TEMPLATE FOR STANDARD OPERATING PROCEDURES



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 water-repellent ‘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 left-hand line of on the colour chart on the strip container.

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.

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.

11. REFERENCE RANGES

N/A

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.

POCT - Cobas® Combur7 Test® Worksheet

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|pH |Numerical value 5,6,7,8 and 9 |

|Glucose |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+ |

Before Testing

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.

Reading and Reporting

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)

Testing

For more detailed instructions please refer to the package insert supplied in every box of test strips.

• 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

Remember

|pH |Numerical value 5,6,7,8 and 9 |

|Glucose |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+ |

• 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.

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