Read Microsoft Word - Clinitest Urine 02-09.doc text version

UTMB POINT OF CARE TESTING PROCEDURES POLICY Clinitest, Urine CLIA WAIVED

Policy 1.3.28 Page 1 of 6 Effective: Revised: 05/00 02/09

Clinitest, Urine

Purpose

This document provides instruction for performing a semi-quantitative chemical analysis on urine for reducing substances using Clinitest tablets. The information in this document is applicable to all medical, nursing, (RN, LVN, HTA, NA) and laboratory personnel. 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. The Clinitest reaction detects all reducing substances (substances that will 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 .

Audience

Policy

Clinical Significance

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 Preparation Specimen

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

· ·

·

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

Page 1of 6

UTMB POINT OF CARE TESTING PROCEDURES POLICY Clinitest, Urine CLIA WAIVED

Policy 1.3.28 Page 2 of 6 Effective: Revised: 05/00 02/09

Clinitest, Urine

indicated. This should be brought to the attention of the attending physician. Improperly stored specimens.

·

Specimen Rejection Supplies

· ·

·

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

Reagents

·

·

Reagent Storage and Stability

Tablets and controls are not to be used past the manufacturer expiration date. Discard all expired tablets and controls. Clinitest Tablets · 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. In addition to manufacturer's quality control guidelines, the following qc requirements are met. Quality control testing must be performed weekly and at change of lot number.

Quality Control Frequency

Page 2 of 6

UTMB POINT OF CARE TESTING PROCEDURES POLICY Clinitest, Urine CLIA WAIVED

Policy 1.3.28 Page 3 of 6 Effective: Revised: 05/00 02/09

Clinitest, Urine

Quality Control Testing

Step 1

Action 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. Add 10 drops of water to each test tube. Shake the test tube gently to mix. 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. Avoid handling the test tube bottom, since the chemical reaction causes the tube to become very hot. At the end of 15 seconds, gently shake the contents of the test tube holding the top of the test. Compare the color of the liquid to the chart provided with the Clinitest tablets. Note: Disregard any changes that occur after 15 seconds. Repeat steps for second control level 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

2 3

4 5 6

7 8

Page 3 of 6

UTMB POINT OF CARE TESTING PROCEDURES POLICY Clinitest, Urine CLIA WAIVED

Policy 1.3.28 Page 4 of 6 Effective: Revised: 05/00 02/09

Clinitest, Urine

Quality Control Corrective Action

All corrective action taken must be documented on QC log. Step 1 Action Do not report patient results if Quality Control results are not within range. Check the expiration date on the controls and the Clinitest tablets. Repeat controls and if still out of established range proceed to step 4. Open fresh controls and Clinitest tablets. If the controls are within limits, repeat patient testing and report. Discard "old" controls and/or Clinitest, whichever found to be the problem. 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.

2 3 4 5 6

Patient Testing

CATION: REACTION WILL CAUSE TUBE CONTENTS TO GENERATE HEAT !! ALWAYS HANDLE GLASS TEST TUBE FROM THE TOP

Step 1 2 3

Action Thoroughly mix the specimen 10 times by inversion. Add 5 drops of urine to 10 drops of distilled water in a test tube and mix thoroughly. 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.

Page 4 of 6

UTMB POINT OF CARE TESTING PROCEDURES POLICY Clinitest, Urine CLIA WAIVED

Policy 1.3.28 Page 5 of 6 Effective: Revised: 05/00 02/09

Clinitest, Urine Patient Testing (cont.)

Step 4 5 Action At the end of 15 seconds, gently shake the contents of the test tube holding the top of the test. 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 Results

The result of the Clinitest must be documented in the patient's chart. Depending upon the findings report as: Negative Trace (1/4%) 1/2 % 3/4 % 1% 2% Clinitest should give negative results for urine specimens from healthy 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. 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. 1. Raphael S: Lynch's Medical Laboratory Technology, 4th ed., W.B. Saunders, Phil., USA, 1983. 2. Bayer Clinitest Tablet Test, Product Insert, 1995.

Normal Ranges

Limitations

References

Page 5 of 6

UTMB POINT OF CARE TESTING PROCEDURES POLICY Clinitest, Urine CLIA WAIVED

Policy 1.3.28 Page 6 of 6 Effective: Revised: 05/00 02/09

Clinitest, Urine

Policy Revision Detail

Date 12/21/06 12/21/07 02/13/09 Page 2 2 6 Revision Specimen Rejection section (addition) No changes Added Signature Column to Policy Revision Detail Signature

Page 6 of 6

Information

Microsoft Word - Clinitest Urine 02-09.doc

6 pages

Find more like this

Report File (DMCA)

Our content is added by our users. We aim to remove reported files within 1 working day. Please use this link to notify us:

Report this file as copyright or inappropriate

34726


You might also be interested in

BETA
URINALYSIS QUALITY CONTROL
Microsoft Word - Clinitest Urine 02-09.doc