Southern Health and Social Care Trust
POCTARKRAYAUTION
Pathology and Laboratory Service
Page 1 of 13
POCT
Date of issue 26/10/2011
Standard Operating Procedure for the use of
Aution Urine Dipsticks.
Visual Interpretation or using Aution Micro PU-4210
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 of examination
Aution Sticks are used for the determination of Glucose, Protein, Bilirubin,
Urobilinogen, pH, Specific Gravity, Blood, Ketones, Nitrite and Leucocytes in urine.
Principle of examination
Glucose – based on the glucoseoxidase-peroxidase-chromogen reaction.
Protein – based on the protein-error reaction of pH indicator.
Bilirubin – A reddish brown azo dye is obtained by the coupling of bilirubin with a
diazonium salt.
Urobilinogen - A reddish brown azo dye is obtained by the coupling of urobilinogen
with a diazonium salt.
pH - The test paper contains indicators which change colour between pH 5 and 9.
Blood – based on the pseudoperoxidase activity of haemoglobin.
Ketones – based on the principle of Legal reaction.
Nitrite – based on the principle of the Griess reaction.
Leucocytes – based on the esterase activity in leucocytes.
SOP for the use of Aution Urine Dipsticks
Controlled Document at: 15/02/2016
Southern Health and Social Care Trust
POCTARKRAYAUTION
Pathology and Laboratory Service
Page 2 of 13
POCT
Date of issue 26/10/2011
Specimen requirements and sample rejection
Collect the urine sample in a clean container.
Prepare an adequate amount of sample so that the whole pad portion of the test strip
can be immersed.
Use uncentrifuged, well mixed and freshly voided urine.
Perform the test within an hour or it may affect the results, especially of blood and
leucocytes.
Refrigerate urine if testing cannot be done within an hour. Return to room
temperature before use.
Avoid direct sunlight while handling the urine specimen.
Do not use urine containing antiseptic.
Use first morning urine specimen or 4 hour specimen for nitrite analysis.
For urobilinogen collect specimens between 2 to 4 pm as urobilinogen appears in
larger quantities during this time.
The ambient temperature at measurement should be 20-25°C.
Drug administered urine or visually observed haematuria can sometimes affect
results.
Equipment
Aution Sticks are intended for use by visual interpretation or with a urine analyser for
Aution Sticks.
Aution Micro PU-4210 supplied by Arkray and distributed by A Menarini Diagnostics
through Medicon Ireland Limited.
Medicon Ireland Ltd.
1a/1b Meridian Estate
Carnbane Business Park
Newry
Co. Down
BT35 6QH
Tel 028 3083 5500
Reagents
The sticks used are 10EA Aution Sticks- Code 20286 (100 test strips)-available from
Pharmacy.
The sticks consist of a plastic strip affixed with reagent areas for each test and a pad
for calibration.
A number of factors can cause incorrect measurements. Use strips as follows:
 Only use Aution test strips with the Aution Micro analyser.
 Do not use expired test strips and/or test strips if the reagent pads show any
sign of discolouration, deformation or deterioration.
SOP for the use of Aution Urine Dipsticks
Controlled Document at: 15/02/2016
Southern Health and Social Care Trust
POCTARKRAYAUTION
Pathology and Laboratory Service
Page 3 of 13
POCT
Date of issue 26/10/2011




Take test strips out of container immediately before use and close cap. Strips
left out may absorb humidity or collect dust causing incorrect measurements.
Do not touch the reagent pad of the test strip.
When using the Aution Micro ensure that it is set for the correct strip type
before measurement.
Keep the desiccant contained in the strip container until all test strips are
used.
Calibration
The calibration pad on each stick corrects interference from the natural colour of
urine automatically and gives highly accurate results when used with the urine
analyser.
Internal Quality Control (IQC)
For users of the Aution Micro a Check Strip (supplied with the analyser) is used to
verify instrument performance.
To run check measurement
 Ensure that the test strip holder is clean (see maintenance).
 Set the test strip type to C by pressing “strip” key from the ready screen until C
appears on the display (changes from 10EA to 9UB to C to 10EA etc.).







Remove a check strip from the check strip container – do not touch the gray
coloured part of the strip.
Press “start”. While the check strip icon is blinking, place the check strip onto
the strip holder.
The strip holder is pulled into the analyser for measurement.
When measurement is complete the result is displayed and printed. Compare
the results with the check strip ranges on the check strip container.
If the results are within range the analyser is performing correctly.
If results are out of range repeat with another check strip.
If results using the second strip are in range the first strip was defective and
should be discarded.
SOP for the use of Aution Urine Dipsticks
Controlled Document at: 15/02/2016
Southern Health and Social Care Trust
POCTARKRAYAUTION
Pathology and Laboratory Service
Page 4 of 13
POCT
Date of issue 26/10/2011


If second strip results are out of range do NOT use the analyser.
Return the reusable check strip to its container.
The check strip should be run at least once a week and when performance of
analyser is in question.
The results of the check strip measurement should be recorded in the urinalysis
POCT results log sheet (available on the POCT website at end of this SOP).
Instructions for the performance of the examination
Visual interpretation
1. Prepare the urine sample (see sample requirements above) and have tissue
paper at hand.
1. Remove strips from container just before use and close cap immediately.
2. Dip the stick completely into fresh, well mixed urine for 2 seconds. Only dip up to
the black marker on the strip.
3. Gently remove excess urine on edge of specimen container or using tissue paper.
4. Keep the strip horizontal to prevent mixture of other reagents.
5. Follow the reaction time for each item and visually interpret the result by
comparing to the colour chart on the bottle. For 10 EA sticks leucocytes are read at
90 seconds and all other tests are 60 seconds.
6. Record the results on the urinalysis POCT results log sheet.
7. Discard strip in a clinical waste bin.
Using the Aution Micro
SOP for the use of Aution Urine Dipsticks
Controlled Document at: 15/02/2016
Southern Health and Social Care Trust
POCTARKRAYAUTION
Pathology and Laboratory Service
Page 5 of 13
POCT
Date of issue 26/10/2011
1. Setting up the parameters (from the ready screen).
Measurement number can be changed by pressing the “No.” key. Once the
number is set it increases with every measurement.
Patient ID MUST be entered. Press the “ID” key and enter a unique patient
identification. Health and Care number is preferable but hospital number or
A+E number can be used where no H+C number is available.
Strip type is entered by pressing “strip” key until the correct strip type shows in
the top left hand corner of the ready screen (usually 10EA).
Ensure that date and time are correctly set. (To change see operating
manual.)
2. Prepare sample (see sample requirements above) and have tissue paper at hand.
3. Remove strip from container and close cap.
4. Press “START”. A 3 second timer counts down to a 2 second buzzer.
5. Dip the stick in the urine while the buzzer sounds. Only dip up to the black marker
on the strip.
6. Remove excess sample with tissue paper.
7. While the test strip icon is blinking, place the test strip onto the strip holder.
8. The strip holder is pulled into the analyser for measurement.
9. When complete the result is displayed and printed.
10. Discard the used strip in a clinical waste bin.
11. When all measurements are complete wash and dry the test strip holder.
12. The analyser can be turned off by pressing the “START” key for 2-3 seconds
although the power turns off automatically when no key entry is made for more than 3
minutes.
13. Discard strip in a clinical waste bin.
14. Record the results on the urinalysis POCT results log sheet. (Available on the
POCT website at end of this SOP)
SOP for the use of Aution Urine Dipsticks
Controlled Document at: 15/02/2016
Southern Health and Social Care Trust
POCTARKRAYAUTION
Pathology and Laboratory Service
Page 6 of 13
POCT
Date of issue 26/10/2011
Recording and calculation of results
● marks an abnormal sample
(ranked as > “+1”)
* printed before a test item marks
an abnormal measurement
(ranked as > “+1”)
All results should be recorded on the urinalysis POCT results log sheet.
Patient name, patient ID, strip lot no. and expiry date, user ID and results should be
recorded.
The thermal printer paper fades with time so for a permanent record all patient
results must be written into the patient’s medical notes and the POCT results
logsheet.
Results must always correlate with the patient’s condition and patient history.
Unexpected or suspect results should be repeated immediately. If doubt still remains,
then a sample should be sent to the laboratory.
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.
(Analyser print outs may be stuck on the log sheet but care must be taken not to
cover any required information with sticky tape as the thermal printing fades quickly
when covered with sticky tape. Also, the thermal printing fades after a number of
years so photocopies of completed log sheets need to be taken and stored with the
originals.)
SOP for the use of Aution Urine Dipsticks
Controlled Document at: 15/02/2016
Southern Health and Social Care Trust
POCTARKRAYAUTION
Pathology and Laboratory Service
Page 7 of 13
POCT
Date of issue 26/10/2011
Interpretation of test results
Item
Glucose
Protein
Bilirubin
Urobilinogen
pH
Specific Gravity
Blood
Ketones
Nitrite
Leucocytes
Interpretation
Semiquantitative symbol
Conc. (mg/dL)
Semiquantitative symbol
Conc. (mg/dL)
Semiquantitative symbol
Conc. (mg/dL)
Semiquantitative symbol
Conc. (mg/dL)
Value
Value
normal
Neg.
Neg.
Normal
5
+
50
+
15
1+
0.5
1+
2
6
1+
100
1+
30
2+
2
2+
4
7
2+
200
2+
100
3+
6
3+
8
8
3+
500
3+
300
4+
over
4+
over
9
4+
1000
4+
1000
1.000 1.005 1.010 1.015 1.020 1.025 1.030
Haemolysis
Semiquantitative symbol
Conc. (mg/dL)
Neg.
Semiquantitative symbol
Conc. (mg/dL)
Semiquantitative symbol
Conc. (Leu/µL)
Neg.
+
Neg.
Neg.
1+
25
+
0.03
Non
haemolysis
1+
0.06
2+
0.2
3+
1.0
1+
15
2+
75
2+
40
3+
80
250
500
1+
2+
4+
150
Limitations (interferences, cross reactions and reportable intervals)
Glucose
This test area reacts singularly to β-D-glucose and should not be affected by
reducing metabolites or reducing sugars.
A large amount of ascorbic acid may cause false negative results.
False positive results are possible with oxidising substances such as hypochlorite
and chlorine and also in strongly acidic urine (pH<4).
A small amount of glucose may be detected in normal urine (2-30 mg/dl).
Protein
This test area is particularly sensitive to albumin but less sensitive to globulin, BenceJones protein and mucoprotein.
Urine with pH < 3 may cause false negative results.
Alkaline urine (pH >8) can produce false positive results.
The following substances may also cause false positive results – a large amount of
haemoglobin, contrast medium, high molecular weight substances, and disinfectant
including quaternary ammonium compound.
A small amount of protein may be detected in healthy individuals. Over exercise,
stress or an unbalanced diet with meat may cause a significant amount of protein in
urine. Pre-menstruation and taking a hot bath may also cause high levels of protein.
Bilirubin
This test area reacts sensitively to direct bilirubin.
Ascorbic acid, uric acid, and nitrite may cause false negative results.
False positive results are possible with urobilinogen and etodolac.
SOP for the use of Aution Urine Dipsticks
Controlled Document at: 15/02/2016
Southern Health and Social Care Trust
POCTARKRAYAUTION
Pathology and Laboratory Service
Page 8 of 13
POCT
Date of issue 26/10/2011
Bilirubin is unstable in light.
Even a small amount of bilirubin should be considered as significant.
Urobilinogen
This test area reacts sensitively to urobilinogen in urine.
Carbapenem may cause false positive results.
Urine with a high level of bilirubin causes the development of a green colour.
Positive results may be obtained after exercise, drinking or may be due to fatigue or
constipation. Healthy individuals may excrete a small amount of urobilinogen.
pH
This strip can measure pH from 5 to 9 in single units.
As urine ages it become more alkaline.
Normal urine is around pH 6. It varies from pH 5 to 8 depending on the diet.
Specific gravity
Specific gravity between 1.000 and 1.030 is measured in steps of 0.005.
Non electrolytes such as glucose do not affect specific gravity.
Highly buffered alkaline urine gives low values.
Urine with a low pH and protein >500 mg/dL may give false positive results.
For urine with pH >8 adding 0.010 gives a more accurate result.
Blood
This test area is more sensitive to pigment (haemoglobin) and myoglobin than to
erythrocytes.
Total absence of haemolysis may cause a negative result despite the presence of
erythrocytes if urine is not well mixed.
A large amount of ascorbic acid may cause false negative results.
Urine with elevated specific gravity and elevated protein may produce false negative
results.
False positive results are possible with oxidising substances such as hypochlorite
and chlorine.
The results of this test may not be accurate if urine is not tested within an hour of
voiding.
A blue-green dotted reaction shows the existence of erythrocytes. Urine from
menstruating females may give a positive result.
Ketones
The test area is more sensitive to acetoacetic acid than to acetone (the reaction to
acetone is 1/10 of that to acetoacetic acid) but should not react to β-hydroxybutyric
acid.
False positives can be produced by L-DOPA, BSP, PSP, phenylketone,
cephalosporine, and aldose reductive antienzyme.
Ketones are not normally detected in healthy individuals. However fasting or over
exercise may cause significant levels in urine.
SOP for the use of Aution Urine Dipsticks
Controlled Document at: 15/02/2016
Southern Health and Social Care Trust
POCTARKRAYAUTION
Pathology and Laboratory Service
Page 9 of 13
POCT
Date of issue 26/10/2011
Nitrite
This test area reacts singularly to nitrite. Reacting colour density does not correlate
to number of bacteria present.
Ascorbic acid and urine with elevated specific gravity may cause false negative
results.
The results of this test may not be accurate if urine is not tested within an hour of
voiding.
Urine with low nitrate reduction ability in bacteriuria may cause a negative result.
A negative result may also occur during fasting because nitrate does not appear in
urine.
Leucocytes
This test area reacts to esterase in urine leucocytes.
Formaldehyde or bilirubin may cause false positive results.
False negative results are possible with glucose >500 mg/dL and protein>300 mg/dL
and also in urine with low pH and elevated specific gravity.
The results of this test may not be accurate if urine is not tested within an hour of
voiding.
External Quality Assessment (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. The base material is human urine from “normal”
volunteers, spiked with the appropriate analytes.
The sample will be forwarded to each registered participant by the POCT team.
Glucose, protein, ketones and leucocytes are stable at room temperature for a week.
Bilirubin and Haemoglobin are stable for 3 days if kept in the dark at 4 C. It is
therefore advisable to analyse the samples immediately on receipt or store in the
refrigerator.
The samples should be analysed as soon as possible, WITHIN ONE WEEK of
receipt.
Use samples as if they were a normal urine sample.
Please note it is good practise to maximise over the yearly EQA cycle the number of
users involved in EQA sample analysis.
Your performance will be communicated to you by the POCT team.
SOP for the use of Aution Urine Dipsticks
Controlled Document at: 15/02/2016
Southern Health and Social Care Trust
POCTARKRAYAUTION
Pathology and Laboratory Service
Page 10 of 13
POCT
Date of issue 26/10/2011
Maintenance
Cleaning
The only manufacturer recommended maintenance is cleaning of the strip holder.
Clean after finishing measurement at the end of the day and as necessary.





Slide strip holder to remove.
Wash with detergent or alcohol taking care to
clean the groove.
Rinse with tap water.
Dry with a soft cloth.
Insert completely using the grooves on the
backside of the holder.
The exterior surface of the meter may be cleaned periodically with a damp cloth or
suitable disinfectant if necessary. Do not allow liquid to seep into the meter or
immerse meter in liquid.
Attachment and removal of printer
Before attaching or removing the printer turn off the power and pull out the AC
adapter of the printer.
To connect printer to analyser insert the hook of the printer in the hole on the bottom
of the meter and then slide it firmly enough to achieve a secure fit.
To remove the printer slide the meter towards you while pressing the release button.
Replacing the paper roll
After confirming the face and the back of the paper, put the thermal paper into the
insertion position and the paper is fed in automatically.
Printer paper code 31478 – non stock item available from
Medicon Ireland Ltd.
1a/1b Meridian Estate
Carnbane Business Park
Newry
Co. Down
BT35 6QH
Tel 028 3083 5500
For trouble shooting refer to operating manual – available in the POCT section of the
trust intranet. Q Pulse document POCTAUTIONMICROMAN.
SOP for the use of Aution Urine Dipsticks
Controlled Document at: 15/02/2016
Southern Health and Social Care Trust
POCTARKRAYAUTION
Pathology and Laboratory Service
Page 11 of 13
POCT
Date of issue 26/10/2011
Reporting reference limits
See under Limitations.
Alert critical values
Local protocol in relation to the reporting of critical results should be adhered to.
In the absence of clinical symptoms and negative results for nitrites and leucocytes
infection is unlikely.
Responsibilities of personnel in authorising, reporting and
monitoring reports
Only those formally trained to use urine dipsticks and the Aution Micro should do so.
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.
The laboratory POCT Team (CAH ext. 2660) will provide the following support
 Advice on troubleshooting or instrument failure
 Advice on POCT QMS
 Schedule training
 Audit
 EQA
Pharmacy will provide the following support
 Supply of Aution Sticks (10 EA) – code 20286
The Biomedical engineering Department (Medical Technical Officers) (CAH ext.
2928)
 Initial advice on instrument failure
Manufacturer
 Service or maintenance (via POCT team).
Hazards and safety precautions
Universal precautions must be followed when handling the body fluids used for
testing.
SOP for the use of Aution Urine Dipsticks
Controlled Document at: 15/02/2016
Southern Health and Social Care Trust
POCTARKRAYAUTION
Pathology and Laboratory Service
Page 12 of 13
POCT
Date of issue 26/10/2011
Dispose of used strips in the appropriate clinical waste bins.
Dispose of urine samples according to departmental protocol.
See COSHH Risk assessment form – available in the POCT section of the Trust
Intranet. QPulse COSHH document POCTAUTIONSTICKS.
Performance criteria
Reportable range
Item
Glucose
Protein
Bilirubin
Urobilinogen
pH
Specific gravity
Blood
Ketones
Nitrite
Leucocytes
Minimum detecting sensitivity
50 mg/dL
15 mg/dL
0.5 mg/dL
2 mg/dL
1.0 unit within the range of pH 5-9
Between 1.000 and 1.030 in steps of 0.005
Haemoglobin 0.03 mg/dL. Erythrocyte about 10Ery/µL
Acetoacetic acid 5 mg/dL
Nitrite 0.08 mg/dL. Bacteria about 105/mL
About 25 leuc/µL
Range
50-1000 mg/dL
15-1000 mg/dL
0.5-6.0 mg/dL
2-8 mg/dL
pH 5-9
1.000-1.030
Hb 0.03-1.0 mg/dL
5-150 mg/dL
0.08-0.5 mg/dL
25-500 leuc/µL
Uncertainty of measurement
Semiquantitive results – not applicable
Comparability with laboratory
Not applicable
Any other details
The latest copy of this SOP and related documentation, including COSHH, can be
found in the POCT section of the Southern trust laboratory inter/intranet site.
http://10.142.1.242/cahgt/Depts/Labs/webhb/Default.htm
References
Arkray Aution Micro Operating manual
Arkray Aution Strips Package Insert
RCPath/IBMS The retention and storage of pathological records and specimens (4th
edition 2009).
SOP for the use of Aution Urine Dipsticks
Controlled Document at: 15/02/2016
Southern Health and Social Care Trust
POCTARKRAYAUTION
Pathology and Laboratory Service
Page 13 of 13
POCT
Date of issue 26/10/2011
Urinalysis POCT Result Log Sheet
Ward Location ________________ Test Kit Name _________________________
Date, Patient ID and Results
(Meter print out or written)
Date
Patient ID
Glu
Pro
Bil
Uro
pH
S.G.
Bld
Ket
Nit
Leu
Date
Patient ID
Glu
Pro
Bil
Uro
pH
S.G.
Bld
Ket
Nit
Leu
Date
Patient ID
Glu
Pro
Bil
Uro
pH
S.G.
Bld
Ket
Nit
Leu
SOP for the use of Aution Urine Dipsticks
Patient name, strip lot no. and expiry
date, user ID and comments
Patient name
Strip lot no.
Strip expiry date
User ID
Patient name
Strip lot no.
Strip expiry date
User ID
Patient name
Strip lot no.
Strip expiry date
User ID
Controlled Document at: 15/02/2016