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Procedure for Urine Testing Using Combur-Test® Strips of Roche Diagnostics

Dr Yap Foo NganPrimary Care, RCMP

A. Combur-Test: Urine collection

i. Use first morning urine and ensure midstream collection.ii. Use clean urine containers, preferably sealed and disposable; do not use any

containers contaminated with detergents from cleaning. iii. Do not add any preservatives to the urine sample.iv. Do not test specimens with bacterial or chemical contamination.v. Do not centrifuge or freeze urine specimens if microscopic examination is needed.

vi. Perform urine test within 2 hours after sample collection. If immediate testing is not possible, store urine at a cool (+ 4°C) and dark

place.vii. Urine samples must have reached room temperature at testing time.

viii. Mix the urine sample thoroughly before testing.ix. Do not touch the test zones with fingers.

B. Combur-Test: Testing procedure

1. Preparationi. Check expiry date.

ii. Take a test strip out & immediately close the container with the desiccant stopper. (Hands must be dry.)

iii. Wear gloves.iv. Read time or start timer.v. Briefly (not more than 1 second) dip the test strip into the urine making sure

that all test areas are moistened. Do not bend test strips during dipping.

2. Removal of excess urine i. Wipe the edge of the strip against the rim of the vessel to remove excess urine.

ii. Briefly (not more than 1 second) dab the long edge and then the back of the test strip on an absorbent surface (e.g. paper towel).

Do not dab test strips with the edge on the paper towel for longer time, or leave the test strip on the paper towel, because this will lead to excessive removal of the urine, making the test results invalid.

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3. Reading and evaluation Visual reading

i. Wait for 60 seconds, but not more than 120 seconds.ii. Compare the reaction colors of the test areas with the colors on the label.

Any color changes appearing only along the edges of the test areas, or developing after more than 2 minutes, do not have any diagnostic significance.

iii. Write result in record sheet.

Reading with the Urilux S Analyzer - follow operators's manual.

4. Conclusioni. Discard urine test strip into clinical waste bin.

ii. Remove gloves and discard into clinical waste bin.iii. Interpret result.

C. Combur-Test: Storage

Store test strip vials always in a cool and dry place. Do not transfer test strips from the original packaging into another vial.

Ref: 1. http://www.diavant.com/diavant/CMSFront.html?pgid=3,2,14,02. Dr Jacky Ho, RCMP

YapFN_071001

Urine Testing Using Urine Test Strips

Use in primary care:

rapid screening diseases of the kidney and the urogenital tract

E.g. urinary tract infections carbohydrate metabolism disorders (diabetes mellitus) liver diseases haemolytic disorders

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What do they test for:

(Leu – leucocytes; nit – nitrite; pro – protein; glu – glucose; ket – ketones; ubg – urobilinogen; bil – bilirubin; bld – blood)

Limitations: http://www.diavant.com/diavant/CMSFront.html?pgid=3%2C2%2C14%2C1#catalog.data

Parameter Reference range Practical detection limit

Specific GravityReference range Physiological range

1.016 - 1.0221.002 - 1.035

Range: 1.000 - 1.030

pH valueFirst morning urine During the day

5 - 64.8 - 7.4

Range: 5 - 9

LeukocytesReference range Grey zone

< 10 Leu/µl10 - 20 Leu/µl

10-25 Leu/µl

Nitrite - 0.05 mg/dl (11 µmol/l)ProteinAlbumin < 2 mg/dl 6 mg/dlGlucoseFirst morning urineDuring the day

< 20 mg/dl< 30 mg/dl

40 mg/dl (2.2 mmol/l)

KetonesAcetoacetic acidAcetone

< 5 mg/dl-

5 mg/dl (0.5 mmol/l)40 mg/dl (7 mmol/l)

Urobilinogen < 1 mg/dl 0.4 mg/dl (7µmol/l)

Bilirubin< 0.2 mg/dl

0.5 mg/dl (9µmol/l)

BloodErythrocytesHemoglobin

0 - 5 Ery/µl-

5 Ery/µl0.03 mg/dl Hb

Practical detection limit Detection limit of a test = concentration at which the test starts to turn from

negative to positive detection limit may vary from urine to urine

Practical detection limit = concentration of the analyte which results in a positive reaction in 90 percent of the examined urines

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