Service: SHYPS/POCT/Y&S

Filename: PC-SOP-iSTATALINITYGAS
Version: 02
Date of Issue: July 2023
Page 1 of 13

Blood Gas Analysis on the Abbott iSTAT Alinity

Document Author/Reviewer Clemora Wilkinson

Document Owner Clemora Wilkinson

Approved By Rachel Lampard

Review Interval 2 years

Changes from last version of this document

New template
Updates to electronic simulator frequency to monthly by POCT staff
Updated advice on filling cartridges

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Table of Contents
1 Purpose and Principle ........................................................................................................... 3
1.1 Purpose ............................................................................................................................................................. 3
1.2 Principle ............................................................................................................................................................ 4

2 Patient Preparation & Sample Requirements ...................................................................... 5

3 Tasks, Responsibilities and Authorisations ........................................................................ 5

4 Equipment .............................................................................................................................. 6

5 Chemicals and Reagents....................................................................................................... 6

6 Risk Assessment (Environmental and Safety Controls) ..................................................... 6

7 Calibration .............................................................................................................................. 7

8 Quality Control ....................................................................................................................... 7

9 External Quality Assurance (EQA)........................................................................................ 8

10 Procedural Steps ................................................................................................................ 9

10.1 How to run a patient sample ............................................................................................................................. 9
10.2 How to find previous patient results ................................................................................................................ 10
10.3 How to change Alinity printer paper ............................................................................................................... 11

11 Reporting of Results ........................................................................................................ 11

12 Reference Intervals .......................................................................................................... 11

13 Performance Characteristics ........................................................................................... 12

14 Known Limitations ........................................................................................................... 13

15 Related Forms/Templates and Documents .................................................................... 13

16 References ........................................................................................................................ 13

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1 Purpose and Principle

1.1 Purpose
Blood gas analysis allows clinicians to assess whether a patient has an acid-base disorder, or
whether these systems are working properly to keep pH in the correct range.
pH: for the evaluation of acid-base status. Low pH = acidosis (excess H+). High pH = alkalosis (not
enough H+). pH needs to be maintained within a tight range as small changes in pH can have a
significant effect on the function of the body’s enzymes and metabolic processes. This provides a
starting point for further testing, such as examination of lung or kidney function.

pCO2: a waste product of metabolism excreted through the lungs which provides an idea of lung
function. Poorly functioning lungs will cause pCO2 to rise.
A small amount of CO2 is usually dissolved in blood, releases H+ and becomes a weak acid. Too
much CO2 can therefore cause an acidosis, and too little can cause alkalosis.
Measurement of pCO2 is particularly important for patients on mechanical / assisted ventilation, who
need to be kept at an appropriate ventilation rate.

pO2: used for a general evaluation of oxygen uptake in the lungs. Oxygen is carried to tissues as
oxyhaemoglobin in red blood cells. A small amount is dissolved in the plasma and is measured as
pO2. Low pO2 indicates either poor perfusion across the alveolar walls or poor ventilation. If it is
ventilation that is impaired, a raised CO2 and an acid-base disorder may also be seen.
Metabolic and Respiratory Acid-Base Disorders
Respiratory acidosis/alkalosis: Caused by poor lung function and increased pCO2. Respiratory
component is assessed by measuring pCO2.
Metabolic acidosis/alkalosis: Disorders not caused by the lungs, but from an overproduction of acid
in the body’s metabolic processes (e.g. lactic acidosis) or a failure of the kidney to maintain pH within
the normal range by excreting H+ and reabsorbing bicarbonate (e.g. acute kidney injury). The
metabolic component of a disorder is assessed by measuring bicarbonate.
Bicarbonate can also be used for calculations, which produce values called the ‘standard
bicarbonate’ and ‘base excess’ (BE). These extra tools are also designed to help understand the
metabolic component of a disorder.
In most disorders, changes in bicarbonate are balanced by changes in pCO2. This is known as
compensation, but rarely manages to correct the underlying disorder.
Main causes include:
Acidosis Alkalosis
Renal failure
Prolonged vomiting
Hypoxia and shock
Metabolic Potassium deficiency
Diabetic ketoacidosis
Administering of bicarbonate
Diarrhoea
Chronic lung disease
Hyperventilation
Acute airways obstruction
Respiratory Over ventilation on respirator
Impaired movement of chest wall
Congestive heart failure
Respiratory distress syndrome

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The typical changes are:

pH pCO2 HCO3-
Initial state  N 
Metabolic
Compensation N () 
Acidosis
Acute change   N
Respiratory
Compensation N  ()
Acute state  N 
Metabolic
Chronic state  N or slightly () 
Alkalosis
Acute change   N or 
Respiratory
Compensation N  ()

KEY
N = Normal  = Primary change () = Compensatory change

Electrolytes
Sodium Concentration [Na+]: A main extracellular ion used for the evaluation of the fluid and
electrolyte balance. A raised [Na+] can be caused by kidney failure or major fluid loss. A low [Na+]
can be caused by heart failure, liver disease and several medications.

Potassium concentration [K+]: The main intracellular ion. A raised [K+] can be caused by
medications, kidney disease or release from cells (e.g., acidosis, cell lysis). A low [K+] can be caused
by medications or nutritional deficiencies. Extreme changes in [K+] increased risk of heart attack or
cardiac arrest (< 2.5 mmol/L or > 7 mmol/L).

Ionised Calcium Concentration [Ca2+]: Free, ionised calcium is directly measured in the blood (i.e.,
bioavailable, ‘active’ calcium which is not bound to albumin or other ions). Ionised calcium can be
particularly useful in patients with low albumin, or who have other ions in the blood (e.g. citrate
following liver transplantation or heavy blood transfusion). Low values can cause seizures and
cardiac arrest, whereas high volumes cause nausea, constipation, and kidney stones.
Haematocrit (Hct) and Hb calculation
Hct can aid the determination and monitoring of normal and abnormal total red cell volume status
including conditions such as anaemia, erythrocytosis and blood loss related to trauma and surgery,
as well as blood’s ability to transport oxygen. Haemoglobin is calculated as follows: hemoglobin (g/dL)
= hematocrit (% PCV) x 0.34 This assumes a normal MCHC.
Lactate (Lac)
Lactate is a metabolite produced by the breakdown of glucose. Under normal conditions, lactate is
produced at a low level by skeletal muscles and red blood cells and cleared by the liver. However,
lactate levels can increase rapidly when oxygen supplies are restricted, or liver function is impaired.
Causes of lactic acidosis include sepsis, lung disease, trauma, exercise, and metabolic disorders.

1.2 Principle
The iSTAT Alinity instrument is a portable analytical, in vitro, diagnostic device utilising single use
iSTAT cartridges containing electrodes and sensors to perform quantitative testing on whole blood.
The test cartridges are filled with two or three drops of blood and inserted into the instrument. The
instrument carefully monitors and controls the test process, including running internal quality checks
to ensure quality of the cartridge. The iSTAT Alinity uses micro-fabricated electrochemical sensors
located in the iSTAT single-use disposable cartridges. The cartridges are able to measure blood
gases and electrolytes. This is mainly achieved by the lungs (which excrete CO2), and kidneys (which
excrete or reabsorb H+ and bicarbonate).

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2 Patient Preparation & Sample Requirements

• Samples should be capped to maintain anaerobic conditions and thoroughly mixed
immediately after collection and again prior to sampling to prevent formation of small clots
and ensure homogenous samples.
• Sample volume 65uL
• Venous or Arterial whole blood should be taken in a dry, balanced heparin blood gas syringe
or capillary tube.
o Fill cartridge within 10 minutes of collection.
• Venous samples can also be collected in a lithium heparin tube
o Fill cartridge within 10 minutes of collection.
• Capillary whole blood should be taken in a balanced heparin capillary tube.
o Fill cartridge immediately after collection.
• When using CG4+ cartridges for blood gas and Lactate the cartridge MUST be filled
immediately.
• Samples should be fully labelled and transported safely in a sample tray.
• Filling cartridge directly from skin puncture is not recommended.
• Samples should be discarded as clinical waste following analysis

3 Tasks, Responsibilities and Authorisations

•These procedures must only be carried out by staff members who have received face-to-
face iSTAT Alinity blood gas analyser training with POCT or with a link trainer and
completed competency paperwork. Access is given in AegisPOC and paperwork is stored
in the X-drive>Biochemistry>POCT>Training Logs. Competency is recertified every 2
years.
• All tasks should be performed under supervision of trained, competent colleague until staff
member has passed competency and feels competent to perform tasks alone.
Tasks Responsible Authorised
Patient testing Clinical staff who have POCT staff
received POCT training trained
as above
Maintenance tasks POCT staff who have
received training

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4 Equipment

• G3+ cartridges: 3P7825 blood gas for respiratory team

• EG7+ cartridges: 3P7625 blood gas and electrolyte
• CG4+ cartridges: 3P8525 blood gas and lactate
• iSTAT printer paper (6F17-11) is obtained from POCT
• Abbott Tricontrol Level 1 (5P7101) and Level 3 (5P7301)

5 Chemicals and Reagents

• All chemical requirements are contained within individual assay cartridges.
• Cartridges are sealed in individual pouches or portion packs.
• There are no published hazardous warnings associated with this procedure.
• Stock supplies of cartridges are stored at 2 to 8°C.
• Do not allow cartridges to freeze.
• Cartridges are stable until the expiry date on the box.
• Allow cartridge to come to room temperature for 5 minutes before use (an entire box of
cartridges should stand at room temperature for one hour).
• Room temperature storage is printed in the cartridge pouch and cartridge box.

6 Risk Assessment (Environmental and Safety Controls)

Please see PC-HSR-ISTAT

Staff carrying out this procedure should have read and understood the Local Rules or
Health and Safety Manual applicable to their site which should be followed at all times during the
procedure.
• All human samples must be treated as potentially BIO-HAZARDOUS.

• Approved Personal Protective Equipment (PPE) including laboratory coats, disposable

gloves must be worn. Eye protection should also be considered and must be worn
when directed within the procedure.

This SOP and the associated risk assessment(s) have considered all hazards and necessary
precautions required to control any risks identified. Where appropriate this is detailed in the
COSHH assessment and Risk Assessment. Any risk; where possible is mitigated and or
monitored with health surveillance to ensure health and safety for all those affected by this
procedure

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7 Calibration
The instrument houses the mechanical and electrical systems necessary to control fluid movement
within the cartridge, control the temperature, measure barometric pressure, measure electrical
signals generated by the sensors, and display and transmit results. The instrument’s functions are
factory calibrated to specifications that are programmed into the instrument along with acceptability
limits, which, when exceeded, cause the instrument to display quality check messages, or to display
*** rather than results. The internal simulator functions as a signal-checking mechanism on every
cartridge inserted.
A one-point calibration is automatically performed as part of the test cycle on each cartridge type,
except coagulation and immunoassay cartridges. Operator intervention is not necessary. The
calibrant solution is automatically released from its foil pack and positioned over the sensors. The
calculation of the result is equivalent to reading the sample’s concentration from an adjusted
calibration curve.

8 Quality Control
1. The iSTAT Alinity System automatically runs quality checks of analyser and cartridge
performance each time a sample is tested. The internal quality control will suppress results
if these do not meet certain internal specifications.
2. The monthly Electronic Simulator Check is performed by POCT staff. It provides an
independent check on the ability of the instrument to take accurate and sensitive
measurement of voltage, current and resistance from the cartridge. To perform the Electronic
Simulator:

a. From the Home Screen touch ‘More Options’ or follow on screen prompts
b. Touch ‘Quality Options’
c. Touch ‘Perform Electronic Simulator Test’
d. Scan your Operator ID
e. Scan the small square barcode on the simulator
f. Remove the blue cap then insert the simulator into the cartridge port with the green
arrow facing upwards
g. Simulator will run – do not remove it until prompted to
h. On completion the screen will show ‘Electronic Simulator Result’ and ‘Pass’ or
‘Fail’ underneath
i. If it has ‘Pass’ message the indicator light will flash green – press ‘Home’ then
remove the simulator and press ‘Home’ again
j. In the case of ‘Fail’ please repeat the Electronic Simulator Check, then try a
different Electronic simulator– if the failure is persistent report to Abbott
The Electronic Simulator Check should also be performed if the meter is dropped. It is also
performed following the 6 monthly Software/CLEW updates which are uploaded by the POCT
Team.

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3. Liquid control solutions are used to verify the integrity of each batch of cartridges that are
issued for use from POCT stock and are also analysed monthly on each meter. Liquid
controls are:
• TriControl Level 1: 5P7101
• Tricontrol Level 3: 5P7301
Quality control results are compared automatically against the eVAS (electronic Value
Assignment) file that is preloaded onto the meter by the POCT Team.
These are performed by POCT staff as follows:
a. Allow QC and cartridges to warm to room temperature
b. From the Home Screen touch ‘More Options’ or follow on screen prompts
c. Touch ‘Quality Options’
d. Touch ‘Scheduled QC’ if running as part of monthly or ‘Unscheduled QC’ if
running outside of the monthly for batch acceptance.
e. Scan your Operator ID
f. Scan ‘Fluid Lot’ barcode from the control vial.
g. Scan ‘Cartridge Pouch’ barcode
h. When ‘Help’ screens are displayed the meter is ready for cartridge insertion.
i. Shake the ampuole vigorously for 5 to 10 seconds to equilibrate the liquid and gas
phases.
j. Protecting your finger, break the glass of the ampuole across the score line carefully
k. Fill the cartridge using a pastette to the blue arrow fill line and shut the cartridge
closure until it clicks. Use ampuole within 10 minutes of opening.
l. Insert into the cartridge port slowly and smoothly until it clicks into place – the
indicator light will turn white, and the screen will change to ‘Processing’ then
‘Analyzing’
m. Once complete, the indicator light should flash green that the QC has passed.
n. If QC fails, the indicator should flash amber. Please re-run QC with fresh control and
fresh cartridge or refer to senior for guidance.

9 External Quality Assurance (EQA)

The meters are enrolled in monthly RIQAS blood gas EQA scheme as per accreditation guidelines.
For EQA protocols please see PC-SOP-EQA.

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10 Procedural Steps
10.1 How to run a patient sample
Please ensure appropriate PPE for patient contact and handling blood
samples. To analyse a patient sample:

1. Bring cartridge from fridge to room temperature (~5 mins for single
cartridge) do not touch!

2. Ensure to thoroughly mix dry heparinised blood gas syringe or

capillary thoroughly when sample is taken and prior to analysis:
• mix by rolling between fingers or gentle inversion
• capped syringe analyse within 15 minutes
• capillary analyse immediately sample
fill line
• label with patient ID

sample
3. From the meter home screen press ‘Perform Patient Test’ well
4. Scan your own Operator ID

5. Enter patient NHS number or scan it from their wristband, confirm patient full ID which
should appear on screen. If patient does not have an NHS number please use the full Case
(be aware that results without NHS number will not automatically transmit to CPD upon docking the
meter. You may be prompted to enter patient age/sex if their ID is not recognised)

6. Scan long barcode on cartridge pouch

7. Select ‘Sample Type’ (venous/arterial/capillary) and press ‘Next’
8. Guidance for taking a patient sample in balanced heparin syringe/capillary and filling the
cartridge will appear on screen – press pause if you want to read through the instructions

9. Remove cartridge from pouch (avoiding touching sensors and calibrant pouch) and fill
cartridge immediately:
o Lay cartridge on a flat surface
o Place Syringe/capillary at the sample well at an angle
o Dispense sample ensuring it travels into the well
o Keep dispensing until sample reaches the Fill Mark Indicator
o 3-4 large drops (65μl) should be enough to fill cartridge to the blue arrow. Please be
careful not to over-/under-fill the cartridge, as this will generate an error.
10. Shut cartridge closure clasp firmly until it snaps into place securely.

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11. Insert into the cartridge port slowly and smoothly until it clicks into place – the indicator light
will turn white and the screen will change to ‘Processing’ then ‘Analyzing’. The instrument
must remain level during testing.

12. Once complete, the meter will alarm until you press ‘Silence’
13. Results will be displayed on screen once test complete. Abnormal results will have
high/low arrows on screen and indicator light turns amber
14. To print, hold meter in front of printer and press ‘Print’
15. Record results in patient notes and escalate if
appropriate.

16. Press the ‘Home’ button in the bottom left corner of

the Alinity screen and you will be prompted to
remove the cartridge by gently pulling it out of the port.

17. Clean the meter with Clinell Wipes between each patient use by wiping the surfaces 3x
times. Avoid forcing liquid into sensitive areas:

Clean the docking station and Electronic

Simulator when/if required.

18. Dock meter after use

19. Ensure all used cartridges, samples and cleaning materials are disposed of as per infection
prevention guidance in clinical waste.

10.2 How to find previous patient results

1. From the instrument's Home screen, touch More Options > Review Results > All Results
2. Scan or Enter your own Operator ID.
3. Choose results by touching the checkbox in front of the result identifier then press View
4. There is also option to print selected results

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10.3 How to change Alinity printer paper

1. Lift printer lid by pulling the black window on the top of the device up
2. Replacement paper is placed into the paper holder with the curl of the paper facing
upwards
3. When shutting the printer lid, leave a little paper overhanging to ensure it will print straight

11 Reporting of Results
• Results will appear on screen.
• Abnormal results outside of reference limits will be displayed with up/down arrows and an
amber indicator light
• Results can be printed by holding meter in front of printer and pressing ‘Print’
• Record results in patients notes and escalate as appropriate if abnormal.
• Results will be visible in patients electronic records once transmitted from the instrument.

12 Reference Intervals

Lower Upper Reportable

Parameter Source
reference limit reference limit Range

PO2 11.07 kPa 14.40 kPa 0.7-106.6 kPa (1) Tietz 5th Ed 2012
PCO2 4.27 kPa 6.00 kPa 0.67-17.33 kPa (1) Tietz 5th Ed 2012
pH 7.350 7.450 6.5-8.2 (1) Tietz 5th Ed 2012
Sodium 136 mmol/L 145 mmol/L 100-180 mmol/L (1) Tietz 5th Ed 2012
Potassium 3.50 mmol/L 5.10 mmol/L 2.0-9.0 mmol/L (1) Tietz 5th Ed 2012
Chloride 98.0 mmol/L 107.0 mmol/L (1) Tietz 5th Ed 2012
Ionised 1.0-10.0 mmol/L
1.150 mmol/L 1.330 mmol/L (1) Tietz 5th Ed 2012
Calcium
tHb 115.0 g/L 178.0 g/L 51-255 g/L (2) Labor und
Diagnose
Hct 36% 53% 15-75% (2) Labor und
Diagnose
Lactate 1.0 mmol/L 2.0 mmol/L 0.3-20.0 mmol/L Locally agreed

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13 Performance Characteristics
A multiday precision study was performed by Abbott Point of Care with aqueous calibration
verification materials in representative cartridges. Duplicates of each aqueous fluid were tested
twice a day for 20 days.

• Please see PC-VERI-ALINITYGAS for full verification (available on Q-Pulse or from POCT,
laboratory medicine).

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14 Known Limitations
• Do not use cold cartridges- pO2 results may be falsely decreased if the cartridge is cold.
• Some suspected interferants listed include: Bromide, Glycolic Acid, Hydroxyurea,
Acetylcysteine, Leflunomide, Magnesium Chloride, Nithiodote, Salicylate, Thiocyanate

15 Related Forms/Templates and Documents

• iSTAT Alinity Blood Gas How To Guide (PC-TEM-ALINITYGASHOWTO)

16 References
• iSTAT Alinity User Guide (Art: 746981-01 Rev. G)
• iSTAT Alinity Quick reference Guide (Art: 731848-01 Rev. I)
Source of Reference Ranges

(1) Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, 5th edition 2012

(2) Lothar Thomas, Labor und Diagnose, 8. Auflage, p. 840

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