BLOOD SCIENCES DEPARTMENT OF CLINICAL BIOCHEMISTRY Title of Document: POCT Abbott Precision Xceed Pro – Ketone Testing Q Pulse Reference No: BS/CB/POCT/GLU/9 Version NO: 2 Authoriser: Francesca Mills POCT – KETONE TESTING USING ABBOTT PRECISION XCEED PRO 1. INTRODUCTION 1.1 Purpose of the Procedure Healthcare professionals may use the Abbott Precision Xceed Pro meter in conjunction with test strips to measure blood β-Ketone (Beta-Hydroxybutyrate) in whole blood samples. 1.2 Staff Only healthcare personnel who have been suitably trained and issued with a POCT Access ID may perform a blood β-Ketone test using the Precision Xceed Pro. 2. PRINCIPLE OF THE PROCEDURE When a blood sample is applied to the test strip β-hydroxybutyrate (β-OHB) the primary ketone body produced when a patient is developing ketoacidosis, reacts with the chemicals on the test strip, producing a small electrical current. This current is measured and then a result is displayed by the meter. The size of the current depends of the amount of β-Ketone in the blood sample. 3. SPECIMEN REQUIREMENTS Test sample: Fresh capillary (i.e. from the finger) or venous whole blood. Sample volume: 1.5μL. NOTE: The meter will beep and the countdown will commence when sufficient sample has been applied to the test strip. 4. HEALTH AND SAFETY All patient samples are a potential infection risk. Follow appropriate procedures (e.g. use gloves). Cover cuts and abrasions on own hands and forearms with waterrepellent ‘island’ type plasters. If hands do become contaminated with blood, wash immediately with soap and water. Used lancets should be disposed of in a sharps bin. Any other used materials should be discarded into clinical waste in accordance with ward/site procedures. Page 1 of 5 If printed this document is uncontrolled and only valid on day of printing. Please refer to the POCT website (www.nbt.nhs.uk/POCT) for the most up to date version. BLOOD SCIENCES DEPARTMENT OF CLINICAL BIOCHEMISTRY Title of Document: POCT Abbott Precision Xceed Pro – Ketone Testing Q Pulse Reference No: BS/CB/POCT/GLU/9 Version NO: 2 Authoriser: Francesca Mills 5. EQUIPMENT AND INSTRUMENTATION Blood lancing device Abbott Precision Xceed Pro Meter Meter docking station Strip port Display Scan Button Alphanumeric keypad Backlight On/ Off Button 6. REAGENTS, STANDARDS, CALIBRANTS AND CONTROLS Abbott Precision Xceed Pro β-Ketone Test Strips. Stable up to the expiry date stated on the packaging – store between 4 - 30°C. Abbott MediSense Glucose & Ketone Control Solutions (LO and HI). Stable up to expiry date on bottles/box unopened. Stable 90 days from time of opening (expiry date to be noted on bottles). Store between 4 - 30°C. 7. METHOD 7.1 Calibration Calibration of the meter is automatic. The calibration data for the meter is encoded into the barcode on the back of the test strip. 7.2 Control Solution Testing This meter is capable of measuring both Glucose and Ketones. A message will appear on the screen if the QC is required and this needs to be done before you can use the meter for a patient test. If both the Glucose and Ketone QC is due, the Glucose QC will need to be performed first then select 1-Ketone to proceed to the Ketone QC. Page 2 of 5 If printed this document is uncontrolled and only valid on day of printing. Please refer to the POCT website (www.nbt.nhs.uk/POCT) for the most up to date version. BLOOD SCIENCES DEPARTMENT OF CLINICAL BIOCHEMISTRY Title of Document: POCT Abbott Precision Xceed Pro – Ketone Testing Q Pulse Reference No: BS/CB/POCT/GLU/9 Version NO: 2 Authoriser: Francesca Mills 1. Wash you hands using warm soapy water and dry them completely. 2. Press the On/Off button on the meter to turn the meter on. The Abbott logo will appear for a few seconds. 3. The meter will then present two options; one option is to run a patient test the other to run a control test. Press the number 2 button on the keypad to select a control test. 4. Enter your operator ID by pressing the SCAN button and barcode reading your ID badge. The meter will then display the LO level solution lot screen. 5. Enter the lot number of the LO level solution by scanning the barcode on the bottle. 6. Enter the lot number of the test strip by scanning the barcode on the test strip foil pack. The meter will then display the Insert Strip screen. 7. Remove the test strip from its foil pack. Tear the foil pack from the ‘shark’s fin’ and down to the left. Make sure the test strip does not appear torn or damaged. 8. Insert the three black lines at the end of the test strip into the strip port and push in until it stops. 9. The test strip with a blood drop will appear and the meter will display Apply Low Solution screen, letting you know the meter is ready to test. 10. Gently invert the control bottle to mix. Apply a small drop of control solution to the test strip. 11. Continue to touch the control solution to the test strip until the meter begins the test with a beep and displays Sample Accepted. 12. The meter will then display the Analyzing Sample screen and countdown 10 seconds. The meter will then display either PASS or FAIL. 13. If FAIL is displayed then press the 2 button on the keypad to repeat the test. The meter will then display the Remove Strip screen. Remove the test strip from the meter and discard it, then go back to step 6. 14. If PASS is displayed then press the 1 button on the keypad to move on to the next control level. The meter will then display the Remove Strip screen. Remove the test strip from the meter and discard it. 15. Repeat steps 5 to 12 with the Hi level control solution. 7.3 Patient Testing 1. Wash your hands and dry them completely. Wear nitrile/latex gloves. 2. Select and prepare the sample site for blood collection. 3. Press the On/Off button on the meter to turn the meter on. The Abbott logo will appear for a few seconds. The meter will then present two options, one options is to run a patient test the other to run a control test. 4. Press the number 1 button on the keypad to select a patient test. Page 3 of 5 If printed this document is uncontrolled and only valid on day of printing. Please refer to the POCT website (www.nbt.nhs.uk/POCT) for the most up to date version. BLOOD SCIENCES DEPARTMENT OF CLINICAL BIOCHEMISTRY Title of Document: POCT Abbott Precision Xceed Pro – Ketone Testing Q Pulse Reference No: BS/CB/POCT/GLU/9 Version NO: 2 Authoriser: Francesca Mills 5. Enter your operator ID by pressing the SCAN button and barcode reading your ID badge. 6. Enter the patient’s ID by either scanning the PID barcode or by manually entering it via the keypad and pressing the ENTER key. 7. Enter the lot number of the test strip by scanning the barcode on the test strip foil pack. The meter will then display the Insert Strip screen. 8. Remove the test strip from its foil pack. Tear the foil pack from the ‘shark’s fin’ and down to the left. Make sure the test strip does not appear torn or damaged. 9. Insert the three black lines at the end of the test strip into the strip port and push in until it stops. 10. Using a suitable blood lancing device, obtain a blood sample. 11. Touch the blood drop to the white target area at the tip of the test strip. 12. Continue to hold the finger in place until the test begins with a beep. 13. There is a 10 second countdown before the ketone result is displayed. Record the ketone result in notes and include any action taken. 14. Remove and discard the test strip. 8. QUALITY CONTROL MediSense Glucose & Ketone Control Solutions are used to check that the meter and test strips are working properly. Control Solution testing, using both High and Low, must be performed weekly or before the next patient. 9. LIMITATIONS OF THE EXAMINATION Test results may be erroneously low if the patient is severely dehydrated, severely hypotensive, in shock or in a hyperglycaemic-hyperosmolar state. NB. The limitations are also provided in each box of test strips. 10. RECORDING AND CALCULATION OF RESULTS All results are displayed in mmol/L. The analytical range is 0.0 – 8.0 mmol/L. A result greater than 8.0 mmol/L will be displayed as >8.0 mmol. Repeat the tests with a new test strip. If the result is still high inform medical staff immediately. 11. REFERENCE RANGES Below 0.6mmol/L: 0.6mmol/L to 1.5mmol/L: Above 1.5mmol/L: Normal May indicated a developing problem. Risk of diabetic ketoacidosis (DKA). Page 4 of 5 If printed this document is uncontrolled and only valid on day of printing. Please refer to the POCT website (www.nbt.nhs.uk/POCT) for the most up to date version. BLOOD SCIENCES DEPARTMENT OF CLINICAL BIOCHEMISTRY Title of Document: POCT Abbott Precision Xceed Pro – Ketone Testing Q Pulse Reference No: BS/CB/POCT/GLU/9 Version NO: 2 Authoriser: Francesca Mills 12. REPORTING AND VALIDATION OF RESULTS If the result does not fit the clinical condition of the patient the repeat the test. ERROR CODES What you see Meter Error (followed by a number) What it means The meter may have a problem that prevents it from working correctly Meter Error 2012 Assay Error (Followed by a number) The meter has detected a problem with the barcode scanner, preventing the scanner from operating There may be a problem with the test strip What you should do Turn meter off and on. If that doesn’t work try docking the meter. Record the four digit error code and contact POCT if the problem persists Turn the meter off and wait at least 5 seconds for the meter to reset, and then turn the meter back on. If the problem persists try turning the meter off again and waiting at least 5 seconds. Contact POCT. 4327- Strip removed during test, repeat with new strip 13. DATA UPLOAD The docking station provides automatic data transfer between the Precision Xceed Pro meter and a PC running the data management application software. Data uploading is required once every 24 hours. 1. Place the meter into the docking station. 2. The meter will turn on, if it isn’t already, and then automatically upload data to the management system. A rotating arrow indicates that the system is working. 3. After the upload is complete the meter will turn off. 4. Remove the meter from the docking station. 5. If an error occurs with the data upload retry ensuring that the PC is switched on. If the problem persists contact POCT Ext: 38380 13. REFERENCES Abbott Precision Xceed Pro Operators Manual POCT Abbott Precision Xceed Pro Blood Glucose Meter SOP Q Pulse Reference No: BS/CB/POCT/GLU/2 Package insert for Abbott Precision Xceed Pro β-Ketone Testing Strips. Replacement meters, QC and batteries can be obtained from POCT ext: 38380. Page 5 of 5 If printed this document is uncontrolled and only valid on day of printing. Please refer to the POCT website (www.nbt.nhs.uk/POCT) for the most up to date version.