobas h 232 Quick guide to Instrument Quality Control (IQC)

cobas h 232 Preparing & storing liquid quality controls Items needed to perform a liquid quality control test: o o o o o o o

cobas h 232 meter Roche CARDIAC control solution vials Level I & Level II (+calibration code chip if required) Roche CARDIAC test strips (+calibration code chip if required) Distilled or deionised water Syringe or pipette for 1ml Roche CARDIAC Pipettes Gloves

Storage and Stability: Stability of the lyophilized control serum at 2-8°C (36-46°F) is up to the stated expiration date. Controls must be stored tightly capped when not in use. Handling Instructions: carefully open a vial, avoiding the loss of lyophilized control serum, and pipette in exactly 1.0ml of distilled or deionized water. Carefully close the vial and dissolve the contents completely by occasional gentle swirling within 15 minutes. Avoid the formation of foam. The CARDIAC control Myoglobin follows the same procedure as above but must be completed within 30 minutes. Stability of components in reconstituted control serum: Depending on the frequency of your quality control tests you can extend the life of your quality control solutions, once reconstituted, by storing in the fridge or freezer. The following table indicates stability for each control parameter when stored at different temperatures. You can freeze and thaw your solutions in the original vial as indicated:

Roche CARDIAC control

Storage Temperature

Stability

Troponin T

18-25oC (64-77oF) 2-8oC (36-46oF) -20oC (-4oF)

24 hours 3 days 8 weeks (can be frozen up to 4 times in original vial)

D-Dimer

2-25oC (36-77oF) -20oC (-4oF)

24 hours 6 weeks (can be frozen up to 5 times in original vial)

proBNP

2-25oC (36-77oF) At and below 20oC (-4oF)

24 hours 12 weeks (can be frozen up to 5 times in original vial)

Myoglobin

18-25oC (64-77oF) 2-8oC (36-46oF)

24 hours 8 weeks

CK-MB

2-25oC (36-77oF) At and below 20oC (-4oF)

24 hours 12 weeks (can be frozen up to 5 times in original vial)

5) Select QC Level

1) Touch ‘Control Test’

7) Apply 150μl QC then touch

8) Countdown to result

4) If prompted, insert QC code chip

For a full protocol refer to the operators manual for your cobas h 232

6) Test strip warms up

2) Insert Test Strip

3) If using a new test strip lot, insert code chip when prompted

cobas h 232 Quick Guide to Liquid Quality Control 4) Select previously used QC code

9) QC Pass or Fail Result displayed

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