Southern Health and Social Care Trust
POCTXCEEDKETONE
Pathology and Laboratory Service
Page 1 of 9
POCT
Date of issue 16/05/2011
STANDARD OPERATING PROCEDURE FOR USE OF
ABBOTT OPTIUM XCEED METER FOR BLOOD β-KETONE
This SOP has been compiled by the POCT committee to
provide a document compatible with Clinical Pathology
Accreditation standards, containing information users need to
achieve consistently reliable and accurate results. This SOP
should be read in conjunction with the manufacturer’s manual
and test device package insert.
Clinical Relevance/Purpose
The energy demands of the body are normally met by the metabolism of glucose.
When there is insufficient glucose, the body turns to its stores of fat as a source of
energy. In order to use fat as energy it must first be broken down into ketones. Low
levels of ketones are not harmful. Ketones will usually appear in the blood during
fasting or after prolonged exercise when glycogen stores are depleted.
Under normal circumstances, when ketone levels rise, glucose levels do not because
the level of ketones in the blood is prevented from rising too high by the presence of
insulin. However, in people with diabetes rising blood ketones and blood glucose
tend to go together and, without insulin, ketone levels will continue to rise and may
reach dangerous levels. High ketone levels make the blood extremely acidic.
A blood ketone level of >1.5 mmol/L would indicate a patient at risk of developing
diabetic ketoacidosis and if over 3 mmol, emergency medical intervention may be
required.
Principle of Examination
The Abbott Optium Xceed Monitoring System is used for the in vitro measurement of
blood ketone (β -hydroxybutyrate). Monitoring β -hydroxybutyrate may be useful in
the treatment of patients with diabetic ketoacidosis. The system consists of two
parts: the sensor (meter) and the disposable electrode strips. When blood is applied
to the electrode the ketone (β -hydroxybutyrate) in the blood reacts with the
chemicals (enzyme – hydroxybutyrate dehydrogenase) on the electrode / strip. This
reaction produces a small electric current proportional to the concentration of β hydroxybutyrate and the result is displayed by the sensor.
Optium Xceed Blood β-Ketone SOP
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POCTXCEEDKETONE
Pathology and Laboratory Service
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POCT
Date of issue 16/05/2011
Specimen Requirements
Optium β-ketone test strips are designed to quantitatively measure blood β-ketone in
fresh capillary whole blood from the fingertip. A 1.5μL sample is required.
Healthcare professionals may also use venous whole blood samples, provided the
samples are used within 30 minutes of collection.
Venous whole blood samples may be collected into sodium or lithium heparin tubes
or EDTA tubes. Do not use tubes containing fluoride or oxalate.
The test strips have not been evaluated for alternative site testing.
Sample Rejection
See specimen requirements.
Equipment
Abbott Medisense Optium Xceed blood glucose and blood β-ketone monitoring
system.
In addition, Trust approved lancet devices are required.
Reagents, Standards or Calibrators and IQC Material
Strips
Optium β-ketone Tests strips – Ref 70784-35
Including 10 test strips individually wrapped in foil packets and 1 calibrator.
• Use the test strip immediately after opening its foil packet.
• Test strips should be stored at a temperature between 4˚ – 30˚C. Storage outside
this range may cause incorrect results. Keep away from direct sunlight and heat.
• Use each test strip once and then discard it.
• Do not use out-of-date test strips. Check the expiration date printed on the test strip
box and on every test strip foil packet.
• Do not use a test strip that is wet, bent, scratched or damaged.
• Do not use the test strip if its foil packet has a puncture or tear in it.
Calibrator
Calibrator strip included with each pack of test strips.
Optium Xceed Blood β-Ketone SOP
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POCTXCEEDKETONE
Pathology and Laboratory Service
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POCT
Date of issue 16/05/2011
IQC
Medisense glucose and ketone control solutions – Ref 99895-05
Low control solution, 4 ml
High control solution, 4 ml
• Store between 4°and 30°C.
• Do not use beyond the printed expiry date.
• Stable for 90 days after opening.
• On opening a new bottle, write the expiry date (90 days from opening) on the bottle
label. Always replace cap tightly.
Instructions for Performance of Examination
Calibration
The meter (sensor) must be calibrated so it can recognize the test strip in use.
Failure to calibrate properly will cause incorrect results.
The meter must be calibrated for each new lot number of ketone electrode strips
before use.
1. Hold the calibrator with the LOT number facing toward you.
2. Insert the calibrator into the test port. Push it in until it stops.
3. Check that the LOT number matches on the following items: sensor display
window, test strip calibrator, test strip instructions for use, test strip foil packet.
Please note: Your sensor may display the word "CODE" with the LOT number.
This number is the LOT number and must match on all items listed.
4. Record the calibration code, date and QC values for that lot in the quality
control/patient record book.
Internal Quality Control
Both LO and HI Internal Quality control material must be run as follows:
 At least once each day the meter is in use.
 After each new electrode strip calibration.
 After any adverse incident.
 Any time to check technique.
 After batteries have been changed or battery compartment opened – this may
lead to loss of calibration code and recalibration will be required.
a)
b)
Check that the current, in use, IQC material has not passed its expiry date.
Check strip lot number. Open the strip using the triangular notch in the foil
tearing down and across the length of the strip. Ensure the 3 electrodes
enter the port facing upward. Insert test strip. The meter turns on
automatically. Check display to ensure time and date are correctly set and
meter is calibrated for the strip lot in use.
Optium Xceed Blood β-Ketone SOP
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POCT
Date of issue 16/05/2011
c)
d)
e)
f)
Wait for flashing “apply sample” symbol. To mark the test as a control test
press and release the mode button once – a control bottle symbol shows on
the display window.
Invert one of the control bottles four times to mix the solution thoroughly.
While inverted, tap the cap to remove any bubbles in the bottle’s nozzle. With
the bottle still inverted remove the cap and apply a drop of control to the
electrode target area. The test should then start automatically when the
sample is detected.
The meter begins to test when the display window shows a status bar and
then the countdown.
If the test fails to start, a second sample can be applied within 30 seconds of
applying the first drop of solution.
After the 10 second countdown the result will appear on the display. Record
the result in the quality control/patient record book.
IMPORTANT
Compare IQC results with the limits printed on the strip package insert (and written in
the quality control/patient record book) for the lot in use. If values fall outside limits
do not use the meter for patient sample analysis.
Repeat the test with a new test strip and ensure the control solution testing
instructions are followed completely. If the result is still not within the printed range
contact the POCT team for advice.
Removing the test strip from the strip port turns off the meter.
The meter may also be turned off by pressing and holding the centre button. The
meter will turn off automatically after 60 seconds if not turned off or test strip
removed.
Patient samples
NB – Ensure IQC is satisfactory first.
1. Prepare patient as follows:
 Use the side of the finger furthest away from the thumb and not the pad. This
is less painful as there are fewer nerve endings. Avoid using the index finger
and thumb – the most used digits.
 Clean the side of the patient’s finger using soap and water and rinse well.
Ensure that the finger is thoroughly dry.
 Promote blood flow to the site by allowing the arm to hang down by the side
for a few seconds and then flex arm and fingers. If the hand is very cold, allow
it to warm up before trying to obtain a blood sample.
2. Check strip lot number. Open the strip using the triangular notch in the foil tearing
down and across the length of the strip. Ensure the 3 electrodes enter the port
facing upward. Insert test strip. The meter turns on automatically. Check
display to ensure time and date are correctly set and meter is calibrated for the
strip lot in use.
3. Wait for flashing “apply sample” symbol.
Optium Xceed Blood β-Ketone SOP
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Pathology and Laboratory Service
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POCT
Date of issue 16/05/2011
4. Collect patient sample :
 Twist off the lancet protective cap until loose (do not pull off until loose)
 Firmly place lancet against side of finger and press firing button.
 Once used , the lancet will retract into it’s protective case
 Lancets are single use devices, dispose of whole device into a sharps bin.
 Allow 5 seconds to elapse after lancing the finger and then, rather than
squeezing at the site of the puncture, milk the blood down the hand towards
the finger. This will encourage the blood to flow more easily and prevent
tissue fluid from damaged capillaries from contaminating the sample.
5. Touch the blood drop to the white area at the top or tip of the test strip. The blood
is drawn into the test strip. Continue to touch the blood drop until the meter
begins the test. The meter begins to test when the display window shows a
status bar and then the countdown. If the test fails to start, a second sample can
be applied within 30 seconds of applying the first drop of blood.
6. After the 10 second countdown the result will appear on the display. Record the
result in the quality control record book before removing the test strip.
7. Dispose of the used strip as clinical waste.
Recording and Calculation of Results
A result “HI” means that the blood ketone result is higher than 8.0 mmol/L or there
may be a problem with the strip. Repeat the test to confirm.
Results should be recorded immediately in the quality control/patient record book
along with date, time, patient name and ID, and operator ID.
Results should be also be recorded immediately in the patient medical records along
with operator’s name, date and time, before the strip is removed from instrument.
The meter turns off automatically when the strip is removed.
The result is only available for 60 seconds before meter turns off automatically if the
strip is not removed.
In the event that a result is not taken down before the screen clears the test should
be repeated. NO ATTEMPT SHOULD BE MADE TO RETRIEVE THE RESULT
FROM THE INSTRUMENT MEMORY.
The RCPath/IBMS recommend that near patient testing results be entered on the
patient’s record.
The log of specimens analysed should be retained for at least the lifetime of the
instrument, minimum of 10 years.
Limitations (interferences, cross reactions and reportable intervals)
Assay Range: 0.0 - 8.0 mmol/L
Optium Xceed Blood β-Ketone SOP
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POCTXCEEDKETONE
Pathology and Laboratory Service
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POCT
Date of issue 16/05/2011
• This test strip has not been evaluated for alternative site testing.
• This test strip is not designed for use with arterial, neonatal, serum or plasma
samples.
• Haematocrit range is 30%-60%.
• The following substances have no significant effect on blood β-Ketone results:
• Captopril up to 500 μg/dL (23 μmol/L)
• L-DOPA up to 600 μg/dL (30 μmol/L)
• Dopamine up to 90 μg/dL (5.8 μmol/L)
• Gentisic acid up to 1.8 mg/dL (117 μmol/L)
• Paracetamol up to 25 mg/dL (1.7 mmol/L)
• Uric acid up to 24 mg/dL (1.4 mmol/L)
• Ascorbic acid up to 4 mg/dL (227 μmol/L)
• Unconjugated bilirubin up to 20 mg/dL (342 μmol/L)
• Cholesterol up to 500 mg/dL (12.9 mmol/L)
• Triglycerides up to 1500 mg/dL (17 mmol/L)
Care should be taken with those patients who are extremely unwell particularly if they
are severely dehydrated, severely hypotensive or in shock, or in a hyperglycaemichyperosmolar state e.g. DKA.
IQC
See under instructions for the performance of examination.
EQA
External quality assurance (EQA) is a program that allows testing sites to assess the
quality of their performance by comparing their results with those of other units.
Samples are sent from Welsh External Quality Assurance Scheme (WEQAS) to the
POCT Team on a bi-monthly basis. WEQAS provide aqueous solution that contains
an unknown concentration of ketone. The sample will be forwarded to each
registered participant by the POCT team. Every meter should be registered on the
EQA scheme.
These WEQAS samples should be tested exactly the same way as a sample from a
patient. For best performance perform test and return results on the same day as
receipt.
Apply the sample in a similar manner to the IQC solutions.
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Pathology and Laboratory Service
Page 7 of 9
POCT
Date of issue 16/05/2011
The return form should be completed, photocopied and returned to the POCT team.
If using internal mail please allow sufficient time to ensure the contact receives the
results prior to the deadline stated on the return form.
When the results are returned to the POCT team and logged on the WEQAS
website, the accuracy of your meter can be checked. This then forms part of the audit
of the blood ketone testing procedure.
Your performance will be communicated to you by the POCT team.
Please note it is good practise to maximise over the yearly EQA cycle the number of
users involved in EQA sample analysis. EQA performance can be used as part of
the annual assessment of competency.
Maintenance
If the surface of the meter gets dirty it may be cleaned with a damp cloth and mild
soap. Acceptable cleaning solutions also include 10% bleach, 70% alcohol and 10%
ammonia.
Do not try to clean the strip port.
Do not pour liquid into the strip port or buttons.
Do not place the meter in water.
Battery icon
When displayed with results the battery is becoming low. It is recommended that the
battery is replaced at this time.
When displayed alone this means the battery is exhausted.
Refer to instrument user guide for explanation of error messages and solutions.
Reference Ranges
Local protocol in relation to the reporting of critical results should be adhered to.
Guidelines from Abbott Opium β -Ketone test strip insert.
Normally, levels of β -Ketone are expected to be less than 0.6 mmol/L.
β -Ketone levels may increase if a person fasts, exercises vigorously or has diabetes
and becomes ill.
If blood β -Ketone result is between 0.6 and 1.5 mmol/L and blood glucose result is
16.7 mmol/L or higher, this may indicate the development of a problem that may
require medical assistance.
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POCTXCEEDKETONE
Pathology and Laboratory Service
Page 8 of 9
POCT
Date of issue 16/05/2011
If blood β -Ketone result is higher than 1.5 mmol/L and blood glucose result is 16.7
mmol/L or higher, there is a risk of developing diabetic ketoacidosis.
For guidance on paediatric diabetic ketoacidosis management, SHSST follow the link
below.
http://shsctintranet.hpss.ni.nhs.uk/HTML/documents/DiabeticKetoacidosisManagementGuidelineBSPED.pdf
Responsibilities of Personnel in Authorising, Reporting and
Monitoring Reports
Staff responsibilities are outlined in the Trust POCT policy.
All staff working in a healthcare environment have a responsibility to report any
incident involving POCT devices to the ward manager and POCT coordinator.
Manufacturer will provide the following support
 Initial training
The laboratory POCT Team (CAH ext 2660) will provide the following support
 Replacement meters
 Result/Quality Control log books
 Replacement batteries (CR2032 Lithium)
 Schedule training
 Audit
 Advice on POCT QMS
Pharmacy will provide the following support
 Optium β-ketone Tests Strips
 Medisense glucose and ketone control solutions
 Lancet devices
Useful contacts:
Medisense Territory Manager
ABBOTT Address
Medisense Address
Deirdre Cahoon Tel 078 99065958
Medisense, Abbott Laboratories Ltd, Mallory
House, Vanwall Business Park, Maidenhead,
Berkshire SL6 4XE
Medisense UK Ltd, Units 14/15 Eyston Way,
Abingdon, OXON OX14 1TR
Abbott Diabetes Customer Care Line on 0500 467466 (Mon– Fri, 8.00am – 5.30pm)
Optium Xceed Blood β-Ketone SOP
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POCTXCEEDKETONE
Pathology and Laboratory Service
Page 9 of 9
POCT
Date of issue 16/05/2011
Hazards and Safety Precautions
Universal precautions must be observed when collecting blood specimens.
All samples should be handled as potentially infectious for HIV, hepatitis B and C,
and other pathogens.
Gloves should always be worn when collecting biological specimens.
Refer to COSHH assessment on POCT website and in QPulse.
Performance Criteria
Reportable range
0.0 - 8.0 mmol/L
Uncertainty of measurement
Mean
0.75
4.17
Standard deviation
0.05
0.14
Uncertainty
0.65 – 0.85
3.89 – 4.45
The uncertainty is based on variation of 10 results of each of 2 levels of QC carried
out 28/4/11 using:
Lo QC lot 11411 A and strip lots 75001 A11 and 75001 A03 (target 0.5-0.9).
HI QC lot 11405 A and strip lot 75001 A35 (target 3.1-5.1).
Comparability with laboratory
Not applicable - assay not available in Southern Trust laboratories.
References
RCPath/IBMS The retention and storage of pathological records and specimens (4th
edition 2009).
Abbott Optium β-ketone Test Strip package insert ART08070 Rev B 04/06
Medisense Glucose and Ketone Control Solutions package insert ART18499 Rev B
09/09
Abbott Optium Xceed User Guide ART19558-001 Rev A 10/09
Optium Xceed Blood β-Ketone SOP
Controlled Document at: 17/02/2016