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UTMB POINT OF CARE TESTING PROCEDURES Policy 1.3.

28
POLICY - Page 1 of 6

Clinitest, Urine Effective: 05/00


CLIA WAIVED Revised: 02/09

Clinitest, Urine

Purpose This document provides instruction for performing a semi-quantitative


chemical analysis on urine for reducing substances using Clinitest tablets.

Audience The information in this document is applicable to all medical, nursing, (RN,
LVN, HTA, NA) and laboratory personnel.

Policy Test requires order from a primary care provider (Physician, Physician
Assistant, Nurse Practitioner). At the discretion of the provider, test results
where clinical indication or departmental protocol suggest confirmatory
testing, (specimen) may be sent to the laboratory.

Clinical The Clinitest reaction detects all reducing substances (substances that will
Significance reduce the copper salts present in the tablet in a hot solution). Reducing
substances present in urine that will cause a reduction of the copper salts are
glucose, lactose, fructose, galactose, and pentose 1 .

Test Principle Unlike urine dip sticks which are specific for glucose, Clinitest is a reagent
tablet that is based on the classic Benedict’s copper reduction reaction,
combining reactive ingredients with sodium hydroxide to generate heat 2.
Clinitest is used to detect the presence of reducing substances. The method
tests for the presence of reducing substances in urine by comparing the color
that is produced to the chart provided with the Clinitest tablets. The color of
the solution can range from blue (negative) to orange (2% or more of
reducing substance present).

Patient The proper departmental protocol must be followed in preparing the patient
Preparation prior to execution of the procedure.

Specimen • Randomly voided urine. Label with appropriate patient information. A


patient label is acceptable.
• Specimen must be tested within 1 hour of collection or it must be
refrigerated and stored for up to 4 hours at 2°- 8° C until testing is
possible or referred to the laboratory for analysis.
• If urine is unusually dark (brown or blackish), tests for hemoglobin,
myoglobin, bile porphyrins, homogentistic acid and urobilinogen are

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UTMB POINT OF CARE TESTING PROCEDURES Policy 1.3.28
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Clinitest, Urine Effective: 05/00


CLIA WAIVED Revised: 02/09

Clinitest, Urine

indicated. This should be brought to the attention of the attending


physician.

Specimen Improperly stored specimens.


Rejection
Supplies • Disposable Pipets
• Glass test tube (13 x 100 mm). DO NOT SUBSTITUTE FOR PLASTIC !
• Color chart
• Urine container

Reagents • Clinitest tablets, MM# 32196


Caution: Clinitest tablets contain sodium hydroxide (caustic soda).
Avoid contact with skin, eyes, mucous membranes, and clothing. The
tablets are highly sensitive to moisture. Excessive moisture may cause
a chemical reaction and an explosion may occur. See MSDS for first
aid.
• Quality Control Material: Quantimetrix Dropper Plus Controls, MM#
32600, both levels

Reagent Tablets and controls are not to be used past the manufacturer expiration date.
Storage and Discard all expired tablets and controls.
Clinitest Tablets
Stability
• The tablets are individually wrapped in foil and are stored at room
temperature. Do not refrigerate. Protect from light, heat, and moisture.
• The discard date is printed on the foil pouch.
Urine Control Solutions
• Refrigerate controls at 2-8° C, away from direct light.
• Control vials can be stored at room temperature for 30 days. If this option
is chosen, the discard date must be written on the bottle.
• Record date opened on the control bottles.

Quality In addition to manufacturer’s quality control guidelines, the following qc


Control requirements are met. Quality control testing must be performed weekly and
at change of lot number.
Frequency

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Clinitest, Urine Effective: 05/00


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Clinitest, Urine

Quality
Control Step Action
Testing
1 Add two drops of the positive and negative urine controls to
separate test tubes. Recap the urine Quality Control vials.
NOTE: If stored in the refrigerator, the controls must be brought
to room temperature before using.
2 Add 10 drops of water to each test tube. Shake the test tube
gently to mix.
3 Add one Clinitest tablet to the test tube containing the negative
urine control (level 1). Solution will start to bubble. Do not shake
the test tube during the boiling period. Once the solution stops
bubbling, allow tube to sit for 15 seconds.
4 Avoid handling the test tube bottom, since the chemical
reaction causes the tube to become very hot.
5 At the end of 15 seconds, gently shake the contents of the test
tube holding the top of the test.
6 Compare the color of the liquid to the chart provided with the
Clinitest tablets.
Note: Disregard any changes that occur after 15 seconds.
7 Repeat steps for second control level
8 Record the result on the Quality Control Log. Compare the
observed result against the expected value stated on the Control
Log. If either control is outside of range, do not perform
patient testing or perform patient testing. See Quality Control
Corrective Action section for additional instructions

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Clinitest, Urine

Quality All corrective action taken must be documented on QC log.

Control Step Action

Corrective 1 Do not report patient results if Quality Control results are not
Action within range.

2 Check the expiration date on the controls and the Clinitest


tablets.
3 Repeat controls and if still out of established range proceed to
step 4.
4 Open fresh controls and Clinitest tablets. If the controls are
within limits, repeat patient testing and report.
5 Discard “old” controls and/or Clinitest, whichever found to be
the problem.
6 If the problems persist, contact POCT (72497). In case of off
working hours contact the laboratory, or manufacturer technical
support. May also send patient specimen to the Clinical
Chemistry Laboratory (at UTMB) or reference lab for analysis.

Patient CATION: REACTION WILL CAUSE TUBE CONTENTS TO GENERATE HEAT !!


ALWAYS HANDLE GLASS TEST TUBE FROM THE TOP
Testing Step Action
1 Thoroughly mix the specimen 10 times by inversion.
2 Add 5 drops of urine to 10 drops of distilled water in a test tube
and mix thoroughly.
3 Add a Clinitest tablet. Solution will start to bubble. Do not shake
the test tube during the boiling period. Once the solution stops
bubbling, allow tube to sit for 15 seconds.

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Clinitest, Urine

Patient Step Action


Testing
(cont.) 4 At the end of 15 seconds, gently shake the contents of the test
tube holding the top of the test.
5 Compare the color of the liquid to the color chart provided with
the Clinitest tablets. Ignore any color changes that occur after 15
seconds and the color of any precipitate that forms at the bottom
of the tube.

Reporting The result of the Clinitest must be documented in the patient’s chart.
Results Depending upon the findings report as:
Negative
Trace (1/4%)
1/2 %
3/4 %
1%
2%

Normal Clinitest should give negative results for urine specimens from healthy
Ranges children and adults. Newborn infants during the first 10 to 14 days of life
may excrete urine that gives a positive reaction due to the presence of
reducing sugars.

Limitations Clinitest is not specific for glucose and will react with any reducing substance
in the stool. Failure to observe the reaction at all times can lead to
erroneously low results if reducing substances are present at extremely high
levels. If more than 2 % sugar is present a rapid color change may occur
during boiling causing the color to pass rapidly through bright orange to a
dark brown or greenish brown.

References 1. Raphael S: Lynch’s Medical Laboratory Technology, 4th ed., W.B.


Saunders, Phil., USA, 1983.
2. Bayer Clinitest Tablet Test, Product Insert, 1995.

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Clinitest, Urine Effective: 05/00


CLIA WAIVED Revised: 02/09

Clinitest, Urine

Policy Revision Detail


Date Page Revision Signature

12/21/06 2 Specimen Rejection section (addition)

12/21/07 2 No changes
Added Signature Column to Policy Revision
02/13/09 6
Detail

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