POCT Ketones - PXP SOP

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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.
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