BLOOD SCIENCES
DEPARTMENT OF CLINICAL BIOCHEMISTRY
Title of Document: POCT Cobas® Combur7 Test®
Q Pulse Reference No: BS/CB/POCT/SOPS/6
Authoriser: Francesca Mills
Version NO: 3
POCT – Cobas® Combur7 Test®
1. INTRODUCTION
1.1 Purpose of the Procedure
Combur7 Test urine test strips are used to measure certain constituents, in urine,
which are significant of renal, urinary, hepatic and metabolic disorders.
1.2 Staff
Only healthcare personnel who have been suitably trained may perform urinalysis
using Combur7 Test urine test strips.
2. PRINCIPLE OF THE PROCEDURE
Combur7 Test urine test strips have seven test areas for the semi-quantitative
determination of pH, glucose, ketone bodies, leukocytes, nitrite, protein and blood in
urine. Details of individual test principles are detailed on the Combur7 Test package
insert.
3. SPECIMEN REQUIREMENTS
Test sample: Urine (ideally early morning (EMU) collected midstream (MSU)
The sample should be collected into a fresh sample container, ideally a plain
universal or foil bowl.
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 urine, wash
immediately with soap and water.
Used materials should be discarded into clinical waste in accordance with
ward/department procedures.
5. EQUIPMENT AND INSTRUMENTATION
Optional - Urisys 1100 or Urilux S analyser
Timing device capable of measuring 60 seconds accurately
6. REAGENTS, STANDARDS, CALIBRANTS AND CONTROLS
Cobas® Combur7 Test® urine test strips
Strips should be within expiry date, stored at room temperature with the desiccant
containing cap securely in place.
7. METHOD
1. Wash and dry your hands and wear gloves.
2. Check the expiry of the test strip on the container and make sure the
container has been stored with the cap in place.
3. Remove the test strip from the container. Hold the white end of the test strip
and inspect the test pads. The pads should look slightly lighter than the lefthand line of on the colour chart on the strip container.
Page 1 of 4
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 Cobas® Combur7 Test®
Q Pulse Reference No: BS/CB/POCT/SOPS/6
Version NO: 3
Authoriser: Francesca Mills
4. Briefly (about 1 second) dip the test strip in the urine, making sure that all the
test areas are moistened. (1)
5. Remove excess urine by dragging the reverse side of the strip over the
containers edge. (2)
6. Briefly dab the long edge of the test strip and place face up on a tissue. (3)
7. Time for exactly 60 seconds and then compare the reaction colours of the test
areas with those on the strip container. (4)
 The white holding strip should be held towards the top of the strip
container.
 Make sure that the test strip is properly aligned so that the test area is
opposite the correct part of the colour chart. Compare the 7th (blood)
test area with both colour scales.
Glucose
Numerical value 5,6,7,8
and 9
normal 1+ 2+ 3+ 4+
Ketones
neg
1+
2+ 3+
Leucocytes
neg
1+
2+ 3+
Nitrites
neg
pos
Protein
neg
1+
2+ 3+
Blood/Haemoglobin neg
1+
2+ 3+ 4+
pH
8. QUALITY CONTROL
Commercially available urine controls or other suitable control material may be used.
9. LIMITATIONS OF THE EXAMINATION
See Cobas® Combur7 Test® package insert for details.
For diagnostic purposes, the results should always be assessed in conjunction with
the patient’s medical history, clinical examinations and other findings. Knowledge of
the effects of drugs or their metabolites upon the individual tests is not complete. In
doubtful cases, it is therefore advisable to repeat the test after discontinuing a
particular drug.
10. RECORDING AND CALCULATION OF RESULTS
The results must be recorded in the patient’s notes in accordance with Clinical
Governance (CG46).
Record all of the parameters measured.
Page 2 of 4
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 Cobas® Combur7 Test®
Q Pulse Reference No: BS/CB/POCT/SOPS/6
Authoriser: Francesca Mills
11. REFERENCE RANGES
N/A
Version NO: 3
12. REPORTING AND VALIDATION OF RESULTS
Inform medical staff of result in accordance with the ward/department procedure.
If the results are not consistent with the patient’s condition, retest with a freshly
collected sample.
Interpretation is subjective; the colour on the strip should be measured to the closest
colour block on the chart.
13. REFERENCES
Cobas® Combur7 Test® package insert
Please contact POCT with any problems or queries.
Page 3 of 4
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 Cobas® Combur7 Test®
Q Pulse Reference No: BS/CB/POCT/SOPS/6
Authoriser: Francesca Mills
Version NO: 3
POCT - Cobas® Combur7 Test® Worksheet
Before Testing
•
•
Early morning urine (EMU) mid stream urine (MSU) is preferable.
Use a clean sample container, deep enough to allow full dipping of
the test strip.
The sample should be at room temperature and not stand for more
than 2 hours before testing.
In case of longer standing, mix before testing.
Test strips should be in date and the pot should be capped.
•
•
Testing
1. Briefly (about 1 second) dip the test strip,
making sure that all the test areas are
moistened. (1)
2. Remove excess urine by dragging the
reverse side of the strip over the containers
edge. (2)
3. Briefly dab the long edge of the test strip and
place face up on a tissue. (3)
Reading and Reporting
4. Time for 60 seconds and then compare the reaction colours of the test areas with
those on the strip container.
• The white holding strip should be held towards the top of the strip container.
• Make sure that the test strip is properly aligned so that the test area is
opposite the correct part of the colour chart. Compare the 7th (blood) test area
with both colour scales.
Glucose
Numerical value 5,6,7,8
and 9
normal 1+ 2+ 3+ 4+
Ketones
neg
1+
2+ 3+
Leucocytes
neg
1+
2+ 3+
Nitrites
neg
pos
Protein
neg
1+
2+ 3+
Blood/Haemoglobin neg
1+
2+ 3+ 4+
pH
Remember
•
•
•
•
Are the results consistent with the patient’s clinic condition? Repeat if necessary.
Results MUST be recorded in patient notes.
Record all parameters that are measured.
Interpretation is subjective
Page 4 of 4
printed
thisinstructions
documentplease
is uncontrolled
and only
valid
on day
of printing.
ForIfmore
detailed
refer to the package
insert
supplied
in every
box of test strips.
Please refer to the POCT website (www.nbt.nhs.uk/POCT) for the most up to
date version.