UTMB POINT OF CARE TESTING PROCEDURES POLICY Clinitest, Stool MODERATELY COMPLEX

Policy 3.3.27 Page 1 of 6 Effective: Reviewed: 07/00 06/10

Clinitest, Stool
Purpose
This document provides instruction to the performance of Clinitest tablets to detect reducing substances in stool samples. 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). This is a moderately-complex test according to CLIA 88 guidelines. As such, this test is covered by the central Laboratorys CAP/CLIA 88 license, and has to comply with the same regulations as the central 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 that will cause a reduction of the copper salts are glucose, lactose, fructose, galactose, and pentose 1. The Clinitest has also been used to detect reducing substances in stools of children with diarrhea 2, 3. For diarrhea in children the differential diagnosis includes primary and secondary disaccharidase deficiencies in addition to monosaccharide malabsorbtion. The Clinitest on stools can also distinguish between diarrhea caused by abnormal excretion of various sugars and those caused by various viruses and parasites. In a healthy term infant the presence of reducing substances in the stool is not uncommon and usually not associated with carbohydrate intolerance 5. For premature infants, however, there is a strong association between a positive Clinitest and necrotizing entercolitis (NEC) 6. Clinitest is a reagent tablet that is based on the classic Benedicts copper reduction reaction, combining reactive ingredients with sodium hydroxide to generate heat. Clinitest is used to detect the presence of reducing substances. The method tests for the presence of reducing substances in stools 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).

Audience

Policy

Clinical Significance

Test Principle

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UTMB POINT OF CARE TESTING PROCEDURES POLICY Clinitest, Stool MODERATELY COMPLEX

Policy 3.3.27 Page 2 of 8 Effective: Reviewed: 07/00 02/09

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

Stools can be collected in disposable diapers. If solid and liquid stool are present they should be mixed prior to testing. The liquid portion of the stool can be aspirated from the diaper using a syringe or alternately can be expressed from the diaper into a cup. If a diaper has gel absorption, a cotton ball will be necessary to collect the liquid portion of the stool. The stool must be tested within 1 hour or stored refrigerated for up to 4 hours. Caution: Testing of only the solid portion of the stool will give a falsely low reading since the liquid portion of the stool contains the watersoluble sugars.

Supplies

Centrifuge or other method to remove stool solids Syringe Sterile water (distilled) Disposable Pipets Glass test tube (16 x 100 mm) Color chart Test tube rack Plastic 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 after the expiration date provided by the manufacturer. Discard all expired tablets and controls. Clinitest Tablets
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UTMB POINT OF CARE TESTING PROCEDURES POLICY Clinitest, Stool MODERATELY COMPLEX

Policy 3.3.27 Page 3 of 8 Effective: Reviewed: 07/00 02/09

Clinitest, Stool
Reagent Storage and Stability (cont.)
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 Control Frequency Quality Control Testing

Quality control testing must be performed weekly and at change of lot number.

If stored in the refrigerator, the controls must be brought to room temperature before using.

Step 1 2 3 4 5

Action Add two drops of the positive and negative urine controls to separate test tubes. Recap the urine Quality Control vials. Add 10 drops of water to each test tube. Shake the test tube gently to mix. Sit tube in a test tube rack. Add one Clinitest tablet to the test tube containing the negative urine control. Allow the chemical reaction to take place and sit for 15 seconds. Note: Do not shake the test tube during the boiling period. Avoid handling the test tube bottom, since the chemical reaction causes the tube to become very hot. Shake the contents of the test tube gently at the end of the 15 second waiting period.

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Policy 3.3.27 Page 4 of 8 Effective: Reviewed: 07/00 02/09

Clinitest, Stool

Quality Control Testing (cont.)

Step 7

Action 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 package insert. If either control is outside of range, do not perform patient testing, see Quality Control Corrective Action section for additional instructions.

8 9

Quality Control Corrective Action

Step 1 2 3 4 5 6

Action Do not report patient results if Quality Control results are not within range. Check the expiration date on the controls and the reagent 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 tablets. If the problems persist, send the specimen to the Clinical Chemistry Laboratory (at UTMB), or reference lab for analysis
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UTMB POINT OF CARE TESTING PROCEDURES POLICY Clinitest, Stool MODERATELY COMPLEX

Policy 3.3.27 Page 5 of 8 Effective: Reviewed: 07/00 02/09

Clinitest, Stool
and call the POCT office (772-2496 or 772-2497). For weekend or after-hours assistance contact the Clinical Chemistry shift supervisor (772-9229). If unable to reach lab personnel contact the manufacturer, Bayer Healthcare (1-800-348-8100).

Patient Testing
Step 1 Action Check urine for glucose with a urine dipstick. If the urine is positive for glucose, it may falsely elevate the result since urine may be present in the diaper. Add 1 volume (0.5 mL 1 mL) of stool to 2 volumes (1 mL 2 mL) of distilled water and mix thoroughly. If fecal solids are present remove the fecal solids by filtration. The stool solution may also be placed into a test tube and centrifuge for 2-6 minutes. With the aid of a pipette transfer 15 drops of the supernatent into a clean test tube and add a Clinitest tablet. After the tablet has been added to the solution boiling of the solution will occur. Do not shake or mix the contents of the tube. Approximately 15 seconds after the solution has stopped boiling, gently shake by holding the top of the tube to mix the contents. Observe the progression of the color change to make sure the color doesnt pass through bright orange to brown or greenishbrown. 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.

2 3

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UTMB POINT OF CARE TESTING PROCEDURES POLICY Clinitest, Stool MODERATELY COMPLEX

Policy 3.3.27 Page 6 of 8 Effective: Reviewed: 07/00 02/09

Clinitest, Stool

Reporting Results

The result of the Clinitest must be documented in the patients chart. Depending upon the findings report as: Negative Trace (1/4%) 1/2 % 3/4 % 1% 2% > 2% < 1 / 4 % reducing substances

Normal Ranges 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. Proficiency testing will be done randomly. Unknown urine samples will be given to an employee for testing.

Proficiency Testing

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Policy 3.3.27 Page 7 of 8 Effective: Reviewed: 07/00 02/09

Clinitest, Stool
References
1. Raphael S: Lynchs Medical Laboratory Technology, 4th ed., W.B. Saunders, Phil., USA, 1983. 2. Kerry K, Anderson C. A ward test for sugar in feces. Lancet 1;981-2, 1964. 3. Ameen VZ, Powell GK, Jones LA. Quantitation of fecal carbohydrate excretion in patients with short bowel syndrome. Gastroenter 92;493-500, 1987. 4. Davidson G, Mullinger M. Reducing substances in neonatal stools detected by clinitest. J Pedi 46;632-5, 1970. 5. Book L, Herbst J, Jung A. Carbohydrate malabsorpbtion in necrotizing entercolitis. Pedi 57;201-4, 1976. 6. Bayer Clinitest Tablet Test, Product Insert, 1995.

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UTMB POINT OF CARE TESTING PROCEDURES POLICY Clinitest, Stool MODERATELY COMPLEX

Policy 3.3.27 Page 8 of 8 Effective: Reviewed: 07/00 02/09

Clinitest, Stool

REVISION HISTORY
Date Page Description Signature

4/23/08 2/3/09 6/25/10 8

No changes Added Signature Column to Revision History No changes

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